Research Project
8452747
DESCRIPTION (provided by applicant): Seroma formation (fluid accumulation in the wound) is among the most common post-surgical complications, occurring in up to 50% of certain surgical procedures. TissuGlu(R) Surgical Adhesive is designed to adhere flaps of tissue and prevent the accumulation of fluid in surgical wounds, thereby reducing the need for drains and improving the time to recovery. Traditional wound closure approaches such as sutures provide point-to- point fixation, which is inadequate to fully adhere planar surfaces. Surgeons need a strong but safe surgical glue that can adhere flaps of tissue, reducing fluid accumulation after surgery by eliminating dead space in the wound and maintaining tissues in position for natural healing to occur. Cohera Medical successfully completed all specific aims from both Phase I and Phase II SBIR grants that supported the development of TissuGlu(R) Surgical Adhesive. As a result, TissuGlu(R) has received CE Mark approval, giving the company permission to market and sell TissuGlu(R) in the European Union and other worldwide markets. The long-term goal of this project is to meet the requirements to obtain FDA regulatory approval to launch TissuGlu(R) in the US market. Cohera proposes to test the hypothesis TissuGlu(R) Surgical Adhesive can meet all regulatory requirements necessary to receive FDA approval to market the product in the US. Since the first submission of this proposal, Cohera has achieved 2 of the 4 specific aims, in that the company has successfully completed all pre-clinical testing requested by the FDA and has obtained FDA approval to initiate the US human clinical trial. In addition the company has established GMP manufacturing procedures and has manufactured units required for the clinical trial. Therefore the revised proposal is focused on the remaining specific aims, which include completion of the US pivotal clinical trial, and the design and verification of moisture barrier packaging to extend shelf life to 18 months. Specific Aim 1: Design and verify moisture barrier packaging with 18 month shelf life. Criteria for acceptance are a) verify that product in moisture barrier packaging passes sterilization validation testing, b) verify that product in moisture barrier packaging can withstand the normal level of stress associated with its distribution to end-user locations by passing shipping validation testing, and c) establish 18 month adhesive shelf life in moisture barrier packaging through adhesive stability testing at multiple time points. Specific Aim 2: Perform pivotal efficacy clinical study in US to support Pre-market Approval (PMA) submission to the FDA. Criteria for acceptance are a) enroll at least 150 patients in study, b) complete all documentation and prepare statistical analysis, and c) submit final report for PMA approval.
