AWCT is focusing its initial commercialization efforts on women’s health issues, specifically pelvic floor disorders. Three indications can be treated with the company’s first-generation device – stress urinary incontinence, fecal incontinence and pelvic organ prolapse. Two clinical studies with a total of 200 subjects have demonstrated the safety and effectiveness of the device in treating stress urinary incontinence. The company is planning a pivotal clinical trial to support a U.S. marketing application for the stress urinary incontinence indication. It also plans to conduct feasibility studies for the fecal incontinence and pelvic organ prolapse indications. These markets are vast, and de minimus market penetration will create significant enterprise value.
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CAUTION – Investigational device. Limited by Federal (or United States) law to investigational use.
Tom F. Lue, MD, ScD (Hon), FACS – Co-founder;Principal Scientific Advisor.
Dr. Lue is Professor and Emil Tanagho Endowed Chair in Clinical Urology at the University of California San Francisco and medical director of the Knuppe Molecular Urology Laboratory. Dr. Lue is an internationally recognized expert on treatment of male sexual dysfunction and a pioneer in surgical methods to treat refractory ED. His research team proved that PDE5 inhibitors enhance erection in animals, providing the scientific basis for Viagra, Levitra and Cialis. He is also an expert on incontinence and developed the first animal model of female stress urinary incontinence,now used widely to study potential treatments. He is co-inventor of the sacral stimulation method of treating urge incontinence, the technology underlying Medtronic’s Interstim product line. Dr. Lue graduated with highest honors from the Kaohsiung Medical University in Taiwan and completed his urologic training at the State University of New York Downstate Medical Center. He has authored or co-authored twelve books and more than 380 publications. He is the recipient of numerous honors, including the Gold Cystoscope Award from the American Urological Association and an award for most innovative research from the American Foundation of Urologic Disease