Onward Medical N.v. · EURONEXT:ONWD
Onward Medical — Onward Med — Q1 2026 Earnings Presentation
44 slides from Onward Medical's earnings presentation, May 26, 2026
Slide 1: Company Deck May 2026
Company Deck May 2026
Slide 2: Forward Looking Statements
Forward Looking Statements This Presentation may include statements, including the Company’s financial and operational medium-term objectives, that may be deemed to be “forward-looking statements”. These forward- looking statements may be identified by the use of forward-looking terminology, includi
Slide 3: Company Overview
Company Overview
Slide 4: ONWARD Overview
Pioneering neuromodulation therapies to restore movement, function, and ONWARD Overview independence after SCI 3 differentiated technology platforms designed to deliver precise spinal cord stimulation Commercial Pivotal trial Clinical underway feasibility 10 FDA Breakthrough Device US & Europe studi
Slide 5: Unmet Need
Legacy standard-of-care Unmet Need approaches do not offer restoration after spinal cord injury (SCI) Devastating Prevalent Costly Not only paralysis & US & Europe1 Global2 $2.9M / €2.6M loss of sensation; Avg Lifetime Cost3 frequently also infection, ~650,000 ~9,000,000 (paraplegic) incontinence, b
Slide 6: Vision
Vision Empowered by independence, people with spinal cord injury will enjoy life in the ways that matter to them ONWARD Medical Company Deck 6
Slide 7: Technology Portfolio
First platform now cleared for use in US and Europe; global pivotal trial for second platform and several Technology clinical feasibility studies ongoing Portfolio Pre-clinical Commercial Human PoC Clinical feasibility First indication: Hand sensation & strength after SCI Pivotal External stimulatio
Slide 8: Growth Strategy
Focus first on near-term indications and path to profitability, then unlock multiple additional Growth Strategy indications and populations Phase 1 Phase 2 Focus ARCEX hand sensation & strength and Label and platform expansion ARCIM blood pressure instability Expected o1 Drive commercial uptake for
Slide 9: Technology and Evidence
Technology and Evidence
Slide 10: External Platform
One of TIME Magazine’s External system for non-invasive, programmed Best Inventions of 2024 stimulation of the spinal cord External Platform ARCEX® Therapy Programmed transcutaneous electrical stimulation to the spinal cord ARCEX® Neurostimulator ARCEX® PRO app via ARCEX® Programmer ARCEX® Therapy I
Slide 11: First indication: Hand strength and sensation
First indication: Hand strength and sensation1 TAM2 US & EU eligible population $6.0B / €5.2B ~200,0003 (30% of SCI cases ) 4 1 The ONWARD Medical ARCEX System is cleared for use in the United States and Europe. FDA clearance (abbreviated) is to deliver programmed transcutaneous electrical spinal co
Slide 12: Pivotal Trial Results ARCEX Therapy
Met all primary and secondary endpoints, highlighting safety and effectiveness in Pivotal Trial Results improving upper limb function after SCI1 (n=65, 14 trial sites globally) ARCEX Therapy 90% 87% 34 YEARS Improved strength or Reported Responders up to 34 function improvement in years post-injury
Slide 13: Home Use Results ARCEX Therapy
LIFT Home trial results support the safety, usability, and therapeutic benefits of at-home ARCEX Home Use Results Therapy as a continuation of in-clinic treatment* (n=17, 5 trial sites in the US) ARCEX Therapy 96% Attempted home therapy sessions completed Compliance with the prescribed therapy was h
Slide 14: Pathfinder2 Study Results
One-year study shows benefits and importance of sustained access to ARCEX Therapy Pathfinder2 Study Results Study details o Multi-center clinical trial o 10 participants with a chronic (>1 year) spinal cord injury o 120 sessions of activity-based therapy combined with ARCEX Therapy Key takeaways o S
Slide 15: Implantable Platform
IPG and leads for direct, programmed stimulation of the spinal cord Implantable Platform myARCIM® App via ARCIM® Controller ARCIM® Lead Family ARCIM® PRO App via ARCIM® Programmer ARCIM® Neurostimulator (IPG) ARCIM® Hub Confidential Note: For investigational use only; IPG = Implantable Pulse Generat
Slide 16: First indication: Improved blood pressure regulation
First indication: Improved blood pressure regulation TAM1 US & EU eligible population $9.3B / €8.2B ~210,0002 (32% of SCI cases ) 3 1 Estimate based on eligible population (see footnotes 2&3) multiplied by pricing in alignment with value in comparison to existing rehabilitation therapies; 2 Estimate
