Cohera Medical Receives ISO 13485 Certification: Company Meets International Standards for Design, Development and Manufacturing of Medical Devices
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 distribution of medical devices and related services.
About Cohera Medical
Cohera Medical, Inc. is a Pittsburgh, PA based company that is developing a revolutionary line of surgical adhesives. Cohera Medical's products are based on a unique chemical design that is purely synthetic, easy to use, biocompatible and fully resorbable. The company's lead product in development, TissuGlu, is an adhesive for plastic surgery procedures. TissuGlu adheres flaps of tissue after surgical procedures, eliminating the spaces where fluid accumulates and reducing wound drainage. Cohera Medical is also developing surgical adhesives targeting mesh fixation, small bone fixation, and other plastic surgery indications, which will fill similar market needs in plastic, orthopedic and general surgery. For more information, visit www.coheramed.com. TissuGlu and the other Cohera products are currently for investigational use only and have not yet been approved for medical use by the Food and Drug Administration (FDA) in the U.S. or in any other market.
Certain statements made throughout this press release that are not historical facts contain forward-looking statements regarding the Company's future plans, objectives and expected performance. Any such forward-looking statements are based on assumptions that the Company believes are reasonable, but are subject to a wide range of risks and uncertainties and, therefore, there can be no assurance that actual results may not differ materially from those expressed or implied by such forward-looking statements.
SOURCE Cohera Medical, Inc.
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