Allied Healthcare Group (ASX: AHZ) has reached a milestone with patients under its ongoing Phase II extension study for the CardioCel® regenerative tissue repair product showing no sign of calcification after five years.
Five patients have been monitored over a five year period post-surgery, six patients over four years and eight beyond three years have all showed no signs of calcification.
Calcification is a major issue with other existing tissue products that in many cases results in the need for additional surgeries. Typically, calcium build-up at the site of repair can be seen within six months post-surgery with existing marketed products.
"These results show the potential of CardioCel® in not only providing a regenerative tissue for the repair and reconstruction of congenital heart disease and cardiovascular defects, but also the long term benefit for patients in preventing calcification of tissue," chief executive officer Lee Rodne said.
The original Phase II study met its primary and secondary endpoints of 30 day survival post-surgery.
Around 20 patients have continued to be monitored in an extension study to explore the longer term benefits of CardioCel® for these patients. Patients in the study were aged from 2 months to 14 years old.
"This data will be used to support ongoing launch activities in Europe by highlighting the long-term benefits of the product. We are expecting initial sales of CardioCel® in Europe in the coming months," Rodne added.
Allied recently received CE Mark approval of CardioCel® in Europe, which allows it to be launched and marketed, and anticipates approval of the product in the U.S. in 2014.
CardioCel® is a regenerative tissue product currently used to repair heart deformities including repairing and reconstructing heart valves.
It offers key benefits for patients and surgeons including showing strong levels of regeneration of self-tissue without needing external stem cells or growth factors and no cytotoxicity at the site of repair, thereby reducing the issue of calcification which can often lead patients to have repeat surgeries.
CardioCel® is also ready to use, off the shelf, saving time during surgery.
It is currently available in Australia for use under the Authorised Prescriber Scheme (APS) and Investigator initiated study scheme (IIS) with six surgeons approved to use it under early access schemes.
With the ongoing extension study highlighting the long-term benefits of its CardioCel® tissue patch, especially its superiority over existing products in the key area of calcium build-up, Allied Healthcare Group is well placed to support its launch activities in Europe.
RBS Morgans had in August noted that securing the CE Mark for CardioCel® would increase its valuation by A$0.01 from its target price of A$0.09.
Shares in Allied are expected to rise today on the positive news.
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