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
o Founded in 2015
- ~100 FTEs
o HQ in Eindhoven, the Netherlands
- Science and Engineering Center in Lausanne, Switzerland
- US office in Boston, Massachusetts
- IPO 2021, Euronext Brussels and Amsterdam
- Followed by Stifel, Bryan, Garnier & Co, Degroof Petercam, Kepler Cheuvreux and KBC Securities
Note: 1 EUR = 1.1 USD; FTE and patent figures as of end of Q4 2023
1 Includes EP country validations
ONWARD® Medical at a Glance
Technology - 2 purpose-built neuromodulation platforms that stimulate the spinal cord via implantable (ARCIM®) or external (ARCEX®) technologies
Innovation - 10 FDA Breakthrough Device Designations and 240+ issued patents1
Clinical Success -
- Pivotal study demonstrated safety and effectiveness of ARCEX Therapy for upper limb mobility; published in Nature Medicine, May 2024
- Positive interim results reported for ARCIM Therapy to improve blood pressure regulation
Market Opportunity - Large total addressable market ($20B+ / €19B) with limited competition
Commercialization - Expect to launch first product and realize first revenues in 2H 2024
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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 |
Costly
Avg Lifetime Cost3 (paraplegic)
$2.9M/€2.6M
Avg Lifetime Cost3 (tetraplegic)
$5.1M/€4.6M
Note: 1 EUR = 1.1 USD
- NSCISC Annual Report, US and Europe only, World Health Organization Fact Sheet, November 2013, estimate 40-80 cases per million
- Kumar et al. 2018, Traumatic Spinal Injury: Global Epidemiology and Worldwide Volume
- 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
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Note: Investigational devices, not available for commercial use
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
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2024 comprises key value inflection points for ONWARD Medical
2024
2024 Strategic Priorities
ARCEX commercial launch (upper limb)
- FDA De Novo request submission (COMPLETED) o FDA clearance
o First commercial sale
ARCIM pivotal study first participant enrollment (blood pressure)
- IDE submission o IDE approval
o 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
1 Funded by European Innovation Council and Christopher & Dana Reeve Foundation grants
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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
- BDD = FDA Breakthrough Device Designation. ONWARD has been granted four additional BDDs for ARCEX Bladder, ARCEX Blood Pressure, ARCEX Spasticity and ARCIM Spasticity
- Includes both early feasibility (typically before device design finalized) and feasibility (near-final or final device design) studies
- Funded by Christopher & Dana Reeve Foundation grant
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Technology and Evidence
Attachments
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Disclaimer
ONWARD Medical NV published this content on 20 May 2024 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 20 May 2024 17:29:08 UTC.