Medical technology company Medtronic (NYSE:MDT) increased revenues in its final quarter driven by steady progress at its cardiac and vascular businesses.  

Overall, revenue rose 4 per cent to US$4.3 billion in the quarter ended April 27, with the cardiac and vascular group increasing revenue to US$2.3 billion from US$ 2.2 billion.  

Medtronic chairman and chief executive Omar Ishrak said: “Our growth was broad-based across our businesses and geographies, including strong US launches of the Resolute Integrity drug-eluting stent and RestoreSensor spinal cord stimulator and strong growth in emerging markets.”

The coronary business grew worldwide revenue by 12 per cent and US revenue by 2 per cent on the back of the launch of the Resolute Integrity drug-eluting stent. 

International sales accounted for 46 per cent of Medtronic’s worldwide revenue in the quarter. 

Although the company’s restorative therapies group also increased revenue during the quarter, its biologics revenue declined 16 per cent, on a constant currency basis due to a fall in US sales of its spinal treatment INFUSE.

Net earnings rose for the three months to US$991 million, from US$776 million. 

Over the full year, revenue for the group increased to US$16.2 billion from US$15.5 billion. Net earnings were US$3.62 million.  

The company said it expects revenue to grow during the next year by between two and four per cent.

“We are beginning to gain momentum worldwide and are optimistic about our ability to improve long-term growth as we expand globally and identify new opportunities to deliver economic value to the changing health care system,”Ishrak added.

“As we continue to focus on innovation, globalisation, and execution, I see many opportunities for improved growth.”

Net income was $2.56 million, or six cents a share, compared with a net loss of $1.77 million, or five cents a share, a year-prior.

For the first three months of the year, revenue stood at $37.3 million versus sales of $28.5 million, a year-earlier.

On average, analysts had forecasted per share earnings of seven cents, on $34.9 million in revenue, according to Bloomberg.

In early morning trade, the company’s stock rose 4.68 percent climbing to $24.85 apiece on the Nasdaq on Wednesday.

"We are happy to report the best quarter and year in company history, in terms of number of patients supported, revenue growth, and profitability," chief executive Michael R. Minogue said in a statement.

"Abiomed is highly motivated to help thousands of patients and create significant shareholder value," Minogue added.

In the U.S., Impella revenue spiked 44 percent to $29.9 million. Worldwide Impella sales totalled $32.3 million, up from $22.6 million a year ago, representing a 43 percent rise.

The Impella is a pump that pulls blood from the left ventricle through an inlet area near the tip, and expels blood from the catheter into the ascending aorta, used for patients that have heart failure.

As targeted, an additional 26 hospitals purchased Impella 2.5 during the quarter, the company said, bringing the total to 631 customer sites.

Gross margin widened to 81.8 percent, compared to 79.5 percent in the prior year period.

Looking ahead, the company expects revenues for the year to be between $152 to $157 million, representing growth of 20 to 24 percent.

Global revenue of the Impella device is forecasted to rise by 30 percent.

CryoLife is a tissue processing and medical device company that distributes implantable living human tissues for use in cardiac and vascular surgeries, throughout the U.S., Canada, and certain countries in Europe.

The Hemosphere deal is expected to expand CryoLife's market with the introduction of the  HeRO (Hemodialysis Reliable Outflow) Graft, used for end-stage renal disease hemodialysis patients, who have exhausted all other options and have central venous obstruction.

The product will complement CyroLife’s own CryoVein and CryoArtery preserved human tissues, which are used as an AV graft for ESRD hemodialysis patients, CryoLife said.

In addition to the $17 million deal price, Hemosphere has been granted potential revenue milestone-based payments of up to $4.5 million.

"The acquisition of Hemosphere significantly advances our strategic initiative to reposition CryoLife's product portfolio with higher growth, higher margin medical devices for cardiac and vascular surgery,” said CryoLife’s president and CEO Steven G. Anderson.

"We believe there is a significant opportunity for our sales team to leverage their strong relationships with vascular surgeons, many of whom already use our preserved human veins and arteries to provide arteriovenous (AV) access for ESRD patients, to introduce and to expand utilization of the HeRO Graft in the U.S.

"In addition, we believe that potential product enhancements and international sales represent incremental HeRO Graft growth opportunities."

CryoLife said the financial and strategic benefits of the transaction include entry into a growing $250 million dollar market through the use of the patent-protected device.

Hemosphere will also gain the use of CryoLife's clinical, regulatory, and research and development teams in order to expand the HeRO Graft product’s enhancement opportunities.

"The HeRO Graft has been clinically proven to reduce bacteremia rates by 69% as compared to patients with tunneled dialysis catheters," said president and CEO of Hemosphere Patrick J. Wethington.

"With over 5,000 HeRO kits sold and nearly 100 clinical publications and presentations, we believe CryoLife's established corporate infrastructure and resources will be beneficial in expanding patient access and further enhancing the HeRO Graft system."

