8-K

SECURITIES AND EXCHANGE

Washington, D.C. 20549

_________________________

FORM 8-K

_________________________

CURRENT REPORT

Pursuant to Section 13 or 15(d) of

the Securities Exchange Act of 1934

Date of report (Date of earliest event reported): June 13, 2025

_________________________

INSPIRE MEDICAL SYSTEMS, INC.

(Exact name of registrant as specified in its charter)

_________________________

Delaware	001-38468	26-1377674
(State or other jurisdiction of incorporation)	(Commission File Number)	(I.R.S. Employer Identification No.)

5500 Wayzata Blvd., Suite 1600

Golden Valley, Minnesota 55416

(Address of principal executive offices) (Zip Code)

(844) 672-4357

(Registrant’s telephone number, including area code)

N/A

(Former name or former address, if changed since last report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

☐    Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐    Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐     Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐     Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each class	Trading Symbol(s)	Name of each exchange on which registered
Common Stock, $0.001 par value per share	INSP	New York Stock Exchange

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company     ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition

period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Item 7.01. Regulation FD Disclosure.

In June 2025, the Company will be participating in various meetings with investors and analysts, and a copy of the Company’s presentation materials being used at these meetings is furnished as Exhibit 99.1 hereto and is incorporated herein by reference. These presentation materials are also available on the Investor Relations page of the Company’s website at https://investors.inspiresleep.com.

The information in Item 7.01 of this Current Report on Form 8-K and the presentation attached as Exhibit 99.1 shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that Section, nor shall it be deemed to be incorporated by reference into any filing of the Company under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such filing.

Item 9.01.    Financial Statements and Exhibits.

(d) Exhibits

Exhibit No.	Description
99.1	Inspire Medical Systems, Inc. Presentation dated June 13, 2025.
104	Cover Page Interactive Data File - the cover page XBRL tags are embedded within the Inline XBRL document.

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SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

		INSPIRE MEDICAL SYSTEMS, INC.
Date:	June 13, 2025	By:	/s/ Richard J. Buchholz
			Richard J. Buchholz
			Chief Financial Officer

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EX-99.1

© 2024 Inspire Medical Systems, Inc. All Rights Reserved Inspire Medical Systems, Inc. Wells Fargo 2025 MedTech Innovation Spotlight June 13, 2025 NYSE: INSP

Disclaimer

Current Sensor Inspire V Sensor Performance Therapy Evolution Built-in • Multiple electrodes capability • Enables new stim targets and sensing features Flexible Software Platform • Downloadable features for clinical studies and field upgrades • Future features could include posture-responsive therapy, auto start/pause, AHI detection State of the Art Technology • Allows stim of multiple targets • Multiple Sensing Modes Proven Cybersecurity Consistent Long Battery Life of 11 years on average SleepSync Connectivity • Support for future remote programming • Remote software updates for all components Inspire V: 20% reduced implant time, improved therapy performance, fewer revisions, & future innovation

Inspire V Accelerometer Performance Data Presented SLEEP 2024

Inspire V Singapore Data Presented SLEEP 2025

Efficacy of Inspire in Supine AHI Presented SLEEP 2025

Closed-Loop System: Inspire V Sensing *Embedded video in presentation – please see attached transcript*

Inspire V Full launch May 2025

Inspire Medical Systems, Inc. We are a medical technology company committed to enhancing patient lives through sleep innovation “Put the pat ient f i r s t and you wi l l never lose your way.” Demonstrate Operational Excellence Drive Therapy Adoption Strengthen Organizational Culture Focused on Outcomes. Fueled by Innovation. Grounded in Integrity. Committed to Compliance. Leading with Respect. Positively Persistent.

No mask. No hose. Just sleep. www.inspiresleep.com ®

Closed-Loop System: Inspire V Sensing (Video Transcript, page 1 of 4) :07 With the release of Inspire 5, one of the most exciting new features is the change in how Inspires respiration sensing technology works. 0:16 With Inspire 4, respiration was detected using our proprietary pressure sensor Lead. 0:22 Inspire 5 has incorporated all our collective knowledge and experience about how to measure a patient's breathing pattern directly inside the generator using an accelerometer. 0:32 With this innovation, there is one less lead implanted in the body and the implant procedure is simplified. 0:39 Sensing a patient's breathing pattern has always been critical to ensuring effective treatment with upper airway stimulation. 0:46 You may be wondering, why is respiration sensing needed at all? 0:50 Why not just leave stimulation on permanently? 0:53 Unfortunately, leaving stimulation on for the whole night leads to tongue muscle fatigue. 0:59 Imagine trying to hold a 5 LB weight in your hand indefinitely. 1:03 You will be putting that weight down faster than you think. 1:06 The tongue muscle is no different. 1:08 It needs time to rest.

