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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. – September 24, 2013 -- 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
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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. Most were mild to moderate and resolved within 30
days following treatment. Minor adverse events reported in a large clinical study included pain or
burning during urination, blood in the urine, frequent or urgent need to urinate, incomplete emptying of
the bladder, and decreased urine flow.
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.
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Contact:
Bitting Communications
Angela Bitting
925-202-6211
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