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Admedus CardioCel® gains approval in Singapore

Last updated: 18:20 02 Nov 2014 EST, First published: 17:20 02 Nov 2014 EST

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Admedus (ASX:AHZ) continues to increase market penetration of its lead regenerative tissue product CardioCel® with four surgeons in Singapore receiving approval to use the product under an early access program.

Shares in Admedus should trade higher today on the news, which marks the first CardioCel® use in Asia.

CardioCel® is also currently in use in 15 centres in the U.S. and 20 centres in Europe, ahead of its 12 month forecast target of 15 centres in each jurisdiction.

“This is a very encouraging milestone for the Admedus Group, with surgeons in Singapore now granted approval to begin working with CardioCel® and establishing familiarity with this innovative medical device for the first time in Asia,” chief executive officer Lee Rodne said.

“The approval provides further endorsement of the benefits of CardioCel® and we hope it will pave the way to full marketing approval in this important health market.”

Admedus is currently seeking marketing approval for CardioCel® in multiple markets in Asia as part of its global strategy to launch the product in significant markets and increase revenue.   

The company reported revenues of $2.27 million in the September 2014 quarter, up 8% from the previous corresponding quarter.

It had $14.4 million in cash as at 30 September 2014.


Singapore Approval and Market Penetration

The approval from the Singapore Health Sciences Authority enables four surgeons from different leading cardiac hospitals to use CardioCel® in the repair of cardiovascular defects.
    
It has already received FDA 510k clearance and CE mark approval in the US and Europe respectively and is in use at cardiac centres throughout those markets.

CardioCel® also recently received its Medical Device Licence in Canada and its use in Australia continues through the early access Authorised Prescriber Scheme.

The company has also participated in a number of international cardiovascular conferences, with a strong presence at the recent European Association for Cardiothoracic Surgery (EACTS) meeting in Italy and the Congenital Heart Surgeons’ Society (CHSS) conference in Chicago.

It will continue to invest in building sales teams for the ongoing roll-out of the product as well as pursuing product extensions in cardiovascular repair and reconstructions and progressing the ADAPT® tissue in non-cardiovascular applications.


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.


Admedus Vaccines


During the September 2014 quarter, Admedus invested an additional $3 million to fund the upcoming Admedus Vaccines Phase II study for the Herpes simplex 2 (HSV-2) therapeutic vaccine.

This resulted in the company increasing its holding in Admedus Vaccines to 66.3%.

Recently, Admedus announced additional Phase I data for the HSV-2 vaccine which showed a clear T-cell response in patients.

The company is working with Professor Ian Frazer and the team to take this vaccine into the next clinical study, which is anticipated to be initiated towards the end of this year or early next year.

Genital herpes affects more than 1 in 6 Americans between ages 14 and 49 according to the U.S. Centers for Disease Control.
        
WHO estimates the number of people aged 15–49 years who are living with HSV-2 worldwide exceeds half a billion.

Most individuals infected with HSV-2 experience either no symptoms or have very mild symptoms that go unnoticed or are mistaken for another skin condition and as a result are often unaware of their infection until an outbreak occurs.

Notably, there is currently no cure for HSV-2.


Analysis

Admedus has achieved a milestone with the early access program allowing four Singaporean surgeons from different hospitals to use CardioCel®.

Coupled with its growing use in the U.S. and Europe, this could increase revenue through further sales of the regenerative tissue product.

The approval in Singapore also paves the way for the company to secure approvals in the rest of Asia.

Share price kickers that could re-rate the company include:

- Extending the use of CardioCel® for an expanded range of indications in cardiovascular surgery;
- Expanding regenerative tissue portfolio and explore the use of ADAPT® prepared tissue for additional surgical applications that have the potential to increase revenue in the future;
- Further market approvals for CardioCel®;
- Initiation of HSV-2 Phase II; and
- Initiation of HPV Phase I.

Admedus has a very healthy $14.4M in cash at September quarter end.

 

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