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Restoring function after paralysis

Restoring function after paralysis

New Capabilities
By Newzino Staff |

Spinal cord stimulation evolves from pain management to movement restoration and autonomic recovery

February 4th, 2026: First Patient Enrolled in Empower BP Pivotal Trial

Overview

For decades, blood pressure instability has silently debilitated people with spinal cord injuries—78% of those with cervical injuries experience dangerous drops when sitting upright, yet only 28% receive treatment that actually works. ONWARD Medical just enrolled the first participant in a pivotal trial testing whether an implanted spinal cord stimulator can solve this problem by restoring the autonomic signals that paralysis disrupts.

The Empower BP trial represents a new frontier for spinal cord stimulation technology. While epidural stimulators have already enabled paralyzed individuals to walk again in research settings, this study targets a less visible but equally life-limiting consequence of spinal cord injury: the inability to maintain stable blood pressure during everyday activities like sitting, eating, or physical therapy.

Key Indicators

10
FDA Breakthrough Device Designations
ONWARD Medical's ARC-IM system has received breakthrough status for movement, blood pressure, trunk stability, bladder control, and spasticity
78%
Tetraplegia patients with orthostatic hypotension
Blood pressure drops when sitting or standing affect the majority of people with cervical spinal cord injuries
~350,000
Affected individuals in US and Europe
People living with blood pressure instability secondary to spinal cord injury
20
Clinical trial sites
Leading neurorehabilitation centers across the US, Canada, and Europe participating in Empower BP

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People Involved

Grégoire Courtine
Grégoire Courtine
Co-founder and Chief Scientific Officer, ONWARD Medical; Professor of Neuroscience, EPFL (Leading scientific development of spinal cord stimulation therapies)
Jocelyne Bloch
Jocelyne Bloch
Co-founder, ONWARD Medical; Professor of Neurosurgery, Lausanne University Hospital and EPFL (Performing surgical implantations and leading clinical development)
Dave Marver
Dave Marver
Chief Executive Officer, ONWARD Medical (Leading company through commercial launch and pivotal trials)
Candy Tefertiller
Candy Tefertiller
Executive Director of Research and Evaluation, Craig Hospital; Empower BP Principal Investigator (Leading pivotal trial enrollment at first clinical site)

Organizations Involved

ONWARD Medical N.V.
ONWARD Medical N.V.
Medical technology company
Status: Conducting pivotal trials and commercializing first FDA-approved spinal cord stimulation system

EPFL spin-off developing implantable and non-invasive spinal cord stimulation therapies to restore movement and autonomic functions after paralysis.

Craig Hospital
Craig Hospital
Rehabilitation hospital
Status: First clinical site to enroll patient in Empower BP trial

World-renowned rehabilitation hospital in Denver specializing exclusively in spinal cord and brain injury treatment.

École Polytechnique Fédérale de Lausanne (EPFL)
École Polytechnique Fédérale de Lausanne (EPFL)
Research university
Status: Origin institution for spinal cord stimulation research underlying ONWARD therapies

Swiss federal technology institute where Grégoire Courtine and Jocelyne Bloch developed the targeted spinal cord stimulation approach that ONWARD Medical is commercializing.

U.S. Food and Drug Administration
U.S. Food and Drug Administration
Federal Regulatory Agency
Status: Granted breakthrough device designations and approved first non-invasive spinal cord stimulator

Federal agency responsible for approving medical devices in the United States, which has granted ONWARD Medical 10 Breakthrough Device Designations.

Timeline

  1. First Patient Enrolled in Empower BP Pivotal Trial

    Clinical Trial

    ONWARD Medical enrolled the first participant at Craig Hospital in the randomized, double-blinded Empower BP study testing the implantable ARC-IM system for blood pressure instability after spinal cord injury.

  2. FDA Clears ARC-EX for Home Use

    Regulatory

    The FDA granted 510(k) clearance expanding the ARC-EX system indication to allow patients to use the non-invasive stimulator at home.

