Proactiveinvestors USA & Canada Admedus Ltd https://www.proactiveinvestors.com Proactiveinvestors USA & Canada Admedus Ltd RSS feed en Fri, 24 May 2019 04:10:58 -0400 http://blogs.law.harvard.edu/tech/rss Genera CMS action@proactiveinvestors.com (Proactiveinvestors) action@proactiveinvestors.com (Proactiveinvestors) <![CDATA[Media files - Admedus CEO in New York to update on recent key milestones ]]> https://www.proactiveinvestors.com/companies/stocktube/12628/admedus-ceo-in-new-york-to-update-on-recent-key-milestones-12628.html Sun, 17 Mar 2019 20:16:00 -0400 https://www.proactiveinvestors.com/companies/stocktube/12628/admedus-ceo-in-new-york-to-update-on-recent-key-milestones-12628.html <![CDATA[News - Admedus Ltd announces settlement of Federal Court proceedings ]]> https://www.proactiveinvestors.com/companies/news/165505/admedus-ltd-announces-settlement-of-federal-court-proceedings-70941.html Admedus Ltd (ASX:AHZ) has announced that it has reached a binding agreement to settle the proceedings that were commenced in the Federal Court by Dr Geoffrey Lane and Dr Keith Woollard (and entities associated with Mr Lane and Mr Woollard) on 7 November 2014, as noted in the company’s announcement on 12 November, 2014.

Wayne Paterson, chairman and interim CEO, said today: "On behalf of the board, I would like to thank the parties for resolving the proceedings.

"I am pleased with the outcome of the settlement which results in Admedus Ltd now owning 100% of the regenerative technology."

The settlement is in full and final resolution of the proceedings and is without admission of liability of Admedus.

The terms and conditions of the settlement agreement remain confidential; however settlement will have a minimal impact on the financial position of the company.

Paterson added: "While we were confident in our position in this matter, the settlement avoids the expense, distraction and uncertainty of a lengthy trial and enables Admedus Ltd to focus on growing the business and increasing shareholder value.

"The path to profitability is now even clearer with the successful resolution of the proceedings.

"Finalising this matter has cut short what was already a lengthy process. I consider the outcome to be fair and equitable to all parties with minimal impact to the balance sheet.

"With the uncertainty of litigation behind us, Admedus can continue to focus on profitable growth of its cardiovascular sales and regenerative product range without distraction.

"The company is on track to launch its vascular product VascuCel in November as well as expansion of its CardioCel product range."

 

Proactive Investors Australia is the market leader in producing news, articles and research reports on ASX emerging companies with distribution in Australia, UK, North America and Hong Kong / China.

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Fri, 09 Sep 2016 09:30:00 -0400 https://www.proactiveinvestors.com/companies/news/165505/admedus-ltd-announces-settlement-of-federal-court-proceedings-70941.html
<![CDATA[News - Admedus Ltd finishes off $18.3M raising to fund growth ]]> https://www.proactiveinvestors.com/companies/news/165504/admedus-ltd-finishes-off-183m-raising-to-fund-growth-70783.html Admedus Ltd (ASX:AHZ) has successfully completed their $8.3 million rights issue which followed the $10 million placement completed earlier in the month.

The healthcare company is developing multiple revenue streams and building a global healthcare company through CardioCel heart valve patch sales, infusion product sales and its immunotherapy programs.

Admedus is focused on continued growth of sales and is expecting at least a 50% growth in revenue in the 2017 financial year.

Funds raised will be used to make improvements to the manufacturing division, expand the regenerative tissue range, refine the research and development portfolio and fund new market expansion.

Wayne Paterson, CEO, commented: “This places the company in a strong financial position as we pursue growth objectives.”


Raising details

Admedus closed its 1:9 fully underwritten rights issue to raise $8.3 million priced at $0.33 on August 29, 2016.

Applications from shareholders for the rights issue were received for $5.7 million, with the balance being placed by the underwriter.

The rights issue follows the recently completed placement of $10 million, also priced at $0.33.

The total raised under the placement and underwritten rights issue is $18.3 million.


Background

Admedus' flagship product is CardioCel®, a bio-engineered tissue scaffold to repair congenital heart defects, and expanding into the heart valve market.

CardioCel is becoming a surgeon-preferred biomaterial for heart valve repair surgeries.

It represents a disruptive technology in the $2.5 billion heart valve repair and replacement market, which is dominated by products commercialized by large medical device companies.

It is now being sold in Canada, Australia, Asia, the Middle East, and North Africa, covering 135 medical centres.

The Admedus infusion portfolio has over 800 customers providing hospital-wide infusion solutions across the Australian and New Zealand healthcare systems.

Beyond CardioCel and infusion sales, Admedus is developing a DNA-based therapeutic vaccine for HSV-2 and HPV.


VascuCel® launch

Admedus remain on track to launch their new vascular product, VascuCel, in November 2016.

VascuCel is used in the repair of vascular surgical procedures.

The vascular repair market is worth US$500 million per annum.

The Perth based factory will be ready to supply VascuCel alongside its current output of
CardioCel by November 1, 2016.


New CFO and Brisbane relocation

Admedus recently appointed Mark Ziirsen as chief financial officer as the company relocates its corporate services functions to Brisbane.

Ziirsen joins Admedus from Cochlear Ltd (ASX:COH), where he held the role of director of finance and I.T. for Asia Pacific for the past five years.

Ziirsen will take over from current CFO and company secretary Stephen Mann, who is based in Perth. He will continue to work with Admedus through this transition until the end of the year.


Analysis

With the capital raising complete, Admedus is in a strong financial position to drive growth and sales this financial year.

The restructure that occurred in June shows that Admedus is committed to reduce costs and focus on near-term revenue growth to create a clear path to being a sustainable, profitable, global healthcare company.

The stock is trading at around A$0.345, which represents a large discount to its broker price targets of A$1.48, A$1.95 and A$2.00.

New York based Maxim Group recently maintained their buy recommendation on the company and $2.00 price target.

 

Proactive Investors Australia is the market leader in producing news, articles and research reports on ASX emerging companies with distribution in Australia, UK, North America and Hong Kong / China.

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Thu, 01 Sep 2016 09:30:00 -0400 https://www.proactiveinvestors.com/companies/news/165504/admedus-ltd-finishes-off-183m-raising-to-fund-growth-70783.html
<![CDATA[News - Admedus Ltd appoints new CFO as part of move to Brisbane ]]> https://www.proactiveinvestors.com/companies/news/165503/admedus-ltd-appoints-new-cfo-as-part-of-move-to-brisbane-70685.html Admedus Ltd (ASX:AHZ) has appointed Mark Ziirsen as chief financial officer as the company relocates its corporate services functions to Brisbane.

Ziirsen joins Admedus from Cochlear Ltd (ASX:COH), where he held the role of director of finance and I.T. for Asia Pacific for the past five years.

Wayne Paterson, interim CEO, commented: “Today’s announcement is regarded as both a significant and essential development for Admedus as we scale our business to meet the demands of all of Admedus’ stakeholders.”

Ziirsen will take over from current CFO and company secretary Stephen Mann, who is based in Perth. He will continue to work with Admedus through this transition until the end of the year.

Admedus is developing multiple revenue streams and building a global healthcare company through CardioCel heart valve patch sales, infusion product sales and its immunotherapy programs.

Admedus' flagship product is CardioCel®, a bio-engineered tissue scaffold to repair congenital heart defects, and expanding into the heart valve market.

The company is about to close a 1:9 fully underwritten rights issue to raise $8.3 million priced at $0.33.

The rights issue follows the recently completed placement of $10 million.

 

Proactive Investors is a global leader reporting financial news, media, research and hosts events for listed emerging growth companies and investors across four continents.

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Fri, 26 Aug 2016 10:00:00 -0400 https://www.proactiveinvestors.com/companies/news/165503/admedus-ltd-appoints-new-cfo-as-part-of-move-to-brisbane-70685.html
<![CDATA[News - Admedus Ltd opens rights issue to support strong growth ]]> https://www.proactiveinvestors.com/companies/news/165502/admedus-ltd-opens-rights-issue-to-support-strong-growth-70527.html Admedus Ltd (ASX:AHZ) has opened a 1:9 fully underwritten rights issue to raise $8.3 million priced at $0.33.

The rights issue will close on 29 August 2016 and follows the recently completed placement of $10 million.

Healthcare company, Admedus, will use the funds raised from the placement and the rights issue for its corporate restructure, with the majority allocated for working capital.

Admedus is focused on continued growth of sales across the company and is expecting at least a 50% growth in revenue in the 2017 financial year, along with expanding its near market product portfolio.

The company is targeting sustainable profitability in FY18. Earlier in the month Admedus revealed that it had grown its FY16 sales to $14.1 million, up 40% on FY15 sales.

Admedus is also well advanced in its restructuring and cost reduction initiatives.


Background

Admedus is developing multiple revenue streams and building a global healthcare company through CardioCel heart valve patch sales, infusion product sales and its immunotherapy programs.

Admedus' flagship product is CardioCel®, a bio-engineered tissue scaffold to repair congenital heart defects, and expanding into the heart valve market.

CardioCel is becoming a surgeon-preferred biomaterial for heart valve repair surgeries.

It represents a disruptive technology in the $2.5 billion heart valve repair and replacement market, which is dominated by products commercialized by large medical device companies.

It is now being sold in Canada, Australia, Asia, the Middle East, and North Africa, covering 135 medical centres.

The Admedus infusion portfolio has over 800 customers providing hospital-wide infusion solutions across the Australian and New Zealand healthcare systems.

Beyond CardioCel and infusion sales, Admedus is developing a DNA-based therapeutic vaccine for HSV-2 and HPV.

 

Proactive Investors is a global leader reporting financial news, media, research and hosts events for listed emerging growth companies and investors across four continents.

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Thu, 18 Aug 2016 10:00:00 -0400 https://www.proactiveinvestors.com/companies/news/165502/admedus-ltd-opens-rights-issue-to-support-strong-growth-70527.html
<![CDATA[News - Admedus Ltd pockets A$10M from oversubscribed placement ]]> https://www.proactiveinvestors.com/companies/news/148026/admedus-ltd-pockets-a10m-from-oversubscribed-placement-70121.html Admedus Ltd (ASX:AHZ) has secured firm commitments for a oversubscribed $10 million private placement of ordinary shares to new institutional and existing and sophisticated investors at $0.33.

Admedus will also undertake a 1:9 renounceable rights issue to existing shareholders to raise up to a further $8.3 million.

Shareholders on the register at 5pm (WST) on 15 August 2016 will be entitled to participate in the rights issue.

The company is targeting sustainable profitability in FY18. Earlier in the month Admedus revealed that it had grown its FY16 sales to $14.1 million, up 40% on FY15 sales.

Wayne Paterson, chairman and interim CEO, commented:

“This capital raise will allow us to continue our current strong sales growth and roll-out additional products into the cardiovascular markets, whilst implementing our corporate strategy of tighter expenditure control.

"The completion of this capital raise, in addition to the implementation of our recent strategic review, removes any concerns about the finances of Admedus and places the company in a very strong position to achieve sustainable profitability for the 2018 financial year (if not before) and beyond.”


Allocation of funds

Admedus will use the funds raised from the placement and the rights issue for its corporate restructure, with the majority allocated for working capital.

In addition, funds will be used for the purposes of:

- Scale up of manufacturing to meet market demand;
- New product and IP development;
- New market expansion across emerging markets and new product ranges;
- Further investment and development in immunotherapy programmes in conjunction with Professor Ian Frazer; and
- Clinical and post market studies.


Background

Admedus is developing multiple revenue streams and building a global healthcare company through CardioCel heart valve patch sales, infusion product sales and its immunotherapy programs.

Admedus' flagship product is CardioCel®, a bio-engineered tissue scaffold to repair congenital heart defects, and expanding into the heart valve market.

CardioCel is becoming a surgeon-preferred biomaterial for heart valve repair surgeries.

It represents a disruptive technology in the $2.5 billion heart valve repair and replacement market, which is dominated by products commercialized by large medical device companies.

It is now being sold in Canada, Australia, Asia, the Middle East, and North Africa, covering 135 medical centres.

The Admedus infusion portfolio has over 800 customers providing hospital-wide infusion solutions across the Australian and New Zealand healthcare systems.

Beyond CardioCel and infusion sales, Admedus is developing a DNA-based therapeutic vaccine for HSV-2 and HPV.

 

Proactive Investors Australia is the market leader in producing news, articles and research reports on ASX emerging companies with distribution in Australia, UK, North America and Hong Kong / China.

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Fri, 29 Jul 2016 09:40:00 -0400 https://www.proactiveinvestors.com/companies/news/148026/admedus-ltd-pockets-a10m-from-oversubscribed-placement-70121.html
<![CDATA[News - Admedus Ltd to outline capital raising ]]> https://www.proactiveinvestors.com/companies/news/148025/admedus-ltd-to-outline-capital-raising-70058.html Admedus Ltd (ASX:AHZ) has been granted a trading halt by the ASX, pending details of a capital raising,

During FY16, the healthcare company grew its sales to $14.1 million, up 40% on FY15 sales.

Furthermore, the company is forecasting over 50% revenue growth in the current financial year through growing the infusion sales business, CardioCel sales growth and introducing additional products.

The halt will remain in place until the opening of trade on Friday 29th July 2016, or earlier if an announcement is made to the market.

 

Proactive Investors Australia is the market leader in producing news, articles and research reports on ASX emerging companies with distribution in Australia, UK, North America and Hong Kong / China.

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Wed, 27 Jul 2016 12:30:00 -0400 https://www.proactiveinvestors.com/companies/news/148025/admedus-ltd-to-outline-capital-raising-70058.html
<![CDATA[News - Admedus Ltd grows FY16 sales by 40% as future forecasts accelerate ]]> https://www.proactiveinvestors.com/companies/news/148024/admedus-ltd-grows-fy16-sales-by-40-as-future-forecasts-accelerate-69927.html Healthcare company, Admedus Ltd (ASX:AHZ) has grown its FY16 sales to $14.1 million, up 40% on FY15 sales.

Furthermore, the company is forecasting over 50% revenue growth in the current financial year through growing the infusion sales business, CardioCel sales growth and introducing additional products.

The recent June quarter saw the completion of a business review with key initiative now underway forecast to decrease operating expenditure in FY17 by $12 million.

During the quarter Admedus was also awarded a major 5-year supply contract within its infusion business expected to contribute to revenue this quarter.

Admedus closed the June quarter with $8.8 million in cash with $3.5 million in rebates expected in FY17.


Background

Admedus is developing multiple revenue streams and building a global healthcare company through CardioCel heart valve patch sales, infusion product sales and its immunotherapy programs.

Admedus' flagship product is CardioCel®, a bio-engineered tissue scaffold to repair congenital heart defects, and expanding into the heart valve market.

CardioCel is becoming a surgeon-preferred biomaterial for heart valve repair surgeries.

It represents a disruptive technology in the $2.5 billion heart valve repair and replacement market, which is dominated by products commercialized by large medical device companies.

It is now being sold in Canada, Australia, Asia, the Middle East, and North Africa, covering 135 medical centres.

The Admedus infusion portfolio has over 800 customers providing hospital-wide infusion solutions across the Australian and New Zealand healthcare systems.

Beyond CardioCel and infusion sales, Admedus is developing a DNA-based therapeutic vaccine for HSV-2 and HPV.


June quarter highlights

Admedus’ FY16 sales of $14.1 million were supported by June quarter sales which rose to $4.0 million, up 13.9% from the previous quarter and 41.5% on June 2015.

During the quarter the company has undertaken an extensive strategic review and implemented significant cost cutting measures such as reducing full time employees by 30% in order to fast-track profitability.

Forecasts are that operating costs will decrease by $12 million during the FY17 compared to the FY16.

Admedus closed the period with a cash balance of $8.8 million, with a further cash receipts of $3.5 million from research and development grants expected in FY17.

The company currently anticipates entering profitability in FY18 but see potential to reduce this timeline.


Analysis

The June quarter and full year sales results showed strong growth for Admedus and are an important milestone for the company reaching profitability.

The completion of the strategic review positions Admedus strongly to continue revenue growth and lower operating costs.

The stock is trading at around A$0.435, which represents a large discount to its broker price targets of A$1.95 and A$2.00.

New York based Maxim Group recently maintained their buy recommendation on the company and $2.00 price target.

The company is well capitalised with $8.8 million in the bank and research and development rebates of a further $3.5 million expected in FY17.

 

Proactive Investors Australia is the market leader in producing news, articles and research reports on ASX emerging companies with distribution in Australia, UK, North America and Hong Kong / China.

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Wed, 20 Jul 2016 12:00:00 -0400 https://www.proactiveinvestors.com/companies/news/148024/admedus-ltd-grows-fy16-sales-by-40-as-future-forecasts-accelerate-69927.html
<![CDATA[News - Admedus Ltd: New York's Maxim Group maintains A$2.00 price target ]]> https://www.proactiveinvestors.com/companies/news/148023/admedus-ltd-new-yorks-maxim-group-maintains-a200-price-target-69766.html Admedus Ltd (ASX:AHZ) has received updated research from the New York based Maxim Group, which maintains its Buy rating and A$2.00 12-month target price.

Admedus last traded at $0.34. The following is an extract from the report.


Half-year Update: Stay Focused on CardioCel

Summary

- Admedus held an investor webinar yesterday and provided an update on the company's product portfolio.

CardioCel.

The CardioCel heart valve patch is commercially available in multiple regions including the U.S., EU, Asia-Pacific, Middle East and North Africa.

KOL engagement remains key to driving early adoption. CardioCel's anti-calcification feature (phase II follow-up data showed no signs of calcification at seven years post-implantation, thus reducing the need for follow-on surgeries) is attracting KOL interest globally.

The company is continuing to build commercial infrastructure, which over time should increase physician uptake.

Immunotherapy programs.

The ongoing phase II study (n=44) evaluating the safety of the glycoprotein D (gD2)-based DNA vaccine as an HSV-2 (herpes simplex virus) immunotherapy remains on track to produce data in 4Q16.

A phase Ib study of the HPV (human papillomavirus) vaccine should initiate this year.

Corporate updates.

Admedus continues to improve its manufacturing capability and maintain effective cost management.

The company is now conducting a global search for a new CEO following the recent departure of now-former CEO Lee Rodne.

Conclusion.

Our focus remains on CardioCel. Admedus continues to focus on building commercial volume through physician engagement and early adoption.

