Business Wire05.30.17
NeoTract Inc., a medical device company focused on addressing unmet needs in the field of urology, recently presentation 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).
Claus Roehrborn, M.D., professor and chair of the Department of Urology University of Texas 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, Mass.
Results of the five-year L.I.F.T. study demonstrate that UroLift System treatment provides:
“The UroLift System has now been proven as a minimally invasive alternative to medication that offers sustained, reliable relief for patients,” said Dr. Steven Gange of Summit Urology Group in Salt Lake City, Utah, who treated numerous patients as a part of the L.I.F.T. clinical trial. “The procedure itself can be performed efficiently by a trained urologist, with little need for anesthetics or pain medication. It involves no cutting, heating, or removal of tissue, and results are evident immediately. Healing and recovery are swift, with patients experiencing symptom relief and improved quality of life within a matter of days or weeks, and sustained similar results after five years. I truly believe the UroLift System is a game-changer for the field of urology.”
Nearly 40 million men in the United States are affected by BPH, which occurs with advancing age when the prostate gland that surrounds the male urethra becomes enlarged and begins to obstruct the urinary system. Symptoms of BPH often include sleepless nights 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 is surgery that cuts, heats or removes prostate tissue to open the blocked urethra.
“The results continue to demonstrate the potential of the UroLift System to become the standard of care first-line treatment for patients with BPH. NeoTract has set the standard for robust BPH clinical data collection with global multi-site studies and proven durability and it’s an area we will continue to invest in,” said Dave Amerson, president and CEO NeoTract Inc. “We are honored to partner with urologists around the world to help men return to normal urinary function and preserve sexual vitality with this safe and effective treatment option.”
The U.S. Food and Drug Administration-cleared UroLift System is a 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 United States, Europe, Australia, Canada, Mexico, and South Korea.
NeoTract Inc. develops minimally invasive 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.
Reference
1. Roehrborn, AUA 2017, Boston
Claus Roehrborn, M.D., professor and chair of the Department of Urology University of Texas 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, Mass.
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 percent and 44 percent improved from baseline, respectively;
- Quality of life (QoL) score improvement of 50 percent over five years;
- A durable treatment with a low retreatment rate of 2 percent to 3 percent 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 Dr. Steven Gange of Summit Urology Group in Salt Lake City, Utah, who treated numerous patients as a part of the L.I.F.T. clinical trial. “The procedure itself can be performed efficiently by a trained urologist, with little need for anesthetics or pain medication. It involves no cutting, heating, or removal of tissue, and results are evident immediately. Healing and recovery are swift, with patients experiencing symptom relief and improved quality of life within a matter of days or weeks, and sustained similar results after five years. I truly believe the UroLift System is a game-changer for the field of urology.”
Nearly 40 million men in the United States are affected by BPH, which occurs with advancing age when the prostate gland that surrounds the male urethra becomes enlarged and begins to obstruct the urinary system. Symptoms of BPH often include sleepless nights 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 is surgery that cuts, heats or removes prostate tissue to open the blocked urethra.
“The results continue to demonstrate the potential of the UroLift System to become the standard of care first-line treatment for patients with BPH. NeoTract has set the standard for robust BPH clinical data collection with global multi-site studies and proven durability and it’s an area we will continue to invest in,” said Dave Amerson, president and CEO NeoTract Inc. “We are honored to partner with urologists around the world to help men return to normal urinary function and preserve sexual vitality with this safe and effective treatment option.”
The U.S. Food and Drug Administration-cleared UroLift System is a 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 United States, Europe, Australia, Canada, Mexico, and South Korea.
NeoTract Inc. develops minimally invasive 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.
Reference
1. Roehrborn, AUA 2017, Boston
