Inspire Medical Systems, Inc. Announces FDA Approval of Two-Incision Implant Procedure

Download as PDF

Two-incision approach reduces average procedure time by approximately 20 percent

MINNEAPOLIS, Minnesota – March 15, 2021 – Inspire Medical Systems, Inc. (NYSE: INSP) (“Inspire”), a medical
technology company focused on the development and commercialization of innovative and minimally invasive
solutions for patients with obstructive sleep apnea, today announced receipt of U.S. Food and Drug Administration
(“FDA”) approval for an improved surgical implant procedure that eliminates one incision with a revised placement
of the pressure sensing lead. This newly approved procedure will reduce the average procedure time for Inspire
therapy by approximately 20 percent.

“Delivering consistent positive patient outcomes remains Inspire’s number one priority, and the receipt of FDA
approval for this two-incision procedure represents further evidence of our commitment to the continuous
improvement of Inspire therapy,” said Tim Herbert, President and Chief Executive Officer of Inspire Medical
Systems. “The new procedure places the sensor in the intercostal muscles directly behind the neurostimulator
pocket, thereby eliminating the need for a third incision lower on the chest and the additional requirement to tunnel
the sensing lead under the skin to the neurostimulator. A number of ENT surgeons highly experienced with the
current Inspire implant procedure initiated the development of this new surgical technique. With this approval, we
now intend to leverage our broad network of leading ENT’s to further improve the Inspire procedure and enhance
therapy outcomes.”

“Placement of the sensor in this revised location simplifies the overall procedure, while maintaining the strong safety
and efficacy profile of the therapy,” stated Dr. Eugene Chio, Director of Sleep Surgery Program at the Ohio State
University Wexner Medical Center. “In partnership with several of my colleagues, we conducted a clinical study
comparing this new two-incision approach to the initially approved three-incision procedure. The results showed no
difference in the safety or effectiveness of the therapy, but yielded a statistically significant decrease in surgical time
to just under 100 minutes on average, which is a 26-minute reduction from the three-incision procedure time.”
The elimination of the third incision, as well as the required lead tunneling procedure, is expected to minimize the
risk of breast and chest wall injury, reduce operative time, and decrease post-operative pain. Training for the two-
incision procedure will begin immediately.

About Inspire Medical Systems

Inspire is a medical technology company focused on the development and commercialization of innovative and
minimally invasive solutions for patients with obstructive sleep apnea. Inspire’s proprietary Inspire therapy is the first
and only FDA-approved neurostimulation technology that provides a safe and effective treatment for moderate to
severe obstructive sleep apnea.

For additional information about Inspire, please visit www.inspiresleep.com.

Forward Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation
Reform Act of 1995. All statements other than statements of historical facts are forward-looking statements,
including, without limitation, statements regarding the expected benefits of the two-incision implant procedure. In
some cases, you can identify forward-looking statements by terms such as ‘‘may,’’ ‘‘will,’’ ‘‘should,’’ ‘‘expect,’’ ‘‘plan,’’
‘‘anticipate,’’ ‘‘could,’’ “future,” “outlook,” “guidance,” ‘‘intend,’’ ‘‘target,’’ ‘‘project,’’ ‘‘contemplate,’’ ‘‘believe,’’
‘‘estimate,’’ ‘‘predict,’’ ‘‘potential,’’ ‘‘continue,’’ or the negative of these terms or other similar expressions, although
not all forward-looking statements contain these words.

These forward-looking statements are based on management’s current expectations and involve known and
unknown risks and uncertainties that may cause our actual results, performance or achievements to be materially
different from any future results, performance or achievements expressed or implied by the forward-looking
statements. Other important factors that could cause actual results, performance or achievements to differ
materially from those contemplated in this press release can be found under the captions “Risk Factors” and
“Management’s Discussion and Analysis of Financial Condition and Results of Operations“ in our Annual Report on
Form 10-K for the fiscal year ended December 31, 2020 filed with the SEC, and as such factors may be updated
from time to time in our other filings with the SEC, which are accessible on the SEC’s website at www.sec.gov and
the Investors page of our website at www.inspiresleep.com. These and other important factors could cause actual
results to differ materially from those indicated by the forward-looking statements made in this press release. Any
such forward-looking statements represent management’s estimates as of the date of this press release. While we
may elect to update such forward-looking statements at some point in the future, unless required by applicable law,
we disclaim any obligation to do so, even if subsequent events cause our views to change. Thus, one should not
assume that our silence over time means that actual events are bearing out as expressed or implied in such
forward-looking statements. These forward-looking statements should not be relied upon as representing our views
as of any date subsequent to the date of this press release.

Investor & Media Contact:
Bob Yedid
LifeSci Advisors
646-597-6989
[email protected]