NeoTract Announces First U.S. Patients Enrolled in Study of New Minimally Invasive Device for Benign Prostatic Hyperplasia
- Device is designed to open blocked passageway that can complicate urination -
PLEASANTON, Calif., March 22, 2011 /PRNewswire/ -- NeoTract, Inc. a medical device company focused on developing urology devices, today announced that the first U.S. patients have been enrolled in a multinational trial of its UroLift® System at Western Urological Clinic in Salt Lake City, Utah. The UroLift System is a minimally invasive approach to treating benign prostatic hyperplasia (BPH) that lifts prostate tissue out of the way so that it no longer blocks the urethra.
"While millions of men suffer from BPH, many remain frustrated because pharmaceutical options are not serving them well and they are concerned with the potential undesirable side-effects, including urinary incontinence and sexual dysfunction, that are associated with currently approved surgical treatments," said Dr. Steven Gange, Principal Investigator for this first U.S. site in the L.I.F.T. Study. "The therapeutic goals of treating with the UroLift® System, a minimally invasive device under investigation here at Salt Lake Research and Western Urological Clinic, are to give men rapid symptom relief by opening up the urethra while preserving normal sexual function. We see enormous promise for this novel approach as a potential treatment option for men diagnosed with BPH," he added.
There are more than 528 million men globally who suffer from BPH, a condition in which the prostate grows and eventually squeezes or blocks the urethra. While the symptoms of BPH vary, the most common are urination problems, such as frequent urination or a weak urine stream. In 8 out of 10 cases, these symptoms suggest BPH. Left untreated, BPH can cause more serious problems, such as bladder or kidney damage, bladder stones, and incontinence(1).
The L.I.F.T. Study targets male patients ages 50 or older who have urinary problems related to BPH. Unlike other treatment procedures, the UroLift System directly opens the urethra without cutting, heating, or removing prostate tissue.
In addition to suffering the physical symptoms of BPH, men with the condition may also experience social problems and unwanted lifestyle changes. "Effective treatment of BPH can greatly improve the quality of life for men who suffer with the condition," explained Dr. Gange. "There is no reason any man should have to live with these difficulties."
The L.I.F.T. study is being conducted in the United States, Canada and Australia in connection with an Investigational Device Exemption to support market approval by the U.S. Food and Drug Administration. More information about the trial can be found at www.clinicaltrials.gov and the identifier is NCT01294150.
Men who are interested in enrolling in the trial may also obtain more information by calling (925) 401-0636 or visiting www.urolift.com.
NeoTract is dedicated to developing innovative and clinically effective devices that address unmet needs in the field of urology. The company's initial focus is to improve the standard of care for patients with BPH (Benign Prostatic Hyperplasia), a broadly underserved market. NeoTract's first product is the UroLift® System, a set of minimally invasive devices designed to treat lower urinary tract symptoms (LUTS) due to BPH. The UroLift system has already received CE mark approval and regulatory approval from the Australian Therapeutic Goods Administration (TGA) and is available for sale in select markets in Europe and Australia. For more information, please visit www.neotract.com.
SOURCE NeoTract, Inc.
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