MAPLE GROVE, Minn.--(EON: Enhanced Online News)--NxThera, Inc., a privately held medical device company developing a proprietary water vapor endourology treatment platform, today announced that Steven Gange, MD, of Western Urological Clinic and Jean Brown Research in Salt Lake City, Utah, used NxThera’s Rezūm® System to enroll and treat the first patients in NxThera’s Rezūm II U.S. investigational device exemption (IDE) clinical trial for the treatment of benign prostatic hyperplasia (BPH). The Rezūm System is designed to rapidly treat prostate tissue using sterile water vapor, or steam, in an office-based, minimally invasive procedure designed to treat the urethral obstruction caused by BPH.
“Millions of men who suffer from the effects of BPH are unable to obtain relief using pharmacologic therapies, and are unwilling to accept the potential complications or side effects associated with other BPH procedures”
The Rezūm II clinical trial is a randomized controlled study for male patients ages 50 or older who have urinary problems related to BPH. NxThera expects to enroll a total of 195 patients at 15 sites in the United States. Kevin McVary, MD, Chair of the Division of Urology at Southern Illinois University and Claus Roehrborn, MD, Chair of the Department of Urology at UT Southwestern are the co-Principal Investigators for the Rezūm II IDE trial.
In aging men, the normal flow of urine from the bladder can be restricted, often as the result of enlarged prostate tissue that obstructs the urethra. Symptoms of BPH include increased urination frequency, sudden urges to urinate, and weak urine flow. More than 12 million men in the U.S. have been diagnosed with BPH and more than 70% of men over age 60 experience symptoms of BPH which, if left untreated, can result in more serious problems such as incontinence, bladder or kidney damage, or bladder stones.
“Millions of men who suffer from the effects of BPH are unable to obtain relief using pharmacologic therapies, and are unwilling to accept the potential complications or side effects associated with other BPH procedures,” commented Dr. Gange. “Many of these men are seeking treatment options that can be performed quickly, with minimal side effects and rapid recovery. The therapeutic objectives of the Rezūm System are to treat the symptoms of BPH in an office-based procedure that can be performed in minutes, with minimal discomfort and rapid symptom relief by alleviating obstruction of the urethra while preserving normal sexual function. This trial has been designed to address this unmet medical need.”
Caution: The NxThera Rezūm® System is investigational and not currently available for sale in the United States. The device is limited by U.S. federal law to investigational use only.
NxThera’s objective is pioneering the application of its sterile water vapor technology platform in a variety of endourology conditions including BPH, prostate cancer and kidney cancer. NxThera’s sterile water vapor, or steam, technology platform enables the delivery of targeted, precise BPH treatments in a simple, office-based procedure designed to take only minutes, with minimal discomfort, and provide improvements in urine flow and quality of life. Founded in 2008, NxThera is located in Maple Grove, Minnesota.
For more information, visit www.rezum.com.