MAPLE GROVE, Minn., Aug. 29, 2017 /PRNewswire/ -- NxThera, Inc., a medical device company pioneering the application of its convective radiofrequency thermal therapy to treat endourological conditions, today announced that new data from the first post-market clinical evaluation of its minimally invasive Rezūm System demonstrated significant, safe and effective urinary symptom relief, improved quality of life and preserved sexual function for men treated for benign prostatic hyperplasia (BPH). The multi-center, post-FDA clearance study included 131 men in a real-world clinical setting, producing positive, rapid and durable results that align with outcomes demonstrated in the company's earlier pivotal trial. The data was recently published in Research and Reports in Urology.
"The positive results from this study are consistent with the clinical data from the Rezūm pivotal trial and pilot studies, showing significant relief of obstructive urinary symptoms, improvement in quality of life and preserved sexual function," said Dr. Micheal Darson, lead researcher and urologist with Arizona Urology Specialists in Scottsdale, Ariz. "Convective radiofrequency thermal therapy with the Rezūm System warrants consideration as a first-line treatment for lower urinary tract symptoms caused by BPH as an alternative to the life-long use of medications."
Developed by NxThera, Rezūm is performed in a clinic or out-patient setting in the U.S. Rezūm uses the natural thermal energy stored in water vapor, or steam, to treat the enlarged prostate tissue that causes BPH symptoms such as frequency, urgency, irregular flow, weak stream, straining and getting up at night to urinate. The water vapor is delivered into the targeted prostate tissue and when the vapor contacts the tissue it condenses, releasing the stored thermal energy, causing the obstructive prostate tissue cells to die. Over the next few weeks, the body's natural healing response eliminates the treated tissue, shrinking the prostate. With the extra tissue removed, the urethra opens, reducing BPH symptoms and improving the patient's quality of life. Studies have shown that the Rezūm treatment allows men to retain sexual function unlike surgical BPH treatments, which typically have higher incidences of long-term sexual side effects. To date, more than 15,000 men have been effectively treated with the Rezūm System across the U.S. and Europe.
This retrospective study of the Rezūm System for treatment of lower urinary tract symptoms (LUTS) caused by BPH is the first "real world" study where there were many differences in the conditions of the patients who were treated, including older patients, patients with significant variations in the size of their prostates, and patients who had previously unsuccessfully tried other options to treat their BPH symptoms, such as long-term medications or more invasive treatments. All Rezūm procedures were performed in a clinic or out-patient setting, and all treatments were successfully completed.
Pre- and post-procedure assessments included International Prostate Symptom Score (IPSS), quality of life (QoL) index, peak urinary flow rate, voided volume and post void residual (PVR) volume. Clinical and statistical improvement of LUTS based on IPSS, QoL and PVR was observed through 12 months. Additionally, the presence of a median lobe and/or enlarged central zone was identified and treated in 54 patients, with significant improvement in symptoms achieved.
"This retrospective analysis is important because it's the first published data, post-FDA clearance, demonstrating the effectiveness of treating a diverse cross-section of BPH patients with the Rezūm System in 'real world,' private practice, office-based settings. The results from this patient population, compared to patients enrolled in a registration-directed, randomized, controlled trial with restrictive inclusion and exclusion criteria, was very consistent and reaffirmed the significant symptom relief BPH patients experience with Rezūm," said Bob Paulson, president and CEO of NxThera. "This post-market study demonstrates that Rezūm is transforming the treatment experience for urologists and their patients suffering from BPH by providing a versatile, in-office or out-patient treatment option for men interested in nonsurgical and non-medication alternatives to treat BPH and resume their quality of life."
For more information about the Rezūm System, visit www.rezum.com.
About NxThera and the Rezūm System
NxThera pioneered its convective radiofrequency thermal therapy platform technology 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 is a next-generation transurethral needle ablation system indicated to treat symptoms of BPH using radiofrequency energy that is convectively delivered to obstructive prostate tissue in targeted, precise thermal energy treatments, with minimal discomfort. Rezūm treatments provide improvements in BPH symptoms, urine flow and quality of life. Founded in 2008, NxThera is located in Maple Grove, Minn. For more information, visit www.rezum.com.
SOURCE NxThera, Inc.