# Image-Guided Transurethral HIFU for Genitourinary Therapy

> **NIH NIH SB1** · ACOUSTIC MEDSYSTEMS, INC. · 2021 · $479,133

## Abstract

Abstract
Stress urinary incontinence (SUI) in women is an increase of pelvic floor compliance which results in
decreased urethral pressure, typically through childbirth, and presents as urine leakage during abdominal
strain. SUI has significant impact on women’s health, including an association with increased levels of
depression. Curative options are limited to the invasive surgical insertion of a tape implant which limits the
mobility of the urethra. Bulking agents injected in the peri-urethral tissue are a longstanding effective but
temporary treatment. Pharmaceuticals are relatively new, prohibitively expensive, and there is no track record
of long-term efficacy and negative side effects can occur. Approximately 14 million women are relegated to the
palliative approaches of wearing absorptive pads or diapers through the day. A substantial clinical need exists
for a noninvasive alternative to traditional surgical approaches with the promise of less morbidity and recovery
time, faster procedure time, and lower cost. Recent clinical investigations of minimally-invasive thermal
techniques have demonstrated targeted thermal modification and stiffening of pelvic tissue can reduce
symptoms of SUI. These techniques have shown promise, but are more invasive than the current surgical
options and are less effective. Our Phase II development study showed encouraging in vivo results suggesting
that our innovative therapeutic ultrasound catheter based noninvasive technology can efficiently deliver thermal
therapy at the target tissue of endopelvic fascia without damaging surrounding tissue (vaginal and urethal
wall), based on histopathological analysis, with demonstrated capabilities to provide dynamic spatial control of
selective heating patterns, well-controlled radial thermal penetration, and fast treatment times. In comparison
to existing thermal approaches, our Phase II results clearly demonstrate a significant advance in technology
and approach for treating SUI with the promise of more accurate and thorough targeting of heat-induced
collagen regeneration, protection of critical non-targeted tissue (e.g., urethral and vaginalmucosa), short
procedure times, and thereby increasing accessibility to a larger number of SUI patients. The objective of this
Phase IIB plan is to design-freeze our therapy applicator design and then conduct a GLP in-vivo study with our
ultrasound SUI catheter and FDA 510(k) cleared TheraVision® system for data to support a follow-on clinical
study under FDA Guidance and to further build additional strong intellectual property around the technology.
Market analyses will be conducted to develop strategies leading to commercialization. Device design, bench
experiments, biothermal and acoustic modeling, together with experimental testing in both human female
pelvis cadaveric studies and an in-vivo GLP compliant study in ewes GU tract, combined with workflow study
will be conducted to freeze device design, extensively characterize de...

## Key facts

- **NIH application ID:** 10259640
- **Project number:** 2SB1DK108458-03A1
- **Recipient organization:** ACOUSTIC MEDSYSTEMS, INC.
- **Principal Investigator:** Everette C Burdette
- **Activity code:** SB1 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $479,133
- **Award type:** 2
- **Project period:** 2015-09-25 → 2023-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10259640

## Citation

> US National Institutes of Health, RePORTER application 10259640, Image-Guided Transurethral HIFU for Genitourinary Therapy (2SB1DK108458-03A1). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10259640. Licensed CC0.

---

*[NIH grants dataset](/datasets/nih-grants) · CC0 1.0*