SBIR/STTR Award attributes
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 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.Project Narrative Stress urinary incontinence (SUI) is a condition which affects more than 16 million American women. Those who seek treatment results in more than 80,000 surgical and other therapeutic interventions each year. The condition is due to weakening or distention of the pelvic floor/fascia/supportive tissues and presents as inadvertent urinary leakage during abdominal strain or exertion, such as exercise, lifting, or laughing. The curative interventions currently available are either invasive surgery or implants, and expensive. The vast majority seek palliative therapies, such as wearing absorptive pads and diapers throughout the day, as their only alternative. The problems associated with SUI extend beyond the apparent symptoms of inadvertent urinary leakage. The associated effects on freedom of activity, embarrassment, self-esteem, and mental health (SUI has a direct association with depression in sufferers) are significant. There is a strong need for a noninvasive and relatively inexpensive method to address the condition in these women’s lives. This new high intensity ultrasound treatment would address both of those issues. Therapeutic ultrasound requires no incisions and may be performed with topical anesthetic. Our Phase II study showed very encouraging results indicating this novel technology will be inexpensive, outpatient/office based, and simple 2-3 minute single treatment procedure, thus potentially allowing many women to receive a durable curative treatment for a lower payment than they spend annually on palliative absorptive pads and diapers. We propose to conduct a rigorous pre-clinical study for treatment applicator and system refinement, FDA compliant GLP studies in a ewe animal model, consultation with FDA in preparation for clinical studies, and commercialization and marketing analysis and strategy development. Moreover, the proposed technique aims to treat SUI using the concept of personalized medicine where the treatment energy pattern is administered precisely according to the respective anatomy of the patient. As such, this treatment will provide a potentially customizable minimally invasive treatment alternative for many of the 16 million women affected by SUI.
