CryoLife to Distribute FDA-approved Hemostatic Agent Under Private Label
CryoLife expects to begin distributing Hemostase MPH in the U.S. in thesecond quarter of 2008, except to approximately 41 hospitals for which Medaforwill retain distribution rights until no later than December 31, 2008.Outside of the U.S., CryoLife expects to begin distributing Hemostase MPH inCanada, United Kingdom and Germany in the second quarter of 2008, withdistribution in other markets beginning in 2009. Department of Defensehospitals are excluded from CryoLife's territory under the distributionagreement, but Veterans' Administration Hospitals are included.
The unique, absorbable powder hemostat, which received CE Mark approval in2003 and FDA pre-market approval in September 2006, will be distributed byCryoLife under the private label name Hemostase MPH.
Hemostase MPH is developed using Medafor's exclusive, licensed MicroporousPolysaccharide Hemospheres technology (MPH(R)), which yields a plant-based,flowable powder engineered to rapidly dehydrate blood, enhancing clotting oncontact. When used as directed, this highly effective hemostatic agentfacilitates the formation of a resilient, natural clot within just a fewminutes.
Available in a convenient ready-to-use applicator, Hemostase MPH, unlikemany hemostatic agents, does not require additional preparation steps in theoperating room or special storage conditions thereby saving valuable operatingroom time and resources. Pre-clinical evaluations have shown that HemostaseMPH does not promote infection and absorbs within 24-48 hours of applicationat the wound site, compared to other surgical hemostats which can take 3-8weeks or more to fully break down.
"Hemostase MPH gives surgeons the ability to quickly control activesurgical bleeding, making it the perfect complement to CryoLife's BioGlue(R)product line, which is much stronger and provides both tissue reinforcementand sealant capabilities," stated Steven G. Anderson, president and chiefexecutive officer. "Hemostase MPH also allows us to compete in the surgicalhemostat market, which we believe totaled approximately $380 million in theU.S. in 2007."
Gary Shope, Medafor's chief executive, said, "We are pleased to be workingwith CryoLife as a major distribution partner. CryoLife is a world leader inits chosen areas, and its strength in sales, marketing and distribution in thecardio and vascular fields should provide great impetus to Medafor's marketpenetration."
The agreement allows for a three-year extension at the option of CryoLifeif certain minimum purchases are met.
About CryoLife, Inc.
Founded in 1984, CryoLife, Inc. is a leader in the processing anddistribution of implantable living human tissues for use in cardiac andvascular surgeries throughout the United States and Canada. The Companyrecently received FDA clearance for its CryoValve(R) SG pulmonary human heartvalve, processed using CryoLife's proprietary SynerGraft(R) Technology. TheCompany's BioGlue(R) Surgical Adhesive is FDA approved as an adjunct tosutures and staples for use in adult patients in open surgical repair of largevessels. BioGlue is also CE marked in the European Community and approved inCanada and Australia for use in soft tissue repair. The Company alsodistributes the CryoLife-O'Brien(R) stentless porcine heart valve, which is CEmarked for distribution within the European Community.
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