SBIR-STTR Award

The long-term goal of this project is to create a sprayable surgical adhesive which would satisfy the surgical need for a strong, easy-to-use adhesive to adhere planar flaps of tissue. This novel adhesive will reduce fluid accumulation after surgery by eliminating dead space in the wound and maintaining tissues in position for natural healing to occur. Seroma formation is among the most common post-surgical complications, occurring in up to 50% of certain surgical procedures. Traditional wound closure approaches such as sutures provide point-to-point fixation, which is inadequate to fully adhere planar surfaces. What surgeons require is a sprayable "glue" that can fully adhere planar flaps of tissue without requiring direct contact with the tissue. The hypothesis of the proposed Phase I research project is that Cohera's proprietary biocompatible polyurethane tissue adhesive can be engineered into a sprayable formulation that will be effective in closure of planar tissues based on its physical properties, delivery process and adhesive strength. Accommodating the physical constraints required to deliver a viscous fluid by spray in the operating room environment will require significant innovation in both product formulation and device design. To test this hypothesis, the following specific aims will be accomplished: 1) Optimize the physical characteristics of the tissue adhesive for spray delivery. In brief, the physical characteristics of the adhesive (such as viscosity, Young's modulus, cure time and tensile strength) must be engineered to produce an adhesive that can be delivered in small volumes by spray in an operating room environment while meeting established performance requirements. 2) Develop delivery device prototypes to spray adhesive evenly onto planar surfaces. A spray tip will be developed which can predictably and reliably disperse a viscous fluid when attached to a syringe delivery device. 3) Establish that adequate bonding strength can be achieved using spray delivery system. The novel formulation will be tested with the novel delivery device to establish that the product performs adequately when delivered by the new device. During Phase II of the project, the sprayable adhesive will be tested in vivo to demonstrate efficacy in closure of planar tissues and preventing post-surgical fluid accumulation. This research project will include finalizing the product specifications including both product formulation and delivery device, performing efficacy testing in an accepted animal model for seroma prevention, and performing feasibility studies in humans to provide data to the FDA in support of a Pre-market Approval (PMA). . Seroma formation is among the most common post-surgical complications, occurring in up to 50% of certain surgical procedures. The long-term goal of this project is to create a sprayable surgical adhesive which would satisfy the surgical need for a strong, easy-to-use adhesive to coapt planar flaps of tissue. This novel adhesive will reduce fluid accumulation after surgery by eliminating dead space in the wound and maintaining tissues in position for natural healing to occur.

Thesaurus Terms:
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The long-term goal of this project is to create a sprayable surgical adhesive which would satisfy the surgical need for a strong, easy-to-use adhesive to adhere planar flaps of tissue. This novel adhesive will reduce fluid accumulation after surgery by eliminating dead space in the wound and maintaining tissues in position for natural healing to occur. Seroma formation is among the most common post-surgical complications, occurring in up to 50% of certain surgical procedures. Traditional wound closure approaches such as sutures provide point-to-point fixation, which is inadequate to fully adhere planar surfaces. Surgeons need sprayable glue that can fully adhere planar flaps of tissue without requiring direct contact with the tissue. During the Company's Phase I SBIR project, Cohera successfully demonstrated the feasibility of developing a resorbable, sprayable adhesive, TissuGlu"", as well as a functional prototype of the spray delivery device. Cohera proposes to test the hypothesis that its novel product will meet the FDA requirements for safety and efficacy, by demonstrating that it is biocompatible and effective at reducing fluid accumulation after surgery in both animal models and human clinical trials. During the proposed Phase II SBIR project, we will achieve the following Specific Aims: 1) Finalize delivery device development. Primary goals include a) preparing custom molding designs for device components, b) establishing filling procedures for adhesive and mobilizing agent, c) manufacturing and assembling an initial run of 100 prototype devices, and d) initiating shelf life and stability testing of product in delivery device. 2) Complete pre-clinical testing for Investigational Device Exemption (IDE) submission to the FDA. Primary goals include a) completing specific physical and chemical characterization studies on adhesive product, b) completing biocompatibility and genotoxicity testing on adhesive product, and c) completing efficacy studies in an acceptable animal model. 3) Establish GMP manufacturing, packaging, and sterilization of adhesive. Primary goals include a) generating manufacturing protocols and batch release criteria, b) establishing sterilization protocols and packaging and labeling requirements, and c) completing pilot scale production batch for first human clinical trials. 4) Perform initial clinical study (feasibility phase) in human patients to support Pre-market Approval (PMA) submission. Primary goals include a) completing proposed clinical trial design for review by FDA, b) submitting a completed IDE application to the FDA, c) completing the feasibility clinical trial in a small set of patients.

Public Health Relevance:
Seroma formation is among the most common post-surgical complications, occurring in up to 50% of certain surgical procedures. The long term goal of this project is to create a sprayable surgical adhesive that will reduce fluid accumulation after surgery by maintaining tissues in position for natural healing to occur. The use of the adhesive to prevent seroma formation will reduce patient discomfort, decrease risk of infection, and speed patient recovery.

Public Health Relevance:
This Public Health Relevance is not available.

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