ONWD Onward Opportunities Limited

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), today announces a grant from the Christopher & Dana Reeve Foundation to support expansion of an ongoing early clinical feasibility study to explore the use of a brain-computer interface (BCI) to restore thought-driven use of the hands and arms after SCI.

The ongoing early feasibility clinical study is also supported by the European Innovation Council under the Reverse Paralysis project. The first study participant was implanted with the investigational ARC-BCI System in August 2023. The Reeve Foundation’s $1.1 million grant to study sponsor and ONWARD Medical research partner, .NeuroRestore, enables up to four additional participants