NeoTract, Inc. Announces Medicare Administrative Contractor First Coast Service Options (FCSO) Coverage for the UroLift® System for BPH

Coverage Expands Access to Minimally Invasive Treatment for Millions
in Florida, Puerto Rico and U.S. Virgin Islands

PLEASANTON, Calif.–(BUSINESS WIRE)–NeoTract, Inc., a medical device company focused on addressing unmet
needs in the field of urology, today announced that First Coast Service
Options, Inc., the Medicare Administrative Contractor (MAC) covering
Florida, Puerto Rico and the U.S. Virgin Islands, has established
coverage for the UroLift® System for the treatment of
enlarged prostate, or benign prostatic hyperplasia (BPH).

With this coverage determination, the minimally invasive UroLift System
is now available to Medicare beneficiaries across the country.

“We are thrilled that millions of men across the United States now have
access to the UroLift System treatment,” said Dave Amerson, president
and CEO, NeoTract, Inc. “The recently published four-year clinical data
showing the durable benefits of the UroLift System, in addition to the
procedure’s already-established uniquely rapid relief, have compelled
Medicare administrative contractors and many commercial insurers to
offer access to this important solution for men suffering from enlarged
prostate.

“In addition to these proven clinical benefits, insurers and healthcare
systems are increasingly acknowledging that treatment with the UroLift
System can also improve efficiency of care, something that can benefit
the entire healthcare system. Recently, the UK’s Accelerated Access
Review designated the UroLift System as one of only six medical
technologies whose adoption should be accelerated to improve National
Health Service (NHS) healthcare efficiency.”

The UroLift System is a proven treatment that can get men off BPH
medications and allow them to avoid major surgery, while preserving
sexual function. Long-term clinical data from the LIFT randomized study
published in Urologic
Clinics of North America
showed that, after four years, patients
treated with the UroLift device continue to experience symptom relief
with minimal side effects, with few patients requiring an additional
procedure for relief.1 A second randomized clinical trial
called BPH6 published in European Urology demonstrated that the
UroLift device compares very well to the classic surgery, transurethral
resection of the prostate (TURP), with regard to efficacy, and is
superior to TURP at preserving sexual function and offering a more rapid
recovery.2

More than 37 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
classic alternative is surgery that cuts, heats or removes prostate
tissue to open the blocked urethra. While current surgical options 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 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.

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.NeoTract.com.

1 Roehrborn Urology Clinics 2016

2 Sonksen et al Eur Urology 2015

MAC00390-01 Rev A

Contacts

for NeoTract, Inc.
Nicole Osmer, 650-454-0505
nicole@nicoleosmer.com

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