Nyxoah Sa · EURONEXT:NYXH
Nyxoah Sa — Nyxoah Symposium: Obstructive Sleep Apnea – From Diagnosis to Treatment (November 2022)
70 slides from Nyxoah Sa's conference presentation, November 2022
Slide 1: Obstructive Sleep Apnea – From Diagnosis to Treatment
Obstructive Sleep Apnea – From Diagnosis to Treatment –
Slide 2: Introduction and Agenda
Introduction and Agenda Introduction David DeMartino – Chief Strategy Officer, Nyxoah Nyxoah Overview Olivier Taelman – Chief Executive Officer, Nyxoah From Diagnosis to Treatment Acurable Overview Diagnosis Emilio Sanz – Chief Executive Officer, Acurable Nyxoah/Acurable AcuPebble Home Hypoglossal N
Slide 3: Olivier Taelman, Chief Executive Officer, Nyxoah
Olivier Taelman Chief Executive Officer, Nyxoah
Slide 4: Nyxoah Our History
Nyxoah Our History Founding of Nyxoah Proof of concept CE Mark approval EURONEXT IPO NASDAQ IPO Genio® 2.1 approval 2009 2014 2019 2020 2021 2022 First-in-Man Genio® invention FDA IDE study 1.5T & 3T full- CCC DREAM complete, 2012 2016 approval body MRI • FDA Breakthrough ACCCESS initiated 2020 2021
Slide 5: A global company with over 150 employees
Nyxoah A global company with over 150 employees 5
Slide 6: Improving Lives Through Restful Nights
Improving Lives Through Restful Nights A patient-centric solution TODAY… … An intelligent medtech solution TOMORROW Single incision procedure Leadless and battery-free Full-body 1.5T and 3T MRI compatible Bilateral stimulation Indicated for both CCC and non-CCC Scalable platform 6
Slide 7: A Patient-Centric Approach to Innovation
A Patient-Centric Approach to Innovation Maximize therapy efficacy • Integrated sensors as a baseline for future developments • Position sensors – Accelerometer and gyroscope • Sound sensor – Microphone • Incorporating learnings from physicians • NAPS team: R&D, clinical, T&E, Physicians Patient own
Slide 8: The Nyxoah “Care4” Program
The Nyxoah “Care4” Program Building an OSA Ecosystem 1 Discover 2 Moderate to severe OSA diagnosis • Snoring • Sleep Lab Polysomnography • Daytime sleepiness Prioritize PSG waiting lists 4 Refractory to CPAP 3 CPAP – First line • Refusal – Failure – Poor compliance Confirm prior PSG Restful Nights 5
Slide 9: Kill Two Birds with One Stone…
Kill Two Birds with One Stone… 9
Slide 10: AcuPebble SA100
AcuPebble® SA1 00 Emilio Sanz – Chief Executive Officer, Acurable
Slide 11: Our solution: AcuPebble SA100
Our solution: AcuPebble® SA100 The first medical device to obtain the CE mark for the automated diagnosis of obstructive sleep apnoea ▸ Over a decade of research ▸ Clinically validated accuracy ▸ Top technology awards ▸ Supported by NHS England Acurable | 12
Slide 12: AcuPebble SA100 makes diagnosis simple
AcuPebble® SA100 makes diagnosis simple Prevalence worldwide (in millions) Using AcuPebble SA100 is as simple as peeling off an adhesive and putting it on Acurable | 13
Slide 13: Clinically validated accuracy
Clinically validated accuracy POWERED CLINICAL TRIAL (150 adult patients) ▸ Proved sleep apnoea diagnosis equivalence to ambulatory gold-standard (polygraphy followed by specialist interpretation). ▸ Validated AHI and ODI based diagnosis for 3% and 4% desaturation criteria with very high accuracy (9
Slide 14: Detailed study report available in minutes
Detailed study report available in minutes DIAGNOSIS DETAILS ▸ Overall diagnosis (test result and severity). ▸ AHI and ODI diagnostic indexes for 3% and 4% desaturation criteria, using estimation of sleep time. ▸ Classification of apnoea events (obstructive vs. central, apnoea vs. hypopnea) ADDITION
Slide 15: Based on acoustic sensing
Based on acoustic sensing HOW IT WORKS 1. Physiological body processes such as the respiratory and cardiac functions generate sounds rich in information. 1. AcuPebble sensor records these internal body sounds which are transferred to a mobile device wirelessly. 1. Sophisticated signal processing alg
Slide 16: Most common use cases
Most common use cases USE CASES ▸ Diagnosis/Screening of patients for sleep apnoea treatment ▸ Titration of therapeutic devices to achieve optimal adjustment ▸ Monitoring of treatment to track patient evolution and improve compliance 17
Slide 17: Benefits AcuPebble SA100
Benefits AcuPebble® SA100 AcuPebble SA100 is a valid alternative to the ambulatory gold-standard with 4 key advantages: ▸ Automated: provides an accurate report with no manual interpretation needed in minutes. ▸ Efficient: requires fewer resources and saves valuable clinician time. ▸ Easy to use: no
Slide 18: emilio@acurable.com
emilio@acurable.com Document version 1.8 // Date 2-Nov-2022
Slide 19: Hypoglossal Nerve Stimulation and the Need for CPAP Alternatives
Hypoglossal Nerve Stimulation and the Need for CPAP Alternatives Prof. Dr. med. Joachim T. Maurer Division of Sleep Medicine Department of ORL-HNS, University Hospital Mannheim
Slide 20: Conflict of interest
Conflict of interest – 36 months • University Hospital Mannheim: Contracts with Inspire, LivaNova, Nyxoah, Medel • J.T. Maurer: Honoraria for presentations and/or surgical training from Inspire, LivaNova, Neuwirth Med. Products, Nyxoah
Slide 21: CPAP as new treatment for OSA
CPAP as new treatment for OSA Colin Sullivan invented CPAP in 1981 to bridge the time gap until UPPP could be performed. Today less than 500 g!
