NIH-funded research Sbir 2 grant

Targeted pelvic warmth/cooling device to relieve pelvic pain

Official title: Targeted Temperature Modulation with Smart Radiometric Monitoring for Effective and Long-Lasting Opioid-Free Pelvic Pain Relief - A Novel Low-Cost, Portable, Tampon-sized Thermal Transfer Device.

Funded at H3pelvic Therapy Systems, INC. · NIH-11410620 · Data updated 2026-11-12

A low-cost, portable device uses controlled temperature changes to soothe pelvic pain from conditions like endometriosis and bladder issues, with the goal of reducing pain and inflammation without opioids.

Quick facts

Grant typeSbir 2 grant
Study typeNIH-funded research
Funding institutionH3pelvic Therapy Systems, INC.
NIH-funded
Lab location1 site (Lewisville, United States)
Project startSeptember 25, 2023
Project endAugust 31, 2028
Funding year2026
Award (this year)$1,099,999
NIH project number2R44HD112219-02A1
Project IDNIH-11410620 on NIH RePORTER

Who could benefit from this research

Could help

Adults with chronic pelvic pain conditions such as endometriosis, interstitial cystitis/painful bladder syndrome, or related pelvic pain disorders.

Less likely to help

People without pelvic pain conditions or those unable to tolerate or access temperature-based therapy may not benefit.

What this research studies

This project aims to finish turning a compact temperature-modulation system into a market-ready medical device that targets pelvic organs. It builds on prior modelling, tissue studies, and live-animal work to show that cooling or warming the vaginal, rectal, or bladder walls can lessen pain. The approach combines advanced thermal transfer, user-friendly electronics, ergonomic design, and a mobile app to safely deliver targeted therapy. If successful, patients with chronic pelvic pain could experience meaningful relief and improved quality of life without opioid medications.

Why it matters

Potential benefit: If successful, patients with pelvic pain could experience reduced pain and better function with a non-drug treatment.

How similar studies have gone: Previous work demonstrated safe and effective temperature modulation in preclinical models, supporting progression to a market-ready device.

Where this research is happening

  • H3pelvic Therapy Systems, INC.
    Lewisville, United States
    Active

Researchers

  • Principal investigator: Lyon, Zachary W — H3pelvic Therapy Systems, INC.
  • Study coordinator: Lyon, Zachary W

Related research

Other NIH-funded projects on the same topics.

About this research

  1. This is an active NIH-funded research project — typically early-stage science, not a clinical trial accepting patient enrollment.
  2. Some NIH-funded labs run parallel clinical studies or seek volunteers for related work. To check, contact the principal investigator or institution listed above.
  3. For full project details, budget, and progress reports, visit the official NIH RePORTER page.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.