Intersect ENT Announces Launch of the New Straight Delivery System Packaged with the PROPEL® Mini Sinus Implant
11 Februar 2021 - 1:00PM
Business Wire
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. availability of the new
Straight Delivery System (“SDS”) packaged with the company’s
PROPEL® Mini (mometasone furoate) Sinus Implant. The combined
packaging of the SDS with PROPEL Mini received premarket approval
(“PMA”) by the U.S. Food and Drug Administration (“FDA”) which
follows PMA for the Straight Delivery System received in July
2020.
The Straight Delivery System is an extension of the PROPEL
family of implants. It is specifically engineered for precise,
consistent and easy delivery of the PROPEL Mini implant into the
ethmoid sinus for maximum tissue apposition. The original curved
delivery system will continue to be available with the PROPEL Mini
sinus implant, offering physicians a suite of options when using
PROPEL Mini following sinus surgery.
“Intersect ENT is pleased to provide our physicians with a
complete package of PROPEL Mini and the Straight Delivery System,”
commented Thomas A. West, President and CEO of Intersect ENT. “We
are dedicated to responding to our customers’ feedback and
providing them with the best combination of products to advance
care for chronic sinusitis patients in various centers of
care.”
“The combination of the PROPEL Mini and the Straight Delivery
System in one package is reflective of Intersect ENT’s ongoing
commitment to supporting the ENT community,” states Roheen
Raithatha, MD, practicing Rhinologist at ENT and Allergy Associates
and faculty member at Mt Sinai Hospital in New York. “I look
forward to utilizing this newly bundled implant and delivery system
during my FESS procedures.”
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, 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.
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 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
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.
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version on businesswire.com: https://www.businesswire.com/news/home/20210211005150/en/
IR: Randy Meier, 650-641-2105 Executive Vice-President
& CFO ir@intersectENT.com
Media: Erich Sandoval, 917-497-2867 Finn Partners for
Intersect ENT IntersectENT@finnpartners.com
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