STAR 36Month Media Kit - inspiresleep.com · 18 Month Data: Strolloet al SLEEP 2015 36 Month Data: Woodson et al OTO‐HNS 2015 FOSQ: Sooseet al JCSM 2015 Normalized Daytime Functioning

© Inspire Medical Systems, Inc. 2014 All Rights Reserved

STAR 36Month Media KitNovember 2015

1


Talking Points• Obstructive sleep apnea (OSA) affects more than 18 million Americans

• It is important for people to find an effective treatment for their OSA– Untreated (OSA) can have devastating effects on heart and brain health,

impair quality of life and increase accident risk

• CPAP is an effective first line therapy for OSA. However, studies show that less than 50% of patients that try CPAP use it. This leaves a substantial number OSA patients untreated and vulnerable

• Unlike CPAP which requires wearing a mask, Inspire therapy works inside the body and with a patient’s natural breathing process. It is a small implant that delivers mild stimulation to key airway muscles to keep airway open during sleep

• Results from the landmark STAR Clinical Trial, which evaluated the safety and efficacy of Inspire therapy, were published in the January 2014 issue of the New England Journal of Medicine.


Untreated OSA Increases Risk for Comorbidities and Accidents

1.1

1.4

1.6

1.7

2.2

2.4

2.4

2.9

3.8

3.8

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

Coronary Artery DiseaseDepression

Type 2 Diabetes Death (moderate OSA) Occupational Accidents

Heart Failure Motor Vehicle Accidents

HypertensionDeath (severe OSA)

Stroke

Increased Risk1

2

3

4

5

6

1

7

8

9

Hazard Ratio

Odds Ratio

Relative Risk

Top 3

1. Artz et al, Am J Respir Crit Care Med 20052. Young et al, Sleep 20083. Peppard et al, N Engl J Med 20004. Tregear et al, J Clin Sleep 20095. Shahar et al, Am J Respir Crit Care Med 20016. Lindberg et al, Am J Respir Crit Care Med 20017. Reichmuth et al. Am J Respir Crit Care Med 2005;8. Smith et al, CHEST 20029. Gottlieb et al, S Circulation. 2010

• Untreated OSA can have devastating effects on heart and brain health, impair quality of life, and increase motor vehicle and occupational accident risk


Talking Points• New three year outcomes data from the Landmark STAR Clinical Trail

was published in Otolaryngology – Head and Neck Surgery, the official peer-reviewed publication of the American Academy of Otolaryngology –Head and Neck Surgery Foundation.

• The peer-reviewed publication website is http://oto.sagepub.com/

• The new long-term study outcomes showed that the significant improvements observed at one-year were sustained at the three-year follow up mark. The outcomes include: – A 78 percent reduction in apnea-hypopnea index (AHI) from baseline – An 80 percent reduction in oxygen desaturation events from baseline– 80 percent of bed partners reported soft or no snoring as compared to 17

percent of bed partners at baseline– Quality of life measures, including daytime sleepiness and functioning,

showed clinically meaningful improvements and a return to normal levels over baseline

• Inspire therapy was FDA approved in May 2014 and is available in over 50 leading medical centers in the United States and in 8 European countries


The Hypoglossal Nerve (Cranial Nerve XII)

• Controls muscles and movements of the tongue

• Motor nerve – Can accept mild stimulation with minimal sensation

The hypoglossal nerve


The Inspire Upper Airway Stimulation System

Stimulation Cuff

Generator

Breathing Sensor

• Fully implanted system • Uses well established technologies and surgical techniques • Typically performed on an outpatient basis

• Breathing sensor monitors a patient’s breathing cycle• Rhythmic, mild stimulation delivered to the hypoglossal nerve on each

breath • Mild stimulation delivered during the inspiration portion of the breathing

cycle which is when the airway is most vulnerable to collapse


Hypoglossal Nerve Stimulation EffectNo Stimulation Mild Stimulation

Base of Tongue Base of TonguePalate Palate

Tongue and palate collapse, obstructing airway during sleep

Mild stimulation nudges the base of tongue forward, preventing the airway from

collapsing during sleep

Open AirwayObstructed Airway


The Inspire Therapy Patient Experience• Patients describe feeling a tingling sensation or

mild muscle contraction

• Inspire therapy is adjustable for patient comfort. Patients can:– Start therapy– Pause therapy– Stop therapy– Increase or decrease energy

• In the STAR Trial:– 86% of patients reported using Inspire

therapy every night– 93% of patients reported using Inspire

therapy five or more night per week

Click here to hear from Inspire therapy Patientshttps://www.inspiresleep.com/inspired‐lives/


