Harvest Technologies Announces Completion of Patient Enrollment in its Randomized, Controlled, Double Blind Multicenter IDE Non-Reconstructable Critical Limb Isch...(of limb loss and/or death. Autologou...)

Autologous cell therapy has been studied as an innovative treatment option for CLI, however; previously published studies did not use a rapid, point of care method for processing the cells therefore making widespread adoption of the therapy problematic. The Harvest trial utilized the BMAC system, which processes the cells in 15 minutes in the operating room. A unique feature of the trial was that it compared the relative effectiveness of the BMAC to a control injection of a placebo. Neither the trial subjects nor the investigators know which material was being injected. Thirty-two of the subjects received the BMAC composition by injection and sixteen received the placebo injection.

In July Harvest announced the completion of enrollment in another trial treating sixty subjects in India suffering from a form of critical limb ischemia referred to as Thromboangitis Obliterans. The 12-week follow up results showed an amputation rate of only 10% and statistically significant improvement in reduction of pain, in perfusion measures, and in quality of life.

"We are particularly pleased that this study is now fully enrolled and by the very promising results shown with the Indian data analysis," said Gary D. Tureski, President of Harvest Technologies. "When combined with our other studies in Germany and the Czech Republic, this study should provide one more step in demonstrating the potential for Harvest's BMAC System to be an effective treatment for Chronic Limb Ischemia regardless of the underlying cause."

Harvest Technologies is a privately held company based in Plymouth, Mass.

    Contact:
    P. Kevin Benoit; VP / General Manager Strategic Business Development
     - 508-732-7500

SOURCE Harvest Technologies Corp.