Slide 22: Immediate CPAP effect - 1986 in Marburg
Immediate CPAP effect - 1986 in Marburg Thanks to HF Becker, Marburg/Hamburg
Slide 23: Cardiovascular morbidity and mortality in OSA
Cardiovascular morbidity and mortality in OSA n=1387 Reduced morbidity and mortality, if regulkarly used (Marin JM et al 2005) 3,3 h/night are not enough (McEvoy et al 2017)
Slide 24: Cardiovascular mortality in elderly patients with OSA
Cardiovascular mortality in elderly patients with OSA n=939; ≥65J AHI≥30, n=173 AHI 15-29, n=108 CPAP therapy ≥ 4h, n=503 Controls AHI < 15, n=155 Martinez-Garcia et al., AJRCCM, 2012)
Slide 25: Are PAP and MAD used sufficiently?
Are PAP and MAD used sufficiently? Soose RJ et al., 2017 World J Otolaryngol Head Neck Surg
Slide 26: Reasons for CPAP failure
Reasons for CPAP failure (n=156) Lam et al JCSM 2017
Slide 27: What to do if PAP and / or MAD are not successful?
What to do if PAP and / or MAD are not successful? • Eliminate the obstacles → Nasal surgery • Add another treatment → MAD + Palatal surgery • Switch to alternative treatment → MMA, TE + palatal surgery • Functional treatment using hypoglossal nerve stimulation
Slide 28: Neurostimulation: When and when not?
Neurostimulation: When and when not? „Normal“ anatomy Impaired function
Slide 29: Concepts of neurostimulation in OSA
Concepts of neurostimulation in OSA • Efferent neurostimulation – Active AP-opening by advancement of tongue and soft palate – Circumferential stiffening of pharyngeal wall by tracheal/laryngeal caudal tug • Afferent neurostimulation – Improving muscle responsiveness to negative pressure
Slide 30: Hypoglossal nerve stimulation: Opening the airway
Hypoglossal nerve stimulation: Opening the airway in an antero-posterior dimension Styloglossus (SG) Hyoglossus (HG) terminal Superior Longitudinal Lateral – proximal Inferior Longitudinal proximal – distal Median distal – terminal fibres M. Genioglossus (GG) N. thyrohyoideus Geniohyoid (GH) Superio
Slide 31: Upper Airway Stimulation (UAS)
Upper Airway Stimulation (UAS) • Distal selective stimulation • Exclusion of retractor branches • Unilateral • Battery implanted • Fixed stimulation settings for entire night
Slide 32: Genio (Nyxoah)
Genio (Nyxoah) • Bilateral stimulation • External battery • MRI full body (3 Tesla) scan is possible • Approved for complete concentric collapse in 2021 • Fixed stimulation settings for entire night
Slide 33: Challenge in hypoglossal nerve stimulation
Challenge in hypoglossal nerve stimulation • Long-term data is needed • Better predictors of response required • Self-adapting stimulation parameters according to varying needs required – night-to night variability, body position, sleep stage • Implants usable for sensing and treatment adjustment
Slide 34: Conclusion
Conclusion • CPAP is standard of care in OSA treatment for any severity • Oral appliances are possible in mild to moderate OSA • PAP and MAD fail long-term use in appr. 50% of patients • Hypoglossal nerve stimulation is indicated for moderate to severe OSA and PAP-failure • Auto-adjusting stimulatio
Slide 35: Bilateral stimulation of the hypoglossal nerve
Bilateral stimulation of the hypoglosal nerve Prof. Dr. Clemens Heiser, M.D., MHBA, PHD Departement of Otorhinolaryngology, Head and Neck Surgery Somnology (DGSM), sleep physician, allergy, plastic surgery Head of sleep laboratory Klinikum rechts der Isar, Technical University Munich, Germany Phone:
Slide 36: Conflict of interest
Clemens Heiser Conflict of interest My conflicts of interest related to the following companies within the last 12 months: Nyxoah, Inspire Medical System, Löwenstein Medizintechnik, Neuwirth Medical Systems, XM Consult - Fees for lectures and/or consulting activities - Accommodation and travel expen
Slide 37: Unilateral vs bilateral vs target HNS comparison
