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® 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 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.
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.
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.
- Completion of HSV-2 Phase II enrolment (end 2Q2015);
- Interim Analysis from study (4Q2015); and
- Starting Phase I study for Human Papilloma Virus vaccine.
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