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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): October 10, 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 October 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 99.2 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 99.2 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						Press release of Inspire Medical Systems, Inc., dated October 10, 2025.

99.2						Inspire Medical Systems, Inc. Presentation, October 10, 2025.

104						Cover Page Interactive Data File - the cover page XBRL tags are embedded within the Inline XBRL document.

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:	October 10, 2025	By:	/s/ Bryan K. Phillips
			Bryan K. Phillips
			Sr. Vice President, General Counsel and Secretary

EX-99.1 2 insp2025-10x10pressrelease.htm EX-99.1 Document

Exhibit 99.1

Inspire Medical Systems, Inc. Publishes Inspire V Data at

ISSS/AAO-HNS Meetings

MINNEAPOLIS, MN – October 10, 2025 – Inspire Medical Systems, Inc. (NYSE: INSP) (Inspire), a medical technology company focused on the development and commercialization of innovative, minimally invasive solutions for patients with obstructive sleep apnea (OSA), today published Inspire V clinical outcomes data from its Singapore clinical study as well as the Company’s limited market release in the United States including single site experience at two leading centers. These data will be presented at the American Otolaryngology-Head and Neck Surgery (AAO-HNS) and International Surgical Sleep Society (ISSS) meetings being conducted in Indianapolis between October 9 and October 14.

“We are incredibly excited to publish first-time clinical evidence on the Inspire V system. The design of the Inspire V system captures experience built over 25 years with Inspire therapy including over 100,000 patients implanted, and we are proud to provide the initial data from this advanced platform,” stated Tim Herbert, Chairman and Chief Executive Officer of Inspire Medical Systems. “Our initial experience raises the bar for what a successful therapy needs to achieve for both safety and efficacy. The data show that the Inspire V system provides very high and consistent patient adherence of over six hours per night which a patient’s physician can monitor with our SleepSync™ patient management platform.”

“The data presented at the ISSS/AAO-HNS meetings in Indianapolis this weekend demonstrate the benefits that Inspire therapy brings to the many patients struggling with OSA,” stated Paul Hoff, M.D., M.S., Inspire Vice President, Senior Medical Director. “The strong safety, superior respiratory sensing, and increased adherence, combined with a 20% reduction in surgical times and features designed to enhance patient comfort, demonstrate a truly significant advancement with the Inspire V system.”

The Inspire V system trial conducted in Singapore at two centers was the initial experience with the new device. The study included 44 patients who received the Inspire V system and are being followed for six months post implant. The surgeons demonstrated a 20% reduction in surgical times as compared to their Inspire IV case times and 100% of the procedures were completed successfully. A key feature of the Inspire V system is that the respiratory sensing is internal to the neurostimulator, eliminating the need for the pressure sensing lead required with prior generations. The Inspire design provides for closed-loop stimulation to optimize therapy outcomes, and the primary endpoint of this Inspire V study was to measure the inspiratory phase overlap percentage (IPOP), which measures how well inspiration is covered by stimulation. The results showed the Inspire V device to be superior to the Inspire IV device (Inspire V IPOP of 87.1% vs 79.4% for Inspire IV with a non-inferiority margin of 4.6%). Important secondary measures included patient adherence to therapy of all 44 patients averaged 5.5±1.7 hours/night at a mean of 246 days post-implant, as well as the median reduction in the Apnea Hypopnea Index (AHI), as measured by overnight polysomnography (PSG), to be 34.4 events/hour at baseline to 8.3 events/hour at month six for the 37 patients who have completed this clinical visit to date. The safety profile was equally strong with only two patients requiring post-operative antibiotics for wound care that resolved within two weeks following the procedure. Once the remaining patients complete their six-month visit, these data will be submitted for publication.

In the United States, the Company conducted a limited market release evaluation of the Inspire V system at 10 leading centers with 101 patients. All device procedures were completed successfully with no serious adverse events, and all patients continue to use their Inspire therapy. At the 60-day check, all 101 patients were using their therapy with an average stimulation amplitude of 1.7 volts and an average usage of 6.8 hours/night.

