MENLO PARK, Calif.--(BUSINESS WIRE)--Nov. 6, 2017--
Intersect ENT, Inc. (NASDAQ: XENT), a company dedicated to improving the
quality of life for patients with ear, nose and throat conditions, today
announced that the U.S. Food and Drug Administration (FDA) has performed
a Pre-Approval Inspection (PAI) of the company’s Menlo Park facility
related to the company’s New Drug Application (NDA) for the
investigational SINUVA™ Steroid Releasing Sinus Implant. At the
conclusion of the inspection, the FDA issued a Form 483 with four
“We appreciate the FDA’s close review and are committed to fully
addressing the agency’s observations within the 15-day response
timeframe,” said Lisa Earnhardt, president and CEO, Intersect ENT. “We
are excited to have completed another important milestone as we continue
to advance SINUVA through the NDA process.”
The FDA has set a PDUFA target action date of January 7, 2018. The
company does not expect these observations to impact the timeline for a
decision from the FDA on approval of the SINUVA implant.
About Intersect ENT®
Intersect ENT is dedicated to transforming the landscape of care for
patients with ear, nose and throat conditions. The company’s PROPEL
family of dissolvable steroid releasing implants are clinically proven
to improve outcomes for chronic sinusitis patients following sinus
surgery. 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 www.IntersectENT.com.
Intersect ENT® and PROPEL® are registered
trademarks and SINUVA is a trademark of Intersect ENT, Inc.
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. These forward-looking statements
include, but are not limited to, statements about proceeding with the
company’s New Drug Application (NDA) for the investigational SINUVA
Steroid Releasing Sinus Implant, fully addressing the FDA’s observations
within the 15-day response timeframe, expectations regarding the timing
and approval of the NDA, and the expansion of adoption of our sinus
implants by clinical practitioners. 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 the company’s ability
to successfully address FDA identified issues on a timely basis and the
ability to receive FDA approval of the company’s NDA for SINUVA on a
timely basis 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, 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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Source: Intersect ENT, Inc.
For Intersect ENT, Inc.
Intersect ENT, Inc.
Jeri Hilleman, 650-641-2105