VenSure and Cube Join the Company’s Portfolio
of Localized Drug Delivery Creating an Integrated Offering of ENT
Technologies to Treat CRS
Intersect ENT®, Inc. (Nasdaq: XENT), a global ear, nose and
throat (“ENT”) medical technology leader dedicated to transforming
patient care, today announced the U.S. nationwide commercial
availability of the VenSure™ Balloon Sinus Dilation System and
Cube™4D Navigation System with VirtuEye™ photo registration. The
VenSure Balloon and Cube 4D Navigation Systems are used in
procedures that are designed to improve debilitating chronic
rhinosinusitis (CRS) symptoms. VirtuEye photo registration is an
exclusive and novel, touchless technology that allows for easy 3D
facial registration, pinpoint accuracy and improved workflow
efficiency for balloon sinus dilation (BSD) procedures and other
ENT related skull-based surgeries. With the addition of the Cube
and VenSure technologies to the already clinically proven portfolio
of localized drug delivery products, PROPEL® (mometasone furoate)
and SINUVA® (mometasone furoate) sinus implants, the company now
offers a more comprehensive and integrated set of treatment
solutions for physicians and their patients across the continuum of
care of CRS regardless of site of care.
As many as 1 in 8 adults in the United States suffer from CRS, a
condition in which the sinuses within the nose and head become
swollen and inflamed for three months or longer, causing blockage
of airflow and drainage. Over time, the sinuses can become infected
leading to inflammation and pain. Up to 60% of CRS patients may not
experience significant improvements in their symptoms despite
trying multiple over the counter and prescription medications. For
these chronic sinus sufferers Intersect ENT offers a range of
device, drug and procedural solutions.
“Chronic rhinosinusitis is an underserved and serious condition
that can reduce patients’ quality of life, their ability to work
and to get restful sleep. There is a clear need for innovative
tools and a broadened armamentarium that can help physicians treat
patients suffering from CRS,” states Rajiv Pandit, MD,
Otolaryngologist at Dallas ENT Head & Neck Surgery. “Balloon
sinus dilation offers CRS patients a convenient, less-invasive,
lower-cost solution by providing rapid resolution of symptoms with
a minimal risk of complications. The VenSure Balloon allows the
technique to be tailored and adapted to each patient’s unique
anatomy and the use of Cube Navigation System with VirtuEye ensures
a simple yet highly precise location of the balloon for optimized
placement within the sinus.”
The BSD procedure entails insertion of a balloon, like the
VenSure device, to open the blocked sinuses with precision,
reducing the risk of complications associated with other, more
invasive surgical procedures. Because balloon sinus dilation
preserves the integrity of the sinus tissue, it allows for quick
recovery times as most patients may return to regular activity as
early as the very next day. Additionally, the sinus procedure can
be performed in the physician’s office, reducing the need for
costly and unsettling hospital stays and expensive medications. The
VenSure Sinus Balloon is a simple yet effective device with a slim,
ergonomic design that tailors to the user’s hand for efficient
maneuverability. The systems responsive feel is driven by its
malleability and integrated components intended to optimize
visibility and feel. The tip tracked technology that is
incorporated into each instrument helps provide confident and
precise placement feedback.
Accompanying the VenSure Sinus Balloon introduction is the Cube
4D Navigation system, a next generation electromagnetic navigation
system that is intuitive, simple and precise. The Cube’s compact
design and small footprint easily integrates into any cart or tower
shelf, preserving valuable procedural room space. The systems
intuitive interface with on-screen instructions and audible
confirmation tones, as well as an open architecture platform
allowing flexibility to track preferred instrumentation, provides
simplicity of use for physician users and staff. Exclusive to the
Cube 4D system is the innovative and touchless VirtuEye photo
registration technology that reduces patient registration time to
under 40 seconds, and its ease of use enhances the user experience
and improves pre-procedure efficiency. Importantly, VirtuEye is
designed to collect over 50,000 patient registration points in one
camera shot, which mitigates common tactile tracing errors that can
occur with most other registration approaches. As a touchless
technology, VirtuEye photo registration also helps to avoid
breaking the sterile field by reducing direct interaction between
the care team and the patient.
