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."
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