FDA News

CryoLife to Distribute FDA-approved Hemostatic Agent Under Private Label

(Aprl 18, 2008)-- CryoLife, a biomaterials, medical device and tissue processing company, announced that it has signed an exclusive three-year agreement with Minneapolis-based Medafor, Inc. Under terms of the agreement CryoLife will distribute Medafor's microporous polysaccharide hemostatic agent for use in cardiac and vascular surgery in the U.S. and for cardiac, vascular and general surgery, other than orthopaedic and ear, nose and throat surgery, outside the U.S. (excluding Japan and China).

CryoLife expects to begin distributing Hemostase MPH in the U.S. in the second quarter of 2008, except to approximately 41 hospitals for which Medafor will retain distribution rights until no later than December 31,
2008. Outside of the U.S., CryoLife expects to begin distributing Hemostase MPH in Canada, United Kingdom and Germany in the second quarter of 2008, with distribution in other markets beginning in 2009. Department of Defense hospitals are excluded from CryoLife's territory under the distribution agreement, but Veterans' Administration Hospitals are included.

The unique, absorbable powder hemostat, which received CE Mark approval in 2003 and FDA pre-market approval in September 2006, will be distributed by CryoLife under the private label name Hemostase MPH.

Hemostase MPH is developed using Medafor's exclusive, licensed Microporous Polysaccharide Hemospheres technology (MPH(R)), which yields a plant-based, flowable powder engineered to rapidly dehydrate blood, enhancing clotting on contact. When used as directed, this highly effective hemostatic
agent facilitates the formation of a resilient, natural clot within just a few minutes.

Available in a convenient ready-to-use applicator, Hemostase MPH, unlike many hemostatic agents, does not require additional preparation steps in the operating room or special storage conditions thereby saving valuable operating room time and resources. Pre-clinical evaluations have shown that Hemostase MPH does not promote infection and absorbs within 24-48 hours of application at the wound site, compared to other surgical hemostats which can take 3-8 weeks or more to fully break down.

"Hemostase MPH gives surgeons the ability to quickly control active surgical bleeding, making it the perfect complement to CryoLife's BioGlue product line, which is much stronger and provides both tissue reinforcement and sealant capabilities," stated Steven G. Anderson, president and chief executive officer. "Hemostase MPH also allows us to compete in the surgical hemostat market, which we believe totaled approximately US$380 million in the U.S. in 2007."

Gary Shope, Medafor's chief executive, said, "We are pleased to be working with CryoLife as a major distribution partner. CryoLife is a world leader in its chosen areas, and its strength in sales, marketing and
distribution in the cardio and vascular fields should provide great impetus to Medafor's market penetration."

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