As KOL awareness increases over time, we expect sales to increase accordingly.


Details

CardioCel is a bio-implant sourced from bovine pericardium that is engineered via Admedus' ADAPT® platform, resulting in a durable, collagen-based scaffold with strong mechanical properties and resistance to calcification, while supporting native cell infiltration, growth, and differentiation for repairing cardiac and vascular defects.

It is processed by a proper decellularization regime, optimized crosslinking, and adequate detoxification to avoid any immunological response that could potentially trigger a calcification cascade, thus rendering calcific degeneration postimplantation.

In July 2015, Admedus announced positive long-term data from the CardioCel phase II study, which showed no follow-on heart procedures related to CardioCel, nor were there any signs of calcification seen.


HSV-2 immunotherapy.

Admedus’ HSV-2 glycoprotein D (gD2)-based DNA vaccine uses codon optimization DNA technology, which enhances protein expression in the cell or tissue targeted, and results in an improved immune response.

Another component of the technology is to use a combination of DNA encoding ubiquitin and non-ubiquitin proteins to enhance the degradation of the protein and optimize Tcell responses, while preserving structural epitopes necessary for B-cell responses, achieving both prophylactic and therapeutic results from the vaccine.

An HSV-2 phase II study (n=44), which is evaluating the safety of the vaccine, impact on viral load and shedding, and viral flare frequency, is ongoing. Interim data showed a favorable safety profile, with a reduction in viral lesions.


Valuation.

Our model only includes CardioCel in CHD and heart valve repair for conservatism.

We use a risk rate of 30%, equally weighted and averaged, across FCFF, SOP and dEPS to derive our $2.00 price target.

 

Proactive Investors Australia is the market leader in producing news, articles and research reports on ASX emerging companies with distribution in Australia, UK, North America and Hong Kong / China.

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Wed, 13 Jul 2016 08:00:00 -0400 https://www.proactiveinvestors.com/companies/news/148023/admedus-ltd-new-yorks-maxim-group-maintains-a200-price-target-69766.html
<![CDATA[News - Admedus Ltd receives Buy recommendation from New York firm ]]> https://www.proactiveinvestors.com/companies/news/148022/admedus-ltd-receives-buy-recommendation-from-new-york-firm-69126.html Admedus Ltd (ASX:AHZ) has received a buy recommendation from the New York based Maxim Group.

Maxim has applied a $2.00 12-month target price. Admedus last traded at $0.35. The following is an extract from the report.


A Heart Valve Patch that Goes the Distance

Summary

- We recently met with two key opinion leaders in cardiovascular surgery: Dr. Sloane Guy, Associate Professor of Cardiothoracic Surgery & Director of Robotic Cardiac Surgery at Weill Cornell School of Medicine/NY Presbyterian
Hospital and Dr. Bart Meuris, Associate Professor from the University Hospitals of the Leuven Institute in Belgium, to discuss Admedus' CardioCel product.

- The anti-calcifying feature of CardioCel patch is capturing the interest of highend KOLs who are early adopters in heart surgery and heart repair. Recall that Admedus phase II follow-up data showed no signs of calcification at seven years post-implantation of its patch, thus reducing the need for followon surgeries. Anti-calcification, coupled with strong mechanical properties and durability, makes CardioCel an attractive alternative to the current bioprosthetic heart valve options. As KOL awareness builds, we see CardioCel potentially becoming a surgeon-preferred biomaterial for heart valve repair surgeries.

- As a reminder, Admedus recently announced the departure of CEO Lee Rodne, and Chairman of the Board Wayne Paterson is now acting as the interim CEO. The company plans to address the results of its restructuring initiative this
summer.

- Conclusion. Admedus is working to build its focus on the global commercialization of CardioCel patch. We see the patch as a potentially disruptive product in the $2.5B heart valve repair and replacement market. As KOL awareness increases, we expect sales traction will follow.


Details

CardioCel is a bio-implant sourced from bovine pericardium that is engineered via Admedus' ADAPT® platform, resulting in a durable, collagen-based scaffold with strong mechanical properties and resistance to calcification, while supporting native cell infiltration, growth, and differentiation for repairing cardiac and vascular defects.

It is processed by a proper decellularization regime, optimized crosslinking, and adequate detoxification to avoid any immunological response that could potentially trigger a calcification cascade, thus rendering calcific degeneration postimplantation.

In July 2015, Admedus announced positive long-term data from the CardioCel phase II study, which showed no follow-on heart procedures related to CardioCel, nor were there any signs of calcification seen.

Admedus' focus is first and foremost on regenerative tissue for heart valve repair and replacement in pediatric and adult patients with congenital heart defects.

Supported by strong clinical data (no signs of calcification reported in seven years post-implantation), CardioCel appears to be what we believe is a next-generation xenograft tissue product, a biocompatible bio-scaffold that elicits minimal immune response, has durable flexibility and elasticity, and has a long shelf life (two years).

One other trait that makes CardioCel a distinguishing competitor, in our view, is its strong resistance to calcification, while still providing sustainable mechanical properties.

This is the key to CardioCel’s success, because it eliminates the need for patients to undergo frequent post-implantation surgeries for replacement due to tissue degeneration.

We believe CardioCel has the potential to reduce the number of future surgeries required and open up more market opportunities in other clinical indications.

CardioCel also targets the large aortic and mitral valve market, and the company worked with KOLs to generate preclinical data.


Valuation.

Our model only includes CardioCel in CHD and heart valve repair for conservatism.

We use a risk rate of 30%, equally weighted and averaged, across FCFF, SOP and dEPS to derive our $2.00 price target.

 

Proactive Investors Australia is the market leader in producing news, articles and research reports on ASX emerging companies with distribution in Australia, UK, North America and Hong Kong / China.

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Thu, 09 Jun 2016 10:30:00 -0400 https://www.proactiveinvestors.com/companies/news/148022/admedus-ltd-receives-buy-recommendation-from-new-york-firm-69126.html
<![CDATA[News - Admedus Ltd undertakes review of operations ]]> https://www.proactiveinvestors.com/companies/news/148021/admedus-ltd-undertakes-review-of-operations-69086.html Admedus Ltd (ASX:AHZ) has introduced a global restructuring initiative to address costs, review commercial effectiveness and accelerate the company’s path to profitability.

This follows the resignation of the CEO and appointment of Wayne Paterson as interim chairman.
   
The review will address all facets of research and development programs to ensure project prioritisation.

A focus is on achieving reductions in operating expenditure as well as addressing global financing of its operations.

A clinical program review will see a global evaluation of R&D initiatives and clinical trials across the organisation as well as a manufacturing review that targets yield and cost improvements.

The results of the restructuring initiative will be delivered before Monday, 11 July 2016.

For the period ending March 2016, YTD sales were up 49% to $9.7 million.

The company had $13 million in cash at the end of March 2016.

 

Proactive Investors Australia is the market leader in producing news, articles and research reports on ASX emerging companies with distribution in Australia, UK, North America and Hong Kong / China.

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Tue, 07 Jun 2016 17:00:00 -0400 https://www.proactiveinvestors.com/companies/news/148021/admedus-ltd-undertakes-review-of-operations-69086.html
<![CDATA[News - Admedus Ltd appoints Mathew Ratty to the board ]]> https://www.proactiveinvestors.com/companies/news/148020/admedus-ltd-appoints-mathew-ratty-to-the-board-68867.html Admedus Ltd (ASX:AHZ) has appointed Mathew Ratty as a non-executive director of the board, bringing experience from domestic and international capital markets.

Ratty is the co-founder of MC Management Group Pty Ltd - a long only venture capital firm operating in both the debt and equity space domestically and internationally.

MC Management Group Pty Ltd is Admedus’ second largest shareholder and is primarily focused on healthcare, financials and technology equities.

Wayne Paterson, chairman, commented: “We welcome Mr Ratty to the board and look forward to his insight and experience.

“Mr Ratty brings to the board significant experience in both domestic and international capital markets as well as investment and funding feasibility analysis.

"These skills will benefit Admedus as we continue our growth in our global markets."

 

Proactive Investors Australia is the market leader in producing news, articles and research reports on ASX emerging companies with distribution in Australia, UK, North America and Hong Kong / China.

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Fri, 27 May 2016 10:30:00 -0400 https://www.proactiveinvestors.com/companies/news/148020/admedus-ltd-appoints-mathew-ratty-to-the-board-68867.html
<![CDATA[News - Admedus Ltd awarded major supply contract with Royal Adelaide Hospital ]]> https://www.proactiveinvestors.com/companies/news/148019/admedus-ltd-awarded-major-supply-contract-with-royal-adelaide-hospital-68810.html Admedus Ltd (ASX:AHZ) has been awarded a major supply contract for the new Royal Adelaide Hospital (new RAH) for the installation of the arcomed Chroma Infusion pump system.

The new RAH is an 800 bed hospital which will provide world class healthcare and facilities for South Australians.

Manufactured by arcomed ag the Swiss made Chroma Infusion pumps offer an innovative whole-of-hospital system with smart pump technology.

The LCD touch screen, drug error reduction system and colour coding of medications on the screen increase patient safety and enhance clinical workflow.

The supply tender includes ongoing technical and clinical support and dedicated consumable products for use with the infusion systems over the coming 5 years.

Wayne Paterson, chairman and interim managing director, commented:

“We are encouraged by the uptake of arcomed Chroma Infusion pump systems within Australia which confirms both the quality and value to the health care system of the product range."


Increasing sales

For the period ending March 2015, YTD sales are up 49% to $9.7 million.

Quarterly sales were $3.3 million, 73% increase from the corresponding period last year.

Other key metrics include:

- CardioCel sales of $1.4 million – up 83% from the corresponding period;
- Infusion sales of $1.9 million – up 12% from the corresponding period; and
- 10th straight quarter of sales growth.


Analysis

Admedus remains focused on providing hospital-wide infusion solutions across the Australian and New Zealand healthcare systems.

The company has one of the largest infusion product ranges on market in Australia and New Zealand.

This demonstrates the company’s ability to provide complex infusion solutions across hospitals and healthcare services groups.

Upcoming catalysts include the potential for additional supply contracts, with the company focused on multiple products across multiple regions.

The company is also working on commercial partnerships and collaborations on its immunotherapy and ADAPT technologies.

Admedus is also forecasting the strongest 4th quarter sales and record sales this financial year.

The company had $13 million in cash at the end of March 2016.

 

Proactive Investors Australia is the market leader in producing news, articles and research reports on ASX emerging companies with distribution in Australia, UK, North America and Hong Kong / China.

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Wed, 25 May 2016 09:30:00 -0400 https://www.proactiveinvestors.com/companies/news/148019/admedus-ltd-awarded-major-supply-contract-with-royal-adelaide-hospital-68810.html
<![CDATA[News - Admedus Ltd outlines board changes ]]> https://www.proactiveinvestors.com/companies/news/148018/admedus-ltd-outlines-board-changes-68754.html Specialist healthcare company Admedus Ltd (ASX:AHZ), has announced that Lee Rodne has resigned as managing director and chief executive officer of the company, effective 30th June 2016.

Wayne Paterson, chairman, commented: “The board thanks Mr. Rodne for his leadership and guidance of the company over the past 10 years and we wish him well in his future endeavours.

“We have an experienced senior management team and board who will work with me to manage the business until the nominations committee selects our new managing director.”

Paterson will act as interim managing director.

Admedus remains focused on investing in and developing next generation technologies with world class partners, acquiring strategic assets to grow product and service offerings and expanding revenues.

The company has assets from research & development through clinical development as well as sales, marketing and distribution.

 

Proactive Investors Australia is the market leader in producing news, articles and research reports on ASX emerging companies with distribution in Australia, UK, North America and Hong Kong / China.

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Tue, 24 May 2016 08:00:00 -0400 https://www.proactiveinvestors.com/companies/news/148018/admedus-ltd-outlines-board-changes-68754.html
<![CDATA[News - Admedus Ltd wins the peer voted ‘Manufacturer of the Year’ award ]]> https://www.proactiveinvestors.com/companies/news/148017/admedus-ltd-wins-the-peer-voted-manufacturer-of-the-year-award-68592.html Admedus Ltd (ASX:AHZ) was awarded ‘Manufacturer of the Year’ at the 2016 Manufacturers’ Monthly Endeavour Awards dinner held in Sydney on Thursday, 12 May.

Admedus was chosen from over 40 other finalists to take out the major award on the night.

Admedus was also awarded ‘Most Innovative Manufacturing Company’ for its work in the research, manufacture and export of its lead regenerative tissue product CardioCel®, which is undertaken at the company’s state-of-the-art bio-manufacturing facility in Malaga, Western Australia.

Lee Rodne, managing director, commented: “We are extremely pleased to have been awarded Manufacturer of the Year and grateful to have been chosen from such a strong field.

"It is an honour to have our innovation and quality in manufacturing recognised by the industry.”


CardioCel

Admedus’ state-of-the-art bio-manufacturing facility was officially opened in August 2014 in order to support global demand for the company’s lead regenerative tissue product CardioCel.

CardioCel is developed using a high-tech engineering process called ADAPT®, whereby scientists treat a piece of animal pericardium (the heart covering membrane) to remove all RNA, DNA and remnants of cells to produce an off-the-shelf, ready to use collagen bio-scaffold that functions like human tissue.

The Admedus bio-manufacturing facility is equipped with in-house research and development labs, which allows Admedus scientists to work closely with the manufacturing team to refine CardioCel, as well as develop and distribute a portfolio of regenerative tissue products for soft tissue repair in the future.

Rodne added: “Admedus continues to invest in our Malaga bio-manufacturing facility to ensure expanded production based on global demand for CardioCel, as well as refine and develop current processes to accommodate for new products and product improvements.”

 

Proactive Investors is a global leader reporting financial news, media, research and hosts events for listed emerging growth companies and investors across four continents.

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Fri, 13 May 2016 09:30:00 -0400 https://www.proactiveinvestors.com/companies/news/148017/admedus-ltd-wins-the-peer-voted-manufacturer-of-the-year-award-68592.html
<![CDATA[News - Admedus Ltd to showcase CardioCel® in the U.S. to drive sales ]]> https://www.proactiveinvestors.com/companies/news/148016/admedus-ltd-to-showcase-cardiocel-in-the-us-to-drive-sales-68571.html Admedus Ltd (ASX:AHZ) has outlined a focus on driving sales of its lead regenerative tissue product CardioCel® in the valve repair market, and as a result the company will be attending several leading U.S. cardiovascular conferences.

These include the American Association for Thoracic Surgery (AATS) Aortic Symposium 2016 May 12-13 in New York, and the 96th AATS Annual Meeting taking place from 14 – 18 May in Baltimore, Maryland.

Lee Rodne, managing director, commented:

“CardioCel is fast becoming the surgeon-preferred material for reconstruction and repairs in the aortic and mitral valve repair market, with the product providing a genuine alternative for patients compared to bio-prosthetic valves.

"We believe CardioCel represents a disruptive technology and we are concentrating on building awareness of our product in this market."

The global market for cardiovascular disease is estimated to grow to USD $4.8 billion by 2020.

In the U.S., surgeons currently perform 106,000 heart valve operations each year.

Rodne added: “Admedus is focused on continuing to show the utility and benefits of CardioCel to patients and surgeons in the multibillion dollar heart valve market, expanding the use of CardioCel in the adult valve market and driving CardioCel sales globally.”


Next steps

Admedus continues to progress its aortic valve reconstruction post-market study with several centres globally recruiting patients.

An update on the study is anticipated in the coming months.

The study is designed to further show the use of CardioCel in repairing aortic heart valves and its potential for improved patient outcomes compared to bio-prosthetic valves.


Broker targets

New York based Maxim Group has a buy recommendation on the company and a $2.00 price target.

Hong Kong based boutique investment bank Cedrus Investments have a fair value of A$1.95 per share by December 2018.

 

Proactive Investors Australia is the market leader in producing news, articles and research reports on ASX emerging companies with distribution in Australia, UK, North America and Hong Kong / China.

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Thu, 12 May 2016 09:00:00 -0400 https://www.proactiveinvestors.com/companies/news/148016/admedus-ltd-to-showcase-cardiocel-in-the-us-to-drive-sales-68571.html
<![CDATA[News - Admedus Ltd posts 73% increase in March quarter sales ]]> https://www.proactiveinvestors.com/companies/news/148015/admedus-ltd-posts-73-increase-in-march-quarter-sales-68349.html Healthcare company, Admedus Ltd (ASX:AHZ) has recorded a strong March quarter with sales of $3.3 million, up 73% on the corresponding period last year.

Sales for the nine months ending 31 March, 2016 were $9.7 million, which is nearly equal to the entire FY2015 sales of $10.2 million.

Admedus anticipate recording its strongest ever revenue performance for the June quarter 2016.

Cost efficiencies and productivity improvements were achieved with a 16% decrease in staff expenses and 7% decrease in working capital compared with the previous quarter.

Admedus continues to progress its strategy of developing multiple revenue streams and building a global healthcare company.

The company’s net cash position as at 31 March 2016 was $13 million.


CardioCel

Admedus' flagship product is CardioCel, a bio-engineered tissue scaffold to repair congenital heart defects.

CardioCel has now been implanted in over 4000 patients in over 145 centres globally, and is becoming a surgeon-preferred biomaterial for heart valve repair surgeries.

It represents a disruptive technology in the $2.5 billion heart valve repair and replacement market.

CardioCel sales for the March quarter were $1.4 million, up 83% from the March 2015 quarter.

Admedus has also recently entered into an exclusive distribution agreements to distribute the Coroneo extra-aortic annuloplasty ring in the UK, Germany, Australia and New Zealand.

The Coroneo extra-aortic annuloplasty ring is a complementary product to CardioCel for repairs of aortic heart valves.

Admedus anticipates booking first sales of the product in Europe in the fourth quarter of 2016 and seeing first revenues from this in Germany with first orders now received.


Infusion portfolio

The Admedus infusion portfolio continues to provide strong revenue growth with $6.2 million of sales year to date.

With over 800 customers, the Admedus team continues to provide hospital-wide infusion solutions across the Australian and New Zealand healthcare systems.

Admedus will be targeting future tenders to drive additional sales.


Analysis

Investment in sales channels by Admedus has yielded reward with the company continuing to post strong revenue growth.

During the March quarter, Admedus achieved first CardioCel sales in the Middle-East and North African region and anticipates additional sales in this region going forward.

Efforts by the company to cut costs and improve productivity have been successful with further efficiencies forecast for the final quarter.