At the subsequent sleep study, data on the first 34 patients demonstrated a median reduction in AHI from 30 to 4.5 events/hours, noting that these are therapeutic values. With these 34 patients, the average amplitude remained steady at 1.7 volts and therapy adherence remained consistent at 6.7 hours/night.

The limited market release also provided single-site results from two of the centers. Dr. Phil Huyett from the Massachusetts Eye and Ear Infirmary in Boston reported that for his first nine patients, all procedures were completed successfully with an average surgical implant time of 34.5 minutes for a standard Inspire placement, and slightly longer for revised techniques. Dr. Nic Beckmann at Colorado ENT and Allergy in Colorado Springs reported an increase in implant volume with Inspire V due to the shorter procedure times averaging 12 implants per surgery day compared to an average of 9 cases per surgery day with Inspire IV. Dr. Beckmann also discussed the current reimbursement levels as well as the proposed 2026 Medicare reimbursement for the Inspire V CPT code.

Sessions of Interest

Friday, October 10 7:00 a.m. – 8:00 a.m. ET: Next Generation Hypoglossal Nerve Stimulation for the Treatment of Obstructive Sleep Apnea: Results of the Inspire V Study (Ryan Soose, M.D., Tom Kaffenberger, M.D., Nic Beckmann, D.O., F.A.A.O.A., Phil Huyett, M.D.)

Sunday, October 12 2:30 p.m. – 3:30 p.m. ET: Next Generation Hypoglossal Nerve Stimulation for the Treatment of Obstructive Sleep Apnea: Results of the Inspire V Study (Nic Beckmann, D.O., F.A.A.O.A., Maria Suurna, M.D., Mark Aloia, Ph.D., Michael Coleman)

About Inspire Medical Systems

Inspire is a medical technology company focused on the development and commercialization of innovative, minimally invasive solutions for patients with obstructive sleep apnea. Inspire’s proprietary Inspire therapy is the first and only FDA, EU MDR, and PDMA-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.

About AAO-HNS

The American Academy of Otolaryngology–Head and Neck Surgery (AAO-HNS) is one of the world’s largest organizations representing specialists who treat the ears, nose, throat, and related structures of the head and neck. Otolaryngologist–head and neck surgeons diagnose and treat medical disorders that are among the most common affecting patients of all ages in the United States and around the world. Those medical conditions include chronic ear disease, hearing and balance disorders, hearing loss, sinusitis, snoring and sleep apnea, allergies, swallowing disorders, nosebleeds, hoarseness, dizziness, and tumors of the head and neck as well as aesthetic and reconstructive surgery and intricate micro-surgical procedures of the head and neck. The Academy has approximately 13,000 members.

About ISSS

The International Surgical Sleep Society (ISSS) is dedicated to improving equitable care for all patients with sleep disordered breathing through collaboration, research, education, advocacy and innovation and has over 600 global members.

Forward Looking Statements

This press release may contain 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, those relating to the strength and potential benefit of the Inspire V system clinical data. Forward-looking statements involve inherent risks and uncertainties, and important factors could cause actual results to differ materially from those anticipated, including the factors identified under “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, 2024, as updated in our Quarterly Report on Form 10-Q for the quarter ended June 30, 2025, 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. Forward-looking statements speak only as of the date they are made, and we undertake no obligation to update them in light of new information or future events.

Investor and Media Contact

Ezgi Yagci

Vice President, Investor Relations

ezgiyagci@inspiresleep.com

617-549-2443

EX-99.2 3 a2025isss-aaoproductthea.htm EX-99.2 a2025isss-aaoproductthea

© Inspire Medical Systems, Inc. All Rights Reserved © 2025 Inspire Medical Systems, Inc. All Rights Reserved Inspire Product Theater Inspire V Real-World Experience One Less Step. Same Proven Results Presents

Inspire Product Theater – Faculty Ryan Soose, MD University of Pittsburgh School of Medicine Pittsburgh, PA Tom Kaffenberger, MD University of Pittsburgh School of Medicine Pittsburgh, PA C-00156.1 Maria Suurna, MD University of Miami Miami, FL Colorado ENT & Allergy Colorado Springs, CO Mass Eye & Ear Boston, MA Nic Beckmann, DO Phil Huyett, MD

