MENLO PARK, Calif.--(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.