In 2011, Hemosphere's revenue was $5.3 million, and the company’s gross margin was 65.6 percent.  The company has six patents on the product in the U.S., Europe, and Japan, with 12 patents pending.

The transaction is expected to close in May, and is subject to customary conditions.

CyroLife’s shares were up 1.22 percent Tuesday Morning at $4.98.

HealthLinx’s (ASX: HTX) successful expansion of sales of its first-in-class ovarian cancer diagnostic test, OvPlex™, into the Singapore and Malaysian markets has prompted further expansion into other Asian markets.

OvPlex™ will hit the Indian market in the September quarter of 2012, with first sales to begin in Mumbai from August 1.

HealthLinx’s distribution partners, NEX Innovations Exchange and Metropolis Healthcare, will then ramp up expansion into all other major Indian cities in the following six months.

Indicating the market potential for OvPlex™, India is one of the world’s fastest growing and largest economies.

Sales in India are expected to rapidly increase over the next six months.

Nick Gatsios, HealthLinx managing director, commented:

“This expansion is an excellent result for women in India who will shortly have access to OvPlex™.

“As a company we are excited with INEX’s proactive expansion strategies and management of both companies is working very closely to ensure further expansion occurs in a seamless, cohesive and timely manner.”


Rapid expansion 

OvPlex™ has been available in the Singapore and Malaysian markets since October 2010.

Since the start of sales in these markets, INEX has exceeded expected sales targets by around 25% with continued growth. 

HealthLinx is ramping up global expansion and development of OvPlex™ following the signing of a four year funding agreement with La Jolla Cove Investors for up to US$9 million (A$8.5 million) in December 2011. 
 
The funding will support HealthLinx’s push into key North American markets to supplement its existing sales jurisdictions of Australia, Singapore and the United Kingdom.

The company also plans to expand sales of OvPlex™ into other jurisdictions in which INEX has an option under the distribution agreement, including Indonesia and Thailand. 


OvPlex™
 
OvPlex™ is a diagnostic test that measures levels of five proteins in a patient’s blood. One of the proteins is CA125, which has been used for several years for the detection and monitoring of ovarian cancer. 
 
The ovarian cancer market is estimated to be around US$270 million per annum.

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The facility, under current good manufacturing practice (cGMP) standards, will be constructed by renovating an existing 18,000 square foot light manufacturing plant on a 4.2 acre lot in Shelton, Connecticut.

Hahn will help with the design, architecture, engineering, and construction of office spaces, and the cGMP facility and laboratory.

NanoViricides is a development stage company that designs drugs to specifically attack and dismantle enveloped virus particles. Its drug pipeline includes candidates to treat diseases like H5N1 bird flu, HIV, hepatitis C, rabies, dengue fever and the Ebola virus.

The cGMP pilot facility will be used to produce sufficient quantities of drugs needed for human clinical trials for the various drug candidates as they advance into the clinical pipeline, such as the recently selected anti-influenza drug candidate.

NanoViricides recently announced the selection of its clinical candidate FluCide, based on positive results seen in previous animal studies.

The company also held a pre-investigational new drug application meeting with the US FDA to define the development plan for the project. As NanoViricides develops the data for the IND application, the company will be required to produce the drug under cGMP conditions.

The company said it had determined after several years of studying cGMP manufacturing options, that building a pilot facility for clinical drug manufacturing was the most appropriate move.

"This will be a unique, state-of-the-art cGMP facility for the pilot scale production of nanomedicines," said president and chairman of NanoViricides’ Anil R. Diwan.

"Along with his great experience, Andy Hahn brings an acute grasp of a wide range of issues that is critically important in making such a challenging endeavor a success."

Hahn, who holds a BA in Architecture from Princeton University, has almost 30 years of architecture, design, and project management experience in the creation of new and refurbished facilities from his time at the Bristol-Myers Squibb Company.

He was the senior director of engineering, pharmaceutical facilities, and global engineering at this company, and is recently retired.

His responsibility at Bristol-Myers Squibb entailed the worldwide design and construction of pharmaceutical plants, pilot plants, clinical supply facilities, and research laboratories and offices, all relevant to NanoViricides’ current project.

"Mr Hahn will assist the company in realizing its goal of a first class cGMP manufacturing plant as well as laboratory space," said NanoViricides’ CEO Eugene Seymour.

"Andy Hahn will be instrumental in helping the company achieve this goal that will enable us to expedite our various drug development programs."

In addition to influenza, the company has several additional drugs in its development pipeline, including eye drops for viral infections of the external eye, skin cream for treatment of oral and genital warts, an anti-HIV drug, as well as a broad-spectrum anti-Dengue virus drug.

NanoViricides also plans to pursue human clinical trials in countries other than the US, which may not require a cGMP product for certain studies. The company said it is currently investigating such possibilities.

New York-based Henry Schein offers products and services to dental, medical as well as animal health office-based practitioners.

