MAPLE GROVE, Minn., Nov. 23, 2015 /PRNewswire/ -- NxThera, Inc., a medical device company pioneering the application of its Convective Water Vapor Energy (WAVE™) platform technology to treat endourological conditions, today announced the digital publication of the one-year data from the Rezūm II pivotal study in The Journal of Urology. The Rezūm II clinical study enrolled 197 patients in this randomized, controlled trial across 15 centers in the United States and documents the sustained symptom reduction and preserved sexual function in patients who underwent the Rezūm treatment. Using radiofrequency energy to create sterile water vapor (steam) to convectively deliver precise thermal energy treatments, the Rezūm System is successful in treating Lower Urinary Tract Symptoms (LUTS) secondary to Benign Prostatic Hyperplasia (BPH).
"As clinicians, we are keenly aware of the importance of quality clinical data when evaluating which therapies to recommend to our patients," said Dr. Kevin T. McVary, co-principal investigator and Professor and Chair, Division of Urology at Southern Illinois University School of Medicine. "The Rezūm treatment met all of its primary and secondary clinical study endpoints by demonstrating statistically and clinically significant improvement in symptom scores and urinary flow rates. It provides a strong safety profile for patients while preserving erectile and ejaculatory function. We're excited to be able to share the outcomes in The Journal of Urology with our professional colleagues and the patients we treat."
Key published findings of the study include:
- Significant reduction in urinary symptom scores as measured by the International Prostate Symptom Score (IPSS) at two weeks;
- IPSS improvement of 11.3 points at three months, which sustained throughout 12 months;
- For patients with a baseline IPSS >19; mean IPSS improvement was 13.5 points at 1 year;
- Peak urinary flow rate increase of 6.3 ml/sec at three months, with sustained improvement throughout 12 months;
- Mild to moderate adverse effects that typically resolved within a few weeks;
- Preservation of erectile and ejaculatory functions.
First Commercial U.S. BPH Patients Receive Rezūm Procedure
On November 3rd, NxThera initiated a limited U.S. launch of its Rezūm System to treat BPH. Over the course of just eight (8) clinic days during the past two weeks, more than thirty-five (35) patients received Rezūm procedures from urologists at five leading U.S. urology clinics - Dr. J. Randolf Beahrs of Metro Urology in St. Paul, Minnesota; Dr. Richard Levin of Chesapeake Urology Associates in Baltimore, Maryland; Dr. Jed Kaminetsky of University Urology in New York, New York; Dr. Michael Darson of Arizona Urology Specialists in Scottsdale, Arizona and Dr. Christopher Cantrill of Urology San Antonio in San Antonio, Texas.
"We are honored to have the opportunity to offer urologists and their patients a transformative new BPH treatment option which not only improves urological health, but also addresses the clinical and lifestyle objectives of urologists and their patients," said Bob Paulson, President & CEO of NxThera. "The compelling clinical results from our Rezūm II pivotal study demonstrate a minimally invasive treatment option that can be performed in a variety of clinical settings, including as an in-office procedure. We are committed to provide urologists with world-class clinical training and patient education to support them in their efforts to improve the lives of men suffering from BPH."
NxThera pioneered its Convective Water Vapor Energy (WAVE™) technology platform to treat a variety of endourological conditions beginning with BPH. The Company is furthering the application of the technology platform through advanced research and development targeting the treatment of prostate cancer and kidney cancer. NxThera's FDA cleared Rezūm System to treat BPH uses radiofrequency energy to create sterile water vapor, or steam, to convectively deliver targeted, precise thermal energy treatments in a simple procedure with minimal discomfort, and provide improvements in LUTS symptoms, urine flow and quality of life. Founded in 2008, NxThera is located in Maple Grove, Minnesota.
SOURCE NxThera, Inc.