FDA Lifts Urological Surgical Restriction for Medafor’s Arista™AH Absorbable Surgical Hemostat

MINNEAPOLIS, July 16, 2007 -- Medafor, Inc., announced today that its Arista™AH Absorbable Hemostat is now available for use in urological surgical procedures. The FDA has removed the restriction on this application of Arista AH from the device indication statement.

Arista AH has compiled a remarkable record of surgical success around the world since its introduction in 2002. The unique, absorbable powder hemostat received FDA PMA approval in September of 2006 and is indicated for most types of surgery including cardiac, orthopedic, spinal and general surgical applications.

Arista AH consists of Medafor’s patented Microporous Polysaccharide Hemospheres (MPH^®), a plant-based, flowable powder engineered to rapidly dehydrate blood, enhancing clotting on contact. Arista AH facilitates the formation of a highly resilient, natural clot within just a few minutes regardless of the patient’s coagulation status.

Arista AH is the only new generation surgical hemostat that is instantly ready to use, requiring no mixing, no addition of patient blood or other components and no special handling or storage conditions.  Pre-clinical evaluations, clinical studies and surgical use have shown the hemostatic capabilities of Arista AH to be comparable to the current popular choice of surgical hemostatic materials while its unique formulation allows for rapid absorption. Arista AH is fully absorbable with studies substantiating no trace of the material at the wound site within 24 to 48 hours of application, and because Arista AH degrades rapidly, it does not promote infection. BACK.