NeoTract, Inc. Announces First Patients Enrolled in New Study to Expand UroLift System Indication
Expanded Indication Would Broaden Patient Population Eligible for
Treatment with UroLift System
PLEASANTON, Calif.–(BUSINESS WIRE)–NeoTract, Inc., a medical device company focused on addressing unmet
needs in the field of urology, today announced that the first patients
have been enrolled in the MedLift™ U.S. IDE trial.
The MedLift IDE trial is a new study that will be conducted across eight
U.S. sites. The study is designed to demonstrate safety and
effectiveness of the UroLift® System for the treatment of
patients with benign prostatic hyperplasia (BPH) who have an obstructive
median lobe, which is currently contraindicated in the United States.
Obstructive median lobes are present in approximately 5% to 10% of BPH
patients who would otherwise be eligible for treatment with the UroLift
System.
“Unlike other BPH procedures, the UroLift System directly opens the
urethra without cutting, heating, or removing prostate tissue. In this
way patients experience very rapid and durable relief,” said Euclid
deSouza, M.D., principal investigator at Adult & Pediatric Urology, PC
in Omaha, Neb. “This treatment option has been very successful for many
of my BPH patients who are unhappy with medical therapy and concerned
about the lengthy recovery and side effects common with other
procedures.”
“Most BPH men have some form of a median lobe and UroLift is an
effective treatment option, but in a small subset this lobe can become
obstructive,” said Ronald Tutrone, M.D., principal investigator at
Chesapeake Urology in Towson, Md. “UroLift would be valuable to patients
with obstructive median lobes since their treatment options are limited.
Patients I see with obstructive median lobes typically require more
aggressive treatment which can come with more complications,” he added.
“This new clinical study will continue to advance our understanding of
the benefits of the UroLift System,” said Dave Amerson, president and
CEO, NeoTract. “We are thrilled that the UroLift System has improved
quality of life for thousands, and we look forward to bringing this
innovative therapy to even more patients.”
Men who are interested in enrolling in the MedLift trial may obtain more
information by visiting www.clinicaltrials.gov
(NCT02625545) or by calling (650) 739-5570.
About BPH
There are more than 500 million men globally who suffer from BPH, a
condition in which the prostate enlarges as men get older. Chronic lower
urinary tract symptoms (LUTS) associated with BPH can cause loss of
productivity and sleep, depression and decreased quality of life.
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 the drugs. For
these patients, the classic alternative has been surgery that cuts or
heats prostate tissue to open the blocked urethra. Although effective,
patients typically only achieve symptom relief after a difficult period
of irritative voiding symptoms and wearing a urinary catheter. 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).
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, Mexico, South Korea and Canada. Learn more at www.UroLift.com.
About NeoTract
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.UroLift.com
or www.NeoTract.com.
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Contacts
NeoTract, Inc.
For NeoTract, Inc.:
Nicole Osmer, 650-454-0504
nicole@nicoleosmer.com
