# Development of an endometrial ablation drug-device combination to treat heavy menstrual bleeding

> **NIH NIH R43** · GYNION, LLC · 2023 · $300,792

## Abstract

PROJECT SUMMARY
Over 10 million women in the US and 100 million women globally suffer from Heavy Menstrual Bleeding (HMB).
Oral medications lack effectiveness and, like hormonal IUDs (intrauterine devices), have significant side effects.
Currently available endometrial ablation options, which is another therapeutic alternative, are complex and
require advanced anesthesia, which significantly limits their in-office use. Because of the high cost, complexity,
and/or clinical limitations of the available options, millions of women receive no treatment or are compelled to
undergo a hysterectomy. An estimated 2-3 million hysterectomies are done for HMB worldwide, including
~400,000 just in the US. Gynion will address this unmet need with Menorrx, a drug/device combination that will
be a non-invasive, easy-to-use, and cost-effective therapy for HMB. It is intended for use by obstetrician-
gynecologists (OB-GYN) practitioners in an office setting with the requirement of only local anesthesia. Menorrx
is a proprietary drug formulation that uses Trichloroacetic Acid (TCA) as an active ingredient. The formulation is
instilled into the uterine cavity which then chemically ablates an endometrial layer using an innovative delivery
system that assures procedural safety and consistent results. The long-term goal of this SBIR project is to market
Menorrx globally, making HMB treatment more available and affordable due to its simplicity, safety, high efficacy,
and cost-effectiveness. To achieve this goal, Gynion needs to obtain regulatory approvals in the US and
internationally. Such approvals require the company to conduct animal and human clinical studies to
demonstrate product safety, including toxicological safety, and efficacy. The focus of Aim 1 is to demonstrate
that the Yorkshire pig is a viable in vivo animal model for intrauterine instillation of Menorrx. A species-appropriate
dose of Menorrx will be developed, and three pigs will be treated in the 96-hour non-GLP study. After the
treatment, a histopathology assessment will confirm dose safety. Aim 2 is to assess the low initial systemic
toxicity of Menorrx that is administered by intrauterine instillation and determine when the peak of toxicity occurs.
In Phase II, Gynion will conduct a 72-hour and 30-day GLP-compliant survival study using this pig model to
assess systemic toxicity levels and confirm no long-term systemic toxicity effects of TCA. This will allow Gynion
to establish preliminary toxicology safety and initiate a human toxicity study as part of the regulatory approval
process. After Gynion obtains New Drug Application (NDA) approval in the US under section 505(b)(2) of the
FD&C Act, and a CE Mark, it will commercialize Menorrx in the global market that is projected to reach $1.6B
with a small direct US sales force and with international distributors. Once commercial viability and rapid adoption
are demonstrated, the company will be well-positioned for acquisition by a major medical device o...

## Key facts

- **NIH application ID:** 10759501
- **Project number:** 1R43HD113457-01
- **Recipient organization:** GYNION, LLC
- **Principal Investigator:** Oleg United States Shikhman
- **Activity code:** R43 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2023
- **Award amount:** $300,792
- **Award type:** 1
- **Project period:** 2023-09-05 → 2025-02-28

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10759501

## Citation

> US National Institutes of Health, RePORTER application 10759501, Development of an endometrial ablation drug-device combination to treat heavy menstrual bleeding (1R43HD113457-01). Retrieved via AI Analytics 2026-05-25 from https://api.ai-analytics.org/grant/nih/10759501. Licensed CC0.

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