Allied Healthcare Group (ASX: AHZ) is rapidly advancing towards clinical trials of its ADAPT® Tissue Engineering technology with yet another successful implant, this time during pelvic floor and hernia reconstruction procedures.
"These positive results will open up the opportunities for a supporting clinical trial and commercial discussions with potential partners in these areas," managing director Lee Rodne said.
The growing global demand for substitutes in the pelvic floor and abdominal hernia area, as well as the controversial outcomes with the use of synthetic meshes to repair pelvic floor abnormalities or herniated soft tissues, prompted subsidiary Celxcel to assess the ADAPT®-treated bovine tissues in these areas.
Rodne told Proactive Investors today both the pelvic floor and hernia reconstruction markets are worth around US$300 million each in the U.S. alone.
However, he said there is the potential for expansion in these markets following a successful clinical trial proving the GyneCel® product's potential as a replacement for synthetic meshes.
"Once we have a successful clinical trial that shows that we don't have similar issues as the synthetic meshes I think that $300 million market cap can be expanded from there," he said.
During the trial, a team of leading gynaecologists from the University of Leuven successfully implanted the GyneCel® patch into the pelvic floor area and the surgical product in the abdominal hernia position.
Celxcel chief executive Bob Atwill said the company will be monitoring the animals implanted over the next six months to determine how well the GyneCel® and surgical patches perform as substitutes for pelvic floor and hernia repair applications.
"All the animals in the study recovered fully from the surgical procedures without any adverse effects during or after surgery," he said.
The six month follow up data is scheduled for release later this year. Following the six month study, Celxcel will begin planning clinical trials.
Over the past decade, the ADAPT®-treated patch has been tested in a number of in vitro and in vivo models to assess the durability, biocompatibility and calcification potential of the implant.
Previously, positive results in an experimental hernia model, an abdominal wall replacement in a small animal model, showed the potential for GyneCel® in the pelvic floor and another of Celxcel's surgical products for abdominal wall hernia applications.
The GyneCel® patch material and the surgical product have previously been successfully used to reconstruct the posterior wall of the vagina and to repair a surgically created abdominal wall hernia respectively.
At the end of the study period, the pelvic floor reconstructions and the hernia repairs will be assessed in terms of functional support, structural changes of the implants, immunological response towards the implants (remodelling) and for any signs of calcification of the implants.
Potential Wider Applications
Celxcel's ADAPT® Tissue Engineering technology has been used to produce the CardioCel®, GyneCel® and surgical products.
The technology uses animal derived tissues to produce products that are compatible with the human body.
The ADAPT® process produces tissue that more closely mimics human tissue and is expected to open up the potential for medical professionals to replace synthetic products currently used in soft tissue repair.
In addition to cardiovascular, pelvic floor reconstructions and hernia repair applications, Celxcel is also evaluating how the process can be used in orthopaedics and as a biological scaffold to grow and deliver stem cells.
Earlier this month the company successfully implanted its cardiovascular patch CardioCel® during a double valve leaflet reconstruction.
Importantly, normal valve function was regained after these reconstructions and all animals survived the open-heart surgical procedures without any adverse effects or immediate complications.
Rodne told Proactive Investors previously in the U.S. alone, the cardiovascular tissue space generates around US$700 million in revenues and is growing.
"We don't need to capture all of that market share to have significant revenue," he said.
Celxcel will be going through the regulatory process for its CardioCel® over the next six to 12 months, with GyneCel® the next in line for commercialisation.
Allied Healthcare's Growth
Allied Healthcare is on the cusp of building a global healthcare company. The company has expanding revenues, with the objective to increase this to $20-30 million within two to three years via organic growth and acquisitions.
The regenerative medicine market is currently around $3 billion and growing. Allied Healthcare has the upper hand, because at present there is no similar product available to surgeons on the market.
The initial application for the CardioCel® patch is congenital heart disease. About eight in 1,000 children are born with the disease and around half of them have surgery. This presents an extensive global market potential for the technology.
Celxcel is targeting the filing for approval of CardioCel® in various markets and the initial market launch in 2012-13.