Net earnings attributable to Henry Schein were $80.8 million, or 89 cents per share, on $2.1 billion in sales for the period that ended March 31.

That compared with a year-prior profit of $76.4 million, or 82 cents per share, on $1.94 billion in sales.

Stripping out restructuring costs and other one-time items, the company earned 98 cents a share, well ahead of analyst estimates for 92 cents. Sales in the latest period also beat analyst forecast for revenue of $2.0 billion.

Shares were up 4.16 percent, climbing to $77.84 apiece in trade on the Nasdaq on Tuesday afternnon.

"Early in 2012 we implemented and largely completed a restructuring with the goal of optimizing our cost structure and improving profitability," chief executive Stanley M. Bergman said in a statement on Tuesday.

Global dental sales rose 5.5 percent to $1.2 billion during the quarter.

"Dental sales growth was strong due to stable or improved patient traffic to dental offices in the major markets we serve," Bergman said.

The company said revenue in its global animal health division jumped 15.3 percent to $525.6 million. Global technology and value-added services sales grew 13.1 percent to $62.9 million, while medical revenue edged up four percent to $354.8 million.

Henry Schein also said it bought back about 540,000 shares of its stock for about $39 million during the quarter.

Looking ahead, the company estimates restructuring costs for the full-year of between $2 and $4 million. For 2012, it expects to see per-share earnings around $4.30 to $4.40, up from its prior outlook of $4.25 to $4.34 per share.

Analysts expect a profit of $4.32 per share.

Under the agreement, the companies plan to develop a next generation sample preparation system by combining PBI’s patented pressure cycling technology (PCT) platform with LEAP’s proprietary robotics and lab automation equipment.

The companies share an industry focus in proteomics sample preparation, primarily in mass spectrometry, an analytical technique used to determine the characteristics of molecules.

PBI and LEAP believe that by combining the best attributes of both technology platforms, they can develop a sample preparation system "superior in quality and robustness" to current methods.

Proteomics is the study of the structure and function of proteins, which has provided new and important insights into human health, and has resulted in a better understanding of diagnosis, prognosis, and possible cures of various diseases.

Automated sample preparation methods increase the precision and quality of laboratory testing, which in-turn lifts the probability of discovery. To that end, increased discovery leads to the development of new and improved vaccines, therapeutics and diagnostics.

President and CEO of Pressure BioSciences, Richard T. Schumacher, told Proactive Investors: "LEAP is an important player in the robotics/lab automation area, especially in mass spectrometry sample preparation workflow. This is a marriage made in heaven.

"We make a great team, as they have proprietary equipment/software and we have instrumentation based on patented, game-changing technology. This is the beginning of what we believe will be a long and mutually-beneficial relationship."

LEAP Technologies has been providing proprietary robotics and laboratory automation equipment and support for specific applications for over 20 years.

Pressure BioSciences, meanwhile, is focused on the development, marketing, and sale of proprietary laboratory instrumentation and associated consumables based on its PCT platform.

The platform uses rapid and repeating cycles of hydrostatic pressure at controlled temperatures to extract cell components in the preparation of a biological sample, such as DNA and proteins from humans, animals and plants, for further study.

The applications of the company's PCT-based products are endless - from the key $2 billion target market of mass spectrometry, to biomarker discovery, forensics and counter-bioterrorism, among other uses.

CEO of LEAP Technologies, Werner Martin, said: "PCT is a powerful and enabling technology platform. Because of its clear advantages, mass spectrometry laboratories have begun to integrate PCT into their standard sample preparation workflow, even though the PCT method has not yet been fully automated.

"This has created a wonderful opportunity for us to partner with Pressure BioSciences, as we have the experience and expertise to bring automation to their patented PCT Platform."

"Over the past 20 years, we have developed a strong reputation in robotics and laboratory automation while working with many of the leading life sciences companies in the world, such as Waters Corporation and Agilent Technologies.

"With a growing need for automation, we look forward to developing, marketing, and selling the next generation sample preparation system for proteomics with our colleagues at PBI."

Since Pressure BioSciences began commercial operations in the middle of 2007, it has come a long way, releasing a number of PCT-based products geared towards the $6 billion sample preparation market, including three pressure-generating instruments named Barocyclers, a patent-pending sample homogenization device (The Shredder SG3), five types of single-use processing containers and six different, application-specific reagent kits.

Late last month, the company signed expanded technology license and supply agreements with Target Discovery Inc, giving Target the right to use its PCT platform for a planned entry into the clinical diagnostics testing market.

The company, which makes bone graft material and antimicrobial coatings for medical applications, said that for the quarter that ended March 31, revenue increased 29 percent to $7.8 million, compared to $6.0 million in the same period a year ago.

Excluding a $1.4 million stocking order sale in the fourth quarter of 2011, the company said revenues increased slightly from $7.7 million to $7.8 million on a sequential basis, largely as a result of increased sales generated from Bacterin's direct sales force and independent distributors.

