Thursday, October 7, 2010

CryoLife Gets Japanese Regulatory Approval For BioGlue

(RTTNews) - CryoLife, Inc. (CRY: News) said its BioGlue Surgical Adhesive has received Shonin approval from the Japanese Ministry of Health, Labor and Welfare, or MHLW, for use in the repair of aortic dissections.
CryoLife's partner Century Medical, Inc., or 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.

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