PITTSBURGH, July 16 /PRNewswire/ -- Cohera Medical Inc. today announced that it has been selected to receive a Phase II Small Business Innovation Research (SBIR) grant of $1.5 million for the ongoing development of TissuGlu, a novel surgical adhesive for application in plastic surgery.
The Phase II SBIR grant, awarded by the National Institutes of Health (NIH), will fund work to finalize the pre-clinical testing that will support submission of an Investigational Device Exemption (IDE) to the Food and Drug Administration (FDA) for approval to initiate human clinical trials. In the second year of the award, human clinical trials will be initiated to establish the product's safety and efficacy.
"Cohera is honored to receive this prestigious and selective award in the current highly competitive environment," said Patrick Daly, president and CEO of Cohera Medical. "Through this award, the NIH acknowledges the innovative nature of Cohera's technology as well as the robust commercial potential of TissuGlu. Our ongoing plans for TissuGlu seek to establish its safety and efficacy as a surgical adhesive to reduce fluid accumulation and the need for drains after surgery. The grant follows the successful completion of the Phase I SBIR project, which established the efficacy of the product formulation and the dispenser device design in preliminary studies."
About Cohera Medical
Cohera Medical Inc. is a Pittsburgh-based company that is developing a revolutionary line of wound management products and 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 a sprayable bonding agent 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 and small bone fixation, which will fill similar market needs in both orthopedics and general surgery. For more information, visit www.coheramed.com. TissuGlu and the other Cohera products have not yet been approved for medical use by the Food and Drug Administration (FDA) in the U.S. or by any other country's regulatory authority.
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.
CONTACT: David Schull, david.schull@russopartnersllc.com, or Tony Russo,
Ph.D., tony.russo@russopartnersllc.com, of Russo Partners, +1-212-845-4271;
or Dottie Clower, Ph.D., Cohera Medical, +1-412-231-1500, ext. 102,
dclower@coheramed.com
Web site: http://www.coheramed.com/
