Nyxoah Sa · EURONEXT:NYXH
Nyxoah Sa — Investor Presentation (June 2025)
22 slides from Nyxoah Sa's investor presentation, June 2025
Slide 1: Company Overview
Company Overview June 2025
Slide 2: Forward-Looking Statements
Forward-Looking Statements Please read the following before continuing. This presentation has been prepared by the management of Nyxoah SA (the "Company"). It does not constitute or form part of, and should not be construed as, an offer, solicitation or invitation to subscribe for, underwrite or oth
Slide 3: Our vision is to make sleep simple
Our vision is to make sleep simple. Nyxoah is a MedTech company with a unique neuromodulation solution for Obstructive Sleep Apnea, putting the patient first.
Slide 4: Nyxoah's Blueprint for Success
Nyxoah’s Blueprint for Success Focused on Rapidly Growing, Underpenetrated $10 Billion US Obstructive Sleep Apnea (OSA) Annual Market Opportunity Breakthrough Treatment For OSA With Unique Bilateral Mode of Action Compelling Clinical Evidence Through DREAM IDE Study Demonstrating Safety and Efficacy
Slide 5: Obstructive Sleep Apnea is a Debilitating Chronic Condition
Obstructive Sleep Apnea is a Debilitating Chronic Condition Obstructive Sleep Apnea (OSA) is a common, chronic disorder where the upper airway repeatedly collapses during sleep, interru pting breathing. Beyond significant quality of life impacts, poorly treated OSA can lead to severe health complica
Slide 6: Existing Therapeutic OSA Solutions Have Significant Limitations
Existing Therapeutic OSA Solutions Have Significant Limitations Mandibular Advancement Devices Standard of Care First Line Therapy: • Only suitable for mild to moderate OSA • Non-predictive therapy efficacy Continuous Positive Airway Pressure • High out-of-pocket cost to patient (CPAP) Unilateral Hy
Slide 7: Rapidly Growing $10 Billion US Market Opportunity with Limited Penetration
Rapidly Growing $10 Billion US Market Opportunity with Limited Penetration OSA is a medical condition that impacts over 54 million patients in the U.S. representing a $10 billion annual market opportunity. Despite this, current HGNS therapies lack widespread adoption with less than 100,000 patients
Slide 8: Make Sleep Simple
GcNlO Make Sleep Simple
Slide 9: Battery-free, MRI compatible implant
1.5T & 3T FULL-BODY MRI COMPATIBLE BATTERY-FREE IMPLANT STIMULATOR NOT VISIBLE AFTER INSERTION
Slide 10: Sleep Wearable
SLEEP WEARABLE Convenient, travel-friendly design Externally powers the system 10 Commercially confidential. Not for distribution.
Slide 11: Travel Friendly, Scalable Platform, Future Ready
(Photo, then implant with bilateral MOA) TRAVEL FRIENDLY SCALABLE PLATFORM FUTURE READY 11
Slide 12: Empowers the Patient to Help Drive Compliance
Empowers the Patient to Help Drive Compliance 12 Commercially confidential. Not for distribution.
Slide 13: DREAM Clinical Study
DREAM Clinical Study
Slide 14: Compelling Clinical Evidence: US Pivotal DREAM Study Achieved Endpoints
Compelling Clinical Evidence US Pivotal DREAM Study Achieved Safety and Efficacy Endpoints Achieved Co-Primary Endpoints Serious Adverse Events – 8.7% SAE Rate Unrelated to Related to Related to Serious Adverse Events Device and/or Device Implant 75% Implant 71.3% Asthenia and Hypoesthesia 2 Atrial
Slide 15: Additional DREAM Efficacy Endpoints
Additional DREAM Efficacy Endpoints Overall 70.8% Median AHI 66.6% Median AHI Reduction in 82% of Patients with Reduction at 12 Months Supine at 12 Months AHI Below 15 at 12 Months Change in AHI (4%)* Change in SUPINE AHI (4%)* (mean ± Standard deviation) (mean ± Standard deviation) 80 AHI at 12-Mon
Slide 16: Commercialization
Commercialization
Slide 17: Commercialization – International Markets
Commercialization – International Markets Germany – Commercial Proof of Concept Selective International Expansion Reimbursement National Coverage – Dedicated DRG • Germany • DRG code established in 2021, dedicated to Hypoglossal Nerve Stimulation • Switzerland • Both Genio and UHGNS use similar code
Slide 18: US Commercialization
US Commercialization Reimbursement • Expect to use an established CPT code recognized by payers for the OSA indication at launch (64568) • Worked closely with the American Academy of Otolaryngology (AAO) on strategy • Participating in the FDA's Early Payer Feedback Program Smart Follower Strategy –
Slide 19: At U.S. Launch: Intend to Cover ~30% of Current U.S. HGNS Market
At U.S. Launch: Intend to Cover ~30% of Current U.S. HGNS Market With 25 Experienced Territory Managers Initial U.S. Launch Markets: Territory Manager Profile • Seattle >10 Years Average Experience • Minneapolis Grand Rapids ● • Detroit • Upstate NY • Newark 44% Cedar Rapids ● •Chicago (2) Prior HGN
Slide 20: Nyxoah's Expected Growth Path Forward
Nyxoah’s Expected Growth Path Forward INNOVATION LEADERSHIP GEOGRAPHIC • Wearables and EXPANSION Internet of Things INDICATION • New stimulation • Additional EXPANSION targets international markets with US LAUNCH • Complete reimbursement Concentric COMMERCIAL Collapse PILOT • FDA approval Q2’25 Expe
Slide 21: Nyxoah's Strategy for Success
Nyxoah’s Strategy for Success Business Poised for Scaled Execution • Proven clinical efficacy with DREAM study data • Successful commercial proof of concept in Germany • Establishing leadership in new markets (UK, Middle East) • Supply chain infrastructure in place Unlocking a $10B Market Opportunit
Slide 22: References
References Sources DREAM Study Design Details 1. Young T. et al: Sleep Disordered Breathing and Mortality: Eighteen-Year Follow-up of the Wisconsin Sleep Cohort, Sleep. 2008 Aug 1; 31(8): 1071–1078. DESIGN 2. Al Lawati NM, Patel SR, Ayas NT. Epidemiology, risk factors, and consequences of obstructiv