Inspire Medical Systems, Inc. · NYSE:INSP
Inspire Medical Systems — Inspire Product Theater (AAO-HNSF 2025)
39 slides from Inspire Medical Systems's conference presentation, Oct 10, 2025
Slide 1: Inspire Product Theater: Inspire V Real-World Experience
© 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
Slide 2: Inspire Product Theater – Faculty
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 &
Slide 3: Inspire Product Theater Agenda
Inspire Product Theater Agenda C-00156.1 • Early-User Implant Experience • Preliminary Patient Outcomes Data • Q&A Discussion with Expert Panel
Slide 4: Next Generation Hypoglossal Nerve Stimulation for OSA: Results of the Inspire V Study
Next Generation Hypoglossal Nerve Stimulation for the Treatment of Obstructive Sleep Apnea Results of the Inspire V Study Singapore General Hospital National University Hospital
Slide 5: Inspire Therapy
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
Slide 6: Inspire V System
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
Slide 7: Simplified Procedure: One Less Step
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 Inspir
Slide 8: Precision Stimulation Timing
Precision Stimulation Timing Stimulation delivered when the airway is most vulnerable to collapse during the inspiratory phase inspiration inspiration airflow stimulation Accelerometer detects breathing
Slide 9: Tailored Therapy Options Designed for Patient Comfort
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
Slide 10: Inspire V Study Design
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 Sub
Slide 11: Study Objectives
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 (E
Slide 12: Clinical Study Design
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)
Slide 13: Study Results to Date
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): 8
Slide 14: Study Results to Date: Procedure Details
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
Slide 15: Primary Endpoint: Inspiratory Phase Overlap Percent (IPOP)
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 foll
Slide 16: Inspire V Sensing Performance
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 (da
Slide 17: Therapy Adherence and Device Parameters
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
Slide 18: Interim Month Results: Effectiveness
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
Slide 19: Interim Month Results: Safety
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 •
Slide 20: Inspire V Clinical Study Conclusions
• 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 severit
Slide 21: Inspire V Limited Market Release Data as of October 3, 2025
© 2024 Inspire Medical Systems, Inc. All Rights Reserved Inspire V Limited Market Release Data as of October 3, 2025
Slide 22: Inspire V Limited Market Release
© 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 Pati
Slide 23: Thank You
Thank You. © 2024 Inspire Medical Systems, Inc. All Rights Reserved
Slide 24: Inspire V Experience at MEE
Inspire V Experience at MEE Phil Huyett, MD Director of Sleep Surgery Massachusetts Eye and Ear Assistant Professor Harvard Medical School
Slide 25: Disclosures
Disclosures • Inspire medical systems – Research support – Educational consultant • Nyxoah – Research support • Part of limited release in February • Still having discussions with insurance!
Slide 26: Inspire V
Inspire V • Faster/less general anesthesia time • No more respiratory sensor revisions • ?reduced PTX % • ?faster recovery • ?less post op pain
Slide 27: Surgical Time: Inspire V vs Inspire IV
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 MEE65
Slide 28: Surgical Time: Inspire V LA vs Inspire IV
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 MEE65
Slide 29: Inspire V LA Surgical Pearls
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
Slide 30: Initial Outcomes Inspire V
Initial Outcomes Inspire V Nic Beckmann, DO Colorado ENT and Allergy Colorado Springs, CO
Slide 31: Inspire V System
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
Slide 32: Consistent Innovation Leads to Simplified Procedure
• 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
Slide 33: Synchronized Stimulation Algorithm
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, Christ
Slide 34: Tailored Therapy Options Designed for Patient Comfort
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
Slide 35: CO Reimbursement
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 • I
Slide 36: Increasing Capacity
• 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 blo
Slide 37: OSA Patient Volume By Year
& <SOLORADO ENT O& ALLERGY Excellence. Commitment. Compassion. COLORADOENT.com Patient Volume OSA Patient Volume By Year
Slide 38: Year over Year Patients Treated
Year over Year Patients Treated
Slide 39: Thank you! Questions
& <SOLORADO ENT O& ALLERGY Excellence. Commitment. Compassion. Thank you! * Questions COLORADOENT.com
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