2014

First U.S. Patient Treated Following FDA Clearance of NeoTract's UroLift® System Innovative UroLift System to Treat Enlarged Prostate Now Available at Select U.S. Medical Centers

PLEASANTON, Calif., Sept. 24, 2013 /PRNewswire/ -- NeoTract, Inc., today announced that the first patient in the United States has been treated with its commercial UroLift® System, the first permanent implant to treat symptoms due to urinary outflow obstruction secondary to benign prostatic hyperplasia (BPH) in men 50 years of age or older. Cleared by the U.S. Food and Drug Administration on September 13, 2013, the UroLift System is designed to relieve symptoms caused by an enlarged prostate, while preserving sexual function.

"Our hospital system is committed to providing patients with the highest quality, most effective options to address their urology needs," said Eugene Rhee, M.D., M.B.A., Chief of the Department of Urologic Surgery at Kaiser Permanente in San Diego. "The commercial availability of the UroLift System, with its excellent safety profile, provides men suffering from an enlarged prostate a beneficial first-line treatment alternative to drug therapy or more invasive surgery. Importantly, the UroLift System provides fast and meaningful relief from BPH symptoms, improving overall quality of life for our patients."

The UroLift System permanent implants, delivered during a minimally-invasive procedure, act like window curtain tie-backs to hold the lobes of an enlarged prostate open. Patients recover from the procedure quickly, and return to their normal routines with minimal downtime.

Data from a recent pivotal 206-patient randomized controlled study, conducted primarily in the U.S., showed that patients receiving UroLift implants reported rapid symptomatic improvement, improved urinary flow rates, and sustained sexual function with minimal adverse events, which mostly resolved two to four weeks following the procedure.  Patients also experienced a significant improvement in quality of life.

"We, at NeoTract, are extremely pleased to bring our straightforward, innovative UroLift System to physicians and patients in selected U.S. centers," commented Dave Amerson, president and CEO of NeoTract. "We are committed to providing excellent physician training and patient education, both important for positive patient outcomes, and believe this product will make a significant difference in the lives of aging men."

BPH is a medical condition in which the prostate gland that surrounds the male urethra becomes enlarged with advancing age and begins to obstruct the urinary system.  The condition is common, affecting approximately 37 million men in the United States. BPH symptoms include sleepless nights and urinary problems, and can cause loss of productivity, depression and decreased quality of life. About one in four men experience BPH-related symptoms by age 55, with 90 percent of men over 70 symptomatic.

The UroLift System provides an alternative to tissue removing surgery for the treatment of an enlarged prostate. Performed through the urethra, a urologist uses the UroLift System to push aside the obstructive prostate lobes and positions small, tailored permanent UroLift implants to hold the prostate lobes in the retracted position. This opens the urethra while leaving the prostate intact. Adverse reactions associated with UroLift System treatment were comparable to other minimally invasive surgical therapies as well as standard cystoscopy.  The most common adverse events reported during the study included pain or burning with urination, blood in the urine, pelvic pain, urgent need to urinate, and the inability to control urine because of an urgent need to urinate.  Most symptoms were mild to moderate in severity and resolved within two to four weeks after the procedure.  

About BPH Treatment

More than 500 million aging men worldwide have an enlarged prostate. Medication is often the first line therapy but relief can be inadequate and temporary.  Side effects of treatment can include sexual dysfunction, dizziness and headaches, prompting many patients to quit using the drugs.  For these patients, the classic alternative is surgery that cuts or ablates prostate tissue to open the blocked urethra. While current surgical options, such as the 'gold standard' surgery, Transurethral Resection of the Prostate (TURP), can be very effective in relieving symptoms, they can also leave patients with permanent side effects such as urinary incontinence, erectile dysfunction and retrograde ejaculation (dry orgasm).

About NeoTract

NeoTract, Inc. is dedicated to developing innovative, minimally-invasive and clinically-effective devices that address unmet needs in the field of urology. Our initial focus is on improving the standard of care for patients with benign prostatic hyperplasia (BPH) using the UroLift System, a minimally-invasive permanent implant system that treats symptoms while preserving normal sexual function. The UroLift System is now available in the U.S. and is also for sale in Europe, Australia and Canada. Learn more at www.NeoTract.com.

SOURCE NeoTract, Inc.



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