The stock is trading at around A$0.40, which represents a large discount to its broker price targets of A$1.95 and A$2.00.

With the company anticipating its strongest ever final quarter, FY2016 sales are set to show strong growth on FY2015.

The company is well capitalised with $13 million in the bank.

 

Proactive Investors is a global leader reporting financial news, media, research and hosts events for listed emerging growth companies and investors across four continents.

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Fri, 29 Apr 2016 09:30:00 -0400 https://www.proactiveinvestors.com/companies/news/148015/admedus-ltd-posts-73-increase-in-march-quarter-sales-68349.html
<![CDATA[News - Admedus Ltd expands distribution agreement with CORONEO ]]> https://www.proactiveinvestors.com/companies/news/148014/admedus-ltd-expands-distribution-agreement-with-coroneo-67962.html Admedus Ltd (ASX:AHZ) has expanded its exclusive distribution partnership with Canada's CORONEO to sell its Extra-Aortic Annuloplasty Ring and related products in Australia and New Zealand.

This builds on original agreement to distribute CORONEO products in UK and Germany.

The ring is implanted into patients to repair heart valves and complements CardioCel, the lead regenerative product marketed by Amdedus.

The product will be sold through the existing sales and marketing network at Admedus.

Admedus anticipates gaining marketing approval for this unique aortic implant in the second half of 2016.


Company overview

Admedus' flagship product is CardioCel®, a bio-engineered tissue scaffold to repair congenital heart defects, and expanding into the heart valve market.

CardioCel is becoming a surgeon-preferred biomaterial for heart valve repair surgeries.

It represents a disruptive technology in the $2.5 billion heart valve repair and replacement market, which is dominated by products commercialized by large medical device companies.

The product is in the process of building early traction, as the company has been capital constrained. CardioCel launched in the EU in 2013 and in the US in 2014.

It is now being sold in Canada, Australia, Asia, the Middle East, and North Africa, covering 135 medical centres.

Beyond CardioCel, Admedus is developing a DNA-based therapeutic vaccine for HSV-2 and HPV. Final data from the ongoing phase II HSV-2 study are expected to be released in 2Q17.


Analysis

Today Admedus revealed that it has extended its distribution agreement with Coroneo to sell its products, including is Aortic Annuloplasty Ring, in Australia and New Zealand.

The Coroneo Aortic Annuloplasty Ring is a complementary product to CardioCel for repairs of aortic heart valves.

CardioCel is used in over 145 centres globally and has been implanted in over 4000 patients for the repair and reconstruction of congenital heart defects and cardiovascular defects.

There is a natural synergy between the Extra-Aortic Ring and the CardioCel product in the lead up to CardioCel being approved in the Australian market.

The Extra-Aortic Ring compliments the use of CardioCel in heart valve repairs and will play an important role as Admedus expands its presence in the heart valve repair market.

Admedus has recently been attracting broker attention, with current price targets of A$1.95 and A$2.00.

With the stock trading at around A$0.48 this represents a large discount to the current price targets.

 

Proactive Investors Australia is the market leader in producing news, articles and research reports on ASX emerging companies with distribution in Australia, UK, North America and Hong Kong / China.

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Fri, 08 Apr 2016 10:30:00 -0400 https://www.proactiveinvestors.com/companies/news/148014/admedus-ltd-expands-distribution-agreement-with-coroneo-67962.html
<![CDATA[News - Admedus Ltd demonstrates close profile to native aortic valve ]]> https://www.proactiveinvestors.com/companies/news/148013/admedus-ltd-demonstrates-close-profile-to-native-aortic-valve-67730.html Admedus Ltd (ASX:AHZ) has received updated research from the New York based Maxim Group.

Maxim has a Buy rating on Admedus, with a $2.00 12-month target price. The target is four-times higher than Admedus' $0.50 last trading price.

The following is an extract from the report.


CardioCel Demonstrates Close Profile to Native Aortic Valve

Summary

- Admedus presented a poster titled "Cusp Interventions in Aortic Valve Repair: Are All Pericardial Patches Created Equal?" at the Heart Valve Society Scientific Meeting 2016 in NYC from Mar. 17-19.

- From the poster presentation, CardioCel for aortic valve repair has demonstrated the closest profile to native aortic valves when compared to two other commercially available bovine pericardial patches St-Jude MedicalTM from St. Jude Medical (STJ-$54.47-NR) and Peri-Guard from Baxter (BAX- $40.28-NR).

- As a reminder, an early clinical study has demonstrated CardioCel in the complete reconstruction of an aortic heart valve with superior durability, anti-calcification properties, and functionality with better hemodynamics. Following the positive data from the pre-clinical study, the company initiated a clinical study in CardioCel for aortic tri-leaflet heart valve reconstruction in October 2015.

- Admedus is currently selling CardioCel®, a bio-engineered tissue scaffold to repair congenital heart defects, and expanding into the heart valve market. It is made of biocompatible bovine tissue; is off-the-shelf available, stentless, durable, and flexible; and shows resistance to calcification.

- Conclusion: We believe the positive result continues to show CardioCel's potential of being the most suited and preferred biomaterial for aortic valve repair.


Details

CardioCel is a bio-implant sourced from bovine pericardium that is engineered via Admedus' ADAPT® platform, resulting in a durable, collagen-based scaffold with strong mechanical properties and resistance to calcification, while supporting native cell infiltration, growth, and differentiation for repairing cardiac and vascular defects.

It is processed by a proper decellularization regime, optimized crosslinking, and adequate detoxification to avoid any immunological response that could potentially trigger a calcification cascade, thus rendering calcific degeneration postimplantation.

In July 2015, Admedus announced positive long-term data from the CardioCel phase II study, which showed no follow-on heart procedures related to CardioCel, nor were there any signs of calcification seen.

Admedus' focus is first and foremost on regenerative tissue for heart valve repair and replacement in pediatric and adult patients with congenital heart defects.

Supported by strong clinical data (no signs of calcification reported in seven years post-implantation), CardioCel appears to be what we believe is a next-generation xenograft tissue product, a biocompatible bio-scaffold that elicits minimal immune response, has durable flexibility and elasticity, and has a long shelf life (two years).

One other trait that makes CardioCel a distinguishing competitor, in our view, is its strong resistance to calcification, while still providing sustainable mechanical properties.

This is the key to CardioCel’s success, because it eliminates the need for patients to undergo frequent post-implantation surgeries for replacement due to tissue degeneration.

We believe CardioCel has the potential to reduce the number of future surgeries required and open up more market opportunities in other clinical indications.

CardioCel also targets the large aortic and mitral valve market, and the company worked with KOLs to generate preclinical data.


Valuation

Our model only includes CardioCel in CHD and heart valve repair for conservatism.

We use free-cash-flow-to-the-firm (FCFF), discounted-EPS, and sum of-the-parts models, with a risk rate of 30%, equally weighted and averaged, to derive our $2.00 price target.

 

Proactive Investors is a global leader reporting financial news, media, research and hosts events for listed emerging growth companies and investors across four continents.

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Tue, 29 Mar 2016 09:30:00 -0400 https://www.proactiveinvestors.com/companies/news/148013/admedus-ltd-demonstrates-close-profile-to-native-aortic-valve-67730.html
<![CDATA[News - Admedus Ltd receives $2.00 price target from New York based Maxim Group ]]> https://www.proactiveinvestors.com/companies/news/148012/admedus-ltd-receives-200-price-target-from-new-york-based-maxim-group-67475.html Admedus Ltd (ASX:AHZ) has received a buy recommendation from the New York based Maxim Group, which has initiated coverage on the company.

Maxim has allocated a $2.00 price target. Shares in Admedus last traded at around $0.50.


The following is an extract from the report.


An Alternative to Bio-Prosthetic Heart Valves; Initiating Coverage with a Buy Rating and a $2.00 Price Target

Summary

Admedus is currently selling CardioCel®, a bio-engineered tissue scaffold to repair congenital heart defects, and expanding into the heart valve market.

It is made of biocompatible bovine tissue; is off-the-shelf available, stentless, durable, and flexible; and shows resistance to calcification.

The major failure mode of implanted tissue is calcification. CardioCel's phase II (follow-up) data showed no signs of calcification at seven years postimplantation, and, as such, it reduces the need for follow-on surgeries.

CardioCel is becoming a surgeon-preferred biomaterial for heart valve repair surgeries.

We believe that it represents a disruptive technology in the $2.5B heart valve repair and replacement market, which is dominated by products commercialized by large medical device companies, such as the Hancock II tissue valve from Medtronic (MDT-$76.27-NR) and SAPIEN 3 from Edwards Scientific (EW-$86.49-NR).

The product has yet to build traction, as the company has been capital constrained. CardioCel launched in the EU in 2013 and in the US in 2014.

It is now being sold in Canada, Australia, Asia, the Middle East, and North Africa, covering 135 medical centers. However, last year's revenues were only $2.64M.

Management is now hoping to build traction as KOL awareness builds.

Beyond CardioCel, Admedus is developing a DNA-based therapeutic vaccine for HSV-2 and HPV. Final data from the ongoing phase II HSV-2 study are expected to be released in 2Q17.

Conclusion. We believe Admedus is an "undiscovered" Australian company with a portfolio of regenerative products in a big market. As revenue builds, we believe valuation will follow.


Details

CardioCel is a bio-implant sourced from bovine pericardium that is engineered via Admedus' ADAPT® platform, resulting in a durable, collagen-based scaffold with strong mechanical properties and resistance to calcification, while supporting native cell infiltration, growth, and differentiation for repairing cardiac and vascular defects.

It is processed by a proper decellularization regime, optimized crosslinking, and adequate detoxification to avoid any immunological response that could potentially trigger a calcification cascade, thus rendering calcific degeneration postimplantation.

In July 2015, Admedus announced positive long-term data from the CardioCel phase II study, which showed no follow-on heart procedures related to CardioCel, nor were there any signs of calcification seen.

HSV-2 immunotherapy. Admedus’ HSV-2 glycoprotein D (gD2)-based DNA vaccine uses codon optimization DNA technology, which enhances protein expression in the cell or tissue targeted, and results in an improved immune response.

Another component of the technology is to use a combination of DNA encoding ubiquitin and non-ubiquitin proteins to enhance the degradation of the protein and optimize Tcell responses, while preserving structural epitopes necessary for B-cell responses, achieving both prophylactic and therapeutic results from the vaccine.

An HSV-2 phase II study (n=44), which is evaluating the safety of the vaccine, impact on viral load and shedding, and viral flare frequency, is ongoing.

Interim data showed a favorable safety profile, with a reduction in viral lesions. Final data are expected in 2Q17.

Valuation. Our model only includes CardioCel in CHD and heart valve repair for conservatism.

We use free-cash-flow-to-the-firm (FCFF), discounted-EPS, and sum-of-the-parts models, with a risk rate of 30%, equally weighted and averaged, to derive our $2.00 price target.

 

Proactive Investors is a global leader reporting financial news, media, research and hosts events for listed emerging growth companies and investors across four continents.

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Mon, 14 Mar 2016 09:30:00 -0400 https://www.proactiveinvestors.com/companies/news/148012/admedus-ltd-receives-200-price-target-from-new-york-based-maxim-group-67475.html
<![CDATA[News - Admedus Ltd receives A$1.95 valuation from Hong Kong firm ]]> https://www.proactiveinvestors.com/companies/news/148011/admedus-ltd-receives-a195-valuation-from-hong-kong-firm-67432.html Admedus Ltd (ASX:AHZ) has now revealed that Cedrus Investments, a Hong Kong based boutique investment bank, has initiated coverage on the company.

Admedus last traded at $0.46. The following is an extract from the report.


Admedus is a Well Balanced Junior Healthcare Company Poised for Substantial Growth

We believe Admedus Ltd (“Admedus”), listed on the Australian Securities Exchange (ASX:AHZ), is a game‐changer in the fast‐growing global cardiovascular market with its proprietary and patented regenerative tissue engineering technology.

In addition, the company has also entered into the promising cancer vaccination/immunotherapy sector, providing another driver for sustained profitable growth.


Recommendation Summary

- We are initiating coverage of Admedus. In our view, shares of Admedus are currently undervalued, as we estimate they will have a fair value of A$1.95 per share by December 2018, versus the closing price of A$0.42 as of March 8, 2016.

- As a well-balanced junior healthcare company, Admedus is poised for substantial and persisted growth. We project the company to become profitable from fiscal year 2017/2018.

- Admedus has developed a cutting-edge regenerative tissue technology named ADAPTR with a wide range of applications. The technology has significant advantages over the competition in terms of ease of use, durability and reliance, among others. The first commercialized product, CardioCelR, is being used by cardiac surgeons in over 135 centres worldwide and generating sales.

- The company has also started clinical trials with a family of immunotherapy vaccines, targeting Human Papillomavirus (HPV) and Herpes simplex virus (HSV.2), in collaboration with Professor Ian Frazer, the original co-developer of the technology behind the HPV vaccine against cervical cancer, now marketed as GardasilR by Merck (NYSE: MRK) and CervarixR by GlaxoSmithKline (NYSE:GSK).

- We believe now is the ideal time to invest in Admedus' shares, as we expect impending and potentially positive clinical catalysts such as the more extensive analysis of unblinded data for the HSV.2 Phase II results likely in 3Q calendar 2016 and the likelihood of getting regulatory approval of CardioCelR in the Middle East and North Africa region between 2Q and 4Q calendar 2016 will give Admedus' shares a boost.


In addition, Admedus captures all key elements of a successful junior healthcare company:

- A track record of fruitful R&D efforts;
- Rapid product commercialization and sales ramp;
- Competitive new products in the pipeline, and
- Potentially gaining significant market share in the industry it competes.

 

Proactive Investors is a global leader reporting financial news, media, research and hosts events for listed emerging growth companies and investors across four continents.

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Thu, 10 Mar 2016 09:30:00 -0500 https://www.proactiveinvestors.com/companies/news/148011/admedus-ltd-receives-a195-valuation-from-hong-kong-firm-67432.html
<![CDATA[News - Admedus Ltd chairman acquires shares on market ]]> https://www.proactiveinvestors.com/companies/news/148010/admedus-ltd-chairman-acquires-shares-on-market-67416.html Admedus Limited (ASX:AHZ) non executive chairman Wayne Paterson has acquired 30,000 shares on market at $0.56 per share.

This week Admedus released encouraging interim results from the Phase II clinical study for a Herpes Simplex Virus (HSV-2) therapeutic vaccine which showed a decrease in viral lesions in patients in the trial.

There was a 90% decrease in viral lesions and outbreaks in trial patients, in the monthly rate versus baseline.

No safety issues were noted in this cohort of patients which is the primary endpoint of the Phase II trial.

The company said the data remains blinded and therefore no definitive conclusions can be made but that an analysis of the unblinded data from these 20 study participants will be performed during Q3 2016.

This will include assessment of the immunological endpoints including T cell response, as well as clinical and virological data.

 

Proactive Investors is a global leader reporting financial news, media, research and hosts events for listed emerging growth companies and investors across four continents.

 

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Wed, 09 Mar 2016 16:40:00 -0500 https://www.proactiveinvestors.com/companies/news/148010/admedus-ltd-chairman-acquires-shares-on-market-67416.html
<![CDATA[Media files - Admedus Ltd's COO Julian Chick talks to Proactive Investors on interim Herpes Simplex Virus Phase II clinical trial data ]]> https://www.proactiveinvestors.com/companies/stocktube/5585/admedus-ltds-coo-julian-chick-talks-to-proactive-investors-on-interim-herpes-simplex-virus-phase-ii-clinical-trial-data-577.html Tue, 08 Mar 2016 08:30:00 -0500 https://www.proactiveinvestors.com/companies/stocktube/5585/admedus-ltds-coo-julian-chick-talks-to-proactive-investors-on-interim-herpes-simplex-virus-phase-ii-clinical-trial-data-577.html <![CDATA[News - Admedus has encouraging results from Phase II herpes simplex trial ]]> https://www.proactiveinvestors.com/companies/news/148009/admedus-has-encouraging-results-from-phase-ii-herpes-simplex-trial-67335.html Admedus (ASX:AHZ) has released very encouraging interim results from its Phase II clinical study for a Herpes Simplex Virus (HSV-2) therapeutic vaccine which showed a decrease in viral lesions in patients in the trial.

The trial blinded, pooled analysis of data was received from the first 20 patients to receive at least three vaccinations in the randomised, placebo–controlled HSV-2 vaccine Phase II study.

No safety issues were noted in this cohort of patients which is the primary endpoint of the Phase II trial. The data remains blinded to protect the integrity of the trial.

Significantly, there was a 90% decrease in viral lesions and outbreaks in trial patients, in the monthly rate versus baseline. A total of 14 patients also received the booster.

The average number of days HSV-2 was detected in patients was also reduced versus baseline.

Admedus CEO Mr Lee Rodne said, "We look forward to the next scheduled analysis, which will be more extensive and will be performed on unblinded data, giving us further insight into the data set. We anticipate this will be completed in the Q3 2016.”

Professor Ian Frazer said: “The initial data appears encouraging and we look forward to additional data from this study being released later this year.”

Prof Ian Frazer's company developed the next generation technology and which is now majority owned by Admedus.


Clinical Trial details

This prospectively designed, double blinded, placebo-controlled trial has randomised 44 patients to receive the Company’s COR-1 HSV-2 vaccine or placebo in a 3:1 ratio.

The primary endpoint of the study is safety.

The patients are divided into two treatment groups:

- Group 1 with 22 patients received a double inoculation split across both arms and
- Group 2 (22 patients) received the double inoculation into one arm.

The secondary endpoint and investigative endpoints included: various virological and immunological assessments such as occurrences of outbreaks (lesions), viral shedding, viral load, T-cell and antibody counts as well as safety.

Patients were assessed for monthly viral outbreaks and percentage of days where HSV-2 was detected in swabs taken from the patients relative to analogous pre-vaccination measurements as a baseline.

Post vaccination/booster virological assessments occurred over a time period of 45 days commencing seven days after the third administration (booster administrations) respectively.

This data is then compared to the baseline virological assessments of each patient occurring for a period of 45 days prior to any vaccination.


Next steps

Admedus said at this point the data remains blinded and therefore no definitive conclusions can be made.

The company plans an analysis of the unblinded data from these 20 study participants to be performed during Q3 2016.

This will include assessment of the immunological endpoints including T cell response, as well as clinical and virological data.