1:11 This is why Inspire is designed to turn on and off with the patient's breathing cycle. 1:16 We have already established the tongue needs to rest after stimulation. 1:21 Since we have to turn stimulation on and off to rest the tongue, does it then matter when stimulation is actually on? 1:28 Why can't we just run stimulation in a pacemaker like mode without needing to detect respiration? 1:35 Obstructive sleep apnea is a difficult problem to solve. 1:39 A patient's airway is dynamic and once it closes, it can be very difficult to reopen it. 1:44 Indeed, the collapse cascade for obstructive sleep apnea begins during the late exhalation phase of breathing and continues through the inhalation phase. 1:53 This is the most vulnerable time for the airway and is the time when it is most prone to collapse. 1:59 It stands to reason that we should target that. 2:02 In the breathing cycle. 2:04 In 1996, Doctor Alan Schwartz and his team at Johns Hopkins proved that rhythmic stimulation targeting the inhalation phase of breathing could stabilize OSA. 2:15 Their research was verified by INSPIRE during the STAR trial, but we also learned that turning on stimulation during the late exhalation phase was critical for success. Closed-Loop System: Inspire V Sensing (Video Transcript, page 2 of 4)

2:25 It is important to deliver stimulation before the collapse cascade of OSA begins. 2:30 Inspires sensing algorithm is designed to provide stimulation during this vulnerable period of breathing and relax the tongue during the beginning of the following exhalation cycle. 2:42 As such, INSPIRE delivers stimulation during most of inhalation and some of exhalation for most breaths. 2:49 This allows some flexibility for the algorithm to adapt to different sleep states, body positions, and breathing patterns. 2:56 Here is a patient example from a sleep study who is having frequent obstructive events because stimulation was not well synchronized. 3:04 After some simple programming adjustments to the sensing settings, this patient's obstructive events resolved. 3:11 Fortunately, the default sensing settings work for the majority of patients and it is very rare that we need to change these settings from their defaults. 3:20 Here is another example. 3:21 Look how the inspiratory flow is limited because stimulation is not capturing inhalation. 3:27 You can see how much the airflow is improved after stimulation is moved to the correct portion of the breathing cycle. 3:34 There have also been several peer reviewed publications that have studied what happens when you do not have well timed sensing. 3:42 In 2019, Doctor Stefan and colleagues examine the effects of poor stimulation timing in three separate patients. Closed-Loop System: Inspire V Sensing (Video Transcript, page 3 of 4)

3:48 By inverting the sensing signal and reducing the sensitivity to breathing cycle detection, they observed worsening in ODIAHI and especially supine AHI. 4:01 These outcomes return to their treatment levels when the settings were corrected in future sleep studies, the authors concluded correct respiratory signaling supports controlling OSA. 4:12 In summary, constant stimulation can cause muscle fatigue. 4:17 Timing of stimulation is critical to target the most vulnerable portion of the breathing cycle to prevent airway collapse. 4:24 INSPIRE 5 uses an accelerometer inside the generator to monitor the patient's breathing cycle. 4:30 Inspire is committed to providing the most cutting-edge technology for our providers and patients. 4:36 Inspire 5's new accelerometer-based sensing not only makes the implant easier, but it continues to deliver stimulation at the right time to ensure the best possible patient outcomes. Closed-Loop System: Inspire V Sensing (Video Transcript, page 4 of 4)

XML

Document and Entity Information	Jun. 13, 2025
Cover [Abstract]
Entity Registrant Name	INSPIRE MEDICAL SYSTEMS, INC.
Entity Central Index Key	0001609550
Document Type	8-K
Amendment Flag	false
Document Period End Date	Jun. 13, 2025
Entity Incorporation, State or Country Code	DE
Entity File Number	001-38468
Entity Tax Identification Number	26-1377674
Entity Address, Address Line One	5500 Wayzata Blvd.
Entity Address, Address Line Two	Suite 1600
Entity Address, City or Town	Golden Valley
Entity Address, State or Province	MN
Entity Address, Postal Zip Code	55416
City Area Code	844
Local Phone Number	672-4357
Written Communications	false
Soliciting Material	false
Pre-commencement Tender Offer	false
Pre-commencement Issuer Tender Offer	false
Title of 12(b) Security	Common Stock, $0.001 par value per share
Trading Symbol	INSP
Security Exchange Name	NYSE
Entity Emerging Growth Company	false