The British Standards Institution (BSI), a notified body under the Medical Device Directive, has awarded a CE mark for the expanded clinical indication for Harvest Technologies' SmartPReP 2 Bone Marrow Aspiration Concentration System (BMAC 2).
The expanded clinical indication allows users to utilize the system at point-of-care for preparing autologous nucleated cell concentrate from Bone Marrow Aspiration (BMA) and administer into ischemic tissues of the affected limb due to No Option critical limb ischemia.
The approval was based on the clinical data from 50 clinical trials and investigations including data using Harvest Technologies BMAC2 system.
The studies demonstrated that the use of BMAC2 system reduces the risk and is a viable option for limb salvage as well as improves severe rest pain.
Harvest Technologies president and CEO Gary Tureski said the expanded 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.
"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," Tureski added.