Zip-stitch for Laparoscopic Hysterectomy - Clinical Validation

Project Abstract This Phase IIB Small Business Innovation Research project will further the development of Zip-stitch, a patented surgical wound closure system for internal surgical incisions. The Zip-stitch system has been developed specifically for laparoscopic hysterectomy to address two key problems in vaginal cuff closure: (1) the technical difficulty of laparoscopic suturing and (2) vaginal cuff dehiscence or wound separation. The Zip-stitch system is comprised of a series of bioabsorbable clips deployed by an applicator tool onto opposing edges of the vaginal cuff wound. Clips are applied with sufficient pressure to achieve hemostasis without piercing tissue and lead to wound healing. This proposal for the clinical validation and development of the Zip-stitch system is responsive to one of the stated research goals of the Gynecologic Health and Disease Branch (GHDB) of NICHD: “Devices and/or technologies designed to address surgical challenges in gynecologic surgeries, including hysterectomy.” To this end, Zip-stitch improves the most challenging step in minimally invasive hysterectomy, making cuff closure easier and faster, and healing better. This Phase IIB research proposal builds on successful results of an initial US clinical study that was conducted in Phase II. The objectives of this proposal are to use the feedback obtained from surgeons in the prior clinical study to develop a refined system and prepare it for commercialization, and to conduct a clinical study that compares vaginal cuff closure time to standard of care suturing. This will be accomplished by means of a 100-patient clinical study and engineering design refinement. The Phase IIB Technical Objectives are: 1. Determine priorities for Zip-stitch applicator improvements based on surgeon feedback; 2. Design and fabricate second-generation applicators; and 3. Conduct a clinical comparison of second-generation Zip-stitch with standard of care suture closure. This project is part of a broader plan to develop, validate, and market the Zip-stitch System across a broad spectrum of minimally-invasive surgeries involving internal 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 Zip-stitch platform of closure devices. Initially, the Zip-stitch system directly addresses a specific unmet clinical need in laparoscopic hysterectomy. There are approximately 500,000 minimally- invasive hysterectomies performed in the U.S. each year, representing an annual addressable domestic market size for Zip-stitch of $420 MM.