NeoTract Inc. Announces Positive Five-Year Results for Minimally Invasive UroLift® System at American Urological Association 2017 MeetingJune 1, 2017 12:29 pm
PLEASANTON, Calif. and Boston – June, 2017 – NeoTract, Inc., a medical device company focused on addressing unmet needs in the field of urology, today announced presentation of the five-year results of the pivotal, randomized L.I.F.T. IDE study, which evaluated the safety and effectiveness of the company’s novel UroLift® System as a treatment for patients with symptomatic benign prostatic hyperplasia (BPH) or enlarged Prostate.
Claus Roehrborn, M.D., Professor and Chair of the Department of Urology UT Southwestern Medical Center in Dallas and co-principal investigator for the L.I.F.T. clinical program, presented the five-year results for the first time to a U.S. audience at the 112th annual American Urological Association meeting in Boston. Five Australian sites where part of this study.
Results of the five-year L.I.F.T. study demonstrate that UroLift System treatment provides:
- A highly tolerable, minimally invasive procedural experience;
- Rapid reduction of symptoms after the procedure while preserving sexual function;
- Sustained effect, with IPSS (International Prostate Symptom Score) and Qmax (peak urinary flow rate) remaining 36% and 44% improved from baseline, respectively;
- Quality of life (QoL) score improvement of 50% over five years;
- A durable treatment with a low retreatment rate of 2-3% per year.1
“The UroLift System has now been proven as a minimally invasive alternative to medication that offers sustained, reliable relief for patients,” said Associate Professor Chin of Wollongong Private Hospital, NSW, who has treated numerous patients as a part of the L.I.F.T. clinical trial. “The procedure can be performed efficiently by a trained Urologist as a day procedure with minimum pain medication. It involves no cutting, heating, or removal of tissue, and results are evident immediately. Healing and recovery have been shown in clinical trials to be swift, with patients experiencing symptom relief and improved quality of life within a matter of days or weeks, with sustained results to at least five years. I believe the UroLift System is a game-changer in the field of urology.”
“NeoTract has set the standard for robust BPH clinical data collection with global prospective multi-site studies to prove durability of the UroLift System procedure and it’s an area we will continue to invest in,” said David Baker, General Manager NeoTract, Australia Pty. Ltd. “This is a proud moment for us in Australia as the history of the UroLift System saw the original clinical research being carried out here from 2005, initially by two Urologists in NSW and then soon expanding across five Australian sites. The UroLift System has been available for use in Australia with reimbursement for men holding private health insurance since February 2013.”
BPH, also known as enlarged prostate, 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 500 million men worldwide. BPH symptoms include interrupted sleep and urinary problems, and can cause loss of productivity, depression and decreased quality of life.
Medication is often the first-line therapy for enlarged prostate, but relief can be inadequate and temporary. Side effects of medication treatment can include sexual dysfunction, dizziness and headaches, prompting many patients to quit using the drugs. For these patients, the alternative until the advent of the UroLift System has been surgery that cuts, heats or removes prostate tissue to open the blocked urethra.
About the UroLift System
The TGA approved UroLift System is a proven, minimally invasive technology for treating lower urinary tract symptoms due to benign prostatic hyperplasia (BPH). The UroLift permanent prostatic retractors, delivered during a minimally invasive transurethral outpatient procedure, relieve prostate obstruction and open the urethra directly without cutting, heating, or removing prostate tissue. Clinical data from a pivotal 206-patient randomized controlled study showed that patients with enlarged prostate receiving UroLift retractors reported rapid and durable symptomatic and urinary flow rate improvement without compromising sexual function. Patients also experienced a significant improvement in quality of life. Most common adverse events reported include hematuria, dysuria, micturition urgency, pelvic pain, and urge incontinence. Most symptoms were mild to moderate in severity and resolved within two to four weeks after the procedure. The UroLift System is available in the U.S., Europe, Australia, Canada, Mexico and South Korea. Learn more at www.urolift.com.au.
NeoTract Australia Pty. Ltd. is a wholly owned subsidiary of NeoTract, Inc., based in Pleasanton, California. dedicated to developing innovative, minimally invasive and clinically effective devices that address unmet needs in the field of urology. The company’s initial focus is on improving the standard of care for patients with BPH using the UroLift System, a minimally invasive permanent implant system that treats symptoms while preserving normal sexual function. Learn more at www.NeoTract.com.
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1 Roehrborn, AUA 2017, Boston
MAC00456-01 Rev A
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