  3. Blood Pressure Feasibility Results Published

    Research

    Nature Medicine published multi-year feasibility data showing the ARC-IM implant produced immediate blood pressure increases, reduced symptoms, and improved quality of life lasting up to two years.

  4. First Commercial Sales of ARC-EX

    Commercial

    ONWARD Medical announced first commercial sales of the ARC-EX system in the United States, days after FDA approval.

  5. FDA Approves First Non-Invasive Spinal Cord Stimulator

    Regulatory

    The FDA granted De Novo classification to ONWARD's ARC-EX system, making it the first FDA-approved technology shown to improve hand strength and sensation after chronic spinal cord injury.

  6. Ottobock Invests €50M, Takes 10% Stake

    Corporate

    ONWARD Medical raised €50 million including a cornerstone investment from prosthetics leader Ottobock, establishing a strategic partnership for commercialization.

  7. UP-LIFT Trial Results Published

    Clinical Trial

    Nature Medicine published results from the 65-participant UP-LIFT trial showing 90% of participants improved upper limb strength or function with non-invasive ARC-EX stimulation.

  8. Brain-Spine Interface Enables Natural Walking

    Research Breakthrough

    Researchers published in Nature a brain-computer interface linked to spinal stimulation that enabled a man with chronic tetraplegia to walk naturally in community settings, with stability maintained for over one year.

  9. Same-Day Recovery Demonstrated in Complete Paralysis

    Research Breakthrough

    Three individuals with complete sensorimotor paralysis stood, walked, cycled, and swam within a single day of implant activation, published in Nature Medicine.

  10. ONWARD Medical Goes Public on Euronext

    Corporate

    The company completed its initial public offering on the Euronext stock exchange, raising capital to advance clinical development.

  11. FDA Grants First Breakthrough Designation for Movement Restoration

    Regulatory

    ONWARD Medical received its first FDA Breakthrough Device Designation for the ARC-IM system to restore leg motor function in people with spinal cord injury.

  12. Paraplegic Patients Walk with Targeted Stimulation

    Research Breakthrough

    EPFL and Lausanne University Hospital researchers demonstrated that activity-specific epidural stimulation programs enabled three paralyzed patients to walk, including outdoors, after five months of rehabilitation.

  13. Four Paralyzed Men Move Legs Voluntarily

    Research Breakthrough

    Expanded study published in Brain showed epidural stimulation enabled four men with complete paralysis to voluntarily control their legs, challenging the belief that complete paralysis is permanent.

  14. ONWARD Medical Founded

    Corporate

    Grégoire Courtine and Jocelyne Bloch founded GTX Medical (later renamed ONWARD Medical) to commercialize their spinal cord stimulation research from EPFL.

  15. First Paralyzed Patient Regains Movement with Epidural Stimulation

    Research Breakthrough

    Rob Summers, paralyzed after being struck by a vehicle, became the first person to regain voluntary movement through epidural electrical stimulation in a study published in The Lancet by University of Louisville, UCLA, and Pavlov Institute researchers.

Scenarios

1

FDA Approves Implant for Blood Pressure, Opens New Market

Discussed by: Industry analysts covering ONWARD Medical; medical device market reports

If Empower BP meets its primary endpoints, the FDA could approve the ARC-IM system for blood pressure instability by 2028-2029. This would create a new treatment category for approximately 350,000 people in the US and Europe who experience this complication. Given ONWARD's track record with breakthrough designations and the ARC-EX approval, the regulatory pathway appears established. Success would validate the company's strategy of expanding from movement restoration to autonomic function recovery.

2

ARC-IM Becomes Multi-Indication Platform

Discussed by: ONWARD Medical investor communications; neurotechnology researchers

With 10 FDA Breakthrough Device Designations covering movement, blood pressure, trunk stability, bladder control, and spasticity, ONWARD could pursue additional pivotal trials for the ARC-IM implant. A single surgical implant addressing multiple complications would substantially increase the value proposition for patients and healthcare systems. The company's partnership with Ottobock and recent brain-computer interface licensing suggest this platform strategy is underway.

