ATLANTA, Sept. 11 /PRNewswire-FirstCall/ -- CryoLife, Inc. , a biomaterials, medical device and tissue processing company, announced today that it has begun distribution in France, through Laboratoire Gamida, of Hemostase MPH for use 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 in other markets outside the U.S. is planned for later in 2008 and in 2009.
Hemostase MPH is developed using Microporous Polysaccharide Hemospheres technology (MPH(R)), which yields a plant-based powder engineered to rapidly dehydrate blood, enhancing clotting on contact. When used as directed, this hemostatic or antibleeding agent facilitates the formation of a resilient, natural clot within just a few minutes. Hemostase MPH received CE Mark approval in 2003 and FDA pre-market approval in September 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 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.
“As a complement to CryoLife’s BioGlue(R) product line, Hemostase MPH gives surgeons the ability to quickly control active surgical bleeding, and we are pleased to begin offering this product in France,” stated Steven G. Anderson, president and chief executive officer. “We will showcase Hemostase MPH at the European Association of Cardiothoracic Surgeons meeting in Lisbon, Portugal later this week.”
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 and France 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 a new product, 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 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.
For additional information about the company, visit CryoLife’s Web site http://www.cryolife.com
CONTACT: D. Ashley Lee, Executive Vice President, Chief Financial Officer
and Chief Operating Officer, CryoLife, Inc., +1-770-419-3355; or Katie
Brazel of Fleishman Hillard for Cryolife, +1-404-739-0150
Web site: http://www.cryolife.com//