Physicians to InterviewContact Information Available Upon Request

• B. Tucker Woodson, MD– Medical College of Wisconsin

• Ryan J. Soose, MD– Univ. of Pittsburgh Medical Center

• M. Boyd Gillespie, MD– Medical University of South Carolina

• Kingman P. Strohl, MD– UH Case Medical Center

• Meir Kryger, MD– Yale University School of Medicine

• Maurits Boon, MD– Thomas Jefferson University Hospital

• Brian Weeks, MD– Senta Clinic


• Christine W.– Cleveland, Ohio

• Dan M.– Milwaukee, Wisconsin

• Al P.– Columbia, South Carolina

Inspire Therapy Patients to InterviewContact Information Available Upon Request

For more information on Inspire therapyhttps://www.inspiresleep.com


Appendix: 36 Month Clinical Data

11


Inspire Therapy Clinical Evidence Development

12 Peer-Reviewed Publications as of November 2015

INSPIRE 1, 2, 3FEASIBILITY STUDIES

First in Man

Patient Selection

Implant Technique

Safety/Efficacy

4 Peer-Reviewed Publications

STAR PHASE III TRIALWITH RANDOMIZED CONTROLLED

WITHDRAWAL STUDY

Safety/Efficacy

FDA Approval

Long-Term Follow-Up

Cost Effectiveness

8 Peer-Reviewed Publications

ONGOING STUDIES

European Post-Approval Study

US Post-Approval Study

Single Center Experience Projects

European Randomized Controlled Study

Peer Reviewed Publications — STAR Trial Outcomes

STAR 1 YEAR: Strollo et. al. The New England Journal of Medicine. January 2014

STAR RANDOMIZED STUDY: Woodson et. al. Otolaryngology Head and Neck Surgery. September 2014

STAR 18 MONTHS: Strollo et. al. SLEEP. June 2015

STAR 2 YEAR: Soose et. al. Journal of Clinical Medicine. July 2015

STAR 3 YEAR: Woodson et. al. Otolaryngology Head and Neck Surgery. November 2015


Inspire TherapyLong‐Term Objective Outcomes: AHI

Results in median, p < 0.01

29.3

9.0 9.76.2

0

5

10

15

20

25

30

35

Baseline N=126

12 Month N=124

18 Month N=121

36 Month N=98

Apne

a Hypop

nea Inde

x

12 Month Data: Strollo et al NEJM 201418 Month Data: Strollo et al SLEEP 2015 36 Month Data: Woodson et al OTO‐HNS 2015


Inspire TherapyLong‐Term Objectives Outcomes: ODI

Oxygen Desaturation Inde

x


25.4

7.4 8.6

4.8

0

5

10

15

20

25

30

Baseline N=126

12 Month N=124

18 Month N=121

36 Month N=98



Inspire TherapyLong‐Term Subjective Outcomes: FOSQ*

Functio

nal O

utcomes of S

leep

Que

stionn

aire


14.6

18.2 18.4 18.8

0

4

8

12

16

20

Baseline N=126

12 Month N=123

18 Month N=123

36 Month N=110

12 Month Data: Strollo et al NEJM 201418 Month Data: Strollo et al SLEEP 2015 36 Month Data: Woodson et al OTO‐HNS 2015FOSQ: Soose et al JCSM 2015

Normalized Daytime Functioning

*All 5 FOSQ subscale variables showed clinically significant improvements. FOSQ subscale variables include (1) activity, (2) productivity, (3) social, (4) intimacy, and (5) vigilance.


Inspire TherapyLong‐term Subjective Outcomes: ESS

11.0

6.0 6.0 6.0

4

6

8

10

12

Baseline N=126

12 Month N=123

18 Month N=123

36 Month N=110

Epworth Sleep

iness S

cale

Normalized Daytime Functioning

Results in median, p < 0.0112 Month Data: Strollo et al NEJM 201418 Month Data: Strollo et al SLEEP 2015 36 Month Data: Woodson et al OTO‐HNS 2015


Inspire Therapy AdherencePatient Self-Reported

From STAR database

86%81% 81%

93%86% 87%

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

12 Month N = 124

24 Month N = 117

36 Month N = 108

Use every night (%) Use at least 5 nights a week (%)


Partner Reported Snoring

No or Soft Snoring Bed Partner Leaves Room

17%

86% 87%80%

0%

20%

40%

60%

80%

100%

Baseline N=108

12 MonthN=103

18 MonthN=103

36 MonthN=97

30%

5% 4% 3%

0%

10%

20%

30%

40%

50%

Baseline N=108

12 MonthN=103

18 MonthN=103

36 MonthN=97


Documents

STAR 36Month Media Kit - inspiresleep.com · 18 Month Data: Strolloet al SLEEP 2015 36 Month Data: Woodson et al OTO‐HNS 2015 FOSQ: Sooseet al JCSM 2015 Normalized Daytime Functioning