With the launch of our VenSure Balloon Sinus Dilation System and
Cube 4D Navigation system with VirtuEye, “Intersect ENT is
transforming to become a more diversified, integrated and
evidence-based growth company participating across the continuum of
care in CRS,” said Thomas A. West, President and Chief Executive
Officer of Intersect ENT. “Our portfolio of related but distinct
technologies inclusive of our localized drug delivery platforms,
PROPEL and SINUVA, along with VenSure and Cube, now provide
surgeon’s an integrated toolbox of solutions to treat patients
suffering from CRS regardless of site of care. We are proud of our
continued leadership in bringing to market innovative novel ENT
technologies that address patient and physician need while
providing significant growth to our company.”
About Intersect ENT
Intersect ENT is a global ear, nose and throat medical
technology leader dedicated to transforming patient care. 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. In October
2020, Intersect ENT acquired Fiagon AG Medical Technologies, a
global leader in electromagnetic surgical navigation solutions with
an expansive portfolio of ENT product offerings, including the
VenSure sinus dilation balloon, which is FDA-cleared in the US,
that complement the Company’s PROPEL® and SINUVA® sinus implants
and extend its geographic reach.
For additional information on the Company or the products
including risks and benefits please visit www.IntersectENT.com. For
more information about PROPEL® (mometasone furoate) sinus implants
and SINUVA® (mometasone furoate) sinus implant, please visit
www.PROPELopens.com and www.SINUVA.com.
Intersect ENT, PROPEL®, and SINUVA® are registered trademarks of
Intersect ENT, Inc in the US and other countries. VenSure, Cube and
VirtuEye have pending trademark applications.
About VenSure
The VenSure Nav Balloon Device is intended for use in
conjunction with the Cube Navigation System during sinus procedures
when surgical navigation or image-guided surgery may be necessary
to locate and move tissue, bone or cartilaginous tissue surrounding
the drainage pathways of frontal, maxillary, and sphenoid sinuses
to facilitate dilation of the sinus ostia. The Cube Navigation
System is indicated for any medical condition in which the use of
stereotactic surgery may be appropriate, and where reference to a
rigid anatomical structure can be identified relative to a CT or MR
based model of the anatomy. The navigation system must not be used
in patients with electronic devices in direct connection to the
brain or the nervous system such as implantable neurostimulators,
programmable CSF shunts or with monopolar pacemakers (older
designs, with lower resistance to interference) or ICD’s.
For full listing of indications, contraindications, warnings and
precautions and adverse effects, please see each product’s
Instructions For Use: www.VenSureandCube.com. Rx only.
PROPEL® Steroid Releasing Sinus Implants
The PROPEL family of products are the first and only
bioabsorbable steroid releasing sinus implants approved by the FDA
to maintain patency and locally deliver steroid to the sinus mucosa
in patients 18 years of age or older after sinus surgery.
Clinically proven to improve outcomes for chronic sinusitis
patients following sinus surgery, PROPEL sinus implants
mechanically prop open the sinuses and release mometasone furoate,
an advanced corticosteroid with anti‐inflammatory properties,
directly into the sinus lining then bioabsorb. PROPEL’s safety and
effectiveness for use in ethmoid sinuses is supported by Level 1‐A
clinical evidence from multiple clinical trials, which demonstrates
that PROPEL implants reduce inflammation and scarring after ethmoid
sinus surgery, thereby lessening the need for post‐operative oral
steroids and surgical interventions. PROPEL is indicated for the
ethmoid sinus; PROPEL Mini is indicated for the ethmoid and frontal
sinuses; and PROPEL Contour is indicated for the frontal and
maxillary sinuses.
SINUVA® Steroid Releasing Sinus Implant
SINUVA is a non‐surgical, corticosteroid‐eluting implant for the
treatment of nasal polyps in adult patients who have had ethmoid
sinus surgery. Its innovative 2‐in‐1 design incorporates a
self‐expanding, bioabsorbable implant structure along with the
targeted delivery of an anti‐inflammatory corticosteroid,
mometasone furoate. It provides localized drug delivery for up to
90 days directly to the site of disease. By nature of its design as
an office‐administered implant with direct delivery of
anti‐inflammatory medication, SINUVA minimizes the reliance on
patient compliance. SINUVA is clinically proven to reduce polyps
and the need for revision nasal surgery, as well as improve the
symptoms of nasal polyps, nasal obstruction, congestion and
decreased sense of smell.
