A Medical Device Daily

Osteotech (Eatontown, New Jersey) reported it has entered into a three-year agreement with Harvest Technologies (Plymouth, Massachusetts) to distribute the Bone Marrow Aspirate Concentrate (BMAC) System. Osteotech has the exclusive right to distribute the BMAC System for bone regeneration in orthopedic and spinal surgical procedures in most of the U.S.

Sam Owusu-Akyaw, Osteotech’s president/CEO, said, “We believe Harvest’s proprietary BMAC System will complement Osteotech’s proprietary technologies in Biocomposite, which includes the Plexur P and Plexur M, and DBM, furthering Osteotech’s regenerative healing equation —Matrix + Signal + Cell.”

“We expect to begin to distribute the BMAC System before the end of the second quarter of 2008. We are currently putting the finishing touches on our roll-out plan and will begin training our sales team shortly,” Owusu-Akyaw said.

The BMAC System, developed and manufactured by Harvest, is the first “point-of-care” platform that makes possible the use of a clinically significant quantity of cellular compositions from a small aspirate of bone marrow. The BMAC System derives bone marrow aspirate concentrate, which is a rich source of autologous adult stem cells, in just 15 minutes.

In other agreements: Advanced Cell Technology (ACT; Los Angeles) said it has reached a supply agreement with the Biologics Delivery Systems Group (BDS) of Cordis (Miami Lakes, Florida), in which BDS will supply catheters for Phase II human clinical trial of ACT’s myoblast therapy for the treatment of heart failure.

ACT’s myoblast therapy successfully completed Phase I human clinical trials in 2007 using the therapy safely in more than 40 patients. The FDA has given the company clearance to proceed with Phase II human clinical trials, which are expected to begin shortly.

ACT’s myoblast therapy involves the transplantation of expanded autologous myoblasts (adult progenitor stem cells) derived from a small biopsy of skeletal muscle from a patient’s leg. The technology allows for the expansion of myoblasts into hundreds of millions of cells over a period of two to three weeks. The resulting myoblasts are then transplanted back into the patient’s scarred heart tissue through the use of a catheter-based procedure.

More than one million new patients with heart attacks are treated annually in the U.S., representing a multi-billion dollar market opportunity. Current therapies do not result in rebuilding of heart muscle and do not prevent progression of congestive heart failure, poor quality of life, and long-term deterioration.

The Phase II human clinical trial will be a multi-center study following a similar protocol used in the company’s Phase I study. That study demonstrated safety and evidence of significant heart function improvement in congestive heart failure patients as a result of the implantation of the ACT’s autologous skeletal myoblasts.