3

Trial Fails, Setback for Autonomic Therapies

Discussed by: Clinical trial analysts; medical device investors

Pivotal trials are inherently uncertain. If Empower BP fails to meet its primary endpoints—demonstrating statistically significant improvement in orthostatic hypotension management compared to sham stimulation—it would delay autonomic function treatments for spinal cord injury patients and potentially impact ONWARD's stock and ability to fund additional indications. However, the strong feasibility data showing two-year benefit durability reduces this risk.

4

Major Medical Device Company Acquires ONWARD

Discussed by: Medical device industry analysts; investment banking reports

ONWARD's proven regulatory pathway, multiple breakthrough designations, and first-mover advantage in spinal cord stimulation for paralysis make it an acquisition target for larger neuromodulation companies like Medtronic, Abbott, or Boston Scientific. The €50 million Ottobock investment at a 10% stake implies a valuation that could attract strategic interest, particularly if the Empower BP trial succeeds.

Historical Context

Deep Brain Stimulation for Parkinson's Disease (1987-1997)

1987-1997

What Happened

French neurosurgeon Alim-Louis Benabid discovered that high-frequency electrical stimulation of the thalamus could suppress tremors in Parkinson's patients. Medtronic commercialized the therapy, which received FDA approval in 1997 for essential tremor and 2002 for Parkinson's disease.

Outcome

Short Term

Deep brain stimulation offered an alternative to brain lesioning surgery, with adjustable and reversible effects.

Long Term

DBS became standard of care for advanced Parkinson's, with over 200,000 patients treated. It established the business model and regulatory pathway for implantable neurostimulation therapies.

Why It's Relevant Today

ONWARD's spinal cord stimulators follow the same translation pattern: academic discovery, breakthrough device designation, pivotal trials, FDA approval, and commercialization by a specialized company. The DBS precedent shows how neurostimulation can evolve from experimental to standard of care over 10-15 years.

Cochlear Implants Restore Hearing (1984-Present)

1984-present

What Happened

The FDA approved the first cochlear implant in 1984, enabling deaf individuals to perceive sound through direct electrical stimulation of the auditory nerve. Early devices provided limited benefit, but decades of refinement dramatically improved outcomes.

Outcome

Short Term

Initial cochlear implants helped only profoundly deaf adults; children were not candidates until 1990.

Long Term

Over one million people worldwide now use cochlear implants. Most deaf children in developed countries receive implants, and many achieve near-normal language development. The technology created a multi-billion dollar industry.

Why It's Relevant Today

Like cochlear implants, spinal cord stimulation for paralysis replaces lost neural function with electrical signals. The cochlear implant trajectory—from crude early devices to sophisticated systems that restore near-normal function—suggests what may be possible as spinal cord stimulation technology matures over the next two decades.

Spinal Cord Stimulation for Chronic Pain (1967-Present)

1967-present

What Happened

Norman Shealy implanted the first spinal cord stimulator for chronic pain in 1967, based on the gate control theory that electrical stimulation could block pain signals. Medtronic, Boston Scientific, and Abbott developed commercial systems that now represent a multi-billion dollar market.

Outcome

Short Term

Early spinal cord stimulators were crude and had high complication rates, limiting adoption.

Long Term

The global spinal cord stimulation market reached approximately $2.5 billion annually, with devices implanted in hundreds of thousands of patients for failed back surgery syndrome and other chronic pain conditions.

Why It's Relevant Today

ONWARD's technology repurposes the same basic approach—epidural electrical stimulation—for a fundamentally different goal: restoring function rather than blocking pain. The established supply chains, surgical expertise, and reimbursement frameworks for pain stimulators provide infrastructure that could accelerate adoption of function-restoring stimulators.

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