# Uterine Wall-Membrane Anchor Device for the Prevention of Preterm Premature Rupture of the Membranes Following Fetoscopic Surgery

> **NIH NIH R44** · FANNIN PARTNERS, LLC · 2021 · $139,727

## Abstract

PROJECT SUMMARY
Of the 4 million babies born in the US each year, 120,000 (3%) have a complex birth defect. Some defects, such
as spina bifida, warrant in utero interventions to improve fetal outcomes. Spina bifida is a condition where there
is incomplete closing of the backbone and membranes around the spinal cord. Texas Children’s Hospital has
pioneered a fetoscopic method to address spina bifida. While much of the surgery can be performed through
ports, the uterus currently needs to be exteriorized in order to position the fetus appropriately and place sutures
to anchor the chorioamniotic membranes to the uterine wall. The sutures are placed to prevent preterm
premature rupture of membranes (PPROM) which leads to both maternal and fetal complications. PPROM is a
common complication of fetal surgery, occurring in about 30% of minimally invasive cases.
The ChorioAnchor device is a linear device that facilitates the percutaneous suturing of chorioamniotic
membranes to the uterine wall during fetoscopic surgery via a resorbable anchor-suture set. This solution
facilitates the conversion of existing open fetal procedures to percutaneous procedures and potentially the
development of new fetal interventions.
There are two major unanticipated additional activities that are necessary to advance the development of
ChorioAnchor towards an FDA premarket submission. This includes the development of an essential safety
feature identified by clinical stakeholders during usability tests. In addition, it will be beneficial to bolster our team
by expanding upon the roles of and adding subject-matter experts to assist in data analysis and path-to-market
decisions. The SBIR Phase II Administrative Supplement Activities are:
1. Data Preparation for Presubmission Meeting and HDE Submission, aided by the addition of subject-
matter experts in biocompatibility, toxicology, and resorbable polymer implant manufacturing to the team.
2. Addition of Tenting and Flushing Safety Features, including concept generation, prototype design,
 usability and risk assessment, and manufacturing.
The expected outcome of the SBIR Phase II Administrative Supplement will be an updated
ChorioAnchor device design with added safety mechanisms and data-driven risk mitigations to present to the
FDA. We believe that the ChorioAnchor will bring value to patients, providers, and children’s hospitals by
providing a solution that reduces maternal and fetal complications, expands the patient population through the
development of a safer percutaneous procedure, and leads to better outcomes for babies with all manners of
fetal conditions.

## Key facts

- **NIH application ID:** 10301644
- **Project number:** 3R44HD094456-03S1
- **Recipient organization:** FANNIN PARTNERS, LLC
- **Principal Investigator:** MICHAEL JOHN HEFFERNAN
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $139,727
- **Award type:** 3
- **Project period:** 2021-03-01 → 2023-07-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10301644

## Citation

> US National Institutes of Health, RePORTER application 10301644, Uterine Wall-Membrane Anchor Device for the Prevention of Preterm Premature Rupture of the Membranes Following Fetoscopic Surgery (3R44HD094456-03S1). Retrieved via AI Analytics 2026-06-02 from https://api.ai-analytics.org/grant/nih/10301644. Licensed CC0.

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