Clemens Heiser unilateral HNS bilateral HNS target HNS Inspire® IV Nyxoah Genio System™ THN System, LivaNova Implantable device 3 pieces (IPG, stimulation & sensor electrode) 1 piece (stimulation electrode) 2 pieces (IPG, stimulation lead) placement stimulation distal (selective) medial branches of
Slide 38: HNS and its evidence in the real world
Clemens Heiser HNS and its evidence in the real world A Randomized Sham-Controlled Crossover Trial Baseline with Stim n = 89 Randomization n = 89 Therapeutic Stimulation Sham Stimulation n = 45 n = 44 Stim - Sham Sham - Stim n = 43 n = 44 Sham - Stim Stim - Sham n = 43 n = 43 Complete n = 86 Summary
Slide 39: Bilateral vs. unilateral HNS responder rate
Clemens Heiser bilateral vs. unilateral HNS – month 6 100% 90% 20% 20% 80% responder rate (Sher criteria) 70% 60% 50% 40% 80% 80% 30% 20% 10% n = 10 n = 10 0% uni HNS biHNS responder non-responder Partly published: Heiser C, Sommer JU, Hofauer B, de Vries N, Ravesloot MJ, Vanderveken OM, Jira D. Bil
Slide 40: Bilateral hypoglossal nerve stimulation
Clemens Heiser bilateral hypoglossal nerve stimulation bilateral stimulation hypoglossal nerve disposable Activation Chip (including battery) Heiser C, deVries N: Upper Airway Stimulation in Obstructive Sleep Apnea: Best Practices in Evaluation and Surgical Management. Springer; 1st ed. 2022 Edition
Slide 41: Bilateral HNS – duty cycle stimulation
Clemens Heiser bilateral HNS – duty cycle stimulation Total cycle length = L + i train length, L confirmatory train train train pulse, c delay time, d interval, interval, interval, i i i pulse duration, p Pulse interval, r duty cycle (e.g. 70%) • stimulation phase (L) = 2.8s pulse amplitude, • rest
Slide 42: Bilateral HNS – duty cycle stimulation
Clemens Heiser bilateral HNS – duty cycle stimulation train length, L confirmatory train train train pulse, c delay time, d interval, interval, interval, i i i pulse duration, p Pulse interval, r parameter description ranges Pulse duration (p) Duration of one stimulation pulse 50-250 µs pulse amplit
Slide 43: Bilateral HNS – duty cycle stimulation
Clemens Heiser bilateral HNS – duty cycle stimulation train length, L confirmatory train train train pulse, c delay time, d interval, interval, interval, i i i pulse duration, p Pulse interval, r target amplitude hold duration pulse amplitude, step down amplitude a ramp–up duration
Slide 44: Bilateral HNS – duty cycle stimulation
Clemens Heiser bilateral HNS – duty cycle stimulation With increase in duty cycle • the HIT rate increases in relation to inspiration • Increases inspiratory volume not yet published
Slide 45: Mechanism to open the upper airway
Clemens Heiser Mechanism to open the upper airway > The pharynx: A flexible muscular tube suspended from the skull base and spine > Modifiable in anterior-posterior and caudal directions > 50 years of sleep surgery only modify A-P dimension > Three physiologic supporting mechanisms 1. Genioglossus T
Slide 46: Mechanism to open the upper airway
Clemens Heiser Mechanism to open the upper airway Unilateral HNS Only: Note partial R palatal movement Unilateral HNS + Sternothyroid: Note improved palatal anteriorly, persistent LW collapse opening; LW stabilization Kent DT, Scott WC, Zealear D, Schwartz AR. Ansa cervicalis stimulation increases p
Slide 47: ANSA cervicalis stimulation
Clemens Heiser ANSA cervicalis stimulation Kent DT, Zealear D, Schwartz AR. Ansa Cervicalis and Hypoglossal Nerve Stimulation in a Patient With Obstructive Sleep Apnea. Otolaryngol Head Neck Surg. 2021 [Epub Ahead of Print] Mwachaka PM et al: Variations in the anatomy of ansa cervicalis. Folia Morph
Slide 48: Summary / Conclusion
Clemens Heiser Summary / Conclusion HNS (uni- & bilateral) in the clinical routine is • safe • well tolerated & accepted by the patients • shows good adherence • And highly effective New innovative therapeutic approaches in this field will make neurostimulation to smart neuromodulation.
