Cohera Medical, Inc. Receives FDA Approval for First Module of its Premarket Approval Application (PMA) for TissuGlu® Surgical Adhesive
10/30/2012 6:35:55 AM
Cohera Medical, Inc.®, a leading innovator and developer of absorbable surgical adhesives and sealants, announced today that it has received approval from the United States Food and Drug Administration ("FDA") for the first of four modules of the Company's PMA filing plan for its TissuGlu® Surgical Adhesive product. Earlier this year, the Company received approval of its modular approach to filing the PMA from the FDA, and submitted the first module pursuant to this plan.
The first module contained the pre-clinical testing profile for TissuGlu including extensive biocompatibility and toxicological testing information. The Company expects to file the second module containing information related to the characterization and specifications of TissuGlu before the end of the year, and the remaining two modules describing the manufacturing, quality system and clinical study information in 2013.
"We are pleased to receive FDA approval for the first module of the PMA in which the biocompatibility and pre-clinical testing profile of TissuGlu is acceptable," said Chad Coberly, JD Vice President of Clinical, Regulatory and Legal affairs of Cohera Medical. "We appreciate the professional and interactive review by the FDA for this module and look forward to working with the Agency on the review of the future modules."
"The first module approval of the TissuGlu PMA is another significant milestone for Cohera and its investors," said Patrick Daly, President and Chief Executive Officer of Cohera Medical. "The approval for this information confirms the basic safety profile of this important new product and allows the Company to proceed with its modular PMA filings on plan."
Cohera Medical recently received CE Marking approval for TissuGlu and began selling product to hospitals and surgeons in Germany in September 2011. The Company plans to expand the commercial availability of TissuGlu in 2012.
About Cohera Medical
Cohera Medical, Inc.® is a leading innovator and developer of absorbable surgical adhesives and sealants. The Company's first product, TissuGlu® Surgical Adhesive, is an internal surgical adhesive for large flap surgeries, such as abdominoplasty (tummy tuck), that eliminates or reduces fluid accumulation and the need for post surgical drains. TissuGlu's chemical composition is resorbable, non-toxic, forms a strong bond between tissue layers and allows for natural healing, which ultimately may enable faster recovery. TissuGlu has received CE Marking approval to be sold in the European Union (EU). Cohera Medical is also developing a unique and proprietary bowel sealant, and a strong adhesive for mesh fixation. Outside of the EU, TissuGlu and the other Cohera products are currently indicated 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. For more information, visit www.coheramed.com.
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.