SBIR-STTR Award

The broader impact/commercial potential of this SBIR Phase I project will advance the development of a bioabsorbable tissue sealant for use in the closure of internal surgical site wounds. Wound care is associated with significant healthcare and economic costs. Surgical wounds account for the majority of acute wounds, as there are over 100 million surgical incisions a year globally, where approximately 80% require a closure product. Improper or ineffective closure of surgical wounds can result in a number of complications, including infection, scarring, improper healing, and blood loss. Currently available products for use in closing internal surgical wounds are often limited in their effectiveness due to low versatility, safety concerns, and slow curing times. An ideal tissue adhesive would provide sufficient strength and be bioabsorbable, thus providing for effective wound closure for internal and external applications. Bezwada Biomedical seeks to meet this unmet need through the development of a polyurethane-based adhesive for internal surgical wounds that is biodegradable, easy to use, and biocompatible. Successful commercialization of this technology will provide clinicians and surgeons with an effective and versatile wound closure product for surgical applications, thus decreasing the likelihood of complications that significantly impact patient outcomes and increase the costs of care.This Small Business Innovation Research (SBIR) Phase I project will develop a polyurethane-based tissue adhesive incorporating hydrolyzable linkage bridging using safe and biocompatible compounds through an innovative chemistry approach. The hydrolyzable feature differentiates the technology from existing absorbable polyurethanes and is the result of highly reactive aromatic isocyanates with a hydrolyzable link connecting the aromatic rings, allowing for safe and tunable degradation. The overall goal of the proposed program is to identify a single lead polyurethane formulation with two Technical Objectives: 1) synthesis of monomers and development of formulations; 2) assessment for physical, mechanical, functional, biocompatibility, and ease-of-use properties to identify the optimal formulation.This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase II project is advancement in the development of an effective wound closure product for internal gastrointestinal (GI) surgical applications. Anastomotic leaks resulting from ineffective GI surgical wound closures are associated with significant healthcare and economic costs. Effective closure of wounds decreases the likelihood of complications that significantly impact patient outcomes and increases the cost of care. Development of an enhanced tissue adhesive to address the limitations of current products has the potential to offer a reliable wound closure product to support improved patient outcomes. Successful development and commercialization of the enhanced GI wound closure product will provide surgeons with an effective tissue adhesive that is easy to use and can be safe for the closure of internal GI wounds, thus ensuring safe and reliable closure, decreasing anastomotic leaks, and allowing for enhanced patient outcomes. Additionally, this project has the potential to support additional product development to generate improved tissue adhesives/sealants for a wide range of surgical applications that will have the potential to decrease surgical complications related to ineffective wound closure. This Small Business Innovation Research (SBIR) Phase II project will advance the development of an enhanced tissue adhesive to improve surgical wound care specific to gastrointestinal (GI) tract surgeries. Gastrointestinal tract surgical wounds have a high rate of anastomotic leaks resulting from incomplete and sub-optimal surgical closures. These leaks put the patients at an increased risk of infection and creates an estimated $28.6 million in hospitalization and readmission costs per 1000 patients. Current tissue adhesives for GI applications are biologically derived, which are amenable for internal use but pose a risk of infection. The technology being developed is a polyurethane-based adhesive that is biodegradable, easy to use, and biocompatible. The overall goal of this SBIR Phase II project is to demonstrate in vivo efficacy for the use of the surgical adhesive in GI surgical wound care. To meet this goal, the surgical adhesive formulation developed from Phase I will be refined to identify the ideal formulation for GI use and a lead formulation will be assessed for in vivo performance. The results from this project have the potential to identify a safe, easy-to-use, and effective lead tissue adhesive for implementation in GI surgical applications to prevent anastomotic leaks and improve GI surgical wound closures.This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.