# A novel device for cervical insufficiency in pregnant women

> **NIH NIH R41** · CX THERAPEUTICS, INC · 2020 · $312,578

## Abstract

Abstract
In normal pregnancy, the cervix remains closed until term and then dilates under the influence of uterine
contractions. In cases of cervical insufficiency (CI), the cervix dilates in the second trimester in the absence of
uterine contractions, which leads to a preterm birth. Infants born prematurely are at risk of lifelong morbidities
including chronic lung disease, feeding difficulties, retinopathy and neurodevelopmental abnormalities. Cervical
cerclage is the current treatment for cervical insufficiency. Cerclage surgery is performed in 15,000 cases per
year in the United States. A cerclage is a surgical suture that is placed around the cervix to provide mechanical
support. Though cerclage suture can prevent preterm birth in women with CI, cerclage has important limitations
and can lead to adverse events. A team of leading researchers and practitioners at Tufts Medical Center is
developing a new technology that addresses the shortcomings of the current cerclage suture. Referred to in this
proposal as the cervical support device (CSD), the new technology rethinks the challenge of providing
mechanical support for the cervix. The CSD preserves compression support of the cerclage suture but spreads
the compression support over a wider surface area, which alleviates excess stress concentrations and decreases
adverse effects. The CSD also permits adjustable compression support over time, which is an innovative feature
not available with cerclage. Cx Therapeutics was founded to further develop and commercialize this innovative
medical device for CI. The studies proposed in this STTR Phase I project will determine the functional feasibility
of the CSD versus cerclage in bench top and animal testing (Aim 1). Aim 2 will establish the foundation of
engineering development through a partnership with a leading and highly experienced medical device developer.
Proof-of-principle devices will be developed for testing in a formative human factors study (Aim 3). At the end of
Phase I, Cx Therapeutics will have developed a prototype CSD with novel features and an improved safety
profile compared with existing cerclage suture. In Phase II, detailed engineering design will occur, further testing
on animal models and activities will be organized around assembling a package of materials for a pre-market
submission to the FDA. The long-term goal is to compare the CSD to cerclage suture in a randomized clinical
trial for women with cervical insufficiency. The randomized trial will test the hypothesis that the CSD will prolong
pregnancy and will cause fewer adverse effects compared with cerclage. The development of an effective
alternative treatment for cervical insufficiency will have an enormous impact in clinical obstetrics.

## Key facts

- **NIH application ID:** 10155661
- **Project number:** 1R41HD102268-01A1
- **Recipient organization:** CX THERAPEUTICS, INC
- **Principal Investigator:** Sabrina Craigo
- **Activity code:** R41 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $312,578
- **Award type:** 1
- **Project period:** 2020-09-21 → 2021-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10155661

## Citation

> US National Institutes of Health, RePORTER application 10155661, A novel device for cervical insufficiency in pregnant women (1R41HD102268-01A1). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10155661. Licensed CC0.

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