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

Rhea-AI Summary

Inspire Medical Systems has received FDA approval for a new two-incision surgical implant procedure for its Inspire therapy, enhancing treatment for obstructive sleep apnea. This method reduces average procedure time by approximately 20%, from around 126 minutes to under 100 minutes, while maintaining safety and efficacy. The procedure simplifies the implant process by eliminating a third incision and lead tunneling, potentially decreasing post-operative pain and risks. Immediate training for surgeons will commence, indicating a swift integration into practice.

Positive

• FDA approval for a new two-incision procedure enhances treatment efficiency.
• Reduces average surgical time by approximately 20%, improving patient experience.
• Elimination of a third incision minimizes the risk of complications.

Negative

• None.

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

MINNEAPOLIS, March 15, 2021 (GLOBE NEWSWIRE) -- 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. Eugine 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
Bob@LifeSciAdvisors.com

FAQ

What recent FDA approval did Inspire Medical Systems receive?

Inspire Medical Systems received FDA approval for a new two-incision surgical implant procedure for its Inspire therapy.

How much does the new procedure reduce surgical time?

The new two-incision procedure reduces the average surgical time by approximately 20%, bringing it to under 100 minutes.

What are the benefits of the two-incision approach?

The two-incision approach simplifies the procedure, reduces post-operative pain, and minimizes the risk of breast and chest wall injury.

Who developed the new surgical technique for Inspire therapy?

The new surgical technique was developed by experienced ENT surgeons in collaboration with Inspire Medical Systems.