In the latest quarter, the company said hospital accounts increased to 756 facilities, an increase of 45 percent over 519 facilities in the first quarter of 2011.

Bacterin's technology optimizes the growth factors in human allografts to promote bone, subchondral repair and dermal growth. Its products are used in a variety of applications including enhanced fusion in spine surgery, relief of back pain, bone growth in foot and ankle surgery, cranial healing following neurosurgery, and subchondral repair in knee and other joint surgeries.

The company reported a net loss of $1.0 million or three cents per share for the latest quarter, compared to net income of $4.9 million, or 13 cents per share, a year earlier.

Losses narrowed from the fourth quarter's net loss of $4.4 million, or 11 cents per basic share.

Operating loss in the most recent first quarter decreased by 34 percent year-over-year to $1.3 million, compared to an operating loss of $1.9 million in the first quarter of 2011.

Gross profit margin was 76 percent, as compared to 84 percent in the year-ago quarter.

"First quarter revenue was lower than anticipated, with six of our top 10 SKUs on backorder much of the first quarter," said chairman and CEO Guy Cook.

"We have substantially increased the receipt of donor inventory as well as production, but don't believe it will have a positive impact on revenues until the third quarter of 2012.

"We are confident we have overcome the short term production issues, however, when our sales force is faced with limited access to products, it slows surgeon uptake when the product finally does become available."

In the first quarter, Bacterin said a peer review article in Orthopedic Research and Reviews determined its flagship product OsteoSponge exhibited "ideal properties for bone regeneration" - similar to those of autograft, or the graft of patient's own bone - with a distinct advantage over autograft, in that there is "no risk of complications at the harvest site or donor pain postoperatively."

"A preclinical study recently completed at Hospital for Special Surgery on our OsteoSelect DBM putty is expected to be a significant driver of sales in the remainder of 2012 and 2013," said Cook.

"OsteoSelect DBM putty proved equivalent to autologous bone graft, which is the current gold standard for spinal fusion, in the posterolateral intertransverse rabbit model.

"We are also expecting data on our coatings in the second half of this year, as well as independent data on OsteoSponge SC," Cook added.

Bacterin said operating expenses for the quarter totaled $7.2 million, as compared to $6.9 million in the first quarter of 2011.

Looking ahead, the company said it has added a second production shift and, later in the year, will be expanding the number of clean rooms it devotes to high demand products to a total of 13.

"Our plan is to optimize production to process less SKUs with a higher concentration of our high demand products, and expect processing capacity to double from current levels by the end of the year," said Cook.

The company said it has secured a three-year agreement with a "leading health care supply chain expertise and contracting company", to provide OsteoSponge, OsteoSelect DBM Putty, OsteoWrap, OsteoLock, BacFast, hMatrix, Sports Medicine Allografts, and traditional allografts, to a nationwide network of hospitals and medical practices.

The company is also ramping up donor inventory levels to eventually support $100 million of annual revenue, though it noted that there is a lag time with processing throughput since it takes around two to nine months to clear a donor due to related paperwork and laboratory testing results.

"We believe that product constraints are a short term issue we have resolved and that the future and long term opportunity for Bacterin products, in multi-billion dollar addressable markets, remain very strong,” added Cook.

Bacterin said that because the industry sells product on a consignment basis, it has poor visibility on reportable revenues until a few weeks after the close of a month, making it difficult to provide revenue guidance on a quarterly basis.

"Based upon production challenges in the fourth quarter of 2011; feedback from the field with respect to second quarter sales; our decision not to pursue stocking order sales of slow moving inventory included in prior revenue guidance as well as delays in revenues generated from our hMatrix, we feel it is prudent to revise guidance from our previously stated expectation of 2012 revenues," Cook concluded.

The company, which had cash and equivalents of $9.0 million at quarter-end, said it now expects full year revenues of $35 to $40 million, down from its prior guidance of between $53 to $56 million.

The company agreed Thursday to snap-up some assets from University Medical Pharmaceuticals Corp. in a deal pegged at $64 million, plus performance milestones.

The Mississauga, Ontario-based company, which will move its headquarters to Montreal, has acquired AcneFree, a retail over-the-counter acne treatment. The acquired assets generated total sales of about $32 million in 2011.

University Medical Pharmaceuticals is a specialty drug company focused on skincare products. It also makes WrinkleMD Eye, a filler patch system that helps reduce fine lines and wrinkles.

Valeant, which has about 320 employees in Quebec, expects the transaction to close by the middle of this year. 

"The addition of a leading OTC (over-the-counter) acne treatment will provide us with the ability to expand our OTC business," Michael Pearson said in a statement.

"These new products will be immediately accretive to our operations and have not been factored into our 2012 financial guidance."

Valeant Pharmaceuticals is a multinational specialty drug company which develops, makes and markets a broad range of pharmaceutical products primarily in the areas of neurology, dermatology and branded generics.

