This Small Business Innovation Research (SBIR) Phase I project develops a novel surgical closure system for closing internal incisions in endoscopy. The initial application is closing the vaginal cuff in laparoscopic 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 minimally-invasive procedures, including laparoscopic hysterectomy. The system is a series of surgical clips that are designed to enable easy closure for difficult-to-access tissue, improving ease of use, speed, and quality of incision closure. The clips do not pierce tissue, but apply continuous compression to close the incision. The applicator tool pulls tissue into apposition for clip application, while reducing tissue handling, necrosis, ischemia, and the risk of infection.
The broader impact/commercial potential of this project is to develop, validate, and market the device across a broad spectrum of surgeries involving internal incisions (a total of 10 million procedures annually in the U.S. alone). This device 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 device platform of closure devices. The closure device is designed to be simple and intuitive to use, which is critical in laparoscopic procedures. Initially, the closure device directly addresses a specific unmet clinical need: reducing both the technical demands of vaginal cuff closure during laparoscopic hysterectomy and the significant complications associated with the use of sutures in this procedure. There are approximately 300,000 laparoscopic hysterectomies performed in the U.S. annually. This number is growing at an estimated rate of 20% per year, and will represent a total annual addressable domestic market size at peak sales of $200 MM ($600 MM globally) for laparoscopic hysterectomy alone.
This Small Business Innovation Research Phase I grant awarded to ZSX Medical funded the continued development of the Zip-Stitch™ surgical closure system. Zip-Stitch™ takes the most difficult parts of performing minimally-invasive surgeries and makes them easy for surgeons. By making minimally-invasive surgery easier, Zip-Stitch™ can enable more patients to access less invasive surgeries, shorter surgical duration, shorter hospitalization time and fewer complications. At the same time, Zip-Stitch™ reduces the cost burden of surgery to both the hospital and society. In this Phase I project, the company evaluated Zip-Stitch™ both in a surgical training simulator and in a live surgical model. Phase I of this project demonstrated feasibility of this novel surgical closure system by showing that Zip-Stitch™ can coapt tissue, leading to healing comparable to or better than sutures after three weeks, and by demonstrating that surgeons can learn to use and apply Zip-Stitch™ more quickly and easily than they can learn to suture laparoscopically. Phase IB of this project further demonstrated feasibility of Zip-Stitch™ by assessing product design risks related to safety and effectiveness, and by determining appropriate performance testing to mitigate these risks. Also in Phase IB, the company developed commercial-ready manufacturing techniques for critical Zip-Stitch™ components. In addition to demonstrating feasibility, this Phase I project has revealed the next critical steps in mitigating technical risks for Zip-Stitch™. These steps will be addressed in continued product development.
