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CryoLife began distributing Hemostase MPH in the U. S., the United Kingdomand Germany in the second quarter of 2008. Distribution will continue toexpand to additional markets later in 2008 and in 2009.
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Hemostase MPH is developed using Microporous Polysaccharide Hemospherestechnology (MPH(R)), which produces a plant-based powder that rapidlydehydrates blood, and enhances clotting on contact. The Hemostase MPH productreceived Health Canada approval in 2002, CE Mark approval in 2003, and FDApre-market approval in 2006.
Available in a convenient ready-to-use applicator, Hemostase MPH, unlikemany hemostatic agents, does not require additional operating room preparationor special storage conditions. In addition, pre-clinical studies have shownthat Hemostase MPH does not promote infection and absorbs within 24-48 hoursof application at the wound site, compared to other surgical hemostats whichcan take 3-8 weeks or more to fully break down.
"Hemostase MPH is complementary to our BioGlue(R) surgical adhesiveproducts. It provides surgeons with the ability to quickly and confidentlycontrol active bleeding during surgery," stated Steven G. Anderson, presidentand chief executive officer. "We are pleased to be able to offer this productin Canada through the Sorin Group."
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 U.S. and Canada. The Company recentlyreceived FDA clearance for the CryoValve(R) SG pulmonary human heart valve,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. CryoLife distributesHemostase MPH(R), a hemostatic agent, in much of the U.S. for use in cardiacand vascular surgery and in the United Kingdom, Germany, France and Canada forcardiac, vascular, and general surgery, subject to certain exclusions. TheCompany also distributes the CryoLife-O'Brien(R) Stentless Porcine AorticBioprosthesis, which is CE marked for distribution within the EuropeanCommunity.
Statements made in this press release that look forward in time or thatexpress management's beliefs, expectations or hopes are forward-lookingstatements within the meaning of the Private Securities Litigation Reform Actof 1995. These statements include those regarding the ability of the Companyto begin distributing the Hemostase MPH product when expected and theanticipated benefits of Hemostase MPH. These future events may not occur asand when expected, if at all, and, together with the Company's business, aresubject to various risks and uncertainties. These risks and uncertaintiesinclude that the Company may be unable to effectively leverage its existingsales force to sell Hemostase MPH, that surgeons may not choose to utilizeHemostase MPH, that Hemostase MPH may not perform in accordance withpreliminary tests and results and that other distributors of the product mayimpede the Company's ability to sell to new or existing customers. Theserisks and uncertainties also include the risk factors detailed in CryoLife'sSecurities and Exchange Commission filings, including CryoLife's Form 10-Kfiling for the year ended December 31, 2007 and the Company's other SECfilings. The Company does not undertake to update its forward-lookingstatements.For add
