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ONWARD Medical N.V. ONWARD Medical N.V. is a dutch medical technology company that develops spinal cord stimulation therapies to improve movement, function, and independence in people with spinal cord injuries and other movement disabilities.
Its CEO is Dave Marver, and its chairman is Rob ten Hoedt.[1]
The company currently markets the ARC-EX® System in the US for use in clinic and at home; The device is designed to improve hand sensation and strength after spinal cord injury (SCI). The ARC-EX is also available in Europe, and received CE Mark approval in September 2025.[2]
The company’s 2021 IPO raised €75.2 million, and it trades on the Euronext Brussels stock exchange under the ticker symbol ONWD with additional listings on Euronext Amsterdam and Euronext Paris, and its American Depositary Receipts (ADRs) can be traded on OTCQX (ticker: ONWRY).[3] [4]
The company headquarters is in the Netherlands with other offices in Lausanne, Switzerland, and Boston, Massachusetts.
History
[edit]ONWARD Medical was founded as G-Therapeutics in 2014, a spin-off from the neuroprosthetics laboratory of neuroscientist Grégoire Courtine at the École Polytechnique Fédérale de Lausanne (EPFL), together with neurosurgeon Jocelyne Bloch of Lausanne University Hospital (CHUV).[5][6][7][8]
TThe company’s origins trace back to research led by Courtine, who in 2012 reported in Science that combining programmed electrical stimulation of the brain and spinal cord with rehabilitation, restored walking ability in paralyzed rats.[9]
The company won the Hello Tomorrow Global Challenge in 2014 and was named among the top 100 Swiss startups from 2015 to 2020.[10][11] The company was renamed GTX Medical in 2018 and became ONWARD Medical in 2021.[12][13]
Technology
[edit]ONWARD developed ARC Therapy, a form of targeted spinal cord stimulation delivered by external or implantable technologies. It has received 10 Breakthrough Device Designations from the US Food and Drug Administration (FDA).[14]
ARC Therapy can be delivered via three platforms:
ARC-EX® System: In December 2024, the ARC-EX System became the first non-invasive spinal cord stimulation device cleared by the US FDA for use in people living with SCI. It is indicated to improve hand strength and sensation in individuals living with chronic cervical SCI. The system consists of a stimulator and electrodes applied to the skin at the back of the neck, enabling personalized rehabilitation. ARC-EX can be used in clinical settings to support functional recovery and at home by patients and persons providing assistance to patients as needed.[15][16]
ARC-IM® System: ARC-IM is an investigational implantable neuromodulation platform designed to deliver targeted and personalized spinal cord stimulation. The system consists of an implanted neurostimulator (IPG) and an epidural lead designed specifically for people with SCI.
On August 18, 2025, the US Food and Drug Administration granted an Investigational Device Exemption (IDE) for the ARC-IM System, enabling the launch of the Empower BP global pivotal study.[17] This study is designed to assess the safety and efficacy of the implantable spinal stimulation system in addressing blood pressure instability following spinal cord injury. This randomized, double-blinded, sham-controlled study is expected to enroll participants across approximately 20 research centers in the United States, Canada, France, Germany, Spain, and the United Kingdom. The first participant was enrolled at Craig Hospital in Denver, Colorado, United States in January 2026.[18][19]
In September 2025, detailed results from multi-year clinical feasibility studies were published in Nature Medicine, demonstrating that participants who received ARC-IM Therapy experienced immediate and robust increases in blood pressure, as well as reduced frequency and severity of hypotensive symptoms. The resulting blood pressure stability resulted in improved quality of life and greater engagement in rehabilitation and daily activities.[20]
ARC-BCI® System: a purpose-built platform pairing a brain-computer interface with an implantable spinal cord stimulation system (ARC-IM) and artificial intelligence to restore thought-driven movement after paralysis.[21]
Clinical Trials
[edit]- Up-LIFT (2021–2024): published in Nature Medicine in 2024, showed improvements in arm and hand function.[22]
- Pathfinder2 Study (investigator-sponsored, 2025): published in Neuromodulation:Technology at the Neural Interface, demonstrated that ARC-EX Therapy, combined with activity-based rehabilitation, delivered significant functional improvements and continued gains over one year.[23]
- LIFT Home Study (2025): published in Neurology: Clinical Practice, showed that continued use of ARC-EX® Therapy at home is effective in maintaining and extending gains achieved in the clinic.[24]
References
[edit]- ↑ https://www.massdevice.com/former-medtronic-president-chair-onward-medical/
- ↑ "https://www.biospace.com/press-releases/onward-medical-receives-ce-mark-for-arc-ex-enabling-commercial-launch-of-breakthrough-spinal-cord-stimulation-system-in-europe"
- ↑ https://www.euronext.com/en/about/media/euronext-press-releases/onward-medical-lists-euronext-paris
- ↑ https://live.euronext.com/en/product/equities/NL0015000HT4-XBRU
- ↑ "G-Therapeutics raises EUR 36 million". EPFL.ch. 21 April 2016.
