Allied Healthcare Group’s (ASX: AHZ) tissue engineering and regenerative medicine division Celxcel is progressing its regulatory strategy for bringing products to market, which it anticipates will accelerate the approval process for its tissue engineering process ADAPT®.
Under this new strategy, Celxcel is confident of obtaining market authorisations in 2012 and 2013 to market CardioCel, a cardiovascular patch to treat congenital heart disease, and other ADAPT® treated products, according to Allied Healthcare Group managing director Lee Rodne.
“With a focus on delivering shareholder returns as well as therapeutic value, our strategy is to get products to market as soon as we can, while at the same time looking at broader applications for future market opportunity,” he said.
Regulatory Approval Progress – Australia, Europe, U.S.
Celxcel has received confirmation from the Therapeutic Goods Administration (TGA) that its CardioCel® cardiovascular patch has been successful in the pre-assessment of the submission.
The company’s submission is now progressing through the conformity assessment evaluation process for the Australian market.
Discussions with opinion leaders on Celxcel’s Advisory Board regarding use of CardioCel® prior to TGA approval in clinical trials and other pre-market access routes are also advancing.
Based on the current progress and interaction, the company expects approval for the program at the end of 2012.
Meanwhile, Celxcel has begun discussions with SGS, an international third party assessment organisation who can act as the company’s Notified Body for European CE Marking.
SGS is also able to assist in obtaining Canadian Marketing Authorisation, in addition to other countries such as Taiwan and Hong Kong.
Celxcel is investigating which other markets it will gain access to outside of Europe by obtaining CE Mark.
The company is also planning a filing for U.S. approval and is investigating, in conjunction with a global contract research organisation and regulatory consulting group, the best approach for U.S. submission.
Celxcel CEO Bob Atwill said, “The ADAPT®-treated patch has over the past decade been successfully tested in a number of in-vitro, in-vivo models and a Phase II clinical trial setting to assess the durability, biocompatibility and calcification potential of the implant.
“We are pleased to be on the threshold of the first product from this platform technology being launched into the cardiovascular marketplace.”
Broader Applications for ADAPT®
In addition to the initial cardiovascular products, Celxcel is also evaluating how the process can be used in pelvic floor reconstructions, hernia repair, orthopaedics and as a biological scaffold to grow and deliver stem cells.
In December 2011, Celxcel delivered positive results from a tissue heart valve study of its ADAPT® technology that show a reduction in visible calcification of implanted tissue heart valves.
Importantly, this opens up the possibility of extending the lifespan of implanted tissue valves dramatically.
Currently, a 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.
The Tissue Heart Valve 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 sterilisation method.
The tissue subjected to Celxcel’s terminal sterilisation method showed significantly reduced levels of calcification, while the tissue subjected to the ADAPT anti‐calcification engineering process, plus the terminal sterilisation 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.
Following the positive study results, Celxcel entered into discussions on partnering and commercial distribution opportunities for CardioCel.