Inspire Product Theater Agenda C-00156.1 • Early-User Implant Experience • Preliminary Patient Outcomes Data • Q&A Discussion with Expert Panel

Next Generation Hypoglossal Nerve Stimulation for the Treatment of Obstructive Sleep Apnea Results of the Inspire V Study Singapore General Hospital National University Hospital

Inspire Therapy • A treatment for OSA patients who are unable to use CPAP In a 60-90 minute outpatient procedure Using the Inspire Remote Using the SleepSyncTM patient management platform 5 Surgically Placed Patient Controlled Managed by SleepSyncTM

Inspire V System 6 The Fifth Generation of a proven therapy for OSA is designed for a(n): • Simplified procedure • Enhanced patient comfort • More efficient patient management

7 Simplified Procedure One Less Step With a new integrated respiratory sensor, Inspire V eliminates the need to place a separate sensing lead, simplifying the procedure. 2 components 2 incisions 3 components 2 incisions3 components 3 incisions Inspire V Inspire IV 2- incision approach Initial Inspire IV

Precision Stimulation Timing Stimulation delivered when the airway is most vulnerable to collapse during the inspiratory phase inspiration inspiration airflow stimulation Accelerometer detects breathing

9 Tailored Therapy Options Designed for Patient Comfort Program patient therapy levels at half or quarter step sizes with Inspire V when needed Stimulation Step Sizes Gently initiate therapy, without disturbing sleep with Inspire V when needed Ramp Option 5, 10, 15 minute options

Inspire V Study Design • Prospective, multicenter cohort study • Designed to confirm effectiveness of Inspire V System • Two investigational centers (Singapore) • Singapore General Hospital (Prof. Toh Song Tar; Dr. Shaun Loh; Dr. Adele Ng) • National University Hospital (Dr. Crystal Cheong) • 44 Subjects • Patient Population • Subjects 21 years or age or older with moderate to severe OSA who meet the Inspire V UAS system indications for use and are willing to participate in the clinical trial

Study Objectives Primary Endpoint: Non-inferiority of Inspire V vs Inspire IV technology as measured by IPOP (Inspiratory Phase Overlap Percent) during in-lab polysomnography. Secondary Endpoints: • Change in Apnea – Hypopnea Index (AHI) at 6 Months post-activation • Mean Epworth Sleepiness Scale (ESS) is less than 10 at 6 Months post- activation Ancillary Information: • Therapy Adherence (hours/day) at 6 months post-activation • Procedure and Device/therapy Adverse Events • IPOP at 6 months post-activation • Mean Function Outcomes of Sleep Questionnaire (FOSQ) at 6 months post- activation

Clinical Study Design Baseline <90 days pre- implant Implant Day 0 Activation Clinic Visit 30 ± 14 days post-implant Activation Sleep Study ~2-3 months post activation 3 Month FU 90 ± 30 days post-activation 6 Month FU 180 ± 30 days post-activation PSG (no titration) for IPOP Analysis (1º endpoint) PSG (Titration) PSG (no titration) 2º endpoint

Study Results to Date Variable Subjects (n=44) Male 39 (88.6%) Age (years)* 55.7 ± 10.2 (35-73) Race Chinese 39 (88.6%) Indian 4 (9.1%) Malay 1 (2.3%) BMI (kg/m2)* 26.9 ± 2.8 (20.4 – 31.6) AHI (events/hr)* 37.0 ± 15.2 (15.2 – 65.0) ESS* 10.9 ± 5.9 (0-23) • Prior OSA treatment (other than surgery): 86.4% • Prior airway surgeries: 40.9% • Cardiovascular comorbidity: 63.6% • Hypertension: 59.1% • Other Sleep comorbidities: 11.4% Demographics Medical History Study Status Enrollments N=54 Screen Failures N=10 Implanted Patients N=44 Primary Endpoint N=44 6 Month Study End N=39* Early Exit: 1 Final Visit Scheduled: 4 *Mean±SD (range) *37 6M PSGs available (6 sleep studies pending)