To date, six patients have withdrawn from the trial for reasons unrelated to vaccine safety, some of whom received their vaccination.

Admedus said it anticipates all study groups to have completed their dosing, including booster, by Q4 2016 and full trial analysis data to be available by Q2 2017.


Market size

The World Health Organisation stated in October 2015 that 417 million people in the 15-49 age group are living with HSV-2.

As a result, a successful HSV-2 vaccine from Admedus could potentially address a market worth more than US$6 billion.

 

Proactive Investors is a global leader reporting financial news, media, research and hosts events for listed emerging growth companies and investors across four continents.

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Fri, 04 Mar 2016 09:00:00 -0500 https://www.proactiveinvestors.com/companies/news/148009/admedus-has-encouraging-results-from-phase-ii-herpes-simplex-trial-67335.html
<![CDATA[News - Admedus delivers strong revenue growth on CardioCel® roll-out ]]> https://www.proactiveinvestors.com/companies/news/148008/admedus-delivers-strong-revenue-growth-on-cardiocel-roll-out-67217.html Admedus Limited (ASX:AHZ) has delivered another very productive half year of activity for the period ending December 2015.

This included consistent quarter on quarter growth in CardioCel® sales, expansion of the product into new markets, and a focus on expanding the ADAPT® tissue portfolio.

It has also made significant progress in its Immunotherapies programs.

Revenue climbed 37% to $6.6 million. Of this, CardioCel revenues were up 130% to $2.3 million, compared to the prior corresponding period.

Over 135 centres are now using CardioCel® globally to date - which is up from 90 centres in July 2015.

The CardioCel European label expansion enables greater access to adult heart valve market.

Admedus has also completed recruitment of the HSV-2 Phase II study.

Admedus holds a very healthy $19.1 million in cash.


Key advancements

- Initiation of the aortic valve reconstruction post-market study to further illustrate the utility and benefits of CardioCel in heart valve repairs and reconstructions versus replacing the valve with a bioprosthetic valve. This followed an extremely positive outcome in the pre-clinical study.

- CardioCel’s indication expansion in Europe, allowing its use in the repair and reconstruction of heart valves, expanding the paediatric market and providing greater opportunity in the adult heart valve market.

- A collaboration with a leading regenerative medicine team using Admedus’ ADAPT bio-scaffolds as a delivery mechanism for stem cells and other cellular therapies.

- Approval and first sales of CardioCel in Malaysia, in line with market expansion into the Asian region.

- Completed recruitment of the HSV-2 Phase II study ahead of the important interim results.

- Completing the manufacturing of the HPV vaccine for formal pre-clinical testing ahead of the initial clinical studies as a treatment for HPV infections and cervical cancer.


Outlook

Admedus said that in the second half of the year the company will continue to drive revenue growth in its product portfolios.

The company will also continue to increase the number of centres using CardioCel for repairing cardiovascular defects including reconstructing heart valves.

Added to this, will be the expansion of its regenerative tissue platform into vascular repairs, dura mater repairs and other applications.

In regards to immunotherapies programs, Admedus expects to deliver key interim data from the HSV-2 study during the period and initiate Ian Frazer’s next HPV vaccine as a therapeutic against HPV infections and Cervical Cancer.

 

Proactive Investors is a global leader reporting financial news, media, research and hosts events for listed emerging growth companies and investors across four continents.

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Fri, 26 Feb 2016 09:00:00 -0500 https://www.proactiveinvestors.com/companies/news/148008/admedus-delivers-strong-revenue-growth-on-cardiocel-roll-out-67217.html
<![CDATA[News - Admedus awaits Herpes Simplex Virus phase 2 clinical study results ]]> https://www.proactiveinvestors.com/companies/news/148007/admedus-awaits-herpes-simplex-virus-phase-2-clinical-study-results-67011.html Admedus (ASX:AHZ) could have the highly anticipated interim results available for its Phase 2 clinical study for a Herpes Simplex Virus (HSV-2) therapeutic vaccine in the coming weeks.

HSV-2 is the major causative agent of genital herpes and further positive trial results would provide a boost to infected individuals and to the commercialisation potential of the vaccine.

The economic burden of genital HSV infection and resulting complications is estimated to be greater than $1 billion annually in the U.S. alone.

Further HSV-2 study data is expected to be released during 2016.

The HSV-2 Phase II study had 40 study participants and each study participant will receive either the vaccine or a placebo. The vaccine is initially given as a 3 injection vaccination program, four weeks apart, plus study participants will also receive another injection, a ‘booster’ as it were, 6 months after the last of the 3 vaccinations.

The study is designed to examine the safety of the HSV-2 vaccine in people with HSV-2 as well as look at its ability to stimulate an immune response against the virus.

The Company and the clinical study investigators remain blinded to the study data in accordance with standard clinical study procedures to protect the integrity of the results.

Inventor Professor Ian Frazer's company developed the next generation technology and is now majority controlled by Admedus.


Proactive Investors is a global leader reporting financial news, media, research and hosts events for listed emerging growth companies and investors across four continents.

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Mon, 15 Feb 2016 10:30:00 -0500 https://www.proactiveinvestors.com/companies/news/148007/admedus-awaits-herpes-simplex-virus-phase-2-clinical-study-results-67011.html
<![CDATA[News - Admedus Limited appoints Wayne Paterson as chairman ]]> https://www.proactiveinvestors.com/companies/news/148006/admedus-limited-appoints-wayne-paterson-as-chairman-66948.html Specialist healthcare company Admedus Limited (ASX:AHZ) has appointed Wayne Paterson as non-executive chairman with immediate effect, following the resignation of Chris Catlow who held the position for five years.

Graeme Rowley, who served as a non-executive director for five years, has also resigned.

Catlow and Rowley had been involved with the group for the past 11 years.

Wayne Paterson, commented: “The board and I would like to thank Chris and Graeme for their work in establishing Admedus and their help in growing it into the diversified healthcare company it is today.

"Their contributions have been invaluable over the years."

Lee Rodne, CEO, added: “The Admedus board now consists of directors with extensive experience in each of our core product areas with specific backgrounds in sales, marketing, general management and corporate governance.

"We look forward to their ongoing input to our outstanding management team."

 

Proactive Investors is a global leader reporting financial news, media, research and hosts events for listed emerging growth companies and investors across four continents.

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Wed, 10 Feb 2016 14:00:00 -0500 https://www.proactiveinvestors.com/companies/news/148006/admedus-limited-appoints-wayne-paterson-as-chairman-66948.html
<![CDATA[News - Admedus to add revenue as heart disease tech distribution grows ]]> https://www.proactiveinvestors.com/companies/news/148005/admedus-to-add-revenue-as-heart-disease-tech-distribution-grows-66722.html Diversified healthcare technology company Admedus (ASX:AHZ) has consolidated its presence in the US$1 billion European heart valve market by signing an exclusive distribution agreement for specialised surgical instruments.

The deal with Canadian company CORONEO will complement Admedus' CardioCel heart reconstruction technology initially in Germany and the UK.

CORONEO’s Extra-Aortic Ring will be sold alongside CardioCel in heart valve repair and reconstruction space and will be managed by Admedus’ existing sales and marketing infrastructure.

The launch of CORONEO products in the UK and Germany will take place in April 2016, with sales expected to contribute to Admedus’ revenue this financial year.

The UK and Germany represent two of the largest heart valve markets in Europe and expansion of the agreement into other regions remains an option.

CardioCel was initially launched in Europe at the end of 2013 and has been implanted in over 3000 patients.

“We believe the CORONEO range is synergistic with CardioCel and Admedus’ work in this space, as we both provide surgeons with specialised implantable devices and instruments to facilitate the repair and reconstruction of dysfunctional heart valves,” CORONEO President & CEO Anthony Paolitto said.

The distribution deal with CORONEO builds Admedus' marketing momentum in Europe on the back of a new approvals milestone for CardioCel.

Late last year, the company received notification from the European Medicines Agency (EMA) that CardioCel has been granted a broader label indication for its use in Europe.

The new, expanded indication for CardioCel means the product is approved for use in the repair and reconstruction of heart valves and is more in line with the U.S. label.
 
The label expansion is part of the global strategy to position CardioCel as the leading bio-scaffold and establishes the product in more than 120 centres globally.


Compelling momentum

Growth of the company’s sales portfolio in early 2016 builds on a strong finish to 2015 with a number of key milestones achieved throughout the year.

These included the closing of a Herpes Simplex Virus (HSV) vaccine study, CardioCel being used in over 135 centres globally and the initiation of a Aortic Heart Valve reconstruction study at leading heart centres.

Over calendar 2105, the company focused on the ongoing global launch of CardioCel which has resulted in continued quarter-on-quarter revenue growth and an additional 80 new centres using CardioCel to treat cardiovascular diseases.

Admedus’ broader portfolio, however, has made strides in developing a technology platform focused on therapeutic vaccines and immunotherapies for infectious disease and oncology.

The company is currently developing a suite of vaccines that treat and prevent infectious diseases and cancers caused by Herpes Simplex Virus and Human Papillomavirus.

This adds value to Admedus given that 1 in 6 people aged between 14 and 49 in the U.S. are estimated to be infected with Herpes Simplex Virus, which has no present cure.


Analysis

The agreement with CORONEO expands Admedus’ product portfolio in the cardiovascular space and adds to its ongoing sales growth allowing for the generation of increased revenue from existing in-house resources.

CORONEO’s Extra-Aortic Ring is a valuable addition to this sales and revenue platform as it represents the first annuloplasty device on the market specifically-designed to surgically repair the aortic valve with a proven, standardised technique.

By preserving the patient’s native valve, the CORONEO product avoids complications attributed to prosthetic valve replacement and compromises to patient’s quality of life such as the need for lifelong anticoagulation.

The CORONEO deal also cements Admedus’ foothold in the key European heart valve market, which is estimated to value $1 billion.

Within this sector, Germany and the UK are considered two of the largest heart valve markets – and will be the initial focus of the Admedus-CORONEO partnership.

The distribution agreement also adds value by complimenting CardioCel as it expands its implementation in Europe to more than 3000 patients.

CardioCel marketing advantages as a bio-scaffold include its durability, elasticity, anti-calcification properties, better haemodynamics and the capacity to be a life-long solution by enabling repair earlier in the valve disease process.

Admedus is expected to add value by further increasing its range of products in its sales and marketing portfolio.


Proactive Investors is a global leader reporting financial news, media, research and hosts events for listed emerging growth companies and investors across four continents.

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Wed, 27 Jan 2016 11:41:00 -0500 https://www.proactiveinvestors.com/companies/news/148005/admedus-to-add-revenue-as-heart-disease-tech-distribution-grows-66722.html
<![CDATA[News - Admedus receives notice of initial substantial holder from Sabby Management ]]> https://www.proactiveinvestors.com/companies/news/148004/admedus-receives-notice-of-initial-substantial-holder-from-sabby-management-66364.html Admedus (ASX:AHZ) has received a notice of initial substantial holder from Sabby Managament LLC.

The notice has Sabby holding 10.5 million shares, or a 5.35% stake.

Admedus recently completed a US$5 million placement at A$0.66 per share to U.S. investors, where the company continues to receive growing investor interest.

Maxim Group LLC acted as sole placement agent in the U.S. for the transaction.

At the time of the placement, Lee Rodne, MD & CEO of Admedus, commented:

“The funds raised from this private placement of our shares provides a significant boost to the company’s financial position as we enter the New Year and reflects growing interest in Admedus by U.S. investors.

"2015 has been a very positive year for Admedus as we’ve continued to show strong successes in our programs and we’re expecting to achieve a number of key milestones in 2016.”


Allocation of funding

Funds raised from the placement will be used to support ongoing programs within the company.

This includes the progression of the HPV immunotherapy program towards a clinical study in 2016 and continued expansion of the ADAPT® regenerative medicine product portfolio.

Admedus, in conjunction with Professor Ian Frazer, is developing a therapeutic vaccine platform, with programs targeting HSV-2, HPV and HPV related cancers.

The HSV-2 program is currently in a Phase II clinical study and the HPV program has shown exceptional results to date and Admedus anticipates that it will enter into a Phase Ib clinical study in HPV infected subjects in the coming year.


CardioCel® expansion

In 2015, the company continued its successful global launch of CardioCel®. CardioCel is now used in over 135 centres globally for the repair and reconstruction of cardiovascular defects and disease in both children and adults.

 

Proactive Investors Australia is the market leader in producing news, articles and research reports on ASX emerging companies with distribution in Australia, UK, North America and Hong Kong / China.

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Tue, 29 Dec 2015 12:00:00 -0500 https://www.proactiveinvestors.com/companies/news/148004/admedus-receives-notice-of-initial-substantial-holder-from-sabby-management-66364.html
<![CDATA[News - Admedus finishes 2015 in strong position after achieving milestones ]]> https://www.proactiveinvestors.com/companies/news/148003/admedus-finishes-2015-in-strong-position-after-achieving-milestones-66357.html Admedus Limited (ASX:AHZ) has finished 2015 in a strong position following a number of key milestones achieved throughout the year.

This includes the HSV-2 therapeutic vaccine Phase II study closing, with initial study results pending; CardioCel® being used in over 135 centres globally; and the Aortic Heart Valve reconstruction study initiated at leading Heart Centres.

Add to this growing revenue and a strong cash position heading into 2016.

Lee Rodne, CEO, commented:

“2015 has been a very positive year for Admedus and we approach 2016 in a very strong position.

"In the last 12 months, we have focused on the ongoing global launch of CardioCel and this has resulted in continued quarter on quarter revenue growth and an additional 80 new centres using CardioCel to treat cardiovascular diseases.

"We have also made significant progress in our immunotherapy programs with key clinical data expected in 2016.”


HSV-2 Study Update

The HSV-2 therapeutic vaccine Phase II study has closed recruitment, with over 40 study participants in the study.

Admedus will continue to progress the existing study participants through the trial to ensure all study participants complete the vaccination period.

The study is progressing well with 25% of study participants having received their six month booster.

The company anticipates the release of additional study data early in the first quarter of 2016 when all study participants have received their initial doses.


HPV Therapeutic Vaccine

Admedus has been working with Professor Ian Frazer on his next HPV product as a treatment against HPV and associated cancers.

In 2015, the HPV therapeutic vaccine continued to show exceptional pre-clinical results targeting HPV and HPV related tumours and is scheduled to enter into a Phase Ib study in 2016 in HPV infected patients.


Aortic Valve Reconstruction Post-market Study

Admedus continues to progress its post market aortic heart valve study with two of the intended four centres now recruiting patients and over 10% of patients already enrolled.

Admedus anticipates the additional study centres to initiate recruitment in the first quarter of 2016.


CardioCel®

In the last 12 months, the company achieved approval for CardioCel in Hong Kong, Singapore and Malaysia, opening up more of the Asian market.

In addition, sales of CardioCel have continued to grow with quarter on quarter sales growth throughout 2015, with the December quarter continuing to be strong for sales, a clear indication of growing interest in the product and its benefits for patients.

During the year, an additional 80 centres came on board using CardioCel to treat cardiovascular defects.

The company has also expanded the CardioCel product range with the addition of 2cm X 2cm and 2cm x 8cm sized products.

Admedus will continue to focus on growing revenue for CardioCel in 2016 in both the paediatric and adult markets treating congenital heart defects and repairing and reconstructing heart valves, increasing centre on centre growth and opening up new markets.

Admedus anticipates its first sales in the MENA region in the first quarter of 2016.


Regenerative Tissue Portfolio

Admedus has been very successful this year in expanding the ADAPT® regenerative tissue portfolio for additional soft tissue repair applications.

In 2016, the company is looking to launch a vascular repair tissue product to complement its existing CardioCel sales in the cardiovascular surgical repair and reconstruction market.

The launch of a vascular product franchise will help build company revenue over the coming years and is intended for procedures such as repairing the carotid arteries to reduce the incidence of stroke.

Admedus said that the R&D team will continue to progress key regenerative ADAPT tissue projects in 2016 in dura mater repair (to treat head and brain injuries) as well as progressing the ADAPT tissue scaffolds for stem cell and cellular therapy delivery and ‘off-the shelf’ whole vessels for applications such as coronary artery bypass grafts (CABG).

Admedus will provide updates on these projects throughout 2016.

Rodne added: “2016 is shaping up to be a very exciting and important year for Admedus with growing sales, key product launches, progressing our regenerative tissue pipeline and important clinical milestones in our regenerative tissue and immunotherapy programs.

"The company is looking forward to continuing to build our company with many successes in 2016."

 

Proactive Investors Australia is the market leader in producing news, articles and research reports on ASX emerging companies with distribution in Australia, UK, North America and Hong Kong / China.

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Thu, 24 Dec 2015 09:00:00 -0500 https://www.proactiveinvestors.com/companies/news/148003/admedus-finishes-2015-in-strong-position-after-achieving-milestones-66357.html
<![CDATA[News - Admedus attracts U.S. investors in private placement ]]> https://www.proactiveinvestors.com/companies/news/148002/admedus-attracts-us-investors-in-private-placement-66313.html Admedus Limited (ASX:AHZ) continues to receive growing interest from U.S. investors, and has now completed a US$5 million placement at A$0.66 per share.

The placement bolsters Admedus’ financial position entering into 2016.

Admedus will also issue one warrant, to purchase an additional share at an exercise price of A$0.79, for each two shares issued.

Maxim Group LLC acted as sole placement agent in the U.S. for the transaction.

Lee Rodne, MD & CEO, commented:

“The funds raised from this private placement of our shares provides a significant boost to the company’s financial position as we enter the New Year and reflects growing interest in Admedus by U.S. investors.

"2015 has been a very positive year for Admedus as we’ve continued to show strong successes in our programs and we’re expecting to achieve a number of key milestones in 2016.”


Allocation of funding

Funds raised from the placement will be used to support ongoing programs within the company.

This includes the progression of the HPV immunotherapy program towards a clinical study in 2016 and continued expansion of the ADAPT® regenerative medicine product portfolio.

Admedus, in conjunction with Professor Ian Frazer, is developing a therapeutic vaccine platform, with programs targeting HSV-2, HPV and HPV related cancers.

The HSV-2 program is currently in a Phase II clinical study and the HPV program has shown exceptional results to date and Admedus anticipates that it will enter into a Phase Ib clinical study in HPV infected subjects in the coming year.


CardioCel® expansion

In 2015, the company continued its successful global launch of CardioCel®. CardioCel is now used in over 135 centres globally for the repair and reconstruction of cardiovascular defects and disease in both children and adults.

