Allied Healthcare Group’s (ASX: AHZ) cardiovascular tissue patch, CardioCel®, has shown the ability to promote new tissue regeneration in a successful pre-clinical heart valve reconstruction study.
The significance of the findings from the study is the capability of CardioCel® to enable tissue regeneration without further intervention such as repeat surgeries.
Notably, valves in the CardioCel® repaired group demonstrated significantly reduced calcification versus the control as well as minimal thickening of the tissue.
Significantly, the adult heart valve industry is a billion dollar industry and expands on CardioCel’s® initial application in the treatment of congenital heart disease.
Lee Rodne, managing director, commented: “These results are remarkable, particularly regarding evidence that the CardioCel® patch material appears to enable tissue regeneration, opening up the possibility for CardioCel® treated valves to regenerate without additional intervention or assistance.
“The demonstration of effective tissue regeneration without adding external stimulation like stem cells or growth factors is a major new finding from this study.”
The histology data showed that after eight months there had been significant new tissue growth on both sides of the implanted CardioCel® patch, consisting of collagen and several different cell types, which are typically found in a healthy cardiovascular healing process as well as in heart valves.
In the study there was no evidence of macroscopic calcification of the CardioCel® implant on echocardiography (heart ultrasound) and in molecular measurement of extractable calcium, the active CardioCel® tissue had 40% less calcium than the control native autologous tissue.
Bob Atwill, chief executive officer of Allied’s regenerative medicine franchise, said: “As well as tissue regeneration, further evidence of the lack of calcification in the CardioCel® tissue is very encouraging.
“Reduced calcification should result in the reduction of repeat surgeries, and therefore the reduction in unnecessary patient risk, stress and cost, promoting a lifelong solution for patients.
“These results provide further support to the importance and benefits of CardioCel® in the area of tissue repair, reconstruction and regeneration.”
Data independently validated
The histology results were independently assessed by Professor Frederick J. Schoen, executive vice chairman, Department of Pathology, Brigham and Women’s Hospital and Professor of Pathology and Health Sciences and Technology (HST), Harvard Medical School.
Calcification levels were independently quantified by the Murdoch University research group.
In his conclusion, Professor Schoen said: “No apparent significant adverse effects were present. Based on the experience in the present study, CardioCel® pericardium appears to be a suitable bioprosthetic substitute for valve reconstruction procedures and consideration as an alternative to autologous pericardium.”
The CardioCel® scaffold appears to attract endogenous stem cells which allow “normal” cell growth, proliferation and differentiation into fully functional valve tissue.
Current research indicates that a tissue matrix becomes incorporated into native tissue over time.
These study results show that CardioCel® becomes enveloped with endothelial cells via normal cell growth, suggesting it is “invisible” to the recipient immune system and becomes native tissue over time.
These results expand the potential for CardioCel® and open up opportunities to develop additional ADAPT® engineered tissue products.
The independent validation of these latest results confirms the regenerative performance of the ADAPT® treated tissue and provides an opportunity to transform valve reconstructive surgery, along with expanding opportunities in congenital heart disease repair surgery.
“These regenerative results, in one of the most challenging models, are significant as native tissue has regenerated after eight months,” Atwill said.
“From a commercial perspective, as CardioCel® is a Class III medical device, it has a much more straightforward and cost effective route to market compared to biologic agents and stem cells that are targeting cardiac repair.”
Allied expects to present the full data at an international scientific meeting and in peer reviewed publication in the near future.
CardioCel® implanted in first patients
Last month, Allied announced CardioCel® had been used for the first time to surgically repair congenital heart defects (CHD) in infants.
The surgery, performed at Brisbane’s Mater Hospital, represents the first use of CardioCel® outside of a clinical trial.
CardioCel® has now been successfully implanted for the repair of congenital heart defects in Australia by Professor Tom Karl under the Authorised Prescriber Scheme.
In September, the Therapeutic Goods Administration (TGA) authorised CardioCel® use for surgical repair of CHD under an Authorised Prescriber Scheme, allowing the authorised cardiothoracic surgeon to use the heart patches to treat their patients prior to full marketing approval.
Other cardiothoracic surgeons are in the final processes of becoming authorised via the Authorised Prescriber Scheme.
Congenital heart defects are a major cause of death in infants globally. In Australia, CHD prevalence has been recorded at around eight cases per 1,000 live births.
Allied Healthcare is in the process of seeking full TGA approval of CardioCel® and will be lodging an application for FDA approval in the U.S. at the end of 2012 or in early 2013.
An application for a CE mark to allow CardioCel® entry to Europe and other markets is also underway.
Allied has previously indicated it expects approval in both Europe and the U.S. early to mid-next year.
The company is targeting initial market launch in 2013.