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April 25, 2011 /PRNewswire/ --
CryoLife, Inc. (NYSE: CRY), an implantable biological medical device and cardiovascular tissue processing company, today announced that its
BioGlue Surgical Adhesive has launched in
Japan and is expected to be available in hospitals by late
BioGlue received Shonin approval from the Japanese Ministry of Health, Labor and Welfare (MHLW) for use in the repair of aortic dissections in
September 2010. Prior to distribution, MHLW completed a remote inspection of CryoLife pursuant to Japanese Quality Management System requirements and required product reimbursement paperwork for Japanese authorities.
CryoLife's partner, Century Medical, Inc. (CMI) will distribute BioGlue in
Japan for use in this subset of cardiac surgery. CryoLife will remain the exclusive supplier of BioGlue to CMI.
"We are pleased to have received Japanese approval for the use of BioGlue in the repair of aortic dissections, a potentially life-threatening condition if not properly repaired," stated Mr.
Akira Hoshino, president and chief executive officer of CMI. "We believe that BioGlue is a valuable tool that will address many issues facing cardiac surgeons in
"We are pleased that BioGlue is approved for this initial use in
Japan. We estimate
Japan to be the second largest market in the world for surgical hemostats and sealants," said
Steven G. Anderson, president and chief executive officer, CryoLife, Inc. "Estimated to have been used in more than 615,000 procedures worldwide, BioGlue has proven to be a safe, efficacious product, and we look forward to continuing to expand both its applications and availability worldwide."
The company estimates that the annual Japanese market for the use of surgical adhesives in the repair of aortic dissection is approximately
$10 million, and the total annual market for the use of adhesives and sealants in
Japan is approximately
$150 million. The initial order is expected to be shipped in late April or early May and the Company estimates approximately
$600,000 in sales for the first 12 months to CMI, our exclusive distribution partner in
Japan. As a part of its product launch, CMI and the Company provided an introduction of BioGlue to approximately 110 physicians during
The Japanese Society of Cardiovascular Surgery conference in Tokyo in February, and renowned cardiac surgeon, Dr.
John W. Fehrenbacher provided clinical data related to BioGlue usage at
The Japanese Society for Vascular Surgery in
Okinawa in April.
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.