Plymouth, Mass.-based cellular therapy manufacturer Harvest Technologies landed expanded CE Mark approval for its bone marrow aspiration concentration system product in point-of-care cell concentrate preparation for treatment of no-option critical limb ischemia.
Clinical studies used to support expanded CE Mark showed that the BMAC2 system could reduce risk for amputation as well as improve "rest pain" in patients with critical limb ischemia, according to the company.
"This indication provides a significant treatment option that can improve the quality of life for approximately 800,000 European patients annually that progress to end stage critical limb ischemia," president & CEO Gary Tureski said in prepared remarks. "The clinical evidence from our European studies is so compelling that we committed to and are currently enrolling patients in a U.S. FDA pivotal trial."
The medical device directive’s British Standards Institution reviewed 50 clinical trials and investigations and awarded a certificate of expanded CE Mark to Harvest, saying the BMAC2 system is appropriate for point-of-care for the safe and rapid preparation of autologous nucleated cell concentrate from bone marrow aspiration for "administration into ischemic tissues of the affected limb due to no-option critical limb ischemia," according to the press release.