In addition, Admedus has recently initiated a post market clinical study with leading heart institutions to show improved patient outcomes in reconstructing aortic heart valves versus the need to use bioprosthetic valves that need to be replaced during the patient’s lifespan.

Rodne added: “Admedus has had another very productive year and is looking forward to reporting the achievement of a number of key milestones in both its immunotherapy programs and regenerative medicine portfolio during 2016.”

 

Proactive Investors Australia is the market leader in producing news, articles and research reports on ASX emerging companies with distribution in Australia, UK, North America and Hong Kong / China.

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Tue, 22 Dec 2015 09:30:00 -0500 https://www.proactiveinvestors.com/companies/news/148002/admedus-attracts-us-investors-in-private-placement-66313.html
<![CDATA[News - Admedus Limited sets sail for raising ]]> https://www.proactiveinvestors.com/companies/news/148001/admedus-limited-sets-sail-for-raising-66252.html Specialist healthcare company Admedus Limited (ASX:AHZ) has been granted a trading halt by the ASX this morning, pending details of a capital raising.

Admedus has assets from research & development through clinical development as well as sales, marketing and distribution.

The halt will remain in place until the opening of trade on Tuesday 22nd December 2015, or earlier if an announcement is made to the market.

 

Proactive Investors Australia is the market leader in producing news, articles and research reports on ASX emerging companies with distribution in Australia, UK, North America and Hong Kong / China.

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Fri, 18 Dec 2015 11:00:00 -0500 https://www.proactiveinvestors.com/companies/news/148001/admedus-limited-sets-sail-for-raising-66252.html
<![CDATA[News - Admedus pumping along: broker report ]]> https://www.proactiveinvestors.com/companies/news/148000/admedus-pumping-along-broker-report-65588.html Admedus (ASX:AHZ) is the subject of a new research report from Morgans stockbrokers research report. Here is a summary:

- Expanded applications of CardioCel® across heart valve reconstruction and vascular repair moves company away from just relying on a single product.

- HSV-2 Phase 2 trial expected to read out interim results this quarter.

- Share consolidation likely to reduce daily share price volatility.

- AGM to highlight continued sales growth of CardioCel®.

- Investment view remains positive.

Current price: A$0.066
Target price: A$0.18
Previous target: A$0.18
Up/downside: 176.6%
Market cap: US$86.01m, A$121.9M
Average daily turnover: US$0.12m, A$0.16m
Current shares o/s 2,247m

 

Regenerative tissue portfolio continues to grow and CardioCel® continues to gain traction

Since our last update AHZ now has CardioCel® in around 120 centres globally and over 2,500 implants. More recently the company announced positive results from an animal study and the initiation using CardioCel® in heart valve reconstructions. 

The product is already cleared the FDA for this indication with the study designed to expand market expansion. The company is also progressing with its vascular tissue product range and expanding into dura mater, illustrating its ability to develop an entire portfolio of tissue products. The excitement is the ability of the company to develop a portfolio of revenue generating products and not replying on a single product.

Immunotherapy phase II recruitment closing AHZ is progressing with two vaccine trials. The first of the trials, a Phase II trial for a therapeutic vaccine for Herpes Simplex Virus (HSV-2), is on track to complete recruitment in 4QFY15 with interim results expected in late CY15. 

The second trial, a therapeutic treatment for HPV, is currently progressing towards a phase Ib trial.

 

AGM and share consolidation

The AGM on 13 November is expected to highlight the continued growth in sales of CardioCel® and confirm that the interim HSV-2 results are due this quarter. The share consolidation (10 to 1) will help reduce the volatility in the daily share price. The last day for trading pre-consolidation is 16 November and shares will trade post consolidation on 27 November.

 

Investment outlook remains positive

We maintain our Add recommendation on AHZ. Catalysts include interim results on the Phase II HSV-2 vaccine trial and further growth in CardioCel® sales which are reported each quarter and expansion of the regenerative tissue portfolio. The key risk to our price target of A$0.18 is a higher-than-forecast cost of building the CardioCel® business.

 

Valuation

Our DCF valuation remains unchanged at A$0.18. The divisional components of our DCF valuation are regenerative medicines at A$0.09 (unchanged), immunotherapies at A$$0.05 (unchanged) and medical products at A$0.04 (unchanged).


FY15 result and 1QFY16

AHZ posted a FY15 net loss of A$26.8m, which was higher than our forecast and largely attributable to increasing costs associated with the launch of CardioCel® and an increasing ownership of the vaccine business, which now sees us consolidating the trial and operating costs. 

The 1QFY16 results reported sales of A$3.0m (up 42.5% on pcp) and net cash outflow of A$7.4m. AHZ had A$16.7m in cash reserves at 30 September 2015. There were no changes in our forecasts for FY16, FY17 and FY18 respectively.

 

Proactive Investors Australia is the market leader in producing news, articles and research reports on ASX emerging companies with distribution in Australia, UK, North America and Hong Kong / China.

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Fri, 13 Nov 2015 12:30:00 -0500 https://www.proactiveinvestors.com/companies/news/148000/admedus-pumping-along-broker-report-65588.html
<![CDATA[News - Admedus taps huge European market with green light for CardioCel ]]> https://www.proactiveinvestors.com/companies/news/147999/admedus-taps-huge-european-market-with-green-light-for-cardiocel-65482.html Admedus (ASX:AHZ) has consolidated its position in European medical markets with a new approvals milestone enabling surgeons on the continent to use the company’s CardioCel heart reconstruction technology.

Admedus received notification from the European Medicines Agency (EMA) that CardioCel has been granted a broader label indication for its use in Europe.

The new, expanded indication for CardioCel means the product is approved for use in the repair and reconstruction of heart valves and is more in line with the U.S. label.
 
The label expansion is part of the global strategy to position CardioCel as the leading bio-scaffold and establishes the product in more than 120 centres globally.

Used in the repair and treat cardiovascular defects, CardioCel was initially launched in Europe at the end of 2013 and has been implanted in over 3000 patients.

This recent label extension will enable surgeons to use CardioCel not only to repair and reconstruct heart valves, but to repair congenital heart defects and heart valve augmentations.

Admedus is currently undertaking a post-approval clinical study with leading heart centres to further bolster the clinical data available for CardioCel to demonstrate the benefits to patients in whole valve reconstructions over bio-prosthetic valve replacement.

The European heart valve market is estimated to be worth over $1 billion.


Growing footprint

A firmer presence for CardioCel in Europe builds on Admedus’ broader strategy of establishing a global franchise for CardioCel.

This plan was most recently advanced by a Malaysian rollout earlier this month for which the first sales have already been registered.

Growth in the treatment’s availability throughout Malaysia in the coming quarters is expected to add to CardioCel revenue in the current financial year.

This projection is supported by Malaysia’s population of more than 30 million people and strong record for cardiothoracic surgery.

The global rollout of CardioCel positions Admedus to benefit from the US$2 billion aortic valve market as surgeons look for better tissues to repair and reconstruct valves.

In addition to Europe, the U.S. and Malaysia, CardioCel is on market in Canada, Hong Kong and Singapore and continues to be accessed in the Australian market through early access programs.

Admedus is also working with its partner Genpharm in the Middle Eastern and Northern Africa region for additional regulatory approvals as well as exploring new markets in Asia.


CardioCel strengths

CardioCel overcomes problems associated with current materials on the market by providing surgeons with a tissue bio-implant that is not only durable, but its natural flexibility and elasticity makes it easier to handle and use and so allows surgeons to more easily work on complex cardiac repairs and their continuum of care.

The lack of calcification in the patients addresses one of the key issues with other existing tissue products and is a key milestone for the technology.

Although traditional treatment using prosthetic valves have improved on earlier technologies, they still do not enable full motion of the aortic valve and root. They therefor result in suboptimal haemodynamics and can require multiple replacements throughout a patient’s life.

In contrast, reconstructing the heart valve with CardioCel has the potential to be a life-long solution and patients can be treated by earlier intervention before requiring a replacement bio-prosthetic or mechanical valve.

Preclinical data for CardioCel has demonstrated durability and anti-calcification properties that facilitate host tissue remodelling as well as the delivery of better functioning valves with better haemodynamics.

Its ability to repair earlier in the valve disease process and bodes well for longer-term patient outcomes, potentially avoiding the need for replacement valves.

CardioCel does not require anticoagulants.


Broader portfolio

CardioCel is the first commercialised product from Admedus’ ADAPT tissue engineering platform and helps de-risk this intellectual property.

ADAPT tissue benefits include safe bio-compatibility, physical durability and the ability to promote site-specific tissue regrowth without calcification in an off-the-shelf application with no special or technical training required.

Products using this tissue technology will also target conditions outside of heart disease in the near future, including spinal and cranial repair needs.

Admedus is also developing a second, differentiated platform technology in therapeutic vaccines and immunotherapies for infectious disease and oncology.

The company is currently developing a suite of vaccines that treat and prevent infectious diseases and cancers caused by Herpes Simplex Virus and Human Papillomavirus.

This adds value to Admedus given that 1 in 6 people aged between 14 and 49 in the U.S. are estimated to be infected with Herpes Simplex Virus, which has no present cure.


Analysis

The European label expansion is important for Admedus since it will help the company to increase the use of CardioCel in this key region, particularly in adult patients.

The heart valve market in Europe is estimated to be worth $1 billion.

Improved access to this market also helps Admedus expand its work with surgeons and key heart centres in Europe on improving patient outcomes in treating heart valve disease by repairing and reconstructing heart valves with CardioCel.

Progress in Europe also illustrates the momentum of Admedus’ global rollout for CardioCel, following quickly on the heels of a Malaysian expansion which brought the number of patients now using CardioCel to more than 3000.

The CardioCel rollout has had a major impact on Admedus income figures, with sales up 42.5% year-on-year in the September quarter to A$3.03 million.

The commercialisation of CardioCel de-risks the upcoming marketing of other ADAPT products, including a carotid endarterectomy treatment planned to be available in 2016.

Other applications expected to roll out of the ADAPT pipeline in coming years include spinal and cranial repair products, treatments for CABG and AV fistula as well as hernia repairs and a stem cell or stem cell factor delivery.


Proactive Investors Australia is the market leader in producing news, articles and research reports on ASX emerging companies with distribution in Australia, UK, North America and Hong Kong / China.

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Mon, 09 Nov 2015 10:00:00 -0500 https://www.proactiveinvestors.com/companies/news/147999/admedus-taps-huge-european-market-with-green-light-for-cardiocel-65482.html
<![CDATA[News - Admedus to add revenue as global CardioCel rollout enters Malaysia ]]> https://www.proactiveinvestors.com/companies/news/147998/admedus-to-add-revenue-as-global-cardiocel-rollout-enters-malaysia-65423.html Admedus (ASX:AHZ) has taken a major step in building a global franchise for its unique CardioCel heart reconstruction technology by launching the product in Malaysia.

With a population of over 30 million people and regional patient needs in treating cardiovascular disease, Malaysia has a strong record for cardiothoracic surgery and therefore plays an important strategic market for Admedus.

Expansion into the country has already registered its first sales, bringing the number of patients now using CardioCel to more than 3000.

Growth in the treatment’s availability throughout Malaysia in the coming quarters is expected to add to CardioCel revenue in the current financial year.

CardioCel is now on market in Europe, the U.S., Canada, Hong Kong, Singapore, and Malaysia and continues to be accessed in the Australian market through early access programs.

Admedus is also working with its partner Genpharm in the Middle Eastern and Northern Africa (MENA) region for additional regulatory approvals as well as exploring new markets in Asia.


About CardioCel

CardioCel is a bio-scaffold used to repair and treat cardiovascular defects, including reconstructing and repairing heart valves to retain their native function.

Admedus is currently undertaking a post-market clinical study with leading heart centres to show improved patient outcomes in reconstructing the aortic heart valve with CardioCel versus replacement bioprosthetic valves that are on the market today.

Strong preclinical data for the product has demonstrated durability and anti-calcification properties that facilitate host tissue remodelling as well as the delivery of better functioning valves with better haemodynamics.

Its ability to repair earlier in the valve disease process and bodes well for longer-term patient outcomes, potentially avoiding the need for replacement valves.

CardioCel does not require anticoagulants. 

The aortic heart valve replacement market is estimated to be worth more than US$2 billion.

CardioCel is the first commercialised product from Admedus’ ADAPT tissue engineering platform and helps de-risk this intellectual property.

ADAPT tissue benefits include safe bio-compatibility, physical durability and the ability to promote site-specific tissue regrowth without calcification in an off-the-shelf application with no special or technical training required.

Products using this tissue technology will also target conditions outside of heart disease in the near future, including spinal and cranial repair needs.


Second proprietary platform

In addition to the ADAPT portfolio, Admedus is developing a second, differentiated platform technology in therapeutic vaccines and immunotherapies for infectious disease and oncology.

The company’s next-generation vaccine technology builds on the novel scientific information discovered, published and patented from Professor Ian Frazer’s work that led to the development of Gardasil – the first prophylactic cervical cancer vaccine.

Admedus technology is particularly effective in stimulating cellular immune responses that have an enhanced ability to destroy infected or cancerous cells.

The company is currently developing a suite of vaccines that treat and prevent infectious diseases and cancers caused by Herpes Simplex Virus and Human Papillomavirus.

Admedus’ unique delivery mechanism ensures that there is a stronger and more effective immune response, creating both a therapeutic (treat) and prophylactic (prevent) effect.

This adds value to the company given that 1 in 6 people aged between 14 and 49 in the U.S. are estimated to be infected with Herpes Simplex Virus, which has no present cure.


Analysis

CardioCel is expected to be available in additional Malaysian centres in the coming quarters, which will add to the growing sources of revenue in FY16.

The global rollout of CardioCel positions Admedus to benefit from the US$2 billion aortic valve market as surgeons look for better tissues to repair and reconstruct valves.
 
Momentum for this rollout has been substantial, with CardioCel already in use across Europe, North America and Southeast Asia. CardioCel studies for Chinese market approval have been initiated and a MENA region approvals process is underway.

The CardioCel rollout has had a major impact on Admedus income figures, with sales up 42.5% year-on-year in the September quarter to A$3.03 million.

The commercialisation of CardioCel de-risks the upcoming marketing of other ADAPT products, including a carotid endarterectomy treatment planned to be available in 2016.

Other applications expected to roll out of the ADAPT pipeline in coming years include spinal and cranial repair products, treatments for CABG and AV fistula as well as hernia repairs and a stem cell or stem cell factor delivery.

Admedus is in a strong financial position, with a cash balance as of the end of September totalling A$16.7 million.


Proactive Investors Australia is the market leader in producing news, articles and research reports on ASX emerging companies with distribution in Australia, UK, North America and Hong Kong / China.

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Wed, 04 Nov 2015 10:10:00 -0500 https://www.proactiveinvestors.com/companies/news/147998/admedus-to-add-revenue-as-global-cardiocel-rollout-enters-malaysia-65423.html
<![CDATA[News - Admedus Limited underlines viability of expanding heart surgery method ]]> https://www.proactiveinvestors.com/companies/news/147997/admedus-limited-underlines-viability-of-expanding-heart-surgery-method-64935.html A new study has confirmed the practical advantages and marketing potential of Admedus Limited’s (ASX:AHZ) unique CardioCel heart reconstruction technology.

A preclinical trial undertaken at KU Leuven University in Belgium indicated successful valve reconstructions and supported the use of CardioCel in the complete reconstruction of aortic heart valves.

The study is important in that it clearly show the benefits of reconstructing heart valves with CardioCel compared to using a bio-prosthetic valve. It also illustrated the benefits of Admedus’ ADAPT tissue engineering process and its ability to produce superior regenerative tissue products.

“The results from the study are very positive and some of the best results we have seen in this model,” KU Leuven lead researcher Professor Bart Meuris said.

This report aims to address the disadvantages found with existing bio-prosthetic valves and emphasises the unique potential for CardioCel to penetrate a global, underserviced market.

CardioCel is currently on the market in the U.S., Canada, Singapore and Europe, and is available to surgeon via special access schemes in Australia and other parts of Asia.

It is used in in 110 heart centres.

CardioCel is a type of cardiovascular bio-scaffold that can be used to repair congenital heart deformities and more complex heart defects.

It is used to repair diseased paediatric and adult hearts. These repairs range from routine hole-in-the-hear operations to major vessel outflow tract repairs.


A step forward

Specifically, the latest CardioCel study focused on aortic tri-leaflet reconstruction and examined nine leaflets replaced in three sheep. Leaflets are cusps connected to the aortic valve.

The results showed either no or minimal calcification. Only minimal calcification was seen around the sutures and a commissure.  In addition, the valves were competent, demonstrating positive haemodynamics, with no leakage and excellent coaptation of the leaflets post reconstruction.

After six months, new collagen had formed on both sides of the leaflet as a clear sign of post-surgery remodelling around CardioCel, with host fibroblasts detected within the CardioCel bio-scaffold.

The six month time-frame in sheep is representative of more than 10 years of data in adult patients.

This work will support a recently announced follow-on study on aortic tri-leaflet heart valve reconstruction using CardioCel in Europe and the U.S.

KU Leuven has already received ethics approval to participate in this clinical trial.


The case for CardioCel

CardioCel overcomes problems associated with current materials on the market by providing surgeons with a tissue bio-implant that is not only durable, but its natural flexibility and elasticity makes it easier to handle and use and so allows surgeons to more easily work on complex cardiac repairs and their continuum of care.

The lack of calcification in the patients addresses one of the key issues with other existing tissue products and is a key milestone for the technology.

Although traditional treatment using prosthetic valves have improved on earlier technologies, they still do not enable full motion of the aortic valve and root. They therefor result in suboptimal haemodynamics and can require multiple replacements throughout a patient’s life.

In contrast, reconstructing the heart valve with CardioCel has the potential to be a life-long solution and patients can be treated by earlier intervention before requiring a replacement bio-prosthetic or mechanical valve.

In addition, a combination of improved haemodynamics, lack of calcification and post-implant remodelling as also seen with reconstructing the valves with CardioCel in previous studies, has the potential to address all of the disadvantages of existing bio-prosthetic valves and reconstruction techniques that utilise other tissues including autologous tissue.

Recent progress in adapting CardioCel to specialise uses has included the development and release in September of a smaller, 2cm by 2cm model. This adds to the existing manufactured and commercially available 4cm by 4cm, 5cm by 8cm and 2cm by 8cm materials.

