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.
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 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.
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.
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.
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