The Toronto-listed shares of Valeant Pharmaceuticals shed 9.16 percent to $50.60 apiece in trade on Thursday afternoon.

Chairman Nigel Keen will say the firm continues to progress its plan to establish the use of the device as standard around the globe and notes the achievements made in the UK, in a statement prepared for today's AGM.

"Sales in the year to date are ahead of 2011, costs remain under tight control and last month we announced that we had raised a further £1.5 million in new equity. 

"As a result we have the resources to support the NHS in England as it starts to implement systematically ODM or similar fluid management monitoring technology at pace and at scale."

CardioQ measures blood flow during procedures and avoids invasive cardiovascular monitoring during surgery.

Keen will note that in March last year the National Institute for Health and Clinical Excellence (NICE) recommended that CardioQ-ODM be considered for use in all patients undergoing major and high risk surgery in the NHS. 

"We have seen a step-up in the growth rate of our UK surgical probe business since December 2011 which we believe to be attributable primarily to NICE's guidance," he will tell the AGM.

"Sales of surgical probes in the UK in the first four months of the year are over 40 per cent ahead of the prior year," he says, adding that the decision to substantially reduce the price of monitors in the UK had been vidicated.

In export markets, the company continues to make progress, with "excellent" results seen in the first phase of a hospital system implementation of CardioQ-ODM in Canada, with further uptake of the device expected in France.

"Positive results from the first South American study of CardioQ-ODM were presented at the World Congress of Anaesthesia. Doctors using the CardioQ-ODM in Spain are progressing with the largest ever multi-centre randomised trial of fluid management," says Keen.

"We have also announced a collaborative research project with Premier Inc which is the most advanced of a number of initiatives we are pursuing to create the circumstances likely to drive accelerated and systematic adoption of our products in the USA."

Consegna Group (ASX: CGP) will exit a trading halt this morning on the positive news that the company has successfully reached an agreement with Imugene (ASX: IMU) for the sale of Linguet™.

Linguet™ is a multi-functional drug delivery platform, and the agreement involves Consegna selling all the outstanding share capital of its wholly owned subsidiary, Lingual Consegna Pty Ltd to Imugene.

In consideration for the deal, Imugene will issue 100 million shares, with the company also receiving a vote of confidence from the market and raising $1 million from clients of Forrest Capital and CPS Securities, through the issue of 100 million shares at $0.01.

Fabio Pannuti, managing director for Consegna, commented on the successful outcome and said, "We are delighted to have taken this next step forward in identifying a suitable partnering team and vehicle in which to place our developing technology.

"This provides the funding to apply a dedicated scientific team to turn Linguet into a near term cash flow generating asset by focussing on product based commercial solutions."

Pannuti further added, "In line with our proposal to IPO Aspen Medisys, it is our intention at an appropriate time in the near future, to distribute in specie the Imugene shares on a pro rata bases to the Consegna shareholders."

Importantly - the acquisition capitalises on the oral modified release drug delivery market valued at $49 billion in 2009, which has been estimated to double by 2016 according to a GBI Research Report.

Warwick Lamb, managing director of Imugene, commented that they are very pleased to acquire the technology and look forward to working with Consegna to complete the development of this valuable asset, while continuing to look at the development of the company's own existing portfolio of assets.


The Linguet™ Technology Platform

Linguet™ is a tablet which can be placed under the tongue or the buccal cavity (cheek) and allowed to dissolve, which releases the active drug which is absorbed immediately into the blood stream through the mucosa of the month.

This method allows the drug to bypass the gastrointestinal tract and is able to reach its target more rapidly and in the process significantly lower side effects.

For the three months that ended March 31, the provider of injectable drugs and infusion technologies posted net income of $46.7 million, or 24 cents a share, down sharply from $149.9 million, or 88 cents a share, a year earlier.

Excluding quality and product-related charges and other items, earnings were down at 47 cents from 93 cents.

Sales for the period fell 3.3 percent to $965.9 million, from $1.0 billion in the same quarter last year, largely due to a year-earlier introduction of generic oncolytic docetaxel, an anti-tumor treatment.

Analysts polled by Thomson Reuters had anticipated 45 cents in earnings on revenue of $950 million.

"Hospira delivered first-quarter results in line with our expectations, which reflects a difficult year-over-year comparison and the impact of our quality improvement initiatives," said CEO F. Michael Ball.

 "We believe these initiatives will position Hospira with an even stronger competitive advantage, creating sustainable, long-term shareholder value."

Adjusted income from operations decreased 49 percent to $104 million in the first quarter of 2012, compared to $203 million a year earlier.

Hospira said operating costs also increased in the first quarter of 2012 due to expected higher research and development spending, as well as higher selling and promotional costs.

Gross margin fell to 31.1 percent from 39.8 percent amid higher costs.

Total American sales fell to $770.3 million, from $808.9 million in the year-ago-period.