The release of the 2cm x 2cm model was part of a strategy to offer a complete range of CardioCel products for all cardiovascular repairs and reconstructions.


ADAPT

Along with this latest research, validation for Admedus’ ADAPT platform has included a recent collaboration with leading regenerative stem biology institute Ear Science Institute Australia (ESIA) on delivery of stem cells on ADAPT tissue in both in vitro and in vivo models.

The studies will investigate a range of bone marrow derived mesenchymal stem cells and adipose derived stem cells delivered on a variety of ADAPT treated tissues.

On identifying the most suitable stem cell population, Admedus will undertake separate models of tissue regeneration, including functional remodelling of the heart after myocardial infarct (heart attack).

These studies are in line with Admedus’ strategy to bring a range of ADAPT based products to market.

Progress in applying adapt in bio-scaffold tissue engineering as well as a delivery platform for stem cells and other cellular therapies demonstrates that the process can be tailored to meet market demand.


Beyond CardioCel

Separately, Admedus is developing a suite of vaccines that treat and prevent infectious diseases and cancers caused by Herpes Simplex Virus and Human Papillomavirus (HPV).

Admedus is focused on commercialising a new era of therapeutic vaccines, with the HPV therapeutic vaccine progressing well in preclinical studies.

The unique delivery mechanism of the vaccine ensures that there is a stronger and more effective immune response creating both a therapeutic (treat) and prophylactic (prevent) effect.

This adds value to the company given that 1 in 6 people aged between 14 and 49 in the U.S. are estimated to be infected with HSV, which has no present cure.

As such, a vaccine could potentially address a market worth more than US$6 billion.


Analysis

The latest CardioCel study data is important in that it confirms the viability and variability of the ADAPT process as well as the practical advantages of Admedus’ product versus conventional heart reconstruction therapies.

The results indicate a range of treatment possibilities in both paediatric and adult patients.

Admedus has demonstrated its ability to penetrate an important global market, with commercialisation of its innovative technology on four continents.

Further technical advantages of CardioCel could be revealed with better understanding of the possible role of stem cells in tissue regeneration. The product therefor has potential to facilitate endogenous stem cells and other cells to regenerate and repair damaged tissue.

Results of the company’s ongoing HSV studies are set to further bolster the company’s market position before the end of the year.

 

Proactive Investors Australia is the market leader in producing news, articles and research reports on ASX emerging companies with distribution in Australia, UK, North America and Hong Kong / China.

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Tue, 06 Oct 2015 11:20:00 -0400 https://www.proactiveinvestors.com/companies/news/147997/admedus-limited-underlines-viability-of-expanding-heart-surgery-method-64935.html
<![CDATA[News - Admedus and Ear Science Institute Australia team up on stem cell delivery ]]> https://www.proactiveinvestors.com/companies/news/147996/admedus-and-ear-science-institute-australia-team-up-on-stem-cell-delivery-64840.html Admedus Limited (ASX:AHZ) will work with leading regenerative stem biology institute Ear Science Institute Australia (ESIA) on delivery of stem cells on ADAPT tissue in both in vitro and in vivo models.

The studies will investigate a range of bone marrow derived mesenchymal stem cells and adipose derived stem cells delivered on a variety of ADAPT treated tissues.

On identifying the most suitable stem cell population, Admedus will undertake separate models of tissue regeneration, including functional remodelling of the heart after myocardial infarct (heart attack).

These studies are in line with Admedus’ strategy to bring a range of ADAPT based products to market.

Lee Rodne, chief executive officer, commented:

“These are important studies to further validate the utility of ADAPT tissue as a delivery platform for stem cells and other cellular therapies.

“The research using ADAPT tissue and stem cells is part of the Admedus strategy to develop a number of regenerative tissue products based on the ADAPT tissue engineering technology, which produces tissues that limit calcification and are effectively remodelled, making them ideal for a broader range of surgical products.”

Rodney Dilley, associate professor and Head of Molecular and Cellular Otolaryngology at ESIA, added:

“We are excited to work with Admedus on this important project. As a leading research institution, there was a natural synergy between our work in studying regenerative cell biology and Admedus’ interest in using their bio-scaffolds to deliver stem cells.

“We look forward to continuing to work closely with Admedus in the aim of improving patient outcomes.”


ESIA Collaboration

The studies with ESIA will explore the levels of regeneration, vascularisation and cell differentiation when ADAPT tissue is used with stem cells.

Previous data in heart valves has shown a strong level of autologous regeneration and vascularisation around the ADAPT tissue that is facilitated by cells.

On identifying the most suitable stem cell population, Admedus will move into a separate larger scale in vivo study of tissue regeneration, including functional remodelling of the heart after myocardial infarct.

Historically, ADAPT tissue has shown to be an ideal platform for cellular therapies such as stem cells.

The data from these studies will assist Admedus in developing its ADAPT scaffolds as the ideal stem cell delivery platform to improve repair in a wide range of indications, including heart tissue after myocardial infarct.


Analysis

Admedus’ collaboration with ESIA will validate the use of the company’s ADAPT tissue as a delivery platform for stem cells and other cellular therapies.

This further supports its strategy of bringing a range of products based on its ADAPT Tissue Engineering Process to market.

Initial results from the study are expected over the next 6 to 12 months.

Successful completion of the studies also opens the door to develop and be at the forefront of numerous cellular based therapies where conventional stem cells haven't achieved efficacy.

 

Proactive Investors Australia is the market leader in producing news, articles and research reports on ASX emerging companies with distribution in Australia, UK, North America and Hong Kong / China.

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Wed, 30 Sep 2015 13:20:00 -0400 https://www.proactiveinvestors.com/companies/news/147996/admedus-and-ear-science-institute-australia-team-up-on-stem-cell-delivery-64840.html
<![CDATA[News - Admedus starts heart valve clinical study ]]> https://www.proactiveinvestors.com/companies/news/147995/admedus-starts-heart-valve-clinical-study-64695.html Admedus Limited (ASX:AHZ) has started a clinical study into aortic tri-leaflet heart valve reconstructions using its cardiovascular bio-scaffold CardioCel following a successful pre-clinical study.

The study will address aortic stenosis, or narrowing, which is the most common valvular heart disease in developed countries.

It gives surgeons access to a bio-prosthetic tissue that can withstand this high pressured area within the heart, not calcify and facilitate host tissue regeneration.  

The pre-clinical study was undertaken in conjunction with KU Leuven University in Belgium.

The study, which will further support the use of CardioCel in heart valve repair and reconstructions, will be undertaken in four leading heart centres in Europe and the U.S.
   
A total of 80 adult patients will be recruited with initial cases already enrolled.

The primary safety endpoint for the clinical study is to ensure same rates of in-hospital survival, while also looking for superior long-term benefits for patients, better haemodynamic outcomes, cell infiltration, regrowth of native tissue and long-term durability without calcification.

Admedus has already been very successful in its initial launch strategy of introducing CardioCel to leading congenital centres in the U.S. and Europe with over 95 centres now using it to treat congenital heart defects.

Lee Rodne, chief executive officer, commented:

“Off the back of a very successful pre-clinical study, we have now commenced a clinical study to provide further data to use CardioCel for complete aortic valve reconstructions.

“This is an important study in aortic valve reconstruction, which has never been done before with a bio-prosthetic tissue like CardioCel.

“We believe the results will highlight the patient benefits of completely reconstructing the aortic valve with CardioCel compared to the current industry need of replacing it multiple times throughout a patient’s life.”


Study Details

The study involves surgeons using CardioCel to reconstruct the three leaflets of the aortic valve as an alternative to replacing it with a bio-prosthetic valve.

This provides an opportunity for autologous repair and the potential for patients to have a ‘native’ valve with better haemodynamic outcomes and overall improved health benefits compared to a replacement valve.

Aortic stenosis is the most common valvular heart disease in developed countries, with the incidence rate of around 25% in people over the age of 65 and prevalence increasing with age.

Last year, there were 165,000 aortic valve replacement surgeries undertaken in the U.S. alone.

While these were symptomatic patients, Admedus expects the market size for valve reconstruction will be larger once the benefits of treating patients earlier and more effectively is recognised.

Domenico Mazzitelli, cardiac surgeon and clinical study lead at the German Heart Centre Munich, commented:

“As a surgeon, you often ask yourself are we really repairing the valve or are we just delaying the next heart valve operation or replacement.

“Where most patients with symptomatic aortic valve disease will be delayed to surgery, this study could prove that CardioCel could offer earlier intervention, with possible life-long benefits.”

The study will enrol 80 adult patients at two European and two U.S. sites, with initial cases already enrolled in the first week post ethics approval.

Ethics approval has been received for the two European centres, KU Leuven University in Belgium and the German Heart Centre Munich, with U.S. ethics approval expected in the coming months.

“While a majority of current aortic valve procedures follow the replacement strategy, we hope to show that reconstructing the valve with CardioCel is superior to replacing the valve and provides patients with long-term health benefits,” Rodne added.

Patients in the clinical study will be reviewed 6, 12 and 24 months post-surgery to evaluate safety data and primary and secondary endpoints.


Analysis

The clinical study into complete aortic valve reconstruction using CardioCel represents the introduction of a disruptive technology into an existing multi-billion dollar market.

It has the potential to provide a long term benefit for patients instead of an ongoing cycle of replacement after replacement.

This is a key milestone in Admedus’ commercial strategy of launching CardioCel initially in the top paediatric centres in treating congenital heart defects and then expanding into the larger adult markets.

Notably, it could expand the use of CardioCel, which will in turn generate more revenue for Admedus.

Demonstrating this potential, the market in the U.S. along is around 165,000 procedures per annum compared to 60,000 for congenital heart disease.

This could build CardioCel as the gold standard regenerative tissue product for adult heart valve reconstructions and will provide further data for global surgeons to be able to repair a heart valve with CardioCel vs the need for these patients to have go through multiple replacement valves throughout their lifetimes.

In addition, most of the procedures are carried out on adults and the study could complement other heart valve markets such as the mitral valve repair market where about 180,000 procedures are performed annually.

 

Proactive Investors Australia is the market leader in producing news, articles and research reports on ASX emerging companies with distribution in Australia, UK, North America and Hong Kong / China.

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Wed, 23 Sep 2015 10:06:00 -0400 https://www.proactiveinvestors.com/companies/news/147995/admedus-starts-heart-valve-clinical-study-64695.html
<![CDATA[News - Admedus develops new CardioCel product for repair of heart defects ]]> https://www.proactiveinvestors.com/companies/news/147994/admedus-develops-new-cardiocel-product-for-repair-of-heart-defects-64347.html Admedus (ASX:AHZ) has developed and released a new 2cm by 2cm CardioCel® bio-scaffold material for repair and reconstruction of congenital heart defects that could help drive sales growth.

This was developed based on feedback from global congenital surgeons who felt the smaller scaffold could potentially be valuable.

It will initially be released to global congenital surgery Key Opinion Leaders to gain further clinical experience of the material with a view to undertaking a broader commercial launch.

This adds to the existing manufactured and commercially available 4cm by 4cm, 5cm by 8cm and 2cm by 8cm materials that are used in over 95 centres internationally.

Earlier this year, the company shipped 2cm by 8cm CardioCel® bio-scaffold materials to the US for use in vascular repairs such as carotid endarterectomies.

In June, Admedus announced positive long-term data from the CardioCel® Phase II clinical trial, which showed no evidence of calcification after 7 years.

Importantly, there have been no repeat heart procedures related to CardioCel for the monitored patients in the study and there are no signs of CardioCel calcification.

Lee Rodne, chief executive officer, commented:

“The release of a 2cm x 2cm CardioCel® bio-scaffold is part of our continued strategy to offer a complete range of CardioCel® products for all cardiovascular repairs and reconstructions.

“We are excited to make the new size available to our key surgeons, as we work closely with them to advance the management of congenital heart defects internationally and offer patients the clinical benefits of the ADAPT® tissue engineering process.”

“We believe the development of different sizes of the CardioCel® product perfectly demonstrates how the ADAPT® tissue engineering process can be tailored to meet market demand and provide multiple product revenue streams in the company and drive sales growth.

“With CardioCel® now used in over 95 centres across the US, Canada, Asia, Australia and Europe, we will continue to investigate the development of additional regenerative tissue products across a range of surgical applications.”


CardioCel

The smaller 2cm by 2cm sized bio-scaffold material was developed based on feedback from global congenital surgeons who felt the smaller scaffold could potentially be valuable across the spectrum of congenital heart defects repair and reconstruction procedures.

These and other sizes of CardioCel® bio-scaffold materials are created using Admedus’ ADAPT® tissue engineering process, which removes DNA and RNA from animal pericardium tissue to create a collagen matrix used for treatment and repair within the body.

CardioCel® has proven utility and importance in the surgical repairs of cardiovascular defects with 11 patients now past 5 years post implantation with no sign of calcification.

Notably, the first patient in the Phase II clinical trial has no sign of calcification after over 7 years.

Four other patients are past the 6 year mark while the company is following another 4 patients who are past 4 years.

This is a key benefit given that most implanted tissues have calcification within an 18 month timeframe in paediatrics.


Analysis

Admedus’ release of the new smaller CardioCel bio-scaffold clearly highlights how its ADAPT® tissue engineering process can be tailored to meet market demand.

This product has now being released to key surgeons that are global thought leaders in treating congenital heart defects with commercial launch expected in early 2016.

In addition, its other regenerative tissue products like Dura Mater repair are also progressing through regulatory studies to get onto the market in the coming 12-24 months.

These are key in Admedus’ strategy to continue developing and bringing to market additional regenerative tissue products for large applications, growing both revenue and value.

Separately, the company’s Herpes Simplex 2 vaccine Phase II study continues to progress after an independent Safety Review Committee (SRC) unanimously recommended that no changes were needed.

This adds value to the company given that 1 in 6 people aged between 14 and 49 in the U.S. are estimated to be infected with HSV, which has no present cure.

As such, a vaccine could potentially address a market worth more than US$6 billion.
   
Share Price Catalysts:

- Growing number of global heart centres using CardioCel to repair heart defects including repairing heart valves;
- Additional regulatory approvals in Asia for CardioCel;
- Initiation of an aortic valve repair study to show CardioCel’s utility and advantages in aortic repair vs aortic valve replacement (aortic valve market today is large and mostly using replacement procedures as they haven’t had suitable tissue to repair);
- Expanded ADAPT pipeline in areas such as vessel repairs, cellular therapies and progressing our dura mater product towards studies for market approvals;
- Interim results from the HSV-2 Phase II study expected towards the end of 2015; and
- HPV vaccine progressing into clinical studies this year.

 

Proactive Investors Australia is the market leader in producing news, articles and research reports on ASX emerging companies with distribution in Australia, UK, North America and Hong Kong / China.

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Thu, 03 Sep 2015 09:00:00 -0400 https://www.proactiveinvestors.com/companies/news/147994/admedus-develops-new-cardiocel-product-for-repair-of-heart-defects-64347.html
<![CDATA[News - Admedus receives $0.18 price target from broker ]]> https://www.proactiveinvestors.com/companies/news/147993/admedus-receives-018-price-target-from-broker-64282.html Admedus (ASX:AHZ) has received an Add rating from broker Morgans, with a target of $0.18.

Based on the last price of $0.074, this implies the potential for a 140.9% upside.

The following is an extract from the report.


Looking for the catalysts

AHZ posted a FY15 result behind our forecast with a tax adjustment the main reason.

The key catalysts to drive the share price higher include growth in CardioCel ® sales and the release of interim HSV-2 results.

AHZ appears in a solid cash position to achieve key milestones. Add.


FY15 result below forecast

AHZ posted a net loss of A$26.8m, which was higher than our forecast of a net loss of A$19.5m. Product revenue of A$9.9m was generated representing A$7.3m from medical products and A$2.6m from CardioCel®.

The main reasons for the difference were:

1) A tax expense of A$$2.9m arising from the reversal of a prior period temporary difference;

2) A loss from non-controlling interest of A$1.5m;

3) Lower revenue from medical products of A$0.9m resulting from some product life cycle management and move to more consumable based operations;

4) Lower interest receipts of A$0.3m;

5) A$0.5m in higher share based payments; and

6) $0.3m in higher amortisation charges.

AHZ has A$24.0m in cash reserves, which we think is sufficient to drive sales in the key regenerative medicines division (CardioCel® is lead product).


Changes to forecasts

We have made a number of changes to our forecasts, moving FY16 to a net loss of A$8.2m (from NPAT of A$1.5m) and reducing our FY17 NPAT to A$11.2m from A$21.0m.

The main changes include:

1) Lower medical products revenue to A$7.8m (was A$8.8m);

2) Lower CardioCel® revenue to A$7m (was A$10m) reflecting a more moderate sales ramp than forecast; and

3) An increase in the cost base to A$23.3m (was A$19.8m) to bring the base in line with FY15, reflecting a higher spend to build the regenerative medicines division and research spend on the vaccines project.


Investment view remains positive

As a result of changes to forecasts our DCF valuation has been revised to A$0.18 (from A$0.20).

The key catalysts we expect in the next six months include growing quarterly sales of CardioCel® and the interim results from the HSV-2 vaccine trial.

The downside risk includes failure of the vaccine trial to achieve its clinical outcomes of safety and lowering viral outbreaks.

 

Proactive Investors Australia is the market leader in producing news, articles and research reports on ASX emerging companies with distribution in Australia, UK, North America and Hong Kong / China.

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Tue, 01 Sep 2015 08:00:00 -0400 https://www.proactiveinvestors.com/companies/news/147993/admedus-receives-018-price-target-from-broker-64282.html
<![CDATA[News - Admedus' herpes therapeutic vaccine study gains safety nod ]]> https://www.proactiveinvestors.com/companies/news/147992/admedus-herpes-therapeutic-vaccine-study-gains-safety-nod-64220.html Admedus Limited (ASX:AHZ) has received a resounding vote of confidence into the safety profile of its Herpes Simplex 2 (HSV-2) vaccine Phase II study.

An independent Safety Review Committee (SRC) unanimously recommended that the trial continue without any modifications after examining initial safety data from the first group of subjects dosed.

No safety issues have been seen in the study to date.

The company has also increased its interest in Admedus Vaccines – the platform vaccine development company, formerly Coridon, led by Professor Ian Frazer – to 72.2% from 66.3%.

More than 80% of the required study participants have either begun screening or received their initial dosing regimen.

The company will continue to recruit people into the study to complete full enrolment.

Interim results are expected towards the end of 2015.

