1. Inspire Better Sleep
Quan Ni, PhD
Inspire Medical Systems
www.inspiresleep.com

2. 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

3. Sleep Study

4. Intermittent
hypoxia
Resp effort continues
No air flow
arousals
Polysomnography
1 minute
Apnea hyponea index (AHI): number of apnea and hypopnea events per hour, AHI~100

5. OSA and Survival
Young etal 2008, Wisconsin Sleep Cohort, n=1,522, 18 year follow-up

6. Continuous Positive Airway Pressure

7. 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

8. Tongue Protrusion as a Therapy

9. Upper Airway Neuroanatomy
9
Styloglossus (SG)
Hypoglossal Nerve (CN XII)
Hyoglossus (HG)
Genioglossus (GG)

10. Inspire II Systems
10
Stimulation Lead
Respiratory
Sensing Lead
Implantable Pulse Generator
Patient Remote
Physician
Programmer

11. Development Process
Plan
• Needs
• Features
• Requirements
Development
• Design
• Prototype
• Manufacture
Testing
• Bench test
• Pre-clinical
testing
• Human
testing

12. 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

13. Upper Airway Stimulation Effect
Stimulation ActiveNo Stimulation
EEG
EMG
Nasal
Therm
Chest
Abdm
SaO2
13

14. Significant Reduction In OSA Severity
Strollo et al on behalf of STAR trial investigators N Engl J Med 2014

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

16. 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

17. 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
PercentofPartners
Bed partner leaves room
Very intense snoring annoying to
anyone nearby
Loud snoring, enough to be
bothersome 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

18. quanni@inspiresleep.com
@quan_ni
Inspire Better Sleep