Sales from the Europe, Middle East, and Africa (EMEA) region increased to $127.9 million, from $120 million a year earlier.

In the Asia Pacific region, sales slumped to $67.7 million from $73.4 million in the same quarter of 2011.

Global sales of the company's specialty injectable pharmaceuticals fell to $586.4 million, from $638.6 million a year earlier, while medication management product sales rose to $256.2 million, from $240.2 million in the year ago quarter.

Looking forward, Hospira said it is maintaining guidance for full year 2012 net sales, projecting a net sales change in the range of negative one to positive two percent on a constant-currency basis.

The company said its forecast for adjusted earnings per share for the year remain in the range of $2.00 to $2.30.

"Going forward, we remain firmly focused on advancing our remediation efforts and, at the same time, expanding our global footprint and capacity to capitalize on our growth opportunities," said Ball.

Hospira provides injectable drugs and infusion technologies, and is headquartered in Lake Forest, Illinois. The company’s shares were trading at $34.75 early Tuesday Morning, down more than one percent.

Consegna Group (ASX: CGP) has been granted a trading halt by the ASX pending the release of an announcement on the proposed sale of the company's Linguet IP.

The halt will remain in place until the earlier of an announcement being made to the market, or the opening of trade on Thursday 3 May 2012.

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ValiRx said it made significant advances in the development of both its treatments VAL101 and VAL201, which are aimed at are aimed at leukaemia and prostate and breast cancers, in their pre-clinical and translational programmes and towards the start of in-human Phase I clinical trials.

On the financial front, the group’s revenues reached £455,000 in 2011, up from £177,000 in the previous year.

During 2011, the company raised £3.3 million via a placing to accelerate the pre-clinical progress of the treatments, allowing it to increase research and development (R&D) spending to £421,000 from £120,000 in 2010.

In addition to the placing proceeds, ValiRx received US$1.11 million from the sale of its Belgian subsidiary ValiBIO S.A., which it considered to be outside of its core technologies.

The group ended the year with £1.63 million in the bank.

ValiRx also highlighted the acquisition of the biomarkers arm of Finnish firm Pharmatest for £137,000 in January this year to enhance its R&D capability.

“We have made excellent progress over the past year, which included a significant capital injection, a strengthened balance sheet and with the company's lead therapeutic products being on the cusp of clinical trials,” said chief executive of ValiRx Satu Vainikka.

“We have a strong platform and offering from which to drive ValiRx forward and firmly position ourselves at the forefront of personalised oncology diagnostic and therapeutics development in the sector.”

Investors cheered the full year results, sending shares in ValiRx up 6.5 percent to 0.51 pence by 8:30, valuing the group at £6.35 million.

Consegna Group (ASX: CGP) has decided to terminate a call option held by OzPharma over the company’s wholly owned subsidiary Lingual Consegna.

Under an agreement struck with OzPharma last year, Consegna must now issue OzPharma 25 million Consegna shares to satisfy the termination of the call option.

Consegna shares were last trading at around A$0.028, valuing the share issue at $700,000.

In 2011, Consegna acquired the drug delivery technology Linguet™ from OzPharma, and as part of the deal entered into a call option agreement over Lingual Consegna, which was formed to hold the Linguet™ technology.

Consegna acquired the technology for an initial cash consideration of $50,000 plus the issue of 1.37 million shares upon the achievement of certain milestones.

The termination of the call option means OzPharma no longer has the right to acquire the subsidiary. 

Fabio Pannuti, Consegna managing director, said, “Over the period we have had Linguet™ in our stable, much has been accomplished to realise the future value of the asset.

“This step affirms Consegna’s ongoing rights to the Linguet™ IP to facilitate any future transactional step for this emerging technology that may occur.”

Linguet™ is a tablet or lozenge formulation technology that releases an active drug ingredient in the mouth and which facilitates absorption through the oral mucosa.

The oral modified release drug delivery market was valued at $49 billion in 2009 and is estimated to double by 2016.

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Spinal muscular atrophy is a neuromuscular disease that affects about 20,000 people in Europe and the United States, and is the leading cause of infant deaths.

The disease is characterized by muscle weakness which leads to severe physical disability and loss of life due to respiratory problems.

The drug, known as RG3039, which was licensed from the patient advocacy organization called Families of Spinal Muscular Atrophy in 2009, had been administered to 32 healthy volunteers in a blinded single dose trial.

RG3039 is the first clinical-stage drug to treat decreased levels of the survival motor neuron protein, a key protein necessary for normal neuromuscular function.

Repligen said the phase 1 study aimed to evaluate RG3039’s safety profile and pharmacokinetics, which is what happens to a drug once it enters the body.

Additionally, data revealed a dose-related drug response, resulting in 90 percent inhibition of the target enzyme.

It also noted that there were no adverse events reported. Repligen intends to present the data at the 64th Annual Meeting of the American Academy of Neurology.

