Healthcare Industry News: CryoLife
News Release - September 17, 2007
CryoLife Signs Distribution Agreement for Inclusion of BioGlue(R) Surgical Adhesive in Hernia Repair Kit with Proxy Biomedical Surgical MeshesHernia repair is one of the most commonly performed surgical procedures worldwide
ATLANTA, Ga., Sept. 17 (HSMN NewsFeed) -- CryoLife, Inc. (NYSE: CRY ), a biomaterials, medical device and tissue processing company, announced today that it has signed a distribution agreement allowing Proxy Biomedical Limited to include CryoLife's BioGlueŽ Surgical Adhesive into a hernia repair kit. In addition to BioGlue, the kit includes a surgical mesh from Proxy Biomedical's line of proprietary synthetic polymer surgical meshes. Initially, Proxy Biomedical will distribute the kits in Ireland, the United Kingdom and Germany.
"We believe that BioGlue provides a highly competitive method for atraumatic surgical mesh fixation. BioGlue has been used effectively for several surgical procedures, and we look forward to providing the product in kit form with our series of next generation surgical mesh products. BioGlue offers a simple and effective solution for surgical mesh fixation with enhanced procedural value," stated Peter Gingras, managing director of Proxy Biomedical Limited.
Currently, the most common methods of hernia mesh fixation include sutures and tacking systems. Between 10 and 20 percent of patients complain of pain resulting from hernia repair, most often associated with the fixation method. It is anticipated that the use of BioGlue, as an adjunct to sutures and tacking systems, will help minimize this incidence of postoperative pain.
BioGlue is distributed directly by CryoLife Europa in the UK and Germany for all types of soft tissue repair, including in cardiac, neuro and general surgery. In Ireland, the product is distributed through a distributor for the same indications.
BioGlue is a two-component adhesive that creates a flexible, mechanical seal, independent of the body's clotting mechanism, within 20 to 30 seconds, and reaches its maximum bonding strength in two to three minutes.
It is FDA approved as an adjunct to sutures and staples for use in adult patients in open surgical repair of large vessels, and is CE-marked in the European Community. In addition, BioGlue is approved in Canada for use in soft tissue repair and in Australia for use in vascular and pulmonary sealing and repair.
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 United States and Canada. In addition to BioGlue, the Company also distributes the CryoLife-O'BrienŽ stentless porcine heart valve and the SG Model 100 vascular graft, which are CE marked for distribution within the European Community. For additional information about CryoLife please visit http://www.CryoLife.com.
About Proxy Biomedical Limited
Founded in 2002, Proxy Biomedical Limited, located in Galway, Ireland, is a privately held, life science company engaged in commercializing proprietary biomaterials for the repair and regeneration of tissue. Proxy Biomedical's proprietary surgical mesh products include MotifMesh, VitaMesh, MotifMesh MIDS, and VitaMesh MIDS, which are CE marked for distribution within the European Community and FDA approved for distribution within the United States.
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 anticipated benefits of using BioGlue in Proxy Biomedical's hernia repair kits. 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 BioGlue may not help minimize post- operative pain to the extent anticipated or may otherwise prove ineffective in hernia repair, and other risk factors detailed in CryoLife's Securities and Exchange Commission filings, including CryoLife's Form 10-K filing for the year ended December 31, 2006, its most recent Form 10-Q, and the Company's other SEC filings. The Company does not undertake to update its forward- looking statements.
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