Harvest Technologies Corporation Granted CE Mark for Expanded Clinical Indication for Treatment of No-Option Critical Limb Ischemia
PLYMOUTH, Mass., Nov. 19, 2012 /PRNewswire/ -- Harvest Technologies, a leader in advancing cellular therapies, is pleased to announce CE Marking for an expanded clinical indication for its SmartPReP®2 Bone Marrow Aspiration Concentration System (BMAC®2) product.
The British Standards Institution (BSI), a notified body under the Medical Device Directive, has awarded a certificate indicating that the Harvest SmartPReP2 Bone Marrow Aspiration Concentrate System (BMAC2) is intended to be used at point-of-care for the safe and rapid preparation of autologous nucleated cell concentrate from Bone Marrow Aspiration (BMA) for administration into ischemic tissues of the affected limb due to No-Option Critical Limb Ischemia.
This is the first time an autologous point-of-care cellular therapy company has presented sufficient clinical evidence for a notified body to grant approval to promote a specific product for this clinical use.
This certification comes after BSI's extensive review of clinical data from nearly 50 clinical trials and investigations, including data using Harvest Technologies BMAC2 System. Previous studies have shown that critical limb ischemia (CLI) patients that have tissue loss (gangrenous or ulcer wounds) are at severe risk for amputation. Harvest studies have shown that the use of the BMAC2 system significantly reduces that risk and is a viable option for limb salvage. The Harvest studies have also been able to show improvement in rest pain for patients with severe rest pain.
"We are pleased about the expansion of our claims. 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," said Gary Tureski, President and CEO, Harvest Technologies Corporation. "The clinical evidence from our European studies is s