PLEASANTON, Calif. – NeoTract, Inc., a medical device company focused on addressing unmet needs in the field of urology, today announced the presentation of new clinical data at the American Urological Association's 2015 Annual Meeting from two studies of the company’s novel UroLift® System for patients with Benign Prostatic Hyperplasia (BPH).
“These results confirm the long-term benefits of the UroLift System and show that it is a compelling alternative to the procedure that has been the standard of care for decades,” said Dave Amerson, president and CEO, NeoTract. Inc. “We are proud to bring rapid relief to patients suffering from BPH, and to provide a safe, effective and easy-to-use treatment alternative to physicians who care for them.”
Randomized BPH Study Shows Favorable Results for UroLift In Comparison to TURP
The BPH6 clinical study, which enrolled 80 patients at 10 European centers, is the first randomized comparison between UroLift and surgical transurethral resection of the prostate (TURP), the most common BPH procedure in which the inner portion of the prostate is surgically removed. When assessed for overall improvement, defined as improving lower urinary tract symptoms without diminishing sexual function, continence or safety, patients treated with the UroLift device responded more consistently than those treated with TURP. In addition, patient satisfaction rose more quickly for those treated with the
UroLift device and was sustained to one year.
“BPH6 is a landmark study that shows that the minimally invasive UroLift device compares very well to TURP, the gold standard, with regard to efficacy, and is superior to TURP at preserving sexual function and offering a more rapid recovery,” said Neil Barber, M.D., consultant urological surgeon, Frimley Park
Hospital NHS Foundation Trust in Frimley, United Kingdom, who presented the data. “These results provide additional evidence that continue to validate the recently published European Association of Urology guidelines giving UroLift a positive recommendation for the treatment of men with BPH.”
International prostate symptom score (IPSS) improvement was significant for both UroLift (-11.4±8.4) and TURP (-15.4±6.8) at 12 months, while quality of life improvements were not different between groups. 52.3% of UroLift patients responded to all six endpoints, vs 20.0% of TURP patients (p=0.005). At one month after treatment, 86% of UroLift patients would recommend the procedure to a friend or relative whereas only 73% of TURP patients would recommend the procedure.
Three-Year Results of L.I.F.T. Study Show Durable Long-Term Benefits
In addition, three-year results were presented from the 206-patient L.I.F.T. IDE Study, a multi-center, randomized, blinded study of the UroLift System for patients with BPH.
The data, presented by 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,demonstrate preserved sexual function and improvement in symptoms, flow and quality of life sustained
to three years.
“These excellent results show that the UroLift system treatment not only offers rapid improvement, but also durable relief for patients with BPH,” said Dr. Roehrborn. “After three years, patients treated with the UroLift device continue to experience symptom relief with minimal side effects, with few patients requiring an additional procedure for symptom relief.”
The analysis from the L.I.F.T. study shows an 88% superiority of treatment (n=140) over control (n=66) at three months and a sustained therapeutic effect in the UroLift implanted patients at three years. IPSS reduction was 44% by one month and sustained at 41% through three years (p-value < 0.0001). Adverse
events were typically mild and transient, with the most frequent being hematuria, dysuria, pelvic pain, urgency and urge incontinence. Sexual function was preserved with no incidence of de novo, sustained erectile or ejaculatory adverse events. There was a low incidence of retreatment for lower urinary tract
symptoms, with only 15 subjects seeking an additional procedure over the course of three years.
About Benign Prostatic Hyperplasia (BPH)
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 37 million men in the United States alone. 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 and by age 70, over 80 percent of men suffer from BPH.
Medication is often the first-line therapy for enlarged prostate, 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 TURP can be very effective in relieving symptoms, it can also leave patients with permanent side effects such as urinary incontinence, erectile dysfunction and retrograde ejaculation (dry orgasm).
About the UroLift System
The FDA-cleared UroLift System is a novel, minimally invasive technology for treating lower urinary tract symptoms due to benign prostatic hyperplasia (BPH). The UroLift permanent implants, 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 implants 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 and Canada. Learn more at www.UroLift.com.
NeoTract, Inc. is 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.
US Media Contact:
EU Media Contact: