Inspire

Inspire Therapy
A Treatment Option for Some Obstructive

Sleep Apnea Patients Who Are Unable to Use CPAP
800-129-001, Rev B Inspire Medical Systems, Inc.

Nov 2015 2015 All Rights Reserved
Obstructive Sleep Apnea (OSA)
Consequences and Treatments
Inspire Medical Systems, Inc.

2015 All Rights Reserved
Some OSA Patients Cannot Achieve Benefit
From Traditional Therapies And Remain
Vulnerable
Airway Airway
Obstruction: Obstruction:
47 seconds 86 seconds
Airflow Over 30 obstructions

per hour (AHI)*
Oxygen Regular desaturations

Saturation below 90%
90%
Moderate to severe range: AHI 15-30

Severe range: AHI 30+
*Patient with severe OSA
84% 74%

Untreated OSA Increases Risk for
Comorbidities and Accidents
Increased Risk
Stroke 1 3.8
Top 3
Death (severe OSA) 2 3.8
Hypertension 3 2.9
Motor Vehicle Accidents 4
2.4
Heart Failure 5 2.4
Occupational Accidents 6 2.2
Death (moderate OSA) 1 1.7
Odds Ratio
Type 2 Diabetes 7 1.6 Hazard Ratio
Depression 8 1.4 Relative Risk
Coronary Artery Disease 9 1.1
0.0 1.0 2.0 3.0 4.0 5.0 6.0 7.0 8.0 9.0 10.0 11.0 12.0 13.0
1. Artz et al, Am J Respir Crit Care Med 2005

2. Young et al, Sleep 2008
3. Peppard et al, N Engl J Med 2000
4. Tregear et al, J Clin Sleep 2009
5. Shahar et al, Am J Respir Crit Care Med 2001
6. Lindberg et al, Am J Respir Crit Care Med 2001
7. Reichmuth et al. Am J Respir Crit Care Med 2005;
8. Smith et al, CHEST 2002
9. Gottlieb et al, S Circulation. 2010 Inspire Medical Systems, Inc.
OSA Treatment Shown to Reduce
Cardiovascular Events
Months
Adapted from Spanish Sleep Cohort (n=1,651, mean follow-up of 10 yrs; age ~ 50 yr)
Untreated severe OSA (AHI of 30+) is associated with an increased risk of both fatal and
non-fatal cardiovascular events
Consistent treatment with Continuous Positive Airway Pressure1 (CPAP) or an AHI <15
reduces risk 1 Consistent use - Average daily use more than 4
hours; Long-term cardiovascular outcomes in men

with obstructive sleep apnoea-hypopnoea w/ or w/o
treatment with CPAP: an observational study; Marin
et al., Lancet 2005

Treating the OSA Patient
Traditional
Therapies
Lifestyle changes Treatment Goals
CPAP
Oral Appliance
OSA
Reduce
Protected Vulnerable symptoms
Patients Patients
Repetitive Obstructions and SaO2 Improve QOL
Desaturations
Minimize risk
-Cardiac
-Brain
-Accidents
Inspire Mission
Provide physicians an
additional treatment option to
protect some patients

How it Works

Airway Obstruction
Sites of Airway Obstruction
Nasal
Palate
Tongue Base
Epiglottis

Airway Obstruction
Sites of Airway Obstruction
Nasal
Palate
Tongue Base
Epiglottis

The Hypoglossal Nerve
(Cranial Nerve XII)
Controls muscles and

movements of the tongue
Motor nerve
Mechanical coupling with
palate is very common

The Distal Hypoglossal Nerve
Styloglossus
Muscle
Hyoglossus
Muscle
Hypoglossal
Nerve (CN XII)
Genioglossus
Muscle
Geniohyoid
Mild stimulation Muscle

Hypoglossal Nerve Stimulation Effect
No Stimulation Mild Stimulation
Base of Tongue Palate Base of Tongue Palate

Stimulation Timed With Breathing
Respiratory Cycle
Timing
Stimulation
delivered during
inspiration
3. Computer
& Battery
1. Mild
stimulation 2. Sense
of HGN Breathing

The Inspire Upper Airway Stimulation System
Stimulation
Cuff Breathing
Sensor
Generator
Several million patients receive implantable stimulation therapies annually

Cardiac conditions (Bradycardia, Tachycardia, Heart Failure)
Pain management
Other neuro-related conditions (Urologic disorders, Parkinsons Disease)

Inspire Therapy:
Sleep Study Illustration
Airflow, breathing and normal oxygen levels restored
Inspire therapy turned on
Airflow
SpO2
Severe OSA Events OSA Events Resolved

Active US Multi-Disciplinary
Inspire Therapy Programs
East South Midwest West
Beth Israel, New York Baptist Health South Florida Advanced Regional Surgical Center Alvarado Hospital
MedStar Georgetown Hospital Baylor Surgical Hospital Cincinnati VA Medical Center IMS/St. Joseph Dignity Health
Keck Hospital of University of Southern
MedStar Washington Hospital Center East Alabama Medical Center Cleveland Clinic
California
Middlesex Hospital Florida Hospital Essentia Health - St Marys, Duluth Mayo Clinic Scottsdale
New York Presbyterian Fairview Health System Osborne Head and Neck Surgery, Los
James A Haley VA Medical Center
Cornell-Weill University of Minnesota Angeles
Thomas Jefferson University Hospital Medical City, Dallas Froedtert & Medical College of Wisconsin Stanford Health Care
University of Pennsylvania Health System Medical University of South Carolina Henry Ford Hospital UCLA Medical Center
University of Colorado Ft. Collins/
University of Pittsburgh Medical Center Methodist Ambulatory Surgical Hospital Indiana University Medical Center
Poudre Valley
Iowa City Ambulatory Surgical Center
University of Virginia Medical Center Navicent Health System Macon, GA
(ENT Medical Services)
Virginia Hospital Center Northside Hospital, Atlanta NorthShore University Health System
Walter Reed Medical Center The Hospital at Westlake Norton Healthcare, Louisville
West Haven VA Hospital, CT University of Alabama Birmingham Ohio State University
University of Florida Medical Center OhioHealth - Riverside Methodist Hospital
Regions Hospital Health Partners
University of Mississippi Medical Center
Minneapolis
University of South Florida/
Rush University Medical Center
Tampa General Hospital
University of Texas Southwestern St. Cloud Hospital
Wellstar Health System, Atlanta St. Vincent Health System, Indianapolis
The Christ Hospital, Cincinnati

University Hospitals Health System
(Case Western)
University of Cincinnati Health

Global Program Footprint
Germany Belgium
Clinic Rechts der Isar, Munich University Hospital, Antwerp
University of Mannheim, Mannheim
University Clinic of Schleswig Holstein, Lbeck
Neurology Clinic of University of Ulm, Gnzburg The Netherlands
Helios Klinikum Berlin-Buch, Berlin OLVG-West, Amsterdam
Sint Antonius Ziekenhuis, Nieuwegein
Switzerland France
Kantonsspital Baselland, Liestal CHU, Bordeaux
Kantonsspital St. Galen, St.Galen
Austria Finland
University Clinic of Innsbruck, Innsbruck HUCS, Helsinki
United States Norway

Haukeland University Hospital, Bergen

The Inspire Patient Experience

What is surgery and recovery like?
What does the therapy feel like?
What is it like living with Inspire therapy?


The Inspire Upper Airway Stimulation System
Stimulation
Cuff Breathing
Sensor
Generator
Several million patients receive implantable stimulation therapies annually

Cardiac conditions (Bradycardia, Tachycardia, Heart Failure)
Pain management
Other neuro-related conditions (Urologic disorders, Parkinsons Disease)

Incisions After Healing is Complete
Incision on neck Incision and device Incision on chest

for stimulation lead under collarbone for sensor lead
*Photos used with patient consent

Inspire Therapy Procedure Overview
Typically an Outpatient Procedure

General anesthesia
Pain Management
Mild discomfort and swelling at the incision sites for a few
days after the procedure, usually managed with over-the-
counter pain medication
Recovery
Return to regular diet and most activities of daily living
immediately after the procedure
Avoid strenuous activities for a few weeks


What Does Inspire Therapy Feel Like?
Patients describe feeling a tingling
sensation or mild muscle contraction when
first activating Inspire therapy
Inspire therapy is adjustable for patient

comfort
Most patients acclimate well to Inspire

therapy within the first month of use
In the STAR Trial at 1 year:

86% of patients reported using Inspire therapy every night
93% of patients reported using Inspire therapy five or more night per week


Living with Inspire Therapy
With the sleep remote, patients can:

- Start therapy
- Stop therapy
- Pause therapy
- Increase or decrease energy

Inspire Therapy Clinical Evidence
Publications and Safety
Adherence, Outcomes, Snoring
Awards and Recognition

Inspire Therapy
Clinical Evidence Development
12 Peer-Reviewed Publications as of November 2015
INSPIRE 1, 2, 3 STAR PHASE III TRIAL

WITH RANDOMIZED CONTROLLED ONGOING STUDIES
FEASIBILITY STUDIES WITHDRAWAL STUDY
First Human Implant Safety/Efficacy European Post-Approval Study

Patient Selection FDA Approval US Post-Approval Study
Implant Technique Long-Term Follow-Up Single Center Experience Projects
Safety/Efficacy Cost Effectiveness European Randomized Controlled Study
4 Peer-Reviewed Publications 8 Peer-Reviewed Publications
Peer Reviewed Publications STAR Trial Outcomes

1 YEAR: Strollo et al. The New England Journal of Medicine. January 2014
RANDOMIZED STUDY: Woodson et al. Otolaryngology Head and Neck Surgery. September 2014
18 MONTHS: Strollo et al. SLEEP. June 2015
2 YEAR: Soose et al. Journal of Clinical Medicine. July 2015
3 YEAR: Woodson et al. Otolaryngology Head and Neck Surgery. November 2015

STAR Trial Safety Summary
126 Patients
Serious adverse events/side effects within the first year

One elective device removal requested by patient
Two device repositionings to resolve patient
discomfort
Serious adverse events/side effects after the first year

Device removal due to insomnia and other
psychological issues (N=1)
Device removal due to septic arthritis of right
shoulder; no device-related infection found with
implanted pulse generator (IPG) pocket (N=1)

Inspire Therapy
Long-Term Objective Outcomes: AHI
35
Apnea Hypopnea Index
29.3
30
25
20
15
9.0 9.7
10
6.2
5
0
Baseline 12 Month 18 Month 36 Month
N=126 N=124 N=121 N=98
12 Month Data: Strollo et al NEJM 2014 Results in median, p < 0.01

18 Month Data: Strollo et al SLEEP 2015
36 Month Data: Woodson et al OTO-HNS 2015

Inspire Therapy
Long-Term Objectives Outcomes: ODI
30
25.4
25
Oxygen Desaturation
20
15
10 8.6
7.4
4.8
5
Index
0
N=126 N=124 N=121 N=98


Inspire Therapy
Long-Term Subjective Outcomes: FOSQ*
20 18.2 18.4 18.8
Normalized daytime functioning
Functional Outcomes
Sleep Questionnaire
16 14.6
12
of
0
N=126 N=123 N=123 N=110
*All 5 FOSQ subscale variables showed clinically significant improvements. FOSQ subscale variables include (1)
activity, (2) productivity, (3) social, (4) intimacy, and (5) vigilance.

FOSQ: Soose et al JCSM 2015

Inspire Therapy
Long-Term Subjective Outcomes: ESS
Epworth Sleepiness Scale
12
11.0
10
6.0 6.0 6.0

6
4
N=126 N=123 N=123 N=110
Results in median, p < 0.01
12 Month Data: Strollo et al NEJM 2014

Inspire Therapy Adherence
Patient Self-Reported
100% 93%
90% 86% 86% 87%
81% 81%
80%
70%
60%
50%
40%
30%
20%
10%
0%
12 Month 24 Month 36 Month
N = 124 N = 117 N = 108
Use every night (%) Use at least 5 nights a week (%)
From STAR database

Partner Reported Snoring Outcomes
No or Soft Snoring Bed Partner Leaves
Room
100% 50%
86% 87%
80%
80% 40%
30%
60% 30%
40% 20%
17%
20% 10%
5% 4% 3%
0% 0%
Baseline 12 Month 18 Month 36 Month Baseline 12 Month 18 Month 36 Month
N=108 N=103 N=103 N=97 N=108 N=103 N=103 N=97


Clinical Research Forum Award 2015
4 of 10 Address Neurologic and Cardiovascular Challenges

Inspire Therapy
Economics and Reimbursement

Implant Coding Scenario
Historically, several codes together describe the initial Inspire therapy implant
scenario:
CPT 64568 for cranial nerve stimulation generator & lead placement
CPT 64999 (unlisted) for pressure sensor placement
CPT 95970 for electronic analysis of the cranial nerve stimulation system
In October 2014, the American Academy of Otolaryngology reiterated an earlier

AMA posting on its website regarding coding of a hypoglossal nerve stimulation
The original AMA posting provided guidance to use an unlisted code 64999 for
the entire procedure as the code 64568 does not describe the placement of
chest wall sensors
The Societies plan on submitting (to AMA CPT) an application for a Level 1
CPT Add-on code to 64568 to describe the respiratory sensor.

Sample Hospital Facility Payments
Inspire: Implant, Replacement, Removal and Follow-up APC Payment
*Sample
Status National Medicare
APC Inspire Description Standard Short Description Commercial
Indicator Base Payment 2015
Payment Estimates
Electrode placement, generator Implantation of Neurostimulator Pulse

0318 implant Generator and Electrode S $26,162.39 $36,627.35
0215 Electronic Analysis Level I Nerve and Muscle Services S $94.97 $132.96
Level I Implantation of Neurostimulator

0039 Generator replacement
Generator S $17,106.04 $23,948.46
Level I Implantation/Revision/
Revision or replacement
0061 electrode array
Replacement of Neurostimulator S $5,290.65 $7,406.91
Electrodes
Removal of electrode array &
0221 pulse generator
Level II Nerve Procedures T $2,947.54 $4,126.56
0692 Complex reprogramming Level II Electronic Analysis of Devices S $128.23 $179.52
* Commercial estimates based on Medicare payment multiplied by 1.4

S= Significant procedure not subject to multiple procedure discounting
T = Discounted procedure, multiple surgical procedure rule applies

Physician PSG and Programming Payment
Medicare 2015
Commercial
CPT Code Short Description National Average
Payment
Payment
95810 Polysomnography > 6 years $628.84 $880.38
95970 Electronic analysis $67.91 $95.07
95974 Complex, first hour $211.65 $296.31
95975 Complex, each additional 30 min $113.55 $158.97
Notes: 1. Commercial payment estimate based Medicare X 1.4.

2. Numbers reflect non-facility (e.g. office) payments

Physician Follow-up and Programming
Model (n=40) based on Medicare 2015 National
Average
Percent of Commercial Medicare Commercia Medicare
Cost Item Description Total
Cohort Payment Payment l (70%) (30%)
Initial Sleep Study 95810 100% $880.38 $628.84 28 12 $32,196.72

Patient Functional
95974 100% $296.31 $211.65 28 12 $10,080.48
Activation
Titration Sleep Study 95810 100% $880.38 $628.84 28 12 $32,196.72
Plus Complex
95974 100% $296.31 $211.65 28 12 $10,080.48
Programming
with (for example) 2
95975 100% $158.97 x2 $113.55 x 2 28 12 $11,627.52
30 min increments
Complex Programming for
95974 10% $296.31 $211.65 3 1 $1,100.58
Therapy Optimization
with (for example) 2
95975 10% $158.97 x2 $113.55 x2 3 1 $1,180.92
30 min increments
1-year check:
Office Visit 99213
100% $100.66 $71.90 28 12 $3,681.28
Electronic Analysis (example)
90% $102.62 $73.30 25 11 $3,371.80
Complex Programming 95970
10% $296.31 $211.65 3 1 $1,100.58
95974
Total: $106,616.68
Notes: 1. Numbers reflect non-facility (e.g. office) payments.
2. It is common for commercial payers to pay approximately 1.4X Medicare.
3. Initial titration estimate based on two hour total complex programming time.

Physician DISE and Implant Payment
Medicare (2015) National Commercial
CPT Inspire Description
Average Payment Payment
DISE Procedure (Commonly Billed Code Examples)
Nasopharyngoscopy with endoscope

92511 $138.34 (office) $193.68
(cannot be billed with 31575)
$98.82
92502 Otolaryngologic exam under general anesthesia $138.35
(must be done hospital or ASC)
31575 Laryngoscopy, flexible fiberoptic diagnostic $117.50 (office) $164.50
Implant, Revision and Removal
64568 Electrode Placement, generator implant $693.52 $970.93
64999 Unlisted procedure, nervous system Carrier Priced Carrier Priced
95970 Electronic analysis $67.91 $95.07
61885 Generator replacement $542.60 $759.64

64569 Revision or replacement electrode array $825.75 $1,156.05
64570 Removal of electrode array & pulse generator $631.22 $883.71
Notes: 1. Commercial payment estimate based on Medicare X 1.4.

RVUs Associated with Implant Scenario
CPT & PRACTICE MALPRACTIC

WORK TOTAL
DESCRIPTION EXPENSE E EXPENSE
64568
9 7.45 .36 16.81
Generator & lead
64999*
0 0 0 0
Sensor placement
95970
.45 .18 .05 .68
Electronic analysis
*The value of CPT 64999 must be negotiated separately with each payer, by choosing a comparator
code to establish an appropriate reference point for payment.

ICD-9 HCPCS & Revenue Codes
ICD-9 Diagnostic Codes
327.23 Obstructive sleep apnea (adult)(pediatric)
ICD-9 Procedure Codes

04.92 Implantation or replacement of peripheral neurostimulator lead(s)
86.94 Insertion or replacement of single array neurostimulator pulse generator
Hospital Revenue Codes

278 Medical devices and implants
360 General classification O.R. services
Hospital Outpatient Category C Codes (Medicare)

C1767 Generator, Neurostimulator
C1778 Lead, Neurostimulator
HCPCS (Non-Medicare)
L8680 Implantable neurostimulator electrode, each
L8688 Implantable neurostimulator pulse generator, dual array, non-rechargeable

Prior Authorization Program
Our goal is to obtain a written pre-determination letter from the insurer
prior to every implant to mitigate the risk of non-payment
We have a dedicated prior authorization team to support the approval

process, and will work with your implanter to ensure this is done accurately
and consistently
We have a packet of best practices Prior Authorization materials to support

the submission process
Furthermore, we have an established hotline number to handle any

reimbursement-related questions you may encounter
Inspire Hotline Number: 844-515-6182

Important Information Related
to Coding and Billing
Inspire provides this information for your convenience only. It is not intended as a
recommendation regarding clinical practice. It is the responsibility of the provider to
determine coverage and to submit appropriate codes, modifiers, and charges for the
services rendered. Consult with your billing advisors or payers for advice on
handling such billing issues. Some payers may have policies that make it
inappropriate to submit claims for such items or related service. Additional
information can also be accessed through CMS, and information, including
Medicare Manuals are available on the Internet. You should also contact your
Medicare Administrative Contractor to clarify your questions or concerns regarding
billing and coding.
Current Procedural Terminology (CPT) is copyright 2013 American Medical

Association. All Rights Reserved. No fee schedules, basic units, relative values, or
related listings are included in CPT. The AMA assumes no liability for the data
contained herein. Applicable FARS/DFARS restrictions apply to government use.
CPT is a trademark of the American Medical Association.

Some OSA Patients Cannot Achieve Benefit
From Traditional Therapies and Remain
Vulnerable
Airway Airway
47 seconds 86 seconds
Airflow Over 30 obstructions

per hour (AHI)*
Oxygen Regular desaturations

Saturation below 90%
90%
Moderate to severe range: AHI 15-30

Severe range: AHI 30+
*Patient with severe OSA
84% 74%

Effective Treatment Produces
Cost Savings
Annual Health Plan Savings CPAP Treatment
Waste Management Schneider Trucking

$8,000 $7,440 $12,000 $10,872
$7,000
$10,000
$6,000
$4,533 $8,000
$5,000
$4,000 $6,000
$5,676
$3,000
$4,000
$2,000
$2,000
$1,000
$0 $0
Pre-treatment Post-treatment Pre-treatment Post-treatment
~$3,000 annual savings ~$5,000 annual savings
Hoffman et al., JOEM, May 2010 | n=248 Schneider National Inc., White Paper, 2006 | n=348

Long-Term Cost-Effectiveness of Upper Airway
Stimulation for the Treatment of Obstructive Sleep
Apnea:
A Model-Based Projection Based on the STAR Trial
Jan B. Pietzsch, PhD,* Shan Liu, PhD,* Abigail M. Garner,
MS,* Eric J. Kezirian MD, MPH
Patrick J. Strollo, MD
*Wing Tech Inc., Menlo Park, CA, USA; University of

Washington, Seattle, WA, USA; University of Southern
California, Los Angeles, CA, USA;
University of Pittsburgh, PA, USA
Pietzsch et al SLEEP 2015 (in press)

Health Outcomes and
Incremental Cost-Effectiveness
Expected Cost ($), Effectivenes ICER
Risk Risk of
Lifetime number of discounte s (QALY), ($/QALY),
of MI Stroke
MVC d discounted discounted
No Treatment 0.481 0.249 1.030 243,543 9.54

UAS
0.389 0.240 0.367 286,497 10.63 39,471
Treatment
Absolute
0.092 0.009 0.663 42,953 1.09
Difference
Relative Risk 0.81 0.96 0.36
Pietzsch et al Sleep 2015 (in press)

Inspire Therapy Cost Analysis
Episode of care Year 0 Years 1-10 Inspire Therapy Cost Profile

(10 year system longevity)
Surgery/Device $27,500
Total Cost: $30,200
Titration $1,200 Annual Cost: $3,020
Monthly Cost: ~$250
Device Check $150
* Data provided by Inspire Medical Systems Health Economics Department

Inspire Therapy
Patient Selection Considerations

Inspire Therapy Indications*
Adults 22 years of age and older
Diagnosed OSA with an AHI range of 20-65 per hour
CPAP failure or inability to tolerate CPAP treatment:
PAP failure is defined as an inability to eliminate OSA (AHI of greater
than 20 despite PAP usage)
PAP intolerance is defined as inability to use PAP (greater than 5 nights
per week of usage; usage defined as greater than 4 hours of use per
night)
Unwillingness to use PAP (for example, a patient returns the PAP
system after attempting to use it)
Appropriate airway anatomy
* Indications approved by the United States

Food & Drug Administration, April 2014

Inspire Therapy Contraindications*
Screening sleep study shows > 25% central+mixed apneas
Anatomical assessment findings that could compromise the
performance of Inspire such as complete concentric collapse
(CCC) at the palate
Pre-existing conditions that have compromised neurological
control of the upper airway
Patients who are unable or do not have the necessary
assistance to operate Inspire therapy
Patients who are pregnant or plan to become pregnant
Patients who will require MRI
Patients with another implantable device (i.e. pacemaker)
should consult the device manufacturer to assess possibility
of interaction
*Indications approved by the United States

Inspire Therapy
Warnings and Precautions*
Body Mass Index 32
BMI > 32 may be associated with decreased likelihood of response to
treatment
Diathermy (primarily used in physical therapy)
Do not use shortwave diathermy, microwave diathermy or therapeutic
ultrasound diathermy on patients with a neurostimulation system
MRI can cause tissue damage as well as damage to the Inspire
system and components
Electromagnetic compatibility and interference (EMI). Extremely
strong sources of EMI could interfere with normal IPG operation
Electrocautery, irradiation, lithotripsy, RF-ablation, x-ray, and
fluoroscopy are typical EM disturbance sources. Treatments that use
ultrasonics, defibrillation, or radiation can adversely affect the Inspire
System. *Indications approved by the United States

Pre-op Anatomical Assessment
Drug Induced Sleep Endoscopy (DISE)
Examples
Complete AP collapse at palate Complete concentric collapse at palate

Good candidate Not a good candidate

OSA Treatment Goals
Reduce Symptoms
Daytime sleepiness
Snoring
Improve Quality of Life
Daytime function
Neurocognitive function
Intimacy
Minimize Cardiovascular Risk
OSA severity
AHI & ODI
Durability

Inspire Therapy
Long-Term Objective Outcomes: AHI
35
Apnea Hypopnea Index
29.3
30
25
20
15
9.0 9.7
10
6.2
5
0
N=126 N=124 N=121 N=98


Inspire Therapy
Long-Term Objectives Outcomes: ODI
Oxygen Desaturation Index
30
25.4
25
20
15
10 8.6
7.4
4.8
5
0
N=126 N=124 N=121 N=98


Inspire Therapy
Long-Term Subjective Outcomes: FOSQ*
20 18.2 18.4 18.8
Functional Outcomes
Sleep Questionnaire
16 14.6
12
of
0
N=126 N=123 N=123 N=110
*All 5 FOSQ subscale variables showed clinically significant improvements. FOSQ subscale variables include (1)
activity, (2) productivity, (3) social, (4) intimacy, and (5) vigilance.

FOSQ: Soose et al JCSM 2015

Inspire Therapy
Long-Term Subjective Outcomes: ESS
Epworth Sleepiness Scale
12
11.0
10
6.0 6.0 6.0

6
4
N=126 N=123 N=123 N=110
Results in median, p < 0.01

Patient Response Curves
Implant / 2-3 Month
1 Year Long Term
Activation Titration
Curves are approximations

OSA Severity
Most
patients
Rapid, durable responder Slow-but-sure responder Partial-to-non responder
Each program should have 10 patients followed 6 months to develop their

programs response curves
Some patients will require advanced therapy titration
Regardless of curve, the goal for all patients is all night every night usage

