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Intersect ENT Announces Launch of SINUVA™ Sinus Implant, a New In-Office Treatment Option for Recurrent Nasal Polyps


New Treatment Is Clinically Proven to Reduce Polyps and Symptoms of
Nasal Congestion

Intersect ENT, Inc. (NASDAQ:XENT), a company dedicated to transforming
care for patients with ear, nose and throat conditions, today announced
U.S. commercial availability of the SINUVA™ (mometasone furoate) Sinus
Implant, a new approach to treating nasal polyp disease in adult
patients who have had previous sinus surgery.

This press release features multimedia. View the full release here:

Placed during a routine doctor's office visit under local or topical
anesthesia, SINUVA is designed to deliver an anti-inflammatory steroid
directly to the site of disease for an extended period of time (up to 90
days) following placement into the sinus cavity. SINUVA is clinically
proven to reduce polyps and symptoms of nasal congestion. In addition,
in a study of patients indicated for repeat sinus surgery, less than
half of patients still needed surgery following placement of the SINUVA

"Recurrent nasal polyposis is one of the most challenging conditions for
ENT physicians. Many sufferers return to their ENT physician despite
sinus surgery due to recurrence of symptoms," said Satish Govindaraj,
M.D., associate professor and vice chairman of Clinical Affairs in the
Department of Otolaryngology of Mount Sinai Medical Center, one of the
clinical trial sites involved in the pivotal study of SINUVA. "The
clinical data supporting the use of the SINUVA implant is compelling. I
believe this innovative treatment option will be attractive for many of
my patients."

Nasal polyps are inflammatory growths along the lining of nasal passages
or sinuses that can cause nasal congestion, infections and loss of sense
of smell. Approximately 635,000 Americans have had previous sinus
surgery and continue to see their ENT physicians for treatment of
recurring symptoms.

"After years of development and multiple clinical studies, we are
thrilled to provide physicians with SINUVA to treat patients with nasal
polyps. SINUVA offers an alternative to patients who have exhausted
routine medical management who don't want to return to the operating
room for a repeat surgery," said Lisa Earnhardt, president and CEO of
Intersect ENT. "We are introducing SINUVA through a targeted launch,
working to build success through positive initial adoption and
positioning SINUVA for the long-term growth we believe is achievable."

"Steroid releasing implants have been a mainstay of my treatment for
patients following sinus surgery. SINUVA represents a related technology
uniquely designed for patients who continue to struggle with nasal
polyps," said Greg Davis, M.D., M.P.H., associate professor of
otolaryngology-head and neck surgery at the University of Washington
School of Medicine in Seattle. He was among the first in the United
States to utilize the SINUVA product. "The SINUVA implant delivers
steroids in a time-released fashion right to the source where we need
it, in a simple office procedure."

The efficacy of the SINUVA Sinus Implant was demonstrated in the
landmark RESOLVE II pivotal study in 300 patients who were indicated for
repeat sinus surgery. RESOLVE II met both co-primary efficacy endpoints
as patients receiving SINUVA experienced (1) a statistically significant
reduction from baseline to 90 days in bilateral polyp grade (p=0.007),
which corresponded to 74% relative reduction in the extent of ethmoid
polyp disease; and (2) a significant reduction from baseline to 30 days
in nasal obstruction/congestion score (p=0.007), which corresponded to
30% relative improvement, compared to controls. Four of the five
pre-specified secondary endpoints achieved statistical significance
through day 90 favoring the SINUVA group, including reduction in percent
ethmoid sinus obstruction, reduction of nasal obstruction/congestion
symptoms, improvement in sense of smell, and reduction in the proportion
of patients still indicated for repeat sinus surgery.

About Steroid Releasing Sinus Implants

Steroid releasing implants provide targeted delivery of an
anti-inflammatory steroid directly to the site of disease. The use of
PROPEL® steroid releasing sinus implants, which are utilized
following a surgical procedure to maintain the opening of the sinus
passages, has been proven to reduce the likelihood that patients will
need additional surgical interventions or require high-dose oral
steroids. Placed during a routine doctor's office visit with local or
topical anesthesia, the SINUVA™ (mometasone furoate) Sinus Implant is
designed to deliver a treatment for nasal polyp disease for adults who
have had prior ethmoid sinus surgery.

The American
Rhinologic Society (ARS)
endorsed the utilization of drug eluting
sinus implants in 2016, citing the number of well-controlled studies on
drug-eluting implants in the paranasal sinuses.