The SRC is comprised of an independent group of physicians who are experts in infectious diseases.

It provides routine checks as per study protocol to ensure patient safety standards are met during each stage of the trial.

Lee Rodne, chief executive officer, commented:

“The outcome of the SRC review is extremely positive and provides further support for the safety profile of our HSV-2 therapeutic vaccine study.

“The trial is progressing well, with some participants already receiving their first three doses, and we look forward to the anticipated interim results.

“The data and progress of the HSV-2 and HPV programs and overall development of the technology is extremely positive and we continue to support Professor Frazer and the team.”

Admedus’ HSV-2 therapeutic vaccine is based on a platform technology initially developed by Professor Frazer. The technology is designed to enable, boost and support the body to fight against diseases, such as HSV-2.


Trial Details

The primary objective of the Phase II study is to explore both the safety of the therapeutic vaccine in people with HSV-2 and assess efficacy through evaluating changes in T-cell counts, HSV-2 viral shedding and viral outbreaks.

It is being run in Brisbane by Q-Pharm at the QIMR Berghofer Medical Research Institute.

The study involves participants undertaking a 45 day pre-vaccination period to establish a baseline and then each participant will receive three monthly intra-dermal injections, followed by a fourth injection 6 months after the initial dose.

A total of 40 otherwise healthy HSV-2 positive volunteers are needed for the trial, although the study does allow for over enrolments.


Admedus Vaccines

Admedus Vaccines was founded in 2000 by the Professor Frazer as a private unlisted company, to develop and commercialise patented technology for improving immune responses to DNA vaccines licensed by UniQuest Pty Ltd and developed at the University of Queensland.

The company has laboratories within the Translational Research Institute at the Princess Alexandra Hospital in Brisbane.

It seeks to utilise its unique optimisation technology to produce prophylactic and/or therapeutic DNA vaccines for a range of infectious diseases and cancers in humans.

Admedus Vaccines has 6 granted US patents protecting its codon optimisation DNA technology, which enhances protein expression in the cell or tissue targeted and results in an improved humoral response.

The second component of the technology, also patent protected, is to use a mixture of DNAs encoding ubiquitinated and non ubiquitinated proteins.


HSV-2

HSV-2 is the major causative agent of genital herpes, which often results in recurrent painful sores in the genital area and for which there is no cure. Infection is also life-ling.

Besides pain and discomfort to infected individuals, the virus can have serious health implications for babies born to infected women.

Herpes is also believed to aid in the transmission of HIV.

Current therapy for HSV-2 involves daily doses of antiviral drugs which can reduce, but not eliminate, outbreaks and viral shedding, so they can only reduce symptoms but are unable to prevent the spread of the virus.

One in eight Australians are infected with HSV-2 and in the U.S., the Center for Disease Control estimates that 16% of Americans between the ages of 15 and 49 are infected with the virus.


Analysis

The unanimously recommendation that the Herpes Simplex 2 vaccine Phase II study continue without any changes is a safety milestone for Admedus.

Progress continues to be made with more than 80% of study participants having joined the study and some participants already receiving their first three doses.

Progression through the study continues to add value for Admedus given that 1 in 6 people aged between 14 and 49 in the U.S. are estimated to be infected with HSV, which has no present cure.

As such, a vaccine could potentially address a market worth more than US$6 billion.

Interim results of the study are expected before the end of this year while the phase II study is expected to be completed towards the end of this financial year with final results to be completed around this time next year.

Gaining an increased shareholding in Admedus Vaccines to 72.2% will increase the revenue and income potential for the company as Professor Frazer’s HPV vaccine proceeds into clinical studies in the coming year.

In addition to the HSV-2 progress, the company has additional strings to its bow.
   
Share Price Catalysts:

- Growing number of global heart centres using CardioCel to repair heart defects including repairing heart valves;
- Additional regulatory approvals in Asia for CardioCel;
- Initiation of an aortic valve repair study to show CardioCel’s utility and advantages in aortic repair vs aortic valve replacement (aortic valve market today is large and mostly using replacement procedures as they haven’t had suitable tissue to repair);
- Expanded ADAPT pipeline in areas such as vessel repairs, cellular therapies and progressing our dura mater product towards studies for market approvals;
- Interim results from the HSV-2 Phase II study expected towards the end of 2015; and
- HPV vaccine progressing into clinical studies this year.

 

Proactive Investors Australia is the market leader in producing news, articles and research reports on ASX emerging companies with distribution in Australia, UK, North America and Hong Kong / China.

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Thu, 27 Aug 2015 09:14:00 -0400 https://www.proactiveinvestors.com/companies/news/147992/admedus-herpes-therapeutic-vaccine-study-gains-safety-nod-64220.html
<![CDATA[News - Admedus rapid revenue growth driven by global sales success ]]> https://www.proactiveinvestors.com/companies/news/147991/admedus-rapid-revenue-growth-driven-by-global-sales-success-63741.html Admedus (ASX:AHZ) has recorded a 16% increase in revenue to $2.9 million for the June 2015 quarter over the previous quarter and 36% over the previous corresponding quarter.

Full-year revenue is up 29% to $10.2 million including Total CardioCel® sales of $2.57 million.

Total income for the group was $11.4 million, which included a tax rebate of $1.1 million and grants of $148,000.

Closing cash balance as at 30th June 2015 was $24 million following a placement of shares in March that raised $28 million.

CardioCel®, the company’s lead regenerative tissue product for the repair of cardiovascular defects, has now being launched in the U.S., Europe, Canada, Singapore and Hong Kong.

Notably, it is used in over 90 centres globally with over 70 centres added just in the past 12 months.

Admedus continues to invest in the expansion of the CardioCel® product portfolio and the overall ADAPT tissue product portfolio in areas such as dura mater repair, building the potential for future revenue growth.

It also continues to work with Professor Ian Frazer and his team to advance the clinical development of its Herpes Simplex 2 (HSV-2) and Human papillomavirus (HPV) therapeutic vaccine programs.

Earlier this year the HSV-2 therapeutic vaccine moved into a Phase II study, with interim results anticipated towards the end of the 2015 calendar year.

The HPV therapeutic vaccine is progressing into clinical studies this financial year.


CardioCel® Activity

During FY2015, the company enhanced its sales teams in Europe, the U.S., Asia and Australia, with CardioCel® now used in over 90 centres.

To date, 2,600 patients have been implanted with the device to treat and repair their heart defects.

In June, Admedus announced positive long-term data from the CardioCel® Phase II clinical trial, which showed no evidence of calcification after 7 years.

Importantly, there have been no repeat heart procedures related to CardioCel for the monitored patients in the study and there are no signs of CardioCel calcification.


Analysis

Admedus’ growing revenue reflects the growing use of its CardioCel® regenerative tissue product as well as increase in sales of its infusion devices.

CardioCel® is now used in more than 90 centres globally to treat and repair heart defects.

The company continues to increase the number of centres using CardioCel® and expects continued sales growth as it brings additional regenerative tissue products onto the market for other large applications.

Catalysts ahead for CardioCel are:

- Growing number of global heart centres using CardioCel to repair heart defects including repairing heart valves;
- Additional regulatory approvals in Asia for CardioCel;
- Initiation of an aortic valve repair study to show CardioCel’s utility and advantages in aortic repair vs aortic valve replacement (aortic valve market today is large and mostly using replacement procedures as they haven’t had suitable tissue to repair);
- Expanded ADAPT pipeline in areas such as vessel repairs, cellular therapies and progressing our dura mater product towards studies for market approvals;
- Interim results from the HSV-2 Phase II study expected towards the end of 2015; and
- HPV vaccine progressing into clinical studies this year.



Proactive Investors Australia is the market leader in producing news, articles and research reports on ASX emerging companies with distribution in Australia, UK, North America and Hong Kong / China.

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Thu, 30 Jul 2015 14:07:00 -0400 https://www.proactiveinvestors.com/companies/news/147991/admedus-rapid-revenue-growth-driven-by-global-sales-success-63741.html
<![CDATA[News - Admedus’ CardioCel has long term potential for congenital heart disease ]]> https://www.proactiveinvestors.com/companies/news/147990/admedus-cardiocel-has-long-term-potential-for-congenital-heart-disease-63342.html Admedus Limited’s (ASX:AHZ) lead CardioCel® product has clear utility and importance in the surgical repairs of cardiovascular defects with 11 patients now past 5 years post implantation with no sign of calcification.

Notably, the first patient in the Phase II clinical trial has no sign of calcification after over 7 years.

This patient was implanted with CardioCel as part of a complex Tetralogy of Fallot procedure at 3 weeks old and is now over 7 years old and very well and healthy.

Four other patients are past the 6 year mark while the company is following another 4 patients who are past 4 years.

Admedus and the participating hospital will continue to follow a number of patients from the Phase II study through this extended program.

CardioCel is currently used in over 90 centres globally including 42 in the U.S., demonstrating a high level of adoption within the first 12 months within the market.

Lee Rodne, chief executive officer, commented:

“This long-term follow-up data illustrates some of the key features of CardioCel that we believe make it the bio-scaffold of choice for the repair of congenital heart disease defects.

“Given that the first patient in this Phase II clinical trial was treated over seven years ago and the patient is doing very well, we are particularly encouraged that there has been no requirement for repeat procedures and no evidence of calcification of the implanted device.”

Professor Leon Neethling, inventor of the ADAPT® technology and CardioCel, added:

“These results are very exciting given the fact that CardioCel show no signs of calcification after 5 plus years, especially since it is known that other tissues implanted in children tends to calcify rapidly, thus proving the effectiveness of the ADAPT® tissue engineering process to produce bioscaffold implantable tissue products like CardioCel®.

“These are very important data as we expand the use of CardioCel into the adult cardiac and the peripheral vascular markets.”


Long Term Outcomes

The positive long-term data from the Phase II clinical trial demonstrates the efficacy and safety of the company’s proprietary bio-scaffold in the repair of congenital heart disease defects.

Importantly, there have been no repeat heart procedures related to CardioCel for the monitored patients in the study and there are no signs of CardioCel calcification.

This data and evidence is important as it represents the only prospective clinical trial data in this patient population of congenital heart defects.  


CardioCel®

CardioCel is a regenerative tissue product engineered by the group’s ADAPT tissue engineering process to be a durable, pure collagen scaffold used to repair heart deformities including repairing and reconstructing heart valves.

The lack of calcification in the patients addresses one of the key issues with other existing tissue products and is a key milestone for the technology.

In May, the company developed a new CardioCel product for vascular repairs such as carotid endarterectomies into the U.S. market.

This is part of the company’s strategy to expand the use of CardioCel across a range of surgical applications.   

It follows on its receiving successful initial results from a pre-clinical study of ADAPT treated tissue in the repair of dura mater, the outer membrane enveloping the brain and spinal cord which is often damaged during traumatic brain injuries.


Analysis

The long-term results are encouraging for Admedus given that most implanted tissues have calcification within an 18 month timeframe in paediatrics, illustrating the importance of CardioCel in surgical repairs of cardiovascular defects.

It also provides very strong evidence of CardioCel’s long term patient outcomes for repairing congenital heart defects.

Catalysts ahead for CardioCel are:

- Growing number of global heart centres using CardioCel to repair heart defects including repairing heart valves;
- Additional regulatory approvals in Asia for CardioCel;
- Initiation of an aortic valve repair study to show CardioCel’s utility and advantages in aortic repair vs aortic valve replacement (aortic valve market today is large and mostly using replacement procedures as they haven’t had suitable tissue to repair); and
- Expanded ADAPT pipeline in areas such as vessel repairs, cellular therapies and progressing our dura mater product towards studies for market approvals.

In addition, the company expects that its therapeutic vaccine Phase II study for Herpes Simplex 2 (HSV-2) will complete enrolment in the near future with interim results reported by the end of this calendar year. 

This vaccine is led by Professor Ian Frazer and represents a large target market, making it an inflection point this year.

In addition, Admedus is progressing Ian Frazer’s next HPV vaccine into clinical study this financial year.  This vaccine is being developed as a treatment against HPV and cervical cancer. 

 

Proactive Investors Australia is the market leader in producing news, articles and research reports on ASX emerging companies with distribution in Australia, UK, North America and Hong Kong / China.

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Wed, 08 Jul 2015 09:08:00 -0400 https://www.proactiveinvestors.com/companies/news/147990/admedus-cardiocel-has-long-term-potential-for-congenital-heart-disease-63342.html
<![CDATA[News - Admedus' CardioCel cardiovascular used in 80 treatment centres ]]> https://www.proactiveinvestors.com/companies/news/147989/admedus-cardiocel-cardiovascular-used-in-80-treatment-centres-62992.html Admedus Limited (ASX:AHZ) has hit a milestone with the receipt of an approval letter for use in Singapore for its lead CardioCel® product, which has been shown to allow tissue regeneration once implanted.
   
CardioCel® has already been used in Singapore under a Special Access program since last year and this approval will accelerate market penetration in the region.

The application was based on the submission for U.S. Food and Drug Administration. It includes indications for use in cardiovascular repairs, suture buttressing and vascular and vessel repairs in both adults and children.

CardioCel® is now being used in over 80 treatment centres, including key institutions in Europe, U.S., Canada, Hong Kong and Singapore.

The company is pursuing additional approvals in Asia and has also partnered with GenPharma Int'l Pvt. Ltd for distribution in North African and Middle East markets.

“The Singapore approval caps off a very productive 12 months for the Admedus team, which is translating into growing sales momentum for CardioCel®, the flagship product from our ADAPT® platform,” chief executive officer Lee Rodne said.

“In addition to our already strong base in Europe, we have gained several new approvals for the product while also expanding our presence in the US, where CardioCel® is now available in 40 centres.”

“CardioCel® is being increasingly utilised by leading surgical groups, and continues to show compelling results and patient outcomes with respect to its ease of use, high tensile strength, low immunogenicity and strong anti-calcification properties.

“Our sales team is marshalling these results to cement the strong clinical rationale for using this product and to actively support further global expansion. We are confident that this highly considered approach will successfully drive topline growth.”

Admedus recently raised $28.1 million through a $12 million placement and $16.1 million rights issue to increase sales of its lead regenerative tissue product CardioCel®, support continued development of its regenerative tissue portfolio and advance its immunotherapy programs with Professor Ian Frazer.


CardioCel®

CardioCel® is a regenerative tissue product engineered by the group’s ADAPT® tissue engineering process to be a durable, pure collagen scaffold used to repair heart deformities including repairing and reconstructing heart valves.

Notably, the first patient from its Phase II study had their 6 year follow up earlier this year and the results show there was still no detectable calcification.

Other patients in the study also continue to show no signs of calcification or follow up surgeries after 3 to 5 years.

The lack of calcification addresses one of the key issues with other existing tissue products and is a key milestone for the technology.

This provides further potential for the future treatment of congenital heart disease, moving closer towards the stage where surgeons can reduce, if not eliminate, the need for patients to undergo repeat procedures.

In May, the company developed a new CardioCel® product for vascular repairs such as carotid endarterectomies into the U.S. market.

This is part of the company’s strategy to expand the use of CardioCel across a range of surgical applications.   

It follows on its receiving successful initial results from a pre-clinical study of ADAPT® treated tissue in the repair of dura mater, the outer membrane enveloping the brain and spinal cord which is often damaged during traumatic brain injuries.


Analysis

The approval in Singapore is a key milestone that will drive market penetration of CardioCel® in the region given that it will likely support the approval process in other Asian countries.

Momentum is building for further sales growth of the cardiovascular bio-scaffold with the product now used in over 80 centres globally.

With the company also developing new uses for CardioCel and its ADAPT tissue engineering technology, there is growth potential ahead.

Share price catalysts are:

- The growing number of global heart centres using CardioCel to repair heart defects including repairing heart valves;
- Additional regulatory approvals in Asia for CardioCel;
- Initiation of an aortic valve repair study to show CardioCel’s utility and advantages in aortic repair vs aortic valve replacement (aortic valve market today is large and mostly using replacement procedures as they haven’t had suitable tissue to repair); and
- Expanded ADAPT pipeline in areas such as vessel repairs, cellular therapies and progressing the dura mater product towards studies for market approvals.



Proactive Investors Australia is the market leader in producing news, articles and research reports on ASX emerging companies with distribution in Australia, UK, North America and Hong Kong / China.

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Thu, 18 Jun 2015 09:40:00 -0400 https://www.proactiveinvestors.com/companies/news/147989/admedus-cardiocel-cardiovascular-used-in-80-treatment-centres-62992.html
<![CDATA[News - Admedus moves to second dose of Herpes vaccine ]]> https://www.proactiveinvestors.com/companies/news/147988/admedus-moves-to-second-dose-of-herpes-vaccine-62766.html Admedus Limited (ASX:AHZ) continues to progress its Herpes Simplex 2 (HSV-2) Phase II study with initially enrolled participants now starting to receive their second dose of the therapeutic vaccine.

Interim data from the study into the vaccine’s safety and efficacy is expected in the fourth quarter of 2015 with final data expected in 2016.

About 25% of the target study numbers have successfully received their initial dose, which is well-tolerated with no safety issues reported.

The study is on track to recruit the required number of participants by the middle of the year, with hundreds already registered to participate.

Admedus’ HSV-2 therapeutic vaccine is based on a platform technology initially developed by Professor Ian Frazer. The technology is designed to enable, boost and support the body to fight against diseases, such as HSV-2.

“The study is progressing extremely well and we anticipate it will be fully enrolled in the coming weeks, with interim results scheduled for later this year. To date, the safety profile of the study has been very positive,” chief executive officer Lee Rodne said.

“The first study participants have now received their second dose of the vaccine. Currently 70% of the required study participants have either begun screening or received their initial dosing regimen so we’re on track.”


Phase II Trial

The primary objective of the Phase II trial is to demonstrate the vaccine’s safety and how well tolerated it is in people with HSV-2.

Secondary and exploratory objectives are to confirm the immunogenicity seen in the first study.

After the initial screening, study participants have a 45 day baseline observation period on trial entry before receiving the first of their three therapeutic vaccine injections.

The trial is exploring two injection regimens, which will be administered by intradermal injection three times, with a four week break between each injection regime.

Admedus’ trial will also include a six month booster.


HSV-2

At present, there is no cure for herpes and the infection is life-long.

Current therapy for HSV-2 involves daily doses of antiviral drugs which can reduce, but not eliminate, outbreaks and viral shedding, so they can only reduce symptoms but are unable to prevent the spread of the virus.