Slide 17: Blood Pressure Unmet Need in SCI
Greater than 90% of patients treated for blood pressure instability continue to Blood Pressure experience symptoms Unmet Need in SCI Orthostatic Hypotension (OH) Autonomic Dysreflexia (AD) Low blood pressure tied to posture or postural Sudden, often dangerous rise in blood pressure in response to a
Slide 18: Clinical Feasibility Results
Clinical feasibility studies’ results show immediate improvement in blood pressure stability and Clinical Feasibility durable reduction of hypotensive symptoms Results HemON clinical feasibility results published in September 2025 in Nature and Nature Medicine + Multi-year clinical feasibility study
Slide 19: EMPOWER BP Study Design
FDA IDE approval received and prospective, randomized, sham-controlled and double- EMPOWER BP blinded study ongoing Study Design Key parameters Leading investigators in the US, Canada, and Europe Up to 112 participants across 22 sites Opportunity for interim analysis based on first 33 participants P
Slide 20: ARCIM Blood Pressure Roadmap
Commercial launch continues to be anticipated in 2H 2028 ARCIM Blood Pressure Roadmap Pivotal trial & commercial launch 2026 2027 2028 2029 Enrollment and primary endpoint completion Follow-up Interim analysis Submission & approval Anticipated commercial launch ONWARD Medical Company Deck 20
Slide 21: Pipeline Overview
Advancing pipeline with grant funding and investigator-initiated studies to ensure focus on Pipeline Overview two initial indications and targeted use of capital Pre-clinical Human PoC Clinical feasibility Pivotal Commercial Eligible population Platform Indication FDA BDD1 Current stage in US & Euro
Slide 22: Next indication: Standing and walking
A Next indication: Standing and walking TAM1 US & EU eligible population $10.6B / €9.4B ~240,0002 (36% of SCI cases ) 3 1 Estimate based on eligible population (see footnotes 2&3) multiplied by pricing in alignment with value in Confidential comparison to existing rehabilitation therapies; 2 Estimat
Slide 23: A Mobility - STIMO Trial
Ability to stand and walk restored in A Mobility - STIMO Trial 9 participants with chronic injuries; even those with AIS-A severity Clinically Incomplete Spinal Cord Injury Clinically Complete Spinal Cord Injury ClinicalTrials.gov Identifier: NCT02936453 Note: For investigational use only ONWARD Med
Slide 24: A SCI Mobility
Promising clinical feasibility study results for A SCI Mobility enabling ability to stand and walk in participants with chronic spinal cord injuries Eligible population Key achievements to date ~240’0001 Published data in Nature demonstrating Unmet need the preliminary effectiveness of spinal cord s
Slide 25: Think B AI-Powered ARCBCI Brain Implant
ARCBCI Brain Implant Brain and spinal cord are reconnected by ONWARD Think B AI-Powered DigitalBridge to restore ARCBCI thought-driven movement Wearable Data Station An intention to move originates in the brain Implantable Platform . Decode An AI algorithm translates that intention into instructions
Slide 26: B Brain Computer Interface (BCI)
We are strategically well positioned: Current B Brain Computer device facilitates research and ARCIM agnostic architecture provides future optionality Interface (BCI) Other BCI Platforms Restore movement of the human body Main Focus Control or communicate with computers Cleared for human research wi
Slide 27: B BCI Mobility & Upper Limb
Enabling thought-driven movement B BCI Mobility & for SCI and stroke patients; already 7 humans implanted1 Upper Limb Eligible population Key achievements to date Expected first indication: First-in-human implant for mobility Mobility2 ~420’000 SCI in 2021 and first-in-human for Potential additional
Slide 28: Commercial
Commercial
Slide 29: Targeting and Channel Strategy
Customer concentration allows us to build direct sales channel and establish enduring Targeting and and valuable relationships Channel Strategy US Europe ~530 CALL POINTS GEOGRAPHICAL FOCUS ~450 ~80 US and select European markets with sophisticated neurorehabilitation infrastructure, clinical partne
Slide 30: Current US Sales Team Buildout
As of 06 March 2026 US field organization now fully deployed and productive, comprised of 100% Physical and Current US Sales Occupational Therapists Team Buildout Territories West Four Corners Red River North Central Ohio Valley South Mid Atlantic 1 Sales leader North East 8 Sales staff 6 Clinical s
Slide 31: Rehabilitation Clinic Importance
Current focus is SCI rehabilitation clinics which are central to ONWARD’s US Rehabilitation Clinic commercialization strategy Importance SCI CLINIC CLINIC HOME Clinics purchase ARCEX devices as Clinics prescribe home use for new Clinics refer patients to capital equipment and bill for or chronic pat
Slide 32: US Home Market Access Landscape and Evolution
Success in clinics will drive home use, which will generate data required for US Home Market broad reimbursement; access to ~30% of market soon after home use authorization Access Landscape and Years 1-3 Years 3 and 4 Evolution Years 5+ No codes required for clinics as they purchase the Expect Medic
Slide 33: High Awareness and Pent-Up Demand
Enthusiasm from leading patient advocacy organizations and eagerness from High Awareness and SCI Community Pent-Up Demand Thousands of people with SCI, their clinicians, and caregivers have inquired about the ARCEX System “This is our most visible success!” Anita Gerhardter CEO Wings for Life “I hav
Slide 34: ARCEX Demand Indications
As of Mar 02, 2026 Continued high inbound global interest ARCEX Demand Indications 6,200+ 3,800+ 510+ Global leads US leads US medical collected1 collected1 professional leads collected High level of awareness, high degree of inbound interest, and limited competition = Reduced need for sales and mar
Slide 35: ARCEX 2025 Sales Acceleration
Sales increasing each quarter, with ARCEX now available in over ARCEX 2025 Sales 80 US clinics Acceleration 117 units sold 2025 sales, # of units sold (cumulative) >80 US clinics penetrated 70 units sold1 >50 US clinics penetrated 30 units sold1 10 units sold Q1 Q2 Q3 Q4 Limited US clinic launch Bro
Slide 36: ARCEX Scaling in 2026
US home use and EU / ROW are ARCEX Scaling new growth drivers for 2026 in 2026 ILLUSTRATIVE US Clinic Sales US Home Use Sales EU & ROW Sales Anticipated 2026 sales acceleration building on 2025 milestones CE Mark received US home use clearance Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 2025 2026 ONWARD Medical Company
Slide 37: ARCEX Supply Chain & Operations
Highly scalable and efficient manufacturing ARCEX Supply Chain & operations and supply chain Operations Scalable manufacturing process Supplier risk mitigations o Use of easily sourced standard components and raw materials, o Build early to ensure product availability providing flexibility and secur
Slide 38: Corporate
Corporate
Slide 39: Leadership Team
Strong leadership and governance with the expertise to scale the company Leadership Team Representative leaders from each stakeholder group Management Board Dave Marver Ali Kiboro Sean Sciara Shari O’Quinn Rob ten Hoedt Tim Denison, Prof. Lucas Buchanan Vivian Riefberg Chief Executive Chief Financia
Slide 40: 2025 Achievements
Very strong execution across all elements of the organization 2025 Achievements Commercial launch Advancing pipeline Corporate Sold 117 ARCEX® Systems to > 80 US clinics Received FDA IDE approval for EMPOWER BP Raised over EUR 50M in equity in first year on the market pivotal study capital, anchored
Slide 41: Financial Profile
Strong shareholder base and access to capital Financial Profile Cap table Capital access Strategic Long-only and specialist US ADRs traded on investors & investors 3 listing venues Brussels NON-EXHAUSTIVE Ticker: ONWRY Amsterdam Paris Sources: Company, public disclosures, Euronext, Bloomberg ONWARD
Slide 42: Strategic Investments
Strategic investments from Ottobock and Christopher Reeve Foundation, with Strategic Investments opportunities for future collaboration o A global leader in the fields of prosthetics, orthotics and o Premier US non-profit organization dedicated to advancing exoskeleton technology innovative research
Slide 43: Upcoming Milestones and News Flow
Several important catalysts expected in the next 12 months Upcoming Milestones ARCEX ARCIM ARCBCI and News Flow ARCEX ARCEX ARCEX ARCEX First commercial clinic First commercial home First commercial home First commercial clinic sale (EU) use sale (US) use sale (EU) sale (ROW) Hand sensation & Hand s
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