Case Study 1
68 y/o Female with Deep Oxygen
Desaturations
Airway Airway
47 seconds 86 seconds Baseline
With Inspire
Treatment Goal (no
for 3 Years
therapy)
Quality of Life Score
Airflow 15.2 *19.8
(FOSQ)
Non adherent
Therapy adherence 5.2 hours/night
to CPAP
Oxygen
Saturation Oxygen Desaturations
23.5 minutes 1.2 minutes
90% (Time <90%)
AHI
(Apnea-Hypopnea 28.3 4.0
Index)
84% 74%
* 17.9 is a normal score

Case Study 2
61 y/o Male Transportation Worker
(Commercial Truck Driver)
Post Inspire Titration
Treatment Goal Baseline (no therapy)
(2 months after implant)
Quality of Life Indicators Significant daytime fatigue Feel rested during the day
Daytime Fatigue Family used to be able to hear My family is very happy
Snoring him snore throughout the house Snoring completely resolved
AHI
31 2.5
(Apnea-Hypopnea Index)
Therapy Adherence Non Adherent to CPAP 6 hours/night

Case Study 3
65 y/o Male Business Professional
(Travels Often)
Treatment Goal Baseline (no therapy) Using Inspire for 4 Years
Quality of Life Indicators I feel sharper at work!

Difficulty concentrating
Work Productivity Sleeping with bed partner now
Big impact on family
Snoring Remains alert throughout the day
AHI
27 3.3
(Apnea-Hypopnea Index)
Untreated, multiple attempts

Therapy Adherence 7.7 hours per night
spanning years to use CPAP

Case Study 4
75 y/o Male Requiring
Advanced Titration
Baseline Month-2 Titration Using Inspire For 3 Years
Advanced sensing and
Programming n/a Default Settings
stimulation parameters
AHI (Apnea-Hypopnea Index) 43.2 42.4 3.5
Therapy Adherence n/a > 6 hours per night 7.8 hours per night
AHI Over Time

50 43.7 42.4
Poor response at M2 titration, but good
40 adherence
Awake endoscopy led to changes in
30 23 sensing and stimulation parameters
20 which dramatically improved response
11.6
8.3 8.4
10 3.5 Post-M18, the patient uses an oral
0 appliance in conjunction with Inspire
Baseline M2 M6 M9 M12 M18 M36

Inspire Therapy Patient Education

Patient Education Materials
Recommende
Education Site
d Materials
Waiting Room Tri-fold

Sticker w/ MD name
Module 1
During Consult
Binder
Inspired Lives
Patient Tri-Fold Patient Guide
Patient Guide
Video Assets
Referring MDs Tri-Fold

Sticker w/ MD name
Module 1 Binder

Inspired Lives on InspireSleep.com
Introduction
Chapter 1: Sleep Apnea: The Journey to Relief
Chapter 2: How Inspire Therapy Works
Chapter 3: Is Inspire Therapy Right for You?
Chapter 4: Making the Decision
Chapter 5: The Inspire Therapy Procedure
Chapter 6: Obtaining Insurance Coverage
Chapter 7: Life with Inspire Therapy

Inspire Therapy
Patient Identification Considerations

Building Steady Patient Flow
Inspire
direct to patient
initiatives
#4
Referring
MDs and AHPs Center initiated
(should include community
cardiologists and outreach & PR
sleep dentists)
#2 #3
Education and screening processes with MDs and

HCPs that work with CPAP strugglers within the
practice
#1

Program Media Outreach
Newspaper Articles Television Stories
New York Daily News CBS New York

July 21, 2015 July 21, 2015
Radio Advertisements Community

Newsletters
University Hospitals, Cleveland
OH NorthShore-
Fall 2014 Chicago Monthly
Newsletter
8 week radio campaign April 2015

Typical Week on InspireSleep.com
July 26-August 1, 2015

Practice Management
Considerations

Inspire Therapy
Episode of Care Summary
Sleep Airway Inspire Therapy Therapy Routine

Clinic Visit
Study Assessment Implant Activation Optimization Follow-ups
Health Status OSA Anatomy Implant Therapy Optimize Routine

Severity Evaluation Procedure turned on in settings checks
OSA History the office during PSG every 6-12
months
CPAP History Therapy
used at
home for a
few months

