Inspire Better Sleep

Quan Ni, PhD

Inspire Medical Systems

www.inspiresleep.com

Sleep Apnea by Numbers

• Obstructive Sleep Apnea (OSA) affects 18 million Americans

• OSA increases risks for

–Hypertension by 2.9 times

– Stroke by 3.8 times, and

–Car crashes by 2.4 times

Sleep Study

Intermittenthypoxia

Resp effort continues

No air flow

arousals

Polysomnography

1 minute

Apnea hyponea index (AHI): number of apnea and hypopnea events per hour, AHI~100

OSA and Survival

Young etal 2008, Wisconsin Sleep Cohort, n=1,522, 18 year follow-up

Continuous Positive Airway Pressure

CPAP… and Adherence

• CPAP is an effective first-line therapy for OSA patients who use it consistently

• General CPAP adherence is about 50%

• Many factors limit adherence

7

Tongue Protrusion as a Therapy

Upper Airway Neuroanatomy

9

Styloglossus (SG)

Hypoglossal Nerve (CN XII)

Hyoglossus (HG)

Genioglossus (GG)

Inspire II Systems

10

Stimulation Lead

Respiratory Sensing Lead

Implantable Pulse Generator

Patient Remote

Physician Programmer

Development Process

Plan

• Needs

• Features

• Requirements

Development

• Design

• Prototype

• Manufacture

Testing

• Bench test

• Pre-clinical testing

• Human testing

Clinical Testing

8 patients @ 4 centers

2001

First in man

1 publication

Inspire 2&3

Feasibility Trials

22 patients @ 4 centers

2009/10

Patient selection

Implant technique

1 peer reviewed publication

126 patients @ 22 centers

2012 /13

Safety / Efficacy /

FDA Review

N Eng J Med &

other publications

Inspire STAR

Pivotal Trial

12 patients @ 7 centers

2010/11

Preliminary

Safety / Efficacy

2 peer reviewed publications

Inspire 2/3

Feasibility Study

Inspire 1

Proof of Principle

Inspire 2/3

Feasibility Study

FDA Approval April 2014

Upper Airway Stimulation Effect

Stimulation ActiveNo Stimulation

EEG

EMG

Nasal

Therm

Chest

Abdm

SaO2

13

Significant Reduction In OSA Severity

Strollo et al on behalf of STAR trial investigators N Engl J Med 2014

Strollo et al on behalf of STAR trial investigators N Engl J Med 2014

Improve Daytime Functioning

Epworth Sleepiness Scale (synthesized): chance of dozing (0-3) during 8 situations:

Sitting and reading; Watch TV; Meeting; Passenger in a car;

Lying down in PM; Sitting and talking; Sitting after lunch; Sitting in traffic

Partner-Reported Level of Snoring

17

6.5%

49.0%

11.1%

36.0%

28.7%

7.0%

24.1%

3.0%

29.6%

5.0%

0.0%

10.0%

20.0%

30.0%

40.0%

50.0%

60.0%

70.0%

80.0%

90.0%

100.0%

Baseline 12-Months

Pe

rce

nt

of

Par

tne

rs

Bed partner leaves room

Very intense snoring annoying toanyone nearby

Loud snoring, enough to bebothersome to the bed partner

Soft snoring which doesn’t interrupt the bed partner’s sleep (social snoring)

No snoring at all

n=108 n=100

18%

85%

STAR trial data

quanni@inspiresleep.com@quan_ni

Inspire Better Sleep