Study Results to Date Procedure Details • 100% successful Implants (n=44) • 20.4% reduction in implant time (vs Inspire IV) • No serious intraoperative adverse events

Primary Endpoint Inspiratory Phase Overlap Percent (IPOP)* Sensing performance is measured using IPOP during in-lab PSG IPOP measures how well inspiration is covered by stimulation. *Based on the mean inspiratory overlap derived from Inspire IV analysis and a non-inferiority margin of 4.59, the following hypothesis will be tested: H0: 𝑥𝑥 ̅_𝐼𝐼𝑂𝑂<74.8%, Ha: 𝑥𝑥 ̅_𝐼𝐼𝑂𝑂≥74.8%, where 𝑥𝑥 ̅_𝐼𝐼𝑂𝑂 is the mean inspiratory overlap of Inspire V. (example) 100% IPOP100% IPOP 100% IPOP

Inspire V Sensing Performance Primary Endpoint: Inspiratory Phase Overlap Percent (IPOP) Results** Inspire V IPOP 87.1% Confidence Interval: 85.5%-88.8% Inspire IV* IPOP 79.4% Non-inferiority Margin: 4.6% Sensing with Inspire V is SUPERIOR to Inspire IV *Inclusive of previous Inspire generations (data collected during the Wear Study) **Inspire V was found to be non-inferior to Inspire IV (retrospective control from Wear Study); superiority was subsequently tested No device setting changes were made during the Inspire V IPOP measurement PSGs

Therapy Adherence and Device Parameters Comfort Settings Utilization % patient use* N=44 Small Step Size 54.5% Start Impulse 31.8% Ramp 22.7% Objective Therapy Adherence 5.5 ± 1.7 hours / night (n=44 at a mean of 246 days post-implant) *at most recently reported visit

Interim* 6 Month Results: Effectiveness *Total of n=43 patients projected at study completion (6 sleep studies pending); early exit: n=1 **6M PSGs were conducted at 1 therapeutic amplitude throughout the entire night; no changes were made to device settings 34.4 8.3 0 5 10 15 20 25 30 35 40 Baseline (n=44) 6 Month (n=37) M ed ia n AH I ( ev en ts /h r) Apnea-Hypopnea Index 11 7 0 2 4 6 8 10 12 Baseline (n=44) 6 Month (n=41) M ed ia n ES S Epworth Sleepiness Scale All-night PSGs**

Interim 6 Month Results: Safety • No revisions/explants • Serious Adverse Events • Wound dehiscence (resolved): 2 • Patients provided antibiotics and event resolved within two weeks post-op • Non-serious Adverse Events • Neuropraxia (resolved): 1 • Right marginal mandibular weakness (resolved): 1 • Difficulty speaking (resolved): 1 • Hypotension during implant (resolved): 1 • Hypertrophic scar: 3

• Simplified implant procedure • 20.4% reduction in implant time • Elimination of respiratory sense lead • Accelerometer technology • Inspire V sensing is superior to previous Inspire generations • Strong objective therapy adherence at 5.5 hrs/night • Clinically significant reductions in OSA severity • Clinically significant improvements in key quality of life measures Inspire V Clinical Study Conclusions

© Inspire Medical Systems, Inc. All Rights Reserved Inspire V Limited Market Release with 101 patients at 11 U.S. Centers Tracking data to date with 34 patients with AHI data 60 day check in 101/101 Activation 101/101 30 day check in 101/101 IMPLANT 101/101 Sleep Study 34/101 Avg Strat Amp 1.1v Patients to date Avg. Amp. 1.7v Avg Adherence 6.7 Hours 85% nights used Patients utilizing new features Small Step Size – 20% Start Impulse – 17% Ramp – 20% Avg Amp. 1.4v Avg Adherence 7.2 hours Avg Amp. 1.7v Avg Adherence 6.8 hours • 100% Successful implants • No serious adverse events • 5 non-serious adverse events • Neuropraxia – resolved before activation(2) • Mild marginal mandibular weakness(1) • Mild ear pain(1) • Incision swelling/tenderness(1)

Inspire V Experience at MEE Phil Huyett, MD Director of Sleep Surgery Massachusetts Eye and Ear Assistant Professor Harvard Medical School

Disclosures • Inspire medical systems – Research support – Educational consultant • Nyxoah – Research support • Part of limited release in February • Still having discussions with insurance!

