R44HD104539

Project Abstract This Direct to Phase II 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 II research proposal builds on successful results from benchtop, animal study and pilot clinical study evaluations. The objectives of this proposal are to evaluate the safety and efficacy of Zip-stitch in a clinical setting and to prepare the applicator for commercialization. This will be accomplished by means of a 59-patient clinical study and engineering design refinement, including prototyping and benchtop testing. The Phase II Technical Objectives are:1. Evaluate the safety and effectiveness of Zip-stich in a clinical setting;2. Determine priorities for Zip-stitch Applicator improvements; and3. Re-design the Zip-stitch Reusable Applicator user interface. 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 $300 MM.Project Narrative This project develops and evaluates Zip-Stitch, a patented system for closing internal surgical incisions with initial application in laparoscopic hysterectomy. Compared to sutures (the standard of care), Zip-stitch is faster and easier for the surgeon to apply, can lead to better healing, and save hospitals money. Completion of the proposed clinical validation and device refinement significantly advances Zip-stitch towards market entry in its initial application.