The study compared the performance (biocompatibility and calcification potential) of the heart valve tissue, treated with the ADAPT anti-cytotoxic and anti-calcification process, plus Celxcel’s terminal sterilization method.
The study demonstrated all forms of the commercial heart valve tissue developed calcification over the 24 weeks. The tissue subjected to Celxcel’s terminal sterilization method showed significantly reduced levels of calcification, whilst the tissue subjected to the ADAPT anti-calcification engineering process, plus the terminal sterilization method demonstrated the lowest levels of calcification during the entire study.
Calcification of tissue heart valves shortens the lifespan of implanted tissue. This often results in clinicians choosing to use mechanical valves, which requires patients to undergo lifelong and complicated anticoagulant therapy.
“The results were in line with our expectations and very positive,” said Allied Healthcare Managing Director Lee Rodne. The results open up the possibility of extending the lifespan of implanted tissue valves dramatically. At the moment the build up of calcification means that implanted heart valve tissue has a shorter lifespan of around 10 years when compared to mechanical valves which is over 20 years.”
Bob Atwill Celxcel CEO said, “With the ADAPT process we are aiming to increase the lifespan of tissue heart valves to allow them to become the “product of choice” for surgeons around the world. This will allow more patients to be free of the need to be tied to complicated anticoagulant therapy for the rest of their lives”.
Summary of results:
- All groups (de novo commercial valves and those treated with ADAPT ± terminal sterilization) in the study were subject to similar “simulated” flow and pressure dynamics
- All groups were exposed to a standardized physiologic phosphate high calcium solution
- Macroscopic assessment (with high contrast color stain) reveals a significant reduction of visible calcification on the tissue valve leaflets treated with ADAPT TEP (± terminal sterilization process).
- Digital X-Rays and independent histology reports confirmed the independent assessors evaluation of a significant reduction in leaflet calcification by the ADAPT technology
- ADAPT treated (± Celxcel’s terminal sterilization) valves had significantly lower extractable calcium than the commercial valves without ADAPT treatment.
Following these positive trial results Allied Healthcare Group has started discussions on partnering and commercial distribution opportunities for Celxcel’s lead product CaridoCel, a cardiovascular patch to treat congenital heart disease.
Celxcel is also evaluating how the ADAPT process can be used in other surgical applications, such as general surgery (hernia repair), urogynaecology (pelvic floor reconstruction), orthopaedics, cardiovascular repair and as a biological scaffold to grow and deliver stem cells.
For more information, please contact:
Lee Rodne – AHG Managing Director Tel: +61 8 9266 0100 or 0433 926 277
Bob Atwill – AHG Executive and CEO, Celxcel Tel: 0448 778880
Paul Dekkers (Media) – Buchan Consulting Tel: 0418 218 722
About Allied Healthcare Group Limited
Allied Healthcare Group Limited (ASX: AHZ) is a diversified healthcare company focused on investing in and developing next generation technologies with world class partners, acquiring strategic assets to grow its product and service offerings and expanding revenues from its existing profitable medical sales and distribution business. The Company has assets from Research & Development through Clinical Development as well as Sales, Marketing and Distribution.
Allied Healthcare Group is in the process of commercializing its innovative tissue engineering technology for regenerative medicine and is a major investor in Brisbane based Coridon Pty Ltd, led by Professor Ian Frazer developing next generation vaccines for global markets.
Further information on the Company can be found on www.alliedhealthcaregroup.com.au
About the ADAPT® Tissue Engineering Process
ADAPT® Tissue Engineering Process (TEP) produces a bioprosthetic scaffold (extracellular matrix) made from animal tissue. Depending on the site of implantation, the patient’s own cells will migrate into the matrix and stimulate site specific controlled remodeling. At the same time, new blood vessels are formed in the matrix and they deliver appropriate cells that lead to a functional tissue repair. The implanted extracellular matrix is gradually remodeled and replaced by the body’s own new tissue structures.