- ↑ "ONWARD Medical SA". www.venturelab.swiss.
- ↑ "ONWARD Medical SA". www.venturekick.ch.
- ↑ "ONWARD Medical's Technology Enables Walking and Standing After Severe Spinal Cord Injuries".
- ↑ "Rehab robot helps paralysed rats walk again". NewScientist.
- ↑ Lebret, Hervé (27 April 2014). "G-Therapeutics wins the €100'000 Hello Tomorrow Award".
- ↑ "Discover Switzerland's 100 Most Promising Startups". www.top100startups.swiss.
- ↑ "GTX medical BV and NeuroRecovery Technologies Inc. Merge to Create Leading Neurostimulation Company for Spinal Cord Injury" (PDF). GIMV.com.
- ↑ "ONWARD Announces First Patient Enrolled in the Up-LIFT Pivotal Trial Assessing Safety and Effectiveness of ARC Therapy for Spinal Cord Injury - ONWARD Medical N.V." ir.onwd.com.
- ↑ "ONWARD® Medical Awarded 10th Breakthrough Device Designation for Brain-Computer Interface (BCI) from US FDA". ONWARD Medical.
- ↑ https://www.christopherreeve.org/community/about-us/executive-memos/onward-medical-arcex/
- ↑ https://www.massdevice.com/onward-wins-expanded-fda-indications-for-spinal-cord-stimulation-at-home
- ↑ https://www.bioworld.com/articles/723176-onward-medical-receives-fda-ide-for-bp-study-with-arc-im-system?v=preview
- ↑ https://shepherd.org/research-innovation/redefining-rehab/find-studies/arc-im-system-to-manage-symptomatic-blood-pressure-instability-secondary-to-chronic-spinal-cord-injury-sci-empower-bp/
- ↑ https://www.biospace.com/press-releases/onward-medical-announces-first-participant-enrolled-in-global-pivotal-study-evaluating-arc-im-system-to-address-blood-pressure-instability-after-spinal-cord-injury
- ↑ https://www.nature.com/articles/s41591-025-03614-w
- ↑ "How Many People Live With Implanted BCIs Today?". www.neurofounders.co.
- ↑ Moritz, Chet; Field-Fote, Edelle C.; Tefertiller, Candace; van Nes, Ilse; Trumbower, Randy; Kalsi-Ryan, Sukhvinder; Purcell, Mariel; Janssen, Thomas W. J.; Krassioukov, Andrei; Morse, Leslie R.; Zhao, Kristin D.; Guest, James; Marino, Ralph J.; Murray, Lynda M.; Wecht, Jill M.; Rieger, Markus; Pradarelli, Jared; Turner, Amanda; D’Amico, Jessica; Squair, Jordan W.; Courtine, Gregoire (May 2024). "Non-invasive spinal cord electrical stimulation for arm and hand function in chronic tetraplegia: a safety and efficacy trial". Nature Medicine. pp. 1276–1283. doi:10.1038/s41591-024-02940-9.
- ↑ "Safety and Effectiveness of Multisite Transcutaneous Spinal Cord Stimulation Combined With Activity-Based Therapy When Delivered in a Community Rehabilitation Setting: A Real-World Pilot Study". Science Direct.
- ↑ Tefertiller, Candace; Trumbower, Randy D.; Morse, Leslie; Pradarelli, Jared; Gelenitis, Kristen; D'Amico, Jessica M.; Moritz, Chet; Field-Fote, Edelle C. (December 2025). "Home-Based Noninvasive Spinal Cord Stimulation Safely Enhances Hand and Arm Function in People With Spinal Cord Injury". Neurology Clinical Practice. pp. e200537. doi:10.1212/CPJ.0000000000200537.
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