# Zip-stitch for Laparoscopic Hysterectomy - Clinical Validation

> **NIH NIH R44** · ZSX MEDICAL, LLC · 2021 · $928,014

## Abstract

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; and
 3. 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.

## Key facts

- **NIH application ID:** 10253968
- **Project number:** 1R44HD104539-01A1
- **Recipient organization:** ZSX MEDICAL, LLC
- **Principal Investigator:** Dan C Mazzucco
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $928,014
- **Award type:** 1
- **Project period:** 2021-09-22 → 2023-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10253968

## Citation

> US National Institutes of Health, RePORTER application 10253968, Zip-stitch for Laparoscopic Hysterectomy - Clinical Validation (1R44HD104539-01A1). Retrieved via AI Analytics 2026-05-27 from https://api.ai-analytics.org/grant/nih/10253968. Licensed CC0.

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