Slide 49: Thanks for your attention
Clemens Heiser Thanks for your attention
Slide 50: The AcuPebble Opportunity
The AcuPebble Opportunity The AcuPebble Opportunity – Prof. Dr. med. J. Ulrich Sommer 54
Slide 51: What is LunaLab?
01 What is LunaLab? The AcuPebble Opportunity – Prof. Dr. med. J. Ulrich Sommer 55
Slide 52: LunaLab
LunaLab The AcuPebble Opportunity – Prof. Dr. med. J. Ulrich Sommer 56
Slide 53: Solution suitable for fast paced workflows?
Solution suitable for fast paced workflows? The AcuPebble Opportunity – Prof. Dr. med. J. Ulrich Sommer 57
Slide 54: What is AcuPebble?
02 What is AcuPebble? And why AcuPebble might be a perfect match for LunaLab… The AcuPebble Opportunity – Prof. Dr. med. J. Ulrich Sommer 58
Slide 55: A sensor records sounds from respiratory and cardiac functions
“ A sensor records sounds generated by respiratory and cardiac functions and blood oxygen. The AcuPebble Opportunity – Prof. Dr. med. J. Ulrich Sommer 59
Slide 56: How it works…
How it works… • Data transfer to a patient • Upload to the cloud • Signal processing algorithms owned mobile device using hyperscalable cloud computing The AcuPebble Opportunity – Prof. Dr. med. J. Ulrich Sommer 60
Slide 57: Report
Report The AcuPebble Opportunity – Prof. Dr. med. J. Ulrich Sommer 61
Slide 58: Report
Report The AcuPebble Opportunity – Prof. Dr. med. J. Ulrich Sommer 62
Slide 59: Clinical data
03 Clinical data The AcuPebble Opportunity – Prof. Dr. med. J. Ulrich Sommer 63
Slide 60: Clinical data
Clinical data • n=150 • AcuPebble + cardiorespiratory polygraphy simultaneously The AcuPebble Opportunity – Prof. Dr. med. J. Ulrich Sommer 64
Slide 61: Positive and negative predictive value
Positive and negative predictive value • Few diagnostic tests have both high PPV and NPV 3% desaturation 4% desaturation • Pulse Oximetry for the diagnosis of OSA 1 • PPV 97% • NPV 48% AHI based PPV: 94.4% PPV: 94.0% • Lung cancer screening test (with low dose CT) 2 diagnosis results NPV: 95.8% NPV:
Slide 62: AcuPebble vs. PG
AcuPebble vs. PG The AcuPebble Opportunity – Prof. Dr. med. J. Ulrich Sommer 66
Slide 63: The AcuPebble Opportunity
04 The AcuPebble Opportunity The AcuPebble Opportunity – Prof. Dr. med. J. Ulrich Sommer 67
Slide 64: Ensure patients most in need receive therapy ASAP
Ensure patients most in need receive therapy ASAP PSG Waiting List PSG CPAP Therapy? 6 Months+ for All Patients The LunaLab Paradigm AcuPebble CPAP Therapy? Sleep Test Faster Treatment for Moderate/Severe Patients The AcuPebble Opportunity – Prof. Dr. med. J. Ulrich Sommer 68
Slide 65: Current CPAP failure practice and shortcut
Current CPAP failure practice and shortcut PSG CPAP CPAP Failure PSG Genio? 6 Months + The LunaLab Paradigm AcuPebble Sleep Test Genio? 6 Days - The AcuPebble Opportunity – Prof. Dr. med. J. Ulrich Sommer 69
Slide 66: Monitoring Genio patients to ensure therapy is optimized
Monitoring Genio patients to ensure therapy is optimized Genio Genio Patient PSG Limitations on Routine Monitoring Waiting Lists, Costs, Inconvenience The LunaLab Paradigm AcuPebble AcuPebble Sleep Test AcuPebble for Routine Sleep Monitoring and Therapy Report Optimization The AcuPebble Opportunity
Slide 67: Summary
05 Summary The AcuPebble Opportunity – Prof. Dr. med. J. Ulrich Sommer 71
Slide 68: AcuPebble enables high-quality OSA screening in a fast-paced environment
“ AcuPebble enables us to provide high-quality OSA screening in a fast- paced and virtualized environment The AcuPebble Opportunity – Prof. Dr. med. J. Ulrich Sommer 72
Slide 69: Thank you and a wonderful evening!
Thank you and a wonderful evening! The AcuPebble Opportunity – Prof. Dr. med. J. Ulrich Sommer 73
Slide 70: Thank You & Enjoy the Evening
Thank You & Enjoy the Evening