Cellular therapy company Harvest Technologies has announced CE Marking for an expanded clinical indication for its SmartPReP®2 Bone Marrow Aspiration Concentration System (BMAC®2) product.
This approval means that, for the first time, European critical limb ischemia patients, at severe risk of amputation, now have a treatment option. And it’s one that the company says is backed up by nearly 50 clinical trials.
Critical limb ischemia (CLI) patients with tissue loss (gangrenous or ulcer wounds) are at severe risk for amputation. Harvest Technology has referenced nearly 50 studies in concluding that the use of its 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.
Harvest SmartPReP2 Bone Marrow Aspiration Concentrate System (BMAC2) is indicated according to its CE mark, for use 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.
A subsidiary of Terumo Corporation, Harvest Technologies is the leading Cellular Therapy global manufacturer that develops point-of-care products to process and concentrate multiple biologics. These include high-density platelet rich plasma (APC+®), bone marrow aspirate concentrate (BMAC®) and adipose tissue.
“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 so compelling that we committed to and are currently enrolling patients in a US FDA pivotal trial.”
Source: Harvest Technologies, PR Newswire