Multi-Disciplinary Program Profile
Strong physician program leader
Sleep physician engaged in longitudinal patient management
Surgeon profile head/neck & OSA expertise, DISE
Patient navigator (patients go-to person)
Coordinate patient throughput
Establish practice screening initiatives
Therapy acclimation coach
Sleep tech highly skilled, can become self-sufficient at titration
Practice administrator orchestrate prior authorization requests
Hospital administrator approve budgets and service line growth
Committed to develop program: 2-3 treated patients per month

Patient Follow-Up with Inspire Therapy
Tablet
Adjust therapy settings wirelessly

Monitor therapy adherence

New Program Selection and Start-up
Each step has objectives and milestones
Review Center Dossier
Inquiry Introduction Connection Site Visit Kick-off Program Quarterly

Call Call Training Reviews
Start-up Phase
Selection Phase (4-7 weeks) (6-8 weeks)
Value Analysis Patient Flow

Process

Program Training Curriculum
Begins upon completion of value analysis and BAA*
Module 1: Module 6:
Module 3:
Intro to Module 2: Module 4: Module 5: Activation /
Prior
Inspire DISE Implant OR Prep Titration and
Authorization
Therapy Programmer
Any MD, AHP or

Any AHP or OR staff that
night tech that
MD that will Physician that MD and staff that will support
Implanting will work
Who discuss Inspire will perform submit prior
surgeon(s)
Inspire
programmer at
therapy with DISEs authorizations therapy
activation or
patients implants
titration
Cadaver lab
Where At center At center At center Tampa or At center At center
Phoenix
Once Value
Analysis is 2 patients One week
1st 2 patients 1st patients have Day prior to 1st
When complete and
are identified passed DISE
scheduled prior to 1st
activation
BAA is for implant case
signed
Goal: Move through this process in first 90 days

* Business Associate Agreement

Program Kickoff: First 90 Days
10 patients identified and referred for DISE

6 positive DISE
4 patients in insurance prior authorization
2 scheduled implants
Requires regular communication between multi-disciplinary team

- Brief weekly check-ins
- Formal quarterly meetings to discuss and measure against goals


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Inspire Therapy

A Treatment Option for Some Obstructive

800-129-001, Rev B Inspire Medical Systems, Inc.

Inspire Medical Systems, Inc.

Airflow Over 30 obstructions

Oxygen Regular desaturations

Moderate to severe range: AHI 15-30

Inspire Medical Systems, Inc.

Depression 8 1.4 Relative Risk

Coronary Artery Disease 9 1.1

1. Artz et al, Am J Respir Crit Care Med 2005

hours; Long-term cardiovascular outcomes in men

Inspire Medical Systems, Inc.

Inspire Medical Systems, Inc.

Inspire Medical Systems, Inc.

Sites of Airway Obstruction

Inspire Medical Systems, Inc.

Sites of Airway Obstruction

Inspire Medical Systems, Inc.

Controls muscles and

Inspire Medical Systems, Inc.

Inspire Medical Systems, Inc.

Base of Tongue Palate Base of Tongue Palate

Inspire Medical Systems, Inc.

Inspire Medical Systems, Inc.

Several million patients receive implantable stimulation therapies annually

Inspire Medical Systems, Inc.

Severe OSA Events OSA Events Resolved

Inspire Medical Systems, Inc.

Wellstar Health System, Atlanta St. Vincent Health System, Indianapolis

The Christ Hospital, Cincinnati

Inspire Medical Systems, Inc.

United States Norway

Inspire Medical Systems, Inc.

Inspire Medical Systems, Inc.

What is surgery and recovery like?

What does the therapy feel like?

What is it like living with Inspire therapy?

Inspire Medical Systems, Inc.

What is surgery and recovery like?

What does the therapy feel like?

What is it like living with Inspire therapy?

Inspire Medical Systems, Inc.

Several million patients receive implantable stimulation therapies annually

Inspire Medical Systems, Inc.

Incision on neck Incision and device Incision on chest

*Photos used with patient consent

Inspire Medical Systems, Inc.

Typically an Outpatient Procedure

Inspire Medical Systems, Inc.

What is surgery and recovery like?

What does the therapy feel like?

What is it like living with Inspire therapy?

Inspire Medical Systems, Inc.

Inspire therapy is adjustable for patient

Most patients acclimate well to Inspire

In the STAR Trial at 1 year:

Inspire Medical Systems, Inc.

What is surgery and recovery like?

What does the therapy feel like?

What is it like living with Inspire therapy?

Inspire Medical Systems, Inc.

With the sleep remote, patients can:

Inspire Medical Systems, Inc.