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® 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.
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.
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