Biologic Therapies Earns Clearance for Two Bone Marrow Cannulas

Ocala, Fla.-based Biologic Therapies Inc., which makes regenerative medicine products, has earned 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Bio-MAC and Bio-CORE cannulas. The Bio-MAC bone marrow aspiration cannula and Bio-CORE bone marrow biopsy cannula are minimally invasive devices that are inserted into bone with any standard surgical drill.

“Unlike traditional bone marrow aspiration cannulas, which are pounded into bone with a mallet or pushed in with brute force, the power driven Bio-MAC and Bio-CORE do not cause microfractures in the bone that can result in pain for the patient,” said Wade McKenna, D.O., Biologic Therapies’ chief medical director. “Plus, the Bio-MAC and Bio-CORE are available in multiple lengths, which allow for fast and easy bone marrow draws throughout the anatomy. In addition to the iliac crest and lumbar vertebral body, the tibia, humerus and calcaneus are now viable sites for bone marrow aspiration.

“Our products enable physicians to aspirate bone marrow in their own office with only local anesthesia, which is revolutionary. The ability to aspirate a patient’s marrow, concentrate the marrow in a centrifuge to derive the maximum number of regenerative cells and growth factors, and then give the concentrated cells and growth factors back to the patient in a physician’s office makes regenerative cell therapy a much easier, more available and less costly procedure. The entire point-of-care procedure takes less than 30 minutes. Of course, the Bio-MAC and Bio-CORE are also used in hospitals and surgery centers.”

For concentrating bone marrow Biologic Therapies offers its Autospin centrifuge and convenience kits. The Autospin is a fully automated dual spin centrifuge that can be programmed to deliver a volume of 3 to 10 ml from each processing cycle. It is a closed system, which dramatically reduces the chance for contamination. Two separate Autospin convenience kits contain all the components needed to process bone marrow aspirate concentrate (BMAC) or platelet-rich plasma (PRP).

“My team and I are very pleased to receive 510(k) clearance for our Bio-MAC and Bio-CORE cannulas,” said CEO Luke Whalen. “We are currently expanding our business throughout the United States, Europe, India, China and South Africa. Biologic Therapies is improving the health of patients around the world by making our products the standard of care for regenerative medicine.”