One in eight Australians are infected with HSV-2 and in the USA, the Center for Disease Control estimates that 16% of Americans between the ages of 15 and 49 are infected with the virus.

This technology for a therapeutic vaccine was developed by Professor Ian Frazer and his scientific team to target HSV-2, the strain of the virus most commonly associated with genital herpes.


Analysis

With initial participants already receiving their second dose and no safety issues reported to date, Admedus’ HSV-2 Phase II study is progressing well.

HSV-2 is a life-long infection with no cure with an addressable market estimated at $6 billion.

Should the company thread the needle and commercialise the work to date, it will be well on its way towards big revenue potential.

Separately, Admedus is also progressing its HPV therapeutic vaccine, which is progressing into a clinical study in the first half of 2016.

Further news on this front is expected with the company formalising the analysis of its pre-clinical HPV data and the natural progression of the HPV clinical study in HPV infected patients.

Other share price catalysts ahead are:

- The growing number of global heart centres using CardioCel to repair heart defects including repairing heart valves;
- Additional regulatory approvals in Asia for CardioCel;
- Initiation of an aortic valve repair study to show CardioCel’s utility and advantages in aortic repair vs aortic valve replacement (aortic valve market today is large and mostly using replacement procedures as they haven’t had suitable tissue to repair); and
- Expanded ADAPT pipeline in areas such as vessel repairs, cellular therapies and progressing the dura mater product towards studies for market approvals.

 

Proactive Investors Australia is the market leader in producing news, articles and research reports on ASX emerging companies with distribution in Australia, UK, North America and Hong Kong / China.

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Fri, 05 Jun 2015 08:00:00 -0400 https://www.proactiveinvestors.com/companies/news/147988/admedus-moves-to-second-dose-of-herpes-vaccine-62766.html
<![CDATA[News - Admedus Limited launches new CardioCel product for vascular repair ]]> https://www.proactiveinvestors.com/companies/news/147987/admedus-limited-launches-new-cardiocel-product-for-vascular-repair-62410.html Admedus Limited (ASX:AHZ) will in June launch a new CardioCel® product for vascular repairs such as carotid endarterectomies into the U.S. market.

This is part of the company’s strategy to expand the use of CardioCel across a range of surgical applications.   

Besides its use for cardiac repairs and reconstructions, CardioCel has already been used successfully in 10 U.S. cases of vascular repair, including carotid endarterectomies and femoral artery repairs.

The vascular repair market represents a significant potential market with an estimated 180,000 carotid endarterectomies performed each year in the U.S.

“The new CardioCel product is part of Admedus’ plan to build an ADAPT™ Tissue franchise, providing surgeons with a range of products for surgical repairs,” managing director Lee Rodne said.

“The Admedus sales team continues to expand the number of centres using CardioCel and this new product size will help to support broader market adoption and momentum in our sales program, which we anticipate will support further revenue growth in the coming year and beyond.”

CardioCel is currently used in 31 European and 35 US centres and over 70 centres globally. Over 1800 patients have been implanted with CardioCel.

Admedus recently raised $28.1 million through a $12 million placement and $16.1 million rights issue to increase sales of its lead regenerative tissue product CardioCel®, support continued development of its regenerative tissue portfolio and advance its immunotherapy programs with Professor Ian Frazer.


CardioCel®

CardioCel® is a regenerative tissue product engineered by the group’s ADAPT® tissue engineering process to be a durable, pure collagen scaffold used to repair heart deformities including repairing and reconstructing heart valves.

Notably, the first patient from its Phase II study had their 6 year follow up earlier this year and the results show there was still no detectable calcification.

Other patients in the study also continue to show no signs of calcification or follow up surgeries after 3 to 5 years.

The lack of calcification addresses one of the key issues with other existing tissue products and is a key milestone for the technology.

This provides further potential for the future treatment of congenital heart disease, moving closer towards the stage where surgeons can reduce, if not eliminate, the need for patients to undergo repeat procedures.

In April, the company announced it was expanding its regenerative tissue portfolio into additional large target repair markets following successful initial results from a pre-clinical study of ADAPT® treated tissue in the repair of dura mater.

Dura mater is the outer membrane enveloping the brain and spinal cord which is often damaged during traumatic brain injuries.

The company will progress this program into the next study as it advances the product towards market approval.


Recent Activity

Admedus recently reported revenue of $2.5 million for the quarter ended 31st March 2015, a jump of 47% over the previous corresponding period.

It has also achieved initial sales for CardioCel in Hong Kong during the period as part of its continued global launch of the product.

The company continues to work with Professor Ian Frazer and his team to progress its therapeutic vaccines portfolio.

The Herpes Simplex 2 (HSV-2) Phase II study is underway and actively recruiting study participants.

Admedus anticipates that recruitment of the Phase II HSV-2 study should be completed by the end of the quarter with interim results due to be delivered by the end of the 2015 calendar year.


Analysis

The introduction of a new CardioCel product for vascular repairs not only targets the U.S. market where an estimated 180,000 carotid endarterectomies are performed each year, it is also in line with Admedus’ strategy to expand the use of CardioCel across a range of surgical applications.   

This support broader market adoption and momentum for CardioCel that together with expansion in the number of centres using its products, will drive further revenue growth.

The company has a pipeline of additional regenerative tissue products that it is developing based on the initial success of CardioCel and its ADAPT tissue engineering technology.



Proactive Investors Australia is the market leader in producing news, articles and research reports on ASX emerging companies with distribution in Australia, UK, North America and Hong Kong / China.

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Mon, 18 May 2015 09:30:00 -0400 https://www.proactiveinvestors.com/companies/news/147987/admedus-limited-launches-new-cardiocel-product-for-vascular-repair-62410.html
<![CDATA[News - Admedus directors increase shareholdings ]]> https://www.proactiveinvestors.com/companies/news/147986/admedus-directors-increase-shareholdings-61942.html Admedus (ASX:AHZ) directors have increased their respective investments in the company through participation in the fully subscribed $16.1 million 1 for 7 rights issue priced at $0.07 per share.

The rights issue is part of a broader $28.1 million capital raising that be used to increase sales of its lead regenerative tissue product CardioCel®.

Proceeds will also support continued development of the company’s regenerative tissue portfolio and advance its immunotherapy programs with Professor Ian Frazer.

Managing director Lee Rodne acquired 714,286 shares for $50,000.02, taking his direct interest up to 26,992,820 shares.

Executive director Michael Bennett subscribed for 80,000 shares for $5,600 while non-executive director Peter Turvey acquired 396,504 shares for $27,755.28.

Turvey now has a direct and indirect interest in 3,172,039 AHZ shares while Bennett has 11,674,000 shares.

Earlier this week, the company appointed Genpharm as its distributor in the Middle East and North Africa region.

This adds to its presence with CardioCel used in 31 centres in Europe, 31 centres in the U.S. as well as recent approvals for use in Canada and Hong Kong.

Over 1,200 patients have benefited from CardioCel® as part of their cardiovascular repair surgery.

 

Proactive Investors Australia is the market leader in producing news, articles and research reports on ASX emerging companies with distribution in Australia, UK, North America and Hong Kong / China.

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Fri, 24 Apr 2015 10:30:00 -0400 https://www.proactiveinvestors.com/companies/news/147986/admedus-directors-increase-shareholdings-61942.html
<![CDATA[News - Admedus appoints Genpharm as Middle East, North Africa distributor ]]> https://www.proactiveinvestors.com/companies/news/147985/admedus-appoints-genpharm-as-middle-east-north-africa-distributor-61902.html Admedus Limited (ASX:AHZ) is expanding the global reach of its lead regenerative tissue product CardioCel® with the appointment of Genpharm as its distributor in the Middle East and North Africa region.

This adds to its presence with CardioCel used in 31 centres in Europe, 31 centres in the U.S. as well as recent approvals for use in Canada and Hong Kong.

Over 1,200 patients have benefited from CardioCel® as part of their cardiovascular repair surgery.

Genpharm is a specialty healthcare company focusing on market access in the Middle East and North Africa, one of the fastest growing healthcare regions globally.

The two companies will leverage Admedus’ existing regulatory approvals from outside the region.

“Admedus is highly strategic in the selection and appointment of specialist distributors in regions where we do not have a direct sales force,” chief executive officer Lee Rodne said.

“This forms an important part of our global launch strategy for CardioCel.

“Genpharm has a strong reputation and presence in the region and we look forward to broadening CardioCel®’s availability globally.”

Earlier this month, the company completed a $28 million capital raising to increase sales of CardioCel, support continued development of its regenerative tissue portfolio and advance its immunotherapy programs with Professor Ian Frazer.


Cardiocel® gains traction

The appointment of Genpharm strengthens CardioCel®’s opportunity in the fast-growing MENA region, where the eight largest countries have a combined population of over 120 million people.

Already, 31 centres in Europe and 31 centres in the U.S. are using the bio-scaffold for the repair of congenital heart deformities and complex heart defects.

Admedus also recently received initial orders in Hong Kong.


CardioCel®

CardioCel® is a regenerative tissue product engineered by the group’s ADAPT® tissue engineering process to be a durable, pure collagen scaffold used to repair heart deformities including repairing and reconstructing heart valves.

Notably, the first patient from its Phase II study had their 6 year follow up earlier this year and the results show there was still no detectable calcification.

Other patients in the study also continue to show no signs of calcification or follow up surgeries after 3 to 5 years.

The lack of calcification addresses one of the key issues with other existing tissue products and is a key milestone for the technology.

This provides further potential for the future treatment of congenital heart disease, moving closer towards the stage where surgeons can reduce, if not eliminate, the need for patients to undergo repeat procedures.


New Applications

Admedus is expanding its regenerative tissue portfolio into additional large target repair markets following successful initial results from a pre-clinical study of ADAPT® treated tissue in the repair of dura mater, the outer membrane enveloping the brain and spinal cord.

This showed that after one month post implantation, the ADAPT® treated tissue repairs demonstrated:

- No signs of post-operative infection;
- No leakage of cerebrospinal fluid (CSF);
- No signs of post-operative chemical meningitis; and
- No signs of tissue rejection.

These are all issues that affect existing, on-market products used in the repair of dura mater, demonstrating the potential for ADAPT® treated tissue to make an impact in this market.

Admedus’ product also has the added benefit of being ready to use off the shelf without the need for pre-implant preparation or rehydration.

The company will complete additional histology studies on the explanted tissues while progressing to the next study to support a product regulatory filing for market approval.

Dura mater is the outer membrane enveloping the brain and spinal cord which is often damaged during traumatic brain injuries (TBI).

In the US alone, it is estimated that there are almost 1.7 million traumatic brain injuries each year, with the Centre for Disease Control estimating around 275,000 hospitalisations per annum.


Immunotherapy Progress

The company is also making progress on the immunotherapy front with the Phase II trial for a therapeutic vaccine for Herpes Simplex Virus (HSV-2) on track to complete patient recruitment in the current quarter.

Dosing of the vaccine is expected to start this month with interim analysis data expected in the fourth quarter of this year.

The second trial, a therapeutic vaccine treatment for Human Papilloma Virus is currently progressing towards a phase Ib trial.


Analysis

The appointment of Genpharm as its Middle East and North Africa distributor brings Admedus’ CardioCel® product into a new and rapidly growing market.

This has the potential to improve revenues as sales of the cardiovascular repair product continue to grow.

Further support will come from the recent $28 million capital raising, of which about $9 million is earmarked for ongoing building and support of the sales team.

This funding will also drive continued development of its regenerative tissue portfolio and advance its immunotherapy programs with Professor Ian Frazer.

Share Price Catalysts

Regenerative tissue portfolio and CardioCel®
- Increase number of centres using CardioCel® globally;
- Growing sales in the US, Asia & Europe;
- Additional market approvals for CardioCel® in Asian markets;
- Initiation of CardioCel® market expansion studies such as a Tri-leaflet Aortic Heart Valve Repair Study;
- Progress on use of ADAPT® treated tissue in the repair of dura mater, the outer membrane enveloping the brain and spinal cord; and
- Expanded regenerative tissue portfolio.

Immunotherapies
- Completion of HSV-2 Phase II enrolment (end 2Q2015);
- Interim Analysis from study (4Q2015); and
- Starting Phase I study for Human Papilloma Virus vaccine.

 

Proactive Investors Australia is the market leader in producing news, articles and research reports on ASX emerging companies with distribution in Australia, UK, North America and Hong Kong / China.

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Wed, 22 Apr 2015 08:40:00 -0400 https://www.proactiveinvestors.com/companies/news/147985/admedus-appoints-genpharm-as-middle-east-north-africa-distributor-61902.html
<![CDATA[News - Admedus receives A$0.20 price target from Morgans ]]> https://www.proactiveinvestors.com/companies/news/147984/admedus-receives-a020-price-target-from-morgans-61856.html Admedus Limited (ASX:AHZ) remains one of Morgans’ High Conviction calls in 2015, which also has an Add recommendation with a price target of A$0.20.

The broker noted that with the A$28 million capital raising, Admedus is cashed up and ready for action.

The following is an extract from the report.

We have updated our forecasts and model to reflect the A$28m capital raising.

The funds will be used to expand the CardioCel® sales teams in Europe and US, expand the regenerative tissue product portfolio and fund the Phase 1b HPV vaccine study.

We maintain our positive stance on AHZ with news on CardioCel® sales growth and clinical study updates likely to drive the share price higher.


Cardiocel® Continues to Gain Traction

CardioCel® use continues to expand, with 28 European centres and a further 28 centres in the US using the product, with the product now used in over 60 centres globally.

Over 1,200 patients have benefited from CardioCel® as part of their cardiovascular repair surgery.

Further applications of the technology are being investigated and AHZ recently announced the successful initial results from a pre-clinical study of ADAPT® treated tissue in the repair of dura mater.

The results demonstrated excellent post-operative responses with no longer term negative outcomes, no fluid leakage or post-operative infections, while proving to be an excellent replacement for surgical procedures.

The dura mater is the outer membrane enveloping the brain and spinal cord which is often damaged during traumatic brain injuries (TBI).


Immunotherapy Recruitment On Track

AHZ is currently undertaking two vaccine trials.

The first of the trials, a Phase II trial for a therapeutic vaccine for Herpes Simplex Virus (HSV-2) is on track to complete recruitment in 4QFY15 with interim results in late CY15.

The second trial, a therapeutic treatment for HPV is currently progressing towards a phase Ib trial.


Investment Outlook

We maintain our Add recommendation on AHZ.

Catalysts include interim results on the Phase II HSV-2 vaccine trial and further growth in CardioCel® sales which are reported each quarter.

The key risk to our price target of $0.20 is a slower CardioCel sales than we expect. AHZ remains one of our High Conviction calls in 2015.



Proactive Investors Australia is the market leader in producing news, articles and research reports on ASX emerging companies with distribution in Australia, UK, North America and Hong Kong / China.

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Tue, 21 Apr 2015 07:10:00 -0400 https://www.proactiveinvestors.com/companies/news/147984/admedus-receives-a020-price-target-from-morgans-61856.html
<![CDATA[News - Admedus Limited with $28M funding to grow global healthcare business ]]> https://www.proactiveinvestors.com/companies/news/147983/admedus-limited-with-28m-funding-to-grow-global-healthcare-business-61829.html Admedus Limited (ASX:AHZ) has raised $16.1 million through a fully subscribed rights issue to undertake a number of strategic business opportunities.

This adds to its successful $12 million placement in March, bringing the total raised up to $28.1 million.

Proceeds will be used to increase sales of its lead regenerative tissue product CardioCel®, supports continued development of its regenerative tissue portfolio and advance its immunotherapy programs with Professor Ian Frazer.

“The company thanks shareholders for their support for this Rights Issue and the recent Placement with the total capital raised of approximately $28 million,” chief executive officer Lee Rodne said.

“This will assist the progression of the Company’s programs and plans as we continue to grow our integrated global healthcare business.”


Use of Funds

Funds raised from the rights issue and placement – totalling up to $28 million – will be used for:

- Ongoing sales team build and support: $9 million;
- CardioCel® cardiovascular expansion studies: $3 million
- Expansion of regenerative tissue portfolio: $3.5 million
- Additional regulatory filings: $1 million
- Tissue manufacturing scale up and process development: $2 million
- HPV Phase I/II preparation and study plus manufacturing: $3.5 million
- Additional immunotherapy R&D: $2 million
- Provide further working capital: $2.5 million
- Cost of the Offer: $1.5 million

This is indicative and subject to change.


Upcoming Activity

The company will this month start vaccine dosing under its Herpes Simplex 2 (HSV-2) Phase II study with patient enrolment on track for completion this quarter.

It is also expanding its regenerative tissue portfolio into additional large target repair markets following successful initial results from a pre-clinical study of ADAPT® treated tissue in the repair of dura mater, the outer membrane enveloping the brain and spinal cord .


Analysis

The fully subscribed $16.1 million rights issue brings the total raised by Admedus up to $28.1 million.

This positions the company to drive sales growth for its lead regenerative tissue product CardioCel®.

The dosing of its Phase II Herpes study is a key milestone and the program is being watched not only by investors but by those afflicted with the condition - worldwide.

Genital herpes affects more than 1 in 6 Americans between ages 14 and 49 according to the Centers for Disease Control in the U.S. WHO estimates the number of people aged 15–49 years who are living with HSV-2 worldwide exceeds half a billion.

Notably, there is currently no cure for HSV-2. The high infection rates make for a large market, which is estimated to be worth up to $6 billion.

The funding will also allow it to continue development of its regenerative tissue portfolio and advance its immunotherapy programs with Professor Ian Frazer.

Share Price Catalysts

Immunotherapies
- Completion of HSV-2 Phase II enrolment (end 2Q2015);
- Interim Analysis from study (4Q2015); and
- Starting Phase I study for Human Papilloma Virus vaccine.

Regenerative tissue portfolio and CardioCel®
- Increase number of centres using CardioCel® globally;
- Growing sales in the US, Asia & Europe;
- Additional market approvals for CardioCel® in Asian markets;
- Initiation of CardioCel® market expansion studies such as a Tri-leaflet Aortic Heart Valve Repair Study;
- Progress on use of ADAPT® treated tissue in the repair of dura mater, the outer membrane enveloping the brain and spinal cord; and
- Expanded regenerative tissue portfolio.



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Fri, 17 Apr 2015 12:53:00 -0400 https://www.proactiveinvestors.com/companies/news/147983/admedus-limited-with-28m-funding-to-grow-global-healthcare-business-61829.html