Press Release: ONWARD Medical Awarded Grant to Study Potential for ARC-BCI Therapy to Restore Movement after Stroke

ONWARD Medical Awarded Grant to Study Potential for ARC-BCI Therapy to Restore Movement after Stroke

Grant supports the first clinical trials studying the potential for brain-computer interface $(BCI.AU)$ and artificial intelligence (AI) technology to restore thought-driven movement after stroke

Funding also supports technology development of ARC-BCI System and ARC-IM Lead

Approximately 15 million people worldwide experience a stroke each year

EINDHOVEN, the Netherlands, Nov. 19, 2024 (GLOBE NEWSWIRE) -- ONWARD Medical N.V. (Euronext: ONWD), the medical technology company creating innovative spinal cord stimulation therapies to restore movement, function, and independence in people with spinal cord injury $(SCI.AU)$, today announces a grant from the European Innovation Council $(EIC)$ to study the use of its investigational ARC-BCI Therapy to restore upper limb movement after subcortical stroke.

"While helping people with spinal cord injury remains our North Star, this grant underscores the potential for our breakthrough therapies to impact people with other movement disabilities, such as stroke," said Dave Marver, CEO of ONWARD Medical. "The funding supports next steps in developing what may be the first-ever therapy to restore thought-driven hand and arm function after stroke."

This is the third EIC grant supporting the development of ARC-BCI Therapy to address movement challenges, and the first targeting stroke; the first two grants were SCI-focused. The Company's research and technology partners in the grant consortium include Commissariat à L'énergie Atomique et aux Énergies Alternatives $(CEA)$ and Dessintey of France, Department of Clinical Sciences, KI DS, Karolinska Institutet, of Sweden, École Polytechnique Fédérale de Lausanne (EPFL) and Centre Hospitalie Universitaire Vaudois (CHUV) of Switzerland.

Total expected funding over five years from this grant and companion funding from the Swiss State Secretariat for Education, Research, and Innovation (SERI) is EUR 6 million with ONWARD receiving almost EUR 2 million.

The Company plans to use this funding to develop the capability to program and simultaneously control two investigational ARC-IM IPGs (implanted neurostimulators), and to further develop its ARC-IM Lead for the cervical spinal cord, the spinal cord region responsible for upper extremity function.

To date, three trial participants have been implanted with ONWARD ARC-BCI Therapy. The first human use of ARC-BCI Therapy for lower limb mobility occurred in 2021, with results published in Nature in May 2023. In the fall of 2023, an individual was implanted to explore the potential for ARC-BCI Therapy to restore upper extremity function after SCI. In the fall of 2024, a third trial participant was implanted to study the potential for ARC-BCI Therapy to restore lower limb mobility after SCI. Several additional ARC-BCI System implants are expected in 2025, with grant support from the Christopher & Dana Reeve Foundation.

The ONWARD ARC-BCI System pairs the WIMAGINE BCI with investigational ONWARD ARC-IM Therapy (targeted implanted spinal cord stimulation) to create a DigitalBridge$(TM)$, facilitating communication between the brain and the body with a wireless BCI to restore thought-driven movement after paralysis. The ARC-BCI System uses AI to decode a person's brain signals and translate their intention into thought-driven movement. The WIMAGINE BCI has seven years of human safety data, and ONWARD ARC-IM Therapy has now been applied in more than 30 study participants. The US FDA awarded Breakthrough Device Designation to the ARC-BCI System in early 2024, one of 10 such designations awarded to the Company.

About 15 million people worldwide experience a stroke each year, of which nearly four million are subcortical, according to the World Stroke Organization and American Heart Association.

Note: All ONWARD Medical devices and therapies, including but not limited to ARC-IM, ARC-EX, ARC-BCI, and ARC Therapy, alone or in combination with a brain-computer interface $(BCI)$, are investigational and not available for commercial use. ONWARD, ARC-EX, ARC-IM, ARC-BCI, and the stylized O-Logo are proprietary and registered trademarks of ONWARD Medical. Unauthorized use is strictly prohibited.

About ONWARD Medical

ONWARD Medical is a medical technology company creating therapies to restore movement, function, and independence in people with spinal cord injury (SCI) and movement disabilities. Building on more than a decade of scientific discovery, preclinical, and clinical research conducted at leading hospitals, rehabilitation clinics, and neuroscience laboratories, the Company has developed ARC Therapy, which has been awarded ten Breakthrough Device Designations from the US Food and Drug Administration (FDA).

ONWARD ARC Therapy is targeted, programmed spinal cord stimulation designed to be delivered by the Company's external ARC-EX or implantable ARC-IM platforms. ARC Therapy can also be delivered by the Company's ARC-BCI platform, which pairs the ARC-IM System with brain-computer interface (BCI) technology to restore movement after SCI with thought-driven control.

Use of non-invasive ARC-EX Therapy significantly improved upper limb function after SCI in the global pivotal Up-LIFT trial, with results published by Nature Medicine in May 2024. The Company has submitted its regulatory application to the FDA for clearance of the ARC-EX System in the US and is preparing for regulatory submission in Europe. In parallel, the Company is conducting clinical studies with its ARC-IM Therapy, which demonstrated positive interim clinical outcomes for improved blood pressure regulation following SCI. Other ongoing clinical studies focus on using ARC-IM Therapy to address mobility after SCI and gait challenges in Parkinson's disease as well as using the ARC-BCI platform to restore thought-driven movement of both upper and lower limbs after SCI.

Headquartered in Eindhoven, the Netherlands, ONWARD Medical has a Science and Engineering Center in Lausanne, Switzerland, and a US office in Boston, Massachusetts. The Company is listed on Euronext Paris, Brussels, and Amsterdam (ticker: ONWD).

For more information, visit ONWD.com, and connect with us on LinkedIn and YouTube.

For Media Inquiries:

Aditi Roy, VP Communications

media@onwd.com

For Investor Inquiries:

Amori Fraser, Finance Director

investors@onwd.com

Disclaimer

Certain statements, beliefs, and opinions in this press release are forward-looking, which reflect the Company's or, as appropriate, the Company directors' current expectations and projections about future events. By their nature, forward-looking statements involve several risks, uncertainties, and assumptions that could cause actual results or events to differ materially from those expressed or implied by the forward-looking statements. These risks, uncertainties, and assumptions could adversely affect the outcome and financial effects of the plans and events described herein. A multitude of factors including, but not limited to, delays in regulatory approvals, changes in demand, competition, and technology, can cause actual events, performance, or results to differ significantly from any anticipated development. Forward-looking statements contained in this press release regarding past trends or activities should not be taken as a representation that such trends or activities will continue in the future. As a result, the Company expressly disclaims any obligation or undertaking to release any update or revisions to any forward-looking statements in this press release as a result of any change in expectations or any change in events, conditions, assumptions, or circumstances on which these forward-looking statements are based. Neither the Company nor its advisers or representatives nor any of its subsidiary undertakings or any such person's officers or employees guarantees that the assumptions underlying such forward-looking statements are free from errors nor does either accept any responsibility for the future accuracy of the forward-looking statements contained in this press release or the actual occurrence of the forecasted developments. You should not place undue reliance on forward-looking statements, which speak only as of the date of this press release. All ONWARD Medical devices and therapies referenced here, including but not limited to ARC-IM, ARC-EX, ARC-BCI and ARC Therapy, are investigational and not available for commercial use.

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November 19, 2024 01:30 ET (06:30 GMT)