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Image-Guided Transurethral HIFU for Genitourinary Therapy

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 2SB1DK108458-03A1
Agency Tracking Number: SB1DK108458
Amount: $947,966.00
Phase: Phase II
Program: SBIR
Solicitation Topic Code: NIDDK
Solicitation Number: PAR20-129
Solicitation Year: 2020
Award Year: 2021
Award Start Date (Proposal Award Date): 2021-07-15
Award End Date (Contract End Date): 2023-06-30
Small Business Information
Savoy, IL 61874-9510
United States
DUNS: 606222896
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 (217) 239-0900
Business Contact
Phone: (217) 359-8424
Research Institution

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 device performance, and applied to
potential treatment approaches in preparation for the ultimate goal of product finalization and clinical
implementation. Devices will be manufactured under our existing ISO compliant Quality Management System.

* Information listed above is at the time of submission. *

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