Cartilage Repair Technologies Coming to Market
BY ROBIN R. YOUNG CFA, AUGUST 30, 2004
Data from the largest clinical trial ever conducted on the human meniscus is starting to make its way into the FDA. The first module was submitted in early July. The next modules are being submitted over the course of 2004. FDA approval could come late 2005 or early 2006. After getting a preview of some of the data (and you can hear first hand from about this product and company at this October's HealthpointCapital Biomaterials Summit), we think this is a most impressive and exciting product.
The product is a type I collagen implant designed for patients with irreparable meniscus tears or loss of meniscus tissue. The trial was held at 14 clinical sites around the U.S. and covered 288 patients. The manufacturer is... ReGen Biologics (RGBI:NASDAQ). A blast from the past, for sure. And many people, including this writer, have responded to learning that ReGen is still around and obviously making strong progress with a little surprise.
Certainly, the landscape is littered with tissue engineering firms that did not make it. We won't go through the roll call right now. But to have survived and to be on the verge of FDA approval is really, truly significant; and a testament, we think, to the strength of the product.
ReGen's data is impressive. Here is a sample:
Using a measure of patient activity following knee surgery (the Tegner Index), patients with ReGen's meniscus scored more than 2x better than patients without ReGen's meniscus have. Specifically, patients with the ReGen Biologics's Collagen Meniscus Implant (CMI) scored over 70% on the Tegner Index two years after implant, while the control group scored just under 30% two years after their surgery.
In another study, researchers found that using ReGen's CMI after a partial meniscuectomy restored as much as 75% of the patient's meniscus after surgery. Not using CMI resulted in only 38% of the meniscus being restored.
Of course, the study that really counts is the large one that is moving into the hands of the FDA. And, we are proud to say, CEO Gerry Bisbee has agreed to present at the HealthpointCapital Biomaterials Summit. We have seen a preview and it is very good.
Another very promising cartilage repair company and one of the presenters at HealthpointCapital's Biomaterials Summit is Texas based OsteoBiologics (OBI). OBI's principal technology is a unique and especially effective blend of polylactide-co-glycolide, calcium sulfate and polyglycolide fibers, currently approved by the FDA for bone void fill.
The material is a unique blend of porosity, bioactivity and structure. For cartilage repair, OBI has taken its core polymer blend technology and enhanced it with bioactive ceramics and another polymer biomaterial to create an innovative and, we think, highly effective cartilage defect fill.
While OBI's other products are FDA cleared and in commercial distribution, the cartilage repair product is still working its way through initial, feasibility trials. Still, the data is very interesting and, we think, will impress attendees at the HealthpointCapital Biomaterials Summit.
