ATLANTA, Sept. 22 /PRNewswire-FirstCall/ -- CryoLife, Inc. , a biomaterials, medical device and tissue processing company, announced today that it has begun distribution in Canada, through Sorin Group Canada, Inc., of Hemostase MPH to control bleeding in general, cardiac and vascular surgery.
CryoLife began distributing Hemostase MPH in the U. S., the United Kingdom and Germany in the second quarter of 2008. Distribution will continue to expand to additional markets later in 2008 and in 2009.
Hemostase MPH is developed using Microporous Polysaccharide Hemospheres technology (MPH(R)), which produces a plant-based powder that rapidly dehydrates blood, and enhances clotting on contact. The Hemostase MPH product received Health Canada approval in 2002, CE Mark approval in 2003, and FDA pre-market approval in 2006.
Available in a convenient ready-to-use applicator, Hemostase MPH, unlike many hemostatic agents, does not require additional operating room preparation or special storage conditions. In addition, pre-clinical studies 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 is complementary to our BioGlue(R) surgical adhesive products. It provides surgeons with the ability to quickly and confidently control active bleeding during surgery," stated Steven G. Anderson, president and chief executive officer. "We are pleased to be able to offer this product in Canada through the Sorin Group."
About CryoLife, Inc.
Founded in 1984, CryoLife, Inc. is a leader in the processing and distribution of implantable living human tissues for use in cardiac and vascular surgeries throughout the U.S. and Canada. The Company recently received FDA clearance for the CryoValve(R) SG pulmonary human heart valve, processed using CryoLife's proprietary SynerGraft(R) Technology. The Company's BioGlue(R) Surgical Adhesive is FDA approved as an adjunct to sutures and staples for use in adult patients in open surgical repair of large vessels. BioGlue is also CE marked in the European Community and approved in Canada and Australia for use in soft tissue repair. CryoLife distributes Hemostase MPH(R), a hemostatic agent, in much of the U.S. for use in cardiac and vascular surgery and in the United Kingdom, Germany, France and Canada for cardiac, vascular, and general surgery, subject to certain exclusions. The Company also distributes the CryoLife-O'Brien(R) Stentless Porcine Aortic Bioprosthesis, which is CE marked for distribution within the European Community.
Statements made in this press release that look forward in time or that express management's beliefs, expectations or hopes are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements include those regarding the ability of the Company to begin distributing the Hemostase MPH product when expected and the anticipated benefits of Hemostase MPH. These future events may not occur as and when expected, if at all, and, together with the Company's business, are subject to various risks and uncertainties. These risks and uncertainties include that the Company may be unable to effectively leverage its existing sales force to sell Hemostase MPH, that surgeons may not choose to utilize Hemostase MPH, that Hemostase MPH may not perform in accordance with preliminary tests and results and that other distributors of the product may impede the Company's ability to sell to new or existing customers. These risks and uncertainties also include the risk factors detailed in CryoLife's Securities and Exchange Commission filings, including CryoLife's Form 10-K filing for the year ended December 31, 2007 and the Company's other SEC filings. The Company does not undertake to update its forward-looking statements.
CONTACT: D. Ashley Lee of CryoLife, Inc., Executive Vice President, Chief
Financial Officer and Chief Operating Officer, +1-770-419-3355; or Katie
Brazel, Fleishman Hillard, +1-404-739-0150, for CryoLife, Inc.
Web site: http://www.cryolife.com/