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Cohera Medical Receives ISO 13485 Certification: Company Meets International Standards for Design, Development and Manufacturing of Medical Devices
Date:9/22/2009

PITTSBURGH, Sept. 22 /PRNewswire/ -- Cohera Medical, Inc. announced today that it has received certification to the ISO 13485:2003 International Standard for the Design, Development, and Manufacture of Surgical Adhesives. Receipt of the certification allows Cohera Medical to proceed with the CE Mark registration and approval process for TissuGlu(R), the company's novel internal surgical adhesive, upon completion of development for its first indication to optimize healing and prevent fluid accumulation following abdominoplasty procedures.

The British Standards Institution issued the certification following an assessment and audit of the Company's quality management system and associated policies and procedures. The ISO 13485 certification is a required component of the CE Mark process for registration/approval of medical devices in the European Union.

"This certification represents a significant achievement and major milestone for an emerging company such as Cohera," said Patrick Daly, chief executive officer of Cohera Medical. "Successfully completing this process assists us in moving forward into clinical development of TissuGlu in the European Union."

Chad Coberly, vice president of clinical, regulatory and legal affairs said, "ISO certification validates that the design, development, and manufacturing systems Cohera has implemented will ensure the integrity of the devices we supply to the medical community worldwide. This means that Cohera is now well positioned as it progresses towards human clinical trials and ultimately applying for regulatory approvals for TissuGlu."

About ISO Certification

The International Organization for Standardization ("ISO") is a worldwide federation of national standards bodies. ISO 13485:2003 certification is an international standard that specifies a quality management system for the development, production and
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SOURCE Cohera Medical, Inc.
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