Intersect ENT Initiates U.S. Clinical Study of a Novel In-Office Treatment
for Chronic Sinusitis Patients
RESOLVE Study Will Evaluate Safety and Effectiveness of Steroid-Eluting
Implant for Post-Sinus Surgery Patients with Recurrent Sinus Obstruction
MENLO PARK, Calif. -- January 31, 2013
Intersect ENT, Inc., an innovator in treatment solutions for ear, nose and
throat clinicians and their patients, today announced the start of RESOLVE, a
prospective, randomized, blinded, multi-center clinical trial to study the use
of the company’s newest steroid delivery implant for patients with chronic
Intersect ENT’s new product, which is placed during a routine physician office
visit, is designed as a treatment alternative for patients with recurrent
sinus obstruction. Like the company’s PROPEL™ and PROPEL™ mini implants used
in the operating room setting to improve surgical outcomes, the product being
studied releases mometasone furoate, an advanced steroid with
anti-inflammatory properties, directly into the sinus lining to resolve
inflammation. The product has more radial strength than the PROPEL products in
order to dilate the re-obstructed sinus, and releases the steroid over a
longer period of time to keep inflammation at bay.
The RESOLVE Study will enroll 100 patients, at up to 20 U.S. sites, who suffer
from chronic sinusitis due to recurrent sinus obstruction so severe that
revision surgery is warranted.
“This novel in-office treatment promises to become an important treatment
alternative to aggressive oral steroid therapy or revision sinus surgery for
chronic sinusitis patients,” said Steven K. Miller, M.D., of Intermountain,
Ear, Nose and Throat Specialists in Salt Lake City, Utah, who treated the
first patient enrolled in the trial. “This patient had a long history of
chronic sinusitis, and continued to be extremely symptomatic despite prior
sinus surgery and treatment with oral steroids. He was reluctant to have
another sinus surgery and was pleased with the opportunity to enter the
Chronic sinusitis is a condition in which patients’ sinuses become swollen and
inflamed, leading to difficulty breathing, facial pain or headache, and
reduced sense of smell and taste. The condition is common, affecting 31
million people in the U.S.,^1 and greatly impacts quality of life. Chronic
sinusitis often requires a complex combination of surgical and medical
treatments. Each year, 500,000 patients undergo sinus surgery to treat the
condition.^2 Although sinus surgery is effective, majority of patients
experience recurrent symptoms within the first year; as many as 25 percent
then undergo revision surgery due to recurrent obstruction of the sinus
The RESOLVE study is designed to evaluate Intersect ENT’s implant in patients
with polyps, which is the most challenging chronic sinusitis patient
population. Polyps recur in up to 60 percent of patients following endoscopic
sinus surgery (ESS) and are the leading cause for revision surgery.^4
Co-Principal Investigators for the study are Keith D. Forwith, M.D., Ph.D. of
Advanced ENT & Allergy in Louisville, KY, and Joseph Han, M.D., director of
Rhinology and Endoscopic Sinus/Skull Base Surgery and professor at the Eastern
Virginia Medical School.
“We are excited about the potential for this less invasive, more
cost-effective treatment for chronic sinusitis patients, who suffer from
debilitating symptoms,” said Lisa Earnhardt, the company’s president and CEO.
“The reception from the physician community to localized steroid delivery and
our PROPEL family of implants has been extraordinary, and we’re proud to be
partnering with leading clinicians on RESOLVE to further expand the treatment
options for sinus sufferers.”
About Intersect ENT
Intersect ENT Inc., located in Menlo Park, Calif., is an innovator in local
drug delivery focused on advancing clinically proven therapy solutions that
improve quality of life for patients with ear, nose and throat conditions. The
company’s initial products, the PROPEL and PROPEL mini dissolvable
steroid-releasing implants, are the only products backed by Level 1-A clinical
evidence to improve sinus surgery outcomes for patients suffering from chronic
sinusitis. Chronic sinusitis is a common condition that affects one out of
seven adults in the U.S. and greatly impacts quality of life. The company
holds twenty issued U.S. patents and more than 75 patents and pending
applications worldwide. Intersect ENT is backed by Kleiner, Perkins, Caufield,
& Byers; U.S. Venture Partners; PTV Sciences; and Medtronic. For more
information please visit www.intersectENT.com.
2013 © Intersect ENT Inc. All rights reserved. INTERSECT ENT^® and PROPEL™ are
trademarks of Intersect ENT, Inc.
Patients with Chronic Sinusitis should consult their ENT surgeon for a full
discussion of risks and benefits to determine whether this product is the
^1 Pleis JR, Lethbridge-Çejku M. National Health Interview Survey, 2006.
National Center for Health Statistics. Vital Health Stat 10(235). 2007.
^2 Rosenfeld et al. Clinical practice guideline: Adult sinusitis.
Otolaryngology–Head and Neck Surgery. 137, S1-S31, 2007.
^3 Shaitkin et al. Endoscopic Sinus Surgery. Laryngoscope, 103, Oct 1993.
^4 Wynn et al, Recurrence Rates after Endoscopic Sinus Surgery for Massive
Sinus Polyposis. Laryngoscope, 114, May 2004.
for Intersect ENT Inc.
Nicole Osmer, 650-454-0504
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