MAPLE GROVE, Minn., May 8, 2016 /PRNewswire/ -- NxThera, Inc. announced today that the sexual function preservation data from the Company's pivotal IDE trial, which previously established the safety and effectiveness of the Rezūm system to treat benign prostatic hyperplasia (BPH), was presented at the 2016 American Urological Association (AUA) annual meeting in San Diego today. The abstract, entitled, "Treatment of Lower Urinary Tract Symptoms Due to Benign Prostatic Hyperplasia with Convective Water Vapor Energy Ablation: Preserved Erectile and Ejaculatory Function," reported an effective non-pharmaceutical treatment option for men with BPH secondary to lower urinary tract syndrome (LUTS). The Rezūm II IDE pivotal study was a prospective, multicenter, randomized (2:1) controlled trial that enrolled 197 subjects across 15 clinical sites in the U.S. A manuscript reporting the sexual function data from the Rezūm II study has been e-published in the Journal of Sexual Medicine.
"The progressive and increasingly bothersome symptoms of BPH afflict more than 75% of men in this country over the age of 65, and LUTS is strongly correlated with compromised sexual function," said Kevin T. McVary, M.D., Professor and Chair, Division of Urology, Southern Illinois University School of Medicine in Springfield, IL. "As urologists, we need BPH treatment options for our patients who decline, are resistant to, or are dissatisfied with medical management therapies, or who are unwilling or unable to undergo a surgical procedure. This data demonstrates the Rezūm system not only provides an effective first-line treatment option for men suffering from BPH, but does so while preserving sexual function and improving their quality of life."
"The previously reported data from our Rezūm trials have demonstrated safe, rapid, and sustained improvement in LUTS and urinary flow over a 24-month period, and now this additional data from the Rezūm II trial demonstrates preservation of both erectile and ejaculatory functions," said J. Robert Paulson, President and CEO of NxThera. "We are thrilled to provide urologists and their patients with a transformational new BPH treatment option."
NxThera pioneered its patented Convective Water Vapor Energy (WAVE®) technology platform to treat a variety of endourological conditions in the Rezūm System to treat BPH. The FDA-cleared Rezūm System uses radiofrequency power to create thermal energy in the form of sterile water vapor, or steam, to convectively deliver targeted, precise treatments to ablate prostate tissue in a simple transurethral procedure with minimal discomfort, and demonstrated improvements in LUTS symptoms, urine flow, quality-of-life, and preserved sexual function. The Company is conducting advanced development and clinical research to potentially expand application of its Convective WAVE technology to include the targeted treatment of cancerous prostate tissue and kidney tumors. Founded in 2008, NxThera is located in Maple Grove, Minnesota.
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SOURCE NxThera, Inc.