About Intersect ENT®

Intersect ENT is dedicated to transforming ear, nose and throat care by
providing innovative, clinically meaningful therapies to physicians and
patients. The company's steroid releasing implants are designed to
provide mechanical spacing and deliver targeted therapy to the site of
disease. In addition, Intersect ENT is continuing to expand its
portfolio of products based on the company's unique localized steroid
releasing technology and is committed to broadening patient access to
less invasive and more cost-effective care.

For additional information on the company or the products including
risks and benefits please visit
For more information about SINUVA, please visit

Intersect ENT and PROPEL are registered trademarks and SINUVA is a
trademark of Intersect ENT, Inc.



The SINUVA Sinus Implant is a corticosteroid-eluting (mometasone
furoate) implant indicated for the treatment of nasal polyps, in
patients ≥ 18 years of age who have had ethmoid sinus surgery.


Patients with a known hypersensitivity to the mometasone furoate drug,
or any of the ingredients in SINUVA, should not use SINUVA.
Hypersensitivity reactions, including rash, pruritus, and angioedema
have been reported with the use of corticosteroids. If corticosteroid
effects such as hypercorticism and adrenal suppression appear in
patients, consider sinus implant removal.

SINUVA is made from bioabsorbable polymers designed to soften over time.
As the implant softens and polyps decrease, the implant may be expelled
out of the nose on its own or with actions such as sneezing or forceful
nose blowing. The implant can be removed 90 days after placement or
earlier at the physician's discretion. Repeat administration of SINUVA
has not been studied.

As with other endoscopic sinus procedures, there are risks associated
with the insertion or removal of SINUVA. SINUVA should be inserted by
physicians trained in otolaryngology.

The nasal mucosa adjacent to the SINUVA Sinus Implant should be
monitored for any signs of bleeding (epistaxis), irritation, infection,
or perforation. Avoid the use of SINUVA in patients with nasal ulcers or

The most common adverse reactions observed in clinical studies were
bronchitis, nasopharyngitis, otitis media, headache, presyncope, asthma,
and epistaxis.

Patients experiencing excessive nasal bleeding, symptoms of infection or
symptoms suggesting that the implant has moved, such as irritation or a
choking sensation in the back of the throat, should immediately contact
a healthcare professional.

Close monitoring is recommended if patients have a change of vision or a
history of increased intraocular pressure, glaucoma and/or cataracts.

You may report side effects to your physician or to the FDA at
1-800-FDA-1088 or
You may also report side effects to Intersect ENT at 1-866-531-6004.

RX Only. For important risk and use information about SINUVA, please see
Full Prescribing Information at



The PROPEL sinus implants are intended for use following sinus surgery
to maintain the sinus openings and to locally deliver a drug to the
sinuses: PROPEL for use in the ethmoid sinus, PROPEL Mini for use in the
ethmoid sinus and frontal sinus opening and PROPEL Contour for use in
the frontal and maxillary sinus openings. The products are intended for
use in patients ≥18 years of age.


These products are not intended for people who are allergic to the drug
(mometasone furoate) or to certain polymers. Safety and effectiveness of
the implant in pregnant or nursing females have not been studied. Risks
may include, but are not limited to, pain/pressure, movement of the
implant (within or out of the sinus), possible side effects of the drug,
infection, and nose bleed. For more information on the risks and
benefits of PROPEL sinus implants, please talk to your doctor. The FDA
approved labeling can be found at
Rx only.

Forward-Looking Statements

This release contains forward-looking statements within the meaning of
Sections 27A of the Securities Act of 1933 and Section 21E of the
Securities Exchange Act of 1934. Forward-looking statements should not
be read as a guarantee of future performance or results and may not
necessarily be accurate indications of the times at, or by, which such
performance or results will be achieved. These statements include those
related to the safety, efficacy and patient and physician adoption of
SINUVA. These forward-looking statements are based on Intersect ENT's
current expectations and inherently involve significant risks and
uncertainties. Actual results and the timing of events could differ
materially from those anticipated in such forward-looking statements as
a result of these risks and uncertainties, which include, without
limitation the company's ability to procure and maintain required
regulatory approvals for our products and the adoption of SINUVA and the
company's other therapies by physicians and patients, as well as other
risks detailed from time to time in Intersect ENT's filings with the
Securities and Exchange Commission (SEC), including Intersect ENT's
filings on Form 10-K and Form 10-Q available at the SEC's Internet site (
Intersect ENT does not undertake any obligation to update
forward-looking statements and expressly disclaims any obligation or
undertaking to release publicly any updates or revisions to any
forward-looking statements contained herein.


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