NeoTract Completes Enrollment of Minimally Invasive Device Study for Benign Prostatic Hyperplasia
PLEASANTON, Calif., Jan. 9, 2012 /PRNewswire/ — NeoTract, Inc., a medical device company developing new urology devices, today announced completion of enrollment in the FDA-approved L.I.F.T. Study for men with urinary tract symptoms due to benign prostatic hyperplasia (BPH). This multi-national study enrolled 206 men, age 50 or older, and was randomized 2:1 to the UroLift® System versus control.
The UroLift System is being investigated as a minimally invasive device designed to increase the opening of the urethra without removing prostate tissue. Deployed through the urethra with the UroLift Delivery Device, small UroLift Implants are permanently placed to hold the obstructing prostate tissue out of the way.
“The L.I.F.T. Study is designed to provide comprehensive information for FDA evaluation. If the UroLift technology keeps performing as it has in previous, single-arm studies, we look forward to offering this new product to U.S. patients,” said co-principal investigator Claus Roehrborn, MD, Professor and Chairman of Urology at the University of Texas Southwestern.
“Completing this study is an important milestone for NeoTract and significantly advances our groundbreaking technology,” said Dave Amerson, President and CEO of NeoTract. “We look forward to serving the millions of U.S. men who want a better option for BPH.”
BPH is a common condition afflicting more than 500 million aging men worldwide. Chronic lower urinary tract symptoms associated with BPH can cause loss of productivity and sleep, depression and decreased quality of life. For patients with moderate-severe symptoms, medication is often the first-line therapy but relief can be inadequate and temporary. Side-effects can include sexual dysfunction, dizziness and headaches, prompting many patients to quit using drugs. For these patients, the classic alternative is surgery that cuts or heats prostate tissue to open the blocked urethra. Although effective, those procedures induce a healing response and tissue inflammation. Patients thus have to ‘earn’ their symptom relief after a difficult period of irritative voiding symptoms and catheterization. Long-term, even the ‘gold standard’ surgery, TURP (transurethral resection of the prostate), can leave patients with permanent side-effects such as urinary incontinence, erectile dysfunction and retrograde ejaculation (dry orgasm). NeoTract’s UroLift System was designed to avoid those problems and offer patients rapid, durable symptom relief.
NeoTract, Inc., founded in 2004 through ExploraMed, a medical device incubator funded by New Enterprise Associates, is dedicated to developing innovative, minimally invasive and clinically effective solutions that will significantly advance the way urology is practiced. The company’s vision is to be the world leader in improving wellness and overall quality of life for people suffering from important urological conditions. The initial focus is on improving the standard of care for patients with BPH using the UroLift® System, a minimally invasive device designed to treat lower urinary tract symptoms (LUTS). This unique technology is CE marked and available for sale in Europe, Canada and Australia. (http://www.neotract.com)
PM12424 Rev B. In the United States: Caution – Investigational device. Limited by U.S. law to investigational use.
SOURCE NeoTract, Inc.