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“A Solution for Obstructive Sleep Apnea: Closed Loop Neuromodulation : ”

“A Solution for Obstructive Sleep Apnea: Closed Loop Neuromodulation : ”. Mark Christopherson Vice President Product Development, Inspire Medical Systems, Inc. NANS, December 6, 2012. The Inspire Therapy is Investigational Use Only in the United States

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“A Solution for Obstructive Sleep Apnea: Closed Loop Neuromodulation : ”

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  1. “A Solution for Obstructive Sleep Apnea: Closed Loop Neuromodulation: ” Mark Christopherson Vice President Product Development, Inspire Medical Systems, Inc. NANS, December 6, 2012 • The Inspire Therapy is Investigational Use Only in the United States • Mark Christopherson is an employee of Inspire Medical Systems

  2. Definition of Obstructive Sleep Apnea • A loss of muscle tone during sleep allowing the upper airway to narrow or close… a physiologic issue • AHI = Apnea/Hypopnea Index is number of events per hour • Sufferers stop breathing for periods of up to 20-30 seconds as many as 40-50 times per hour • Breathing cessations eventually cause the brain to send what is essentially a wake-up call to the body

  3. Health Consequences of OSA Many co-morbidities have been directly linked with Obstructive Sleep Apnea… Early Mortality High Blood Pressure Congestive Heart Failure Stroke Neuro-cognitive Problems Daytime Sleepiness Job Impairment Fatigue-related accidents

  4. Prevalence of OSA and Clinical Treatment Guidelines – United States • +13 million patients • Moderate to Severe OSA in >30 yrs old: • Diagnosed • 20% • CPAP • Surgical Intervention • Fail CPAP30%-60% • Oral Appliance • Remain Untreated Many patients remain untreated or undertreated

  5. Moderate to Severe OSA Treatments • Gold standard • ~1 mil units per year • Low compliance 50% High (CPAP) Maxillofacial advancement • Facial reconstruction • Good clinical results • <2k procedures / yr Intrusiveness • Variable results • Painful recovery • 40k procedures / yr Inspire therapy UPPP Surgical removal: tonsils, uvula, adenoids, soft palate Low Low Invasiveness High Upper Airway Stimulation addresses and unmet need: Less invasive, durable results, high patient compliance

  6. The Inspire System Neurostimulation worksWITH patient’s physiology • No removing / altering anatomy • Straightforward, scalable procedure • Fast post-op recovery • Non invasive therapy titration

  7. The Inspire System Closed-loop Synchronized Stimulation Stimulation Lead - Self sizing cuff - Multiple stimulation vectors Implanted Pulse Generator (IPG) - Commercial grade technology platform - 6-8 year projected longevity Respiration Sensor - Secure, stable location - Direct measurement of respiratory effort

  8. Upper Airway Neuro-anatomy &Stimulation Site Superior Longitudinal Styloglossus (SG) Inferior Longitudinal Hyoglossus (HG) Stimulation Site: Medial branch of the hypoglossal nerve, activates only protrusors (genioglossus, geniohyoid), distal to retractors (styloglossusand hyoglossus) Geniohyoid (GH) Thyrohyoid Superior root of ansacervicalis Genioglossus (GG) Stimulation Site Mauer JT 2012 Hypoglossal Nerve (XII)

  9. Cuff Electrode Placement on the Hypoglossal Nerve

  10. Sensor Location: Minimally Invasive • Sensor Incision/Dissection: • Within Intercostal muscles 2 3 4 5

  11. Typical Stimulation Parameters:2.5 volts, 90 microseconds, 33 Hz Inspiratory Expiratory Sensor Signal Stimulating Pulses

  12. Upper Airway StimulationImmediate effect on stabilizing airway Therapy activated EEG EMG Nasal Therm Chest Abdm SaO2 Therapy ON Therapy OFF 30 second

  13. Sleep Study – Apneic events return upon Turning the Inspire system OFF Stimulation turned off Effort shows patient is trying to breath Airflow obstructions Snoring

  14. Inspire Clinical Trial Experience

  15. Feasibility Trial - AHI ResponsePatients meeting Pivotal Selection Criteria (N=18) 34 ±6.2 AHI = Apnea-Hypopnea Index

  16. Inspire Therapy: 20 years of Clinical Research and Product Development Experience 2000 2007 2012 STAR Pivotal Trial Implants Complete Target for FDA approval & US commercial launch 2nd Gen Technology Development Medtronic Feasibility Study 1 Complete Feasibility Studies 2&3 Complete • Inspire is a spin out from Medtronic • 170+ global implants conducted at 25+ global clinical sites • Commercially available in Europe (CE Mark received in 2010) • The Inspire system is for Investigational Use Only in the United States • Mark Christopherson is an employee of Inspire Medical Systems

  17. Inspire Therapy Aims to Improve Comfort, Convenience and Utilization CPAP therapy Inspire therapy • Clinically effective • Utilization / compliance 40-70% Patient uses Controller to: - Start, stop, pause therapy

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