Inspire V • Faster/less general anesthesia time • No more respiratory sensor revisions • ?reduced PTX % • ?faster recovery • ?less post op pain

HGNS Model Case Gender Age (years) BMI (kg/m2) Surgical time (min) 1st incision to cuff placement (min) V LA MEE647 F 52 27.5 41 15 V LA MEE650 M 51 21.9 38 14 V LA MEE660 M 55 31.3 37 11 V LA mean 52.7 26.9 38.7 13.3 V MEE646 M 59 26.5 38 15 V MEE672 M 54 30.9 36 16 V MEE670 M 53 22.9 41 17 V MEE653 M 59 32.8 28 10 V MEE656 M 46 28.6 30 10 V MEE658 M 57 31.8 34 12 V mean 54.7 28.9 34.5 13.3 IV MEE648 M 59 21.8 45 18 IV MEE651 M 68 33.5 48 27 IV MEE643 M 61 32.5 67 24 IV MEE644 M 76 29.1 40 17 IV MEE645 F 73 32.1 40 14 IV MEE649 M 71 26.2 41 19 IV MEE673 M 40 28 42 20 IV MEE674 M 38 26.5 43 25 IV MEE652 M 52 30.6 48 22 IV MEE671 F 78 21.8 41 15 IV MEE654 M 37 24.2 45 27 IV mean 59.4 27.8 45.5 20.7 = 24.2% less time Standard IV Standard V

Inspire V LA surgical pearls • IPG replacement probably more challenging • Doesn’t add significant time • Be sure to parachute IPG medially • Alternative to other HGNS systems for patients who don’t want anterior chest incision

Initial Outcomes Inspire V Nic Beckmann, DO Colorado ENT and Allergy Colorado Springs, CO

Inspire V SYSTEM The Fifth Generation of a proven therapy for OSA is designed for a: • Simplified procedure • Enhanced patient comfort • More efficient patient management

• From a 3 component/incision procedure -> 2 component procedure Consistent Innovation Leads to Simplified Procedure 2 components 2 incisions 3 components 2 incisions 3 components 3 incisions One Less Step with Inspire V

Deliver Stimulation At The Right Time With A Synchronized Stimulation Algorithm* * Accelerometer Control Performs Comparable to Pressure Sensor Control of Hypoglossal Nerve Stimulation Timing Asim Roy, MD1, Karl Doghramji, MD2, Shalini Manchanda, MD3, Israel Byrd, PhD4, James Manne-Nicholas4, Christopher K Thorp, MS4, Dave Dieken4, Jason Cornelius, MD5, SLEEP2024 Accelerometer

34 Tailored Therapy Options Designed for Patient Comfort Program patient therapy levels at half or quarter step sizes with Inspire V when needed Stimulation Step Sizes Gently initiate therapy, without disturbing sleep with Inspire V when needed Ramp Option 5, 10, 15 minute options

CO Reimbursement Note: In July 2025, the Center for Medicare Services (CMS) proposed the Hospital and Physician Medicare payment starting January 1, 2026 will change (pending final approval in November 2025): • Implant (hospital) Medicare reimbursement will increase from $30,473.59 to $31,751.65 • Inspire IV physician payment (64582) will decrease from $815.78 to $723.56 • Inspire V physician payment (64568) will increase from $593.56 to $660.33

• Flip rooms with surgical assist – Multiple stacked cases on OR days • Prior to V averaging 9 cases • Post V averaging 12 cases – 8 inspires with parotid and tonsils – 3 tonsils/adenoids, tubes, 3 septo/turbs combined with 6 implants – Intraoperative time saving allows for better utilization of block time Increasing Capacity

Patient Volume

Year over Year Patients Treated

• Questions Thank you!