Uroplasty, Inc. has announced that it has received an approvable letter from the U.S. Food and Drug Administration (FDA) relating to its pre-market approval (PMA) application for Macroplastique Implants for the treatment of female stress urinary incontinence (SUI).
The receipt of the approvable letter follows FDA's completion of the scientific review of the safety and efficacy of Macroplastique. The FDA determined that the PMA is approvable subject to Uroplasty's manufacturing facilities, methods and controls being audited by the FDA and in compliance with applicable Quality System Requirements. The FDA is currently auditing Uroplasty's manufacturing facilities in Minneapolis, Minnesota and Eindhoven, The Netherlands.
David B. Kaysen, Uroplasty's President and CEO, commented, "Macroplastique is already a market leader and a preferred treatment outside the U.S. for SUI resulting primarily from intrinsic sphincter deficiency. Since its introduction in Europe, over 60,000 people have been treated with Macroplastique and numerous clinical publications reinforce the safety and efficacy of this product. I am pleased that our development efforts, now supported by the FDA's scientific review of our safety and clinical data, are bringing us within clear sight of PMA approval and the ability to market this product in the United States. Our direct sales team is excited about adding Macroplastique to our platform of voiding dysfunction products. With this response from the FDA, we will begin preparing for the launch of Macroplastique across the U.S."
With her extensive company history and direction of these PMA clinical studies, Susan Hartjes Holman, Uroplasty's Chief Operating Officer, is extremely pleased with FDA's decision. "This moves us into the final stages of FDA approval and toward our goal to bring this exceptional product to the thousands of women in this country who can benefit from Macroplastique's proven safety and performance ... an effective, non-surgical treatment for a frustrating and often embarrassing condition affecting women's lifestyle, relationships and emotional well-being. Women with stress urinary incontinence may have endured their condition for years, many still having bladder control problems after previous surgical treatments. The approvable letter represents the efforts of so many of our employees worldwide. I am very proud to be associated with this product and the dedicated, capable staff at Uroplasty."
Uroplasty's patented Macroplastique is a soft tissue, injectable bulking agent for use in a minimally-invasive, out-patient procedure to treat female SUI which primarily results from intrinsic sphincter deficiency. SUI is the most common type of urinary incontinence and affects approximately 13 million Americans, 85% of whom are women. SUI is described as the sudden, accidental loss of urine during normal, everyday activities such as sneezing, coughing, laughing, straining or lifting items. Fifteen percent of the individuals with SUI suffer from a condition called intrinsic sphincter deficiency -- a condition in which certain muscles circling the urethra weaken and can no longer properly close to hold urine. When a physician injects Macroplastique into the tissues surrounding the urethra, the increased "bulk" allows the urethra to close more effectively and prevents urine from leaking.
Mr. Kaysen continued, "The anticipated FDA approval of Macroplastique's PMA marks an exciting time in Uroplasty's history. This is a significant example of Uroplasty's continued growth as a company, as well as its dedication to the treatment of urological disorders and voiding dysfunctions."
Uroplasty, Inc., headquartered in Minnetonka, Minnesota, with wholly-owned subsidiaries in The Netherlands and the United Kingdom, is a medical device company that develops, manufactures and markets innovative, proprietary products for the treatment of voiding dysfunctions, including urinary and fecal incontinence, overactive bladder and vesicoureteral reflux.
The Urgent PC Neuromodulation System is a proprietary, minimally invasive nerve stimulation device designed for office-based treatment of overactive bladder symptoms of urge incontinence, urinary urgency and urinary frequency. Application of neuromodulation therapy targets specific nerve tissue and disrupts the signals that lead to the symptoms of overactive bladder. Uroplasty sells the Urgent PC system in the United States, in Canada and in countries recognizing the CE mark. Outside the United States, the Urgent PC is also indicated for the treatment of fecal incontinence.
The I-STOP(TM) Mid-Urethral Sling is a biocompatible, tension-free sling used to treat female stress urinary incontinence. The I-STOP sling provides a hammock-like support for the urethra to prevent urine leakage associated with activities such as coughing, laughing, lifting or jumping. Uroplasty sells the I-STOP Sling in the United Kingdom and in the United States.