Slide 1: Investor Webcast 2024 Full Year Results
Investor Webcast 2024 Full Year Results April 01, 2025
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, inclu
Slide 3: Speaking Today
Speaking Today Dave Marver Amori Fraser Mary Jones, PT, MPT Dan Spencer CEO Finance Director Clinician at Next ARCEX user at Next Steps Chicago Steps Chicago April 2025 Webcast 3
Slide 4: Introduction
Introduction April 2025 Webcast 4
Slide 5: ONWARD Medical Summary
Summary ONWARD Medical Key Facts Technology: 3 purpose-built neuromodulation platforms o Founded in 2015 o ARCEX® delivers ARC Therapy externally through the skin o ~100 FTEs o ARCIM® delivers ARC Therapy via a fully implanted system o ARCBCI® pairs ARCIM with an implanted brain-computer interface t
Slide 6: Vision
Vision Empowered by independence, people with spinal cord injury will enjoy life in the ways that matter to them Confidential April 2025 Webcast 6
Slide 7: Technology Portfolio
First platform now FDA approved; global pivotal trial for second platform to start in 2025; several clinical Technology feasibility studies ongoing Portfolio Pre-clinical Commercial Human PoC Clinical feasibility First indication: Hand sensation & strength after SCI Pivotal External stimulation Pivo
Slide 8: 2024 Business Update
2024 Business Update April 2025 Webcast 8
Slide 9: 2024 Publicly Announced Achievements
20 major achievements announced in 2024 2024 Publicly Announced Achievements Q1 Q2 Q3 Q4 Details to follow Clinical Clinical Science Development Announced expansion of ARCIM clinical Submitted De Novo application to Announced publication highlighting Secured exclusive rights to CEA’s WIMAGINE BCI fe
Slide 10: 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 No serious device-related adverse events 90% Study participants also reported reduced spasm frequency, Improv
Slide 11: Secured Leading BCI Technology
Exclusive rights to CEA’s WIMAGINE® BCI technology provides several opportunities Secured Leading BCI Technology License agreement signed with CEA for the WIMAGINE BCI system provides Company with the opportunity to: ” The early clinical feasibility research o Be first to market with a BCI-enabled s
Slide 12: Added Strategic Investor
Strategic investment from Ottobock offers opportunities for future collaboration Added Strategic Investor ” ONWARD Medical has the potential o A global leader in the fields of prosthetics, to become a gamechanger in the orthotics and exoskeleton technology therapy of spinal cord injuries with o Pres
Slide 13: Board Changes
Welcomed Rob ten Hoedt as Chairman of the Board Board Changes o Former Medtronic President and Executive Committee Member o Over 30 years of experience in medical devices o Successful track record in technology development, commercialization, and business-model innovation o Former Chairman of MedTec
Slide 14: ARCEX Recognition
Named one of TIME’s Best Inventions of 2024 ARCEX Recognition ” For most people with a spinal cord injury, there’s some [brain signal] conduction making it through the block, but not enough for movement,’ says Dave Marver, CEO of ONWARD. ‘This device serves as an amplifier. TIME Magazine The Best In
Slide 15: ARCEX FDA Approval
Received FDA De Novo classification and US market authorization for ARCEX ARCEX FDA Approval On December 19, 2024, ONWARD received FDA De Novo classification and authorization to market the ARCEX System in the US and with that is the first FDA-approved non-invasive spinal cord stimulation technology
Slide 16: 2024 Full Year Results
2024 Full Year Results April 2025 Webcast 16
Slide 17: FY 2024 Financial Review
FY 2024 Financial Review EUR Million For the year ended, 31 December 20241 2023 Total Revenues & Other Income 1.7 0.5 R&D Expenses (incl. Clinical & Regulatory) (17.2) (18.8) Marketing & Market Access Expenses (3.4) (2.9) Patent Fees & Related Expenses (1.4) (1.5) Quality Assurance Expenses (2.0) (1
Slide 18: Cash Update
Strong cash position of €60M Cash Update at year end Burn Burn Burn Ending Balance €10.7M used €17.9M used €36.0M used €60.0M net cash2 during Q4 2024 during H2 2024 in 20241 as of 31 Dec 2024 Note: 2024 results are unaudited 1 Cash burn represents cash invested in operation excluding proceeds from
Slide 19: 2025 YTD Business Update
2025 YTD Business Update April 2025 Webcast 19
Slide 20: 2025 YTD Achievements
ARCEX now available on VA online procurement platforms and new ARCEX publication shows 2025 YTD sustained benefits after one year Achievements January January February Commercial Commercial Clinical EX Announced first ARC System now Announced publication of commercial sales of available on US Vetera
Slide 21: Market Access
ARCEX System now available on US Veterans Affairs online procurement Market Access platforms ARCEX System is now available to US government clinics and other healthcare facilities o Department of Veterans Affairs' Federal Supply Schedule National Acquisition Center (VA FSS NAC) Service-Disabled Vete
Slide 22: Pathfinder2 Study Results (I)
One-year study shows benefits and importance of sustained Pathfinder2 Study access to ARCEX Therapy Results (I) Study details o Multi-center, non-randomized clinical trial o 10 participants with a chronic (>1 year) spinal cord injury o 120 sessions of activity-based therapy combined with ARCEX Thera
Slide 23: Pathfinder2 Study Results (II)
Enthusiasm and eagerness from SCI community Pathfinder2 Study Results (II) ” It's now time to stop talking about spinal cord injury as being incurable and to start talking about it as improvable. This breakthrough device demonstrates that function can be restored. With proper investment in spinal co
Slide 24: ARCEX Early Experience
EX ARC Early Experience April 2025 Webcast 24
Slide 25: Speaking Today
Speaking Today Mary Jones, PT, MPT Dan Spencer Clinician at Next Steps Chicago ARCEX User at Next Steps Chicago April 2025 Webcast 25
Slide 26: 2025 Outlook
2025 Outlook April 2025 Webcast 26
Slide 27: 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 FDA authorization (US) First commercial sale (US) CE mark (EU) Home use authorization (US) Hand sensation & strength Hand sensation & strength Hand sensation & stre
Slide 28: Next Business Update
Next Business Update Q1 2025 Business Update and Year-To-Date Highlights (June 17) April 2025 Webcast 28
Slide 29: Q&A
Q&A April 2025 Webcast 29
Slide 30: Thank you!
Thank you! April 2025 Webcast 30
Slide 31: Slide 31