CryoLife, Inc. (NYSE: CRY), an implantable biological medical device and cardiovascular tissue processing company, today announced that its BioGlue Surgical Adhesive has received Shonin approval from the Japanese Ministry of Health, Labor and Welfare (MHLW) for use in the repair of aortic dissections.
CryoLife's partner Century Medical, Inc. (CMI) will distribute BioGlue in Japan for use in this subset of cardiac surgery. Prior to distribution, MHLW will need to complete certain additional steps, most notably an on-site inspection of CryoLife pursuant to Japanese Quality Management System requirements and required product reimbursement paperwork for Japanese authorities. As a result, management estimates that distribution in Japan will begin in the first half of 2011. 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 Japan."
"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 600,000 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.