IMPORTANT SAFETY INFORMATION FOR PROPEL SINUS
IMPLANTS
The PROPEL sinus implants are indicated to maintain patency and
locally deliver steroid to the sinus mucosa in patients 18 years of
age or older after sinus surgery: PROPEL for the ethmoid sinus,
PROPEL Mini for the ethmoid sinus/frontal sinus opening and PROPEL
Contour for the frontal/maxillary sinus ostia.
Contraindications include patients with intolerance to
mometasone furoate (MF) or hypersensitivity to bioabsorbable
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, displacement of the implant, possible
side effects of intranasal MF, sinusitis, epistaxis and infection.
For full prescribing information see IFU at
https://www.IntersectENT.com/techologies/. Rx only
SINUVA Indication & Important Safety Information
INDICATION
SINUVA Sinus Implant is a prescription steroid‐releasing
(mometasone furoate) implant indicated for the treatment of nasal
polyps in patients 18 years or older who have had ethmoid sinus
surgery.
IMPORTANT SAFETY INFORMATION
Who should not use SINUVA?
Do not use SINUVA if you are allergic to mometasone furoate or
any ingredients of the implant.
What should I tell my doctor before receiving SINUVA?
Before you receive SINUVA, tell your doctor about all medical
conditions you have including nasal/sinus problems (such as nasal
ulcers or trauma), eye problems (such as glaucoma or cataracts), or
any untreated fungal, bacterial, or viral infections.
What are the possible side effects of SINUVA?
Serious side effects of SINUVA can include:
- Local reactions including nosebleed and injury to nerves or
blood vessels in the nose/sinus.
- Serious allergic reactions have happened in patients using
mometasone furoate including rash, itching or swelling of the lips,
face, tongue, and throat, and breathing problems. Call your doctor
right away if you have any of these reactions.
- Weakened immune system that may increase your risk of
infections. Avoid contact with people who have contagious diseases
such as chickenpox or measles. Call your doctor right away if you
have been near someone with chickenpox or measles.
- Adrenal insufficiency is a condition in which the adrenal
glands do not make enough steroid hormones and can cause tiredness,
weakness, nausea and vomiting and low blood pressure.
Talk to your doctor if steroid effects such as Cushing Syndrome
and adrenal suppression appear.
The most common side effects of SINUVA in clinical studies were
bronchitis, cold symptoms, middle ear infections, headache,
lightheadedness or dizziness, asthma, and nosebleeds. The following
adverse reactions have been identified during post‐approval use of
the SINUVA sinus implant. These events include implant migration,
lack of efficacy, nasal pain, headache, and nosebleeds. Tell your
doctor if you have any side effects that bother you or don’t go
away.
Risks related with the insertion and removal of SINUVA are
similar to other endoscopic sinus procedures.
SINUVA is made from materials designed to soften over time and
may fall out of the nose on its own as polyps decrease or if you
sneeze or blow your nose forcefully. The implant will be removed 90
days after placement or earlier at your doctor’s discretion.
Contact your doctor immediately if you have any changes in
vision, 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.
You are encouraged to report negative side effects of
prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call
1‐800‐FDA‐1088. For important risk and use information, please see
Full Prescribing Information for SINUVA (www.SINUVA.com/PI)
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. We may, in some cases,
use terms such as “look forward,” “confident,” “promises,”
“predicts,” “believe,” “potential,” “anticipates,” “expects,”
“plans,” “intends,” “may,” “could,” “might,” “will,” “should,” or
other words that convey uncertainty of future events or outcomes to
identify these forward‐looking statements. 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 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 those related to the safety, efficacy
and patient and physician adoption of the company’s products and
therapies, the ability to obtain and maintain reimbursement codes
for its products, the company’s ability to procure and maintain
required regulatory approvals for our products, the company’s
ability to grow and expand its business, 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 (www.sec.gov). 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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20210726005244/en/
IR Contact: Randy Meier, 650‐641‐2105 Executive
Vice‐President & CFO ir@intersectENT.com
Media Contact: Erich Sandoval, 917‐497‐2867 Finn Partners
for Intersect ENT IntersectENT@finnpartners.com
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