"The safety and PK outcomes from our Phase 1 study are encouraging," chief executive Walter Herlihy said in a statement.

"We look forward to initiating the next steps for this drug candidate in alignment with guidance from the U.S. Food and Drug Administration."

The health regulator has already granted Orphan Drug and Fast Track designations to the medicine, as there is an unmet medical need that exists for patients with spinal muscular atrophy.

Orphan designation grants exclusive marketing rights for seven years in the U.S. and 10 years in Europe. Rare diseases are defined as those affecting fewer than 200,000 Americans.

Repligen, which is a biopharmaceutical company, has two central nervous system rare disease programs in phase 1 clinical trials.

Shares of the company traded higher by 11.29 percent, climbing to $7.08 apiece in trade on the Nasdaq Wednesday afternoon.

The developer of bone graft material and antimicrobial coatings for medical applications said the revolving loan facility allows the company to borrow up to $5 million through January 1, 2015.

The facility allows borrowings based on a pre-determined formula of up to 80 percent of Bacterin's eligible accounts receivable, as defined in the credit and security agreement.

"Due to the high working capital needs of our business associated with the necessity for our inventory to be consigned to our hospital accounts, the accounts receivable facility is an efficient way for Bacterin to access cash, from time to time, without diluting equity," said chairman and CEO, Guy Cook.

"Our strong relationships with Silicon Valley Bank and Midcap Financial helped us to secure this non-dilutive financing option, as we prepare for the next stage of growth at Bacterin International."

In late March, the company said that fourth quarter revenue increased sharply, while full year revenue almost doubled to record levels, with the company reaffirming its 2012 sales forecast.

For the quarter that ended December 31, revenue increased 72 percent to $9.1 million, compared to $5.3 million in the same period a year ago.

The increase was primarily attributed to continued market penetration, the company said, combined with the continued expansion of its direct sales force.

Bacterin's technology optimizes the growth factors in human allografts to promote bone, subchondral repair and dermal growth. These products are used in a variety of applications including enhancing fusion in spine surgery, relief of back pain, bone growth in foot and ankle surgery, cranial healing following neurosurgery and subchondral repair in knee and other joint surgeries.

In the fourth quarter, two-year study results showed the company's flagship product, OsteoSponge, was equivalent to rhBMP-2 in spinal fusion, an important feature at a time when surgeons are moving away from rhBMP-2 because of concerns over complications, the company said.

OsteoSponge had already been used in 100,000 procedures prior to the release of the data, and the company expects this study to help further increase its market share.

In the fourth quarter, the company also said it "materially increased" the number of medical facilities in which its products are used, and began the doubling of operating capacity through the installation of new equipment.

Hospital accounts increased to 616 facilities, an increase of 27 percent over 484 facilities in the fourth quarter of 2010.

The company's medical device division also develops and licenses bioactive coatings for various medical device applications.

Consegna Group (ASX: CGP) managing director Fabio Pannuti has increased his shareholding to 8.04% from 7.41%.

Pannuti acquired an additional 37.4 million shares following the acquisition of the remaining 19% stake in Leading Edge Instruments.

Last week Consegna exercised two call options to acquire the remaining share in Leading Edge Instruments in exchange for the issue of 252 million shares to the vendors. 

Leading Edge Instruments holds the BreatheAssist™ technology that Consegna is moving to commercialise.

Consegna has eliminated one of the major hurdles in gaining market entry for new products with the BreatheAssist™ Sport technology falling outside the regulatory approval requirements in the U.S., Europe and Australia. 

The significance of this is that Consegna now has clear access to the US$6.4 billion sport performance apparel market, which de-risks the BreatheAssist™ technology. 

Importantly, removing the regulatory hurdle altogether also supports Consegna’s licensing talks, allowing the company and its potential licensors to tap into this massive market.

Pannuti told Proactive Investors last week the company is in licensing negotiations with a number of groups.

Proactive Investors is a market leader in the investment news space, providing ASX “Small and Mid-cap” company news, research reports, StockTube videos and One2One Investor Forums.

African Medical Investments (LON:AMEI) has secured a US$375,000 loan from its major shareholder Harbinger Capital Partners to provide working capital for its network private hospitals in Africa.

This new financing adds to the US$450,000 loan provided by Habringer last month.

The unsecured loan notes carry an 18 percent per annum coupon and are repayable on February 2 2016.

African Medical is targeting the market for private healthcare as demand increases from the growing African middle classes and the expatriate, non-governmental organisations, diplomatic and tourist markets.

The company owns and operates private hospitals in Dar es Salaam, Maputo and Harare.

Losses in the six months to August reduced from US$11.9 million to US$3.9 million, which reflected a 58% reduction in head office expenses.

In August, African Medical raised US$700,000 from Harbinger, also through the issue of loan notes with a 10 per cent coupon.

