SBIR Phase II: Novel Surgical Closure Device for Minimally Invasive Procedures

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase II project is as part of a broader plan to develop, validate, and market this new surgical device across a broad spectrum of surgeries involving internal incisions (a total of 10 million procedures annually in the U.S. alone). This technology has particular value in the rapidly-growing minimally-invasive surgery market, in which internal closure is made difficult by the small size of superficial incisions. These markets represent more than 6 million surgeries per year in the U.S., creating a domestic market potential of more than $2.5 billion for the platform of closure devices under development. Initially, the system directly addresses a specific unmet clinical need: reducing both the technical demands of internal closure during minimally-invasive hysterectomy and the significant complications associated with the use of sutures in this procedure. There were approximately 420,000 of these surgeries performed in the U.S. in 2013, representing more two-thirds of all U.S. hysterectomies. This fraction of hysterectomies performed in this manner is continuing to grow, and will represent a total annual addressable domestic market size at peak sales of $200 MM ($600 MM globally). The proposed project develops a novel surgical closure system for closing internal incisions in endoscopy. Our initial application is in laparoscopic (minimally-invasive) hysterectomy. Sutures are typically used to close internal incisions in laparoscopic surgery. Throwing loops and tying knots are among the most difficult parts of laparoscopic procedures; these difficulties have slowed the adoption of laparoscopic hysterectomy. In Phase II, the Technical Objectives are (1) to refine the closure system to meet the requirements of a minimum viable product; (2) to demonstrate safety and efficacy of the system in a large animal model of laparoscopic hysterectomy; and (3) to demonstrate efficacy of the system in laparoscopic hysterectomy in a cadaveric model. These objectives are designed to complete the evaluation of the performance of this novel closure system against product requirements identified by the surgical community and utilized in the design process.