Company Deck

May 2024

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, including the terms '' believes''," aims"," forecasts"," continues",'' estimates'','' plans'','' projects'','' anticipates'','' expects'','' intends'','' may'','' or '' or, in each case, their negative or other variations or comparable terminology, or by discussions of strategy, plans, objectives, goals, future events or intentions. Forward-looking statements may and often do differ materially from actual results. Any forward-looking statements reflect the Company's current view concerning future events and are subject to risks relating to future events and other risks, uncertainties, and assumptions relating to the Company's business, results of operations, financial position, liquidity, prospects, growth, or strategies. Forward-looking statements speak only as of the date they are made.

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Company Overview

Key Facts

  1. Founded in 2015
  1. ~100 FTEs
  1. HQ in the Netherlands
  1. Science and Engineering Center in Switzerland
  1. Growing US presence
  1. IPO 2021, Euronext Brussels and Amsterdam
  1. Followed by Stifel, Bryan, Garnier & Co, Degroof Petercam, Kepler Cheuvreux and KBC Securities

ONWARD® Medical at a Glance

Technology: 3 purpose-built neuromodulation platforms

  1. ARCEX® delivers ARC Therapy externally through the skin o ARCIM® delivers ARC Therapy via a fully implanted system

o ARCBCI pairs ARCIM with an implanted brain-computer interface to restore thought- driven movement via a wireless DigitalBridge

Innovation: 10 FDA Breakthrough Device Designations; 265+ issued patents1

Clinical Success:

  1. Safety and effectiveness of ARCEX Therapy for upper limb mobilitydemonstratedin Up-LIFT clinical trial; results publishedin Nature Medicine, May 2024
  1. Positive interim results for ARCIM Therapy to improve blood pressure regulation

Market Opportunity: $20B+ / €19B+ total addressable market with limited competition

Commercialization: First revenues expected 2H 2024 with ARCEX launch

Note: 1 EUR = 1.1 USD; FTE figures as of end of Q4 2023; patent figures as of end of Q1 2024

1 Includes EP country validations

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There are no cures nor effective therapies for spinal cord injury (SCI)

Unmet Need

Devastating

Prevalent

Not only paralysis & loss of

US & Europe1,2

sensation; frequently also

Prevalence ~650,000

infection, incontinence, blood

Incidence ~50,000

pressure instability, loss of sexual

function, and other challenges

Global2

Prevalence ~7,000,000

Assistance required to support

Incidence ~768,000

activities of daily life

Quality of life can be poor

Note: 1 EUR = 1.1 USD

Costly

Avg Lifetime Cost3 (paraplegic)

$2.9M/€2.6M

Avg Lifetime Cost3 (tetraplegic)

$5.1M/€4.6M

  1. NSCISC Annual Report, US and Europe only, World Health Organization Fact Sheet, November 2013, estimate 40-80 cases per million
  2. Kumar et al. 2018, Traumatic Spinal Injury: Global Epidemiology and Worldwide Volume
  3. NSCISC Traumatic Spinal Cord Injury Facts and Figures at a Glance (2023 SCI Data Sheet); estimated lifetime costs for a person aged 25 at the time of injury with injury severity AIS ABC; costs for a tetraplegic person calculated as the average cost for a person with high tetraplegia and a person with low tetraplegia

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Targeted, programmed electrical stimulation of the spinal cord to restore movement, function, and independence in people with spinal cord injury

Our Technology

Note: Investigational devices, not available for commercial use. The ARCBCI graphical representation includes ONWARD Medical's ARCIM with CEA Clinatec's WIMAGINE® brain-computer interface.

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Reach commercial stage by year-end, then expand labeling and platforms

Company Focus

Short Term

Medium Term

2024

2026

Commercialize external platform (ARCEX)

Commercialize implantable platform (ARCIM)

First indication: Upper Limb

First indication: Blood Pressure

Population: SCI

Population: SCI

Generate revenue and develop market for ARCIM

Enter traditional medtech IPO/M&A window

Note: Investigational devices, not available for commercial use; SCI = Spinal Cord Injury. The ARCBCI graphical representation includes ONWARD Medical's ARCIM with CEA Clinatec's WIMAGINE® brain-computer interface.

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2024 comprises key value inflection points for ONWARD Medical

2024

2024 Strategic Priorities

ARCEX commercial launch (upper limb)

  1. FDA De Novo request submission (COMPLETED) o FDA clearance
  1. First commercial sale

ARCIM pivotal study first participant enrollment (blood pressure)

  1. IDE submission
  1. IDE approval
  1. First participant enrollment

Continue clinical studies1 and strengthen unique position in BCI field (upper limb and mobility)

Note: Investigational devices, not available for commercial use

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1 Funded by European Innovation Council and Christopher & Dana Reeve Foundation grants

9 indications under clinical or pre-clinical evaluation, with 3 in current roadmap

Short and medium term focus

Funded primarily through grants and research partners

Current Pipeline

Platform

Indication

FDA BDD1 Pre-clinical

Human PoC

Clinical

Pivotal

Feasibility2

ARCEX

Upper Limb

ARCIM

Blood Pressure

ARCIM

Mobility / Second

Indication

ARCEX

Mobility

ARCIM

Parkinson's - Mobility

ARCIM

Bladder

Human PoC

expected in 20243

ARCBCI

Mobility

ARCBCI

Upper Limb

ARCDBS

Mobility

BDD1 Granted

Current Roadmap

Label Expansion

Platform Expansion

Note: The company may modify the pipeline based on clinical progress and marketplace considerations

  1. BDD = FDA Breakthrough Device Designation. ONWARD has been granted four additional BDDs for ARCEX Bladder, ARCEX Blood Pressure, ARCEX Spasticity and ARCIM Spasticity
  2. Includes both early feasibility (typically before device design finalized) and feasibility (near-final or final device design) studies
  3. Funded by Christopher & Dana Reeve Foundation grant

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Technology and Evidence

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Disclaimer

ONWARD Medical NV published this content on 23 May 2024 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 23 May 2024 13:19:01 UTC.