Biologic Therapies Receives FDA Clearance for Bio-MACTM Bone Marrow Aspiration Catheter

Ocala, FL, August 08, 2012 --(PR.com)-- Biologic Therapies, a medical device company specializing in the design and manufacturing of proprietary, groundbreaking medical components, has received clearance from the Food and Drug Administration (FDA) to begin marketing its new Bio-MACTM Bone Marrow Aspiration Catheter. The Company’s management feels the Bio-MAC will significantly enhance physicians’ use of autologous Bone Marrow Aspirate Concentrate (BMAC) in surgical procedures for the treatment of orthopedic conditions.

Biologic Therapies’ Bio-MAC catheter was designed to simplify and safely harvest bone marrow, which can be processed by any point-of-care centrifugation system. The bone marrow aspirate concentrate (BMAC) is then administered to patients at the time of surgery. BMAC contains growth factors and adult cells which have proven to accelerate healing of bone, tendon, muscle and cartilage injuries. This autologous orthobiologic is traditionally used in surgical fields such as Spine and Sports Medicine.

Dr. Wade McKenna, Biologic Therapies’ Chief Medical Director and co-inventor of the Bio-MAC catheter, has practiced the science known as Regenerative Medicine extensively. Dr. McKenna has been testing the Bio-MAC catheter in point-of-care procedures for his patients on a custom, prescription-only basis.

“The Bio-MAC Bone Marrow Aspiration Catheter makes marrow harvesting much easier for clinicians and increases access of bone marrow aspirate for the patients, while decreasing the complication and pain associated with other current bone marrow harvesting devices,” states Dr. McKenna. “My clinical experience with autologous bone marrow aspirate concentrate in over 500 cases has produced dramatic clinical results in patient outcomes, which prompted the invention of the Bio-MAC catheter.”

The Bio-MAC Bone Marrow Aspiration Catheter is a power driven catheter containing eight large, smooth, bevel-edged fenestrations, which allow for a gentle aspiration. The Bio-MAC’s unique design also incorporates a proprietary plunger component that when inserted down the catheter creates a void (frac) where marrow pools. Together, the fenestrations and the plunger-created void provide for higher bone marrow aspiration efficiency and an easier draw, when compared to other current bone marrow aspiration devices.

One of the leading features of the Bio-MAC is the insertion process. Unlike most bone marrow aspiration devices, which are manually manipulated with either brute force or a mallet, the Bio-MAC can be inserted with any standard surgical drill. This delivery system eliminates the potential micro-fracturing, bruising and subsequent pain that is associated with "hammering" marrow aspiration catheters into bone. Additionally, the Bio-MAC’s power driven feature brings autologous orthobiologics to an in-office clinical use.

To accompany the Bio-MAC, Biologic Therapies is developing a family of proprietary medical devices designed to significantly enhance autologous orthobiologic procedures. According to the February 2012 issue of Orthopedics This Week magazine, the Autologous Regenerative Medicine segment of the orthopedic market is estimated to grow to over six billion dollars by the year 2020, and Biologic Therapies expects to capture a significant share of that market.

Biologic Therapies’ COO and VP of Sales & Distribution, Chuck Bolles, states, “The Bio-MAC Bone Marrow Aspiration Catheter will quickly become the catheter of choice for marrow aspirations. The uniqueness, ease of use and clinical advantages open up the autologous orthobiologic market to many specialty physicians, such as Podiatrists, who currently do not utilize autologous bone marrow aspirate concentrate.” Bolles continues, “We’ve created an opportunity for millions of patients not currently benefiting from BMAC to have their surgical procedures or sports medicine injuries treated with concentrated growth factors and adult cells.”

Biologic Therapies’ President, Steve Bales, adds, “We believe the Bio-MAC catheter will set a new ‘Standard of Care’ for bone marrow aspiration and regenerative medicine procedures. Point-of-care autologous orthobiologic therapy is now being proven in a number of medical specialties, both human and animal, and we expect the Bio-MAC to be the first in a pipeline of successful products designed to effectively meet the needs of physicians and patients worldwide. All our products are designed for use in the treatment of common, high volume orthopedic conditions.”