Admedus Limited’s (ASX:AHZ) lead CardioCel® product has clear utility and importance in the surgical repairs of cardiovascular defects with 11 patients now past 5 years post implantation with no sign of calcification.
Notably, the first patient in the Phase II clinical trial has no sign of calcification after over 7 years.
This patient was implanted with CardioCel as part of a complex Tetralogy of Fallot procedure at 3 weeks old and is now over 7 years old and very well and healthy.
Four other patients are past the 6 year mark while the company is following another 4 patients who are past 4 years.
Admedus and the participating hospital will continue to follow a number of patients from the Phase II study through this extended program.
CardioCel is currently used in over 90 centres globally including 42 in the U.S., demonstrating a high level of adoption within the first 12 months within the market.
Lee Rodne, chief executive officer, commented:
“This long-term follow-up data illustrates some of the key features of CardioCel that we believe make it the bio-scaffold of choice for the repair of congenital heart disease defects.
“Given that the first patient in this Phase II clinical trial was treated over seven years ago and the patient is doing very well, we are particularly encouraged that there has been no requirement for repeat procedures and no evidence of calcification of the implanted device.”
Professor Leon Neethling, inventor of the ADAPT® technology and CardioCel, added:
“These results are very exciting given the fact that CardioCel show no signs of calcification after 5 plus years, especially since it is known that other tissues implanted in children tends to calcify rapidly, thus proving the effectiveness of the ADAPT® tissue engineering process to produce bioscaffold implantable tissue products like CardioCel®.
“These are very important data as we expand the use of CardioCel into the adult cardiac and the peripheral vascular markets.”
Long Term Outcomes
The positive long-term data from the Phase II clinical trial demonstrates the efficacy and safety of the company’s proprietary bio-scaffold in the repair of congenital heart disease defects.
Importantly, there have been no repeat heart procedures related to CardioCel for the monitored patients in the study and there are no signs of CardioCel calcification.
This data and evidence is important as it represents the only prospective clinical trial data in this patient population of congenital heart defects.
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.
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.
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 long-term results are encouraging for Admedus given that most implanted tissues have calcification within an 18 month timeframe in paediatrics, illustrating the importance of CardioCel in surgical repairs of cardiovascular defects.
It also provides very strong evidence of CardioCel’s long term patient outcomes for repairing congenital heart defects.
Catalysts ahead for CardioCel are:
- 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 our dura mater product towards studies for market approvals.
In addition, the company expects that its therapeutic vaccine Phase II study for Herpes Simplex 2 (HSV-2) will complete enrolment in the near future with interim results reported by the end of this calendar year.
This vaccine is led by Professor Ian Frazer and represents a large target market, making it an inflection point this year.
In addition, Admedus is progressing Ian Frazer’s next HPV vaccine into clinical study this financial year. This vaccine is being developed as a treatment against HPV and cervical cancer.
Proactive Investors Australia is the market leader in producing news, articles and research reports on ASX emerging companies with distribution in Australia, UK, North America and Hong Kong / China.