The company, headquartered in Natick, Massachusetts, makes everything from coronary stent systems to ultrasound imaging catheters, defibrillators and implantable pacemakers.

Net earnings climbed to $113 million, or eight cents a share for the period that ended March 31. That is up from $46 million, or three cents a share, in the year ago quarter.

Stripping out restructuring-related charges and amortization costs of $107 million, adjusted earnings were 15 cents a share.

Sales fell by three percent to $1.86 billion from $1.92 billion a year earlier.

Analysts polled by Bloomberg were forecasting profits of eight cents per share, on sales of $1.9 billion.

"I am pleased with the achievements we made in the first quarter,” chief executive Hank Kucheman said in a press release, "which demonstrate continued progress towards improving our future growth profile and in executing our strategic plan."

The cardiac rhythm management unit recorded a 10 percent decline in sales to $501 million. Revenue at its interventional cardiology segment also fell by five percent to $603 million.

Sales from its endoscopy unit notched up five percent to $302 million. The peripheral interventions and neuromodulation segments saw sales both rise by eight percent to $190 million and $84 million, respectively.

Overall gross margins fell to 66.2 percent from 67.2 percent a year ago.

For the fiscal second quarter, the company projected adjusted profits of between 14 to 17 cents per share, on revenue of $1.85 to $1.95 billion.

Analysts expect to see earnings of 10 cents and revenue of $1.9 billion.

For the full-year 2012, the medical device maker expects adjusted earnings of about 60 to 70 cents a share, on revenue of $7.35 to $7.65 billion.

Analysts expect to see 45 cents a share, on revenue of $7.5 billion.

Boston Scientific’s share price moved up 35 cents, or 6.32 percent, reaching $5.89 apiece in trade on the New York Stock Exchange.

The drug, known as CK-2017357, is a fast skeletal muscle troponin activator designed for the potential treatment of amyotrophic lateral sclerosis (ALS), also commonly known as Lou Gehrig's Disease.

Under the FDA Modernization Act of 1997, the fast track process was designed to facilitate the development and expedite the review of drug candidates intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs.

CK-2017357 is the leading drug candidate from Cytokinetics’ skeletal sarcomere activator program, and is currently in phase 2 clinical trials intended to inform a potential registration program.

"We are pleased that FDA has granted fast track designation to CK-2017357 for the potential treatment of ALS, recognizing that our novel drug candidate may address significant unmet medical needs in patients suffering from this grievous and uniformly fatal disease," said Cytokinetics senior VP and chief medical officer Andrew A. Wolff, M.D.

"Fast Track designation may improve both the speed and quality of our development program for CK-2017357 as it facilitates our interactions with FDA towards further evaluating the safety and efficacy of CK-2017357 in patients confronting ALS."

Cytokinetics anticipates that results from two recently completed phase 2 clinical trials, designed to assess the safety and tolerability of CK-2017357 in patients with ALS, will be presented at the American Academy of Neurology, 64th Annual Meeting in New Orleans, LA on April 25, 2012.

The company said that ALS is a progressive neurodegenerative disease that afflicts 20,000 to 30,000 people in the U.S. Approximately 5,600 new cases of ALS are diagnosed each year in the U.S.

The average life expectancy of an ALS patient is approximately three to five years and only 10 percent of patients survive for more than 10 years. Death is usually due to respiratory failure because of diminished strength in the skeletal muscles responsible for breathing.

Cytokinetics said CK-2017357 demonstrated potentially clinically relevant pharmacodynamic effects in ALS patients involved in the phase 2 clinical trials.

Cytokinetics said both patients and investigators perceived a dose-dependent positive change in the patients' overall status at six hours after dosing with CK-2017357, based on a global assessment in which the patient and the investigator each independently assessed the patient's status compared to prior to dosing.

Data from that clinical trial also demonstrated a statistically significant increase in the maximum volume of air patients could inhale and exhale at both six and 24 hours after 500 mg of CK-2017357, as well as small but statistically significant increases in maximum strength of certain muscle groups tested, said the company.

Cytokinetics is assessing options that may enable the initiation of a registration program for CK-2017357, and said it anticipates having additional interactions with U.S. and European regulatory authorities during 2012 to discuss the development of CK-2017357 as a potential treatment for patients with ALS, including potential registration strategies.

In July 2010, Cytokinetics was awarded a grant of approximately $2.8 million from the National Institute of Neurological Disorders and Stroke to support research and development of CK-2017357 in myasthenia gravis - an autoimmune neuromuscular disease.

The company said it continues to enroll and dose patients in a phase 2a clinical trial of CK-2107357 in patients with generalized myasthenia gravis.

Cytokinetics anticipates that data will be available from this trial in 2012.

Cytokinetics is a clinical-stage biopharmaceutical company focused on the discovery and development of novel small molecule therapeutics that modulate muscle function for the potential treatment of serious diseases and medical conditions.

The company’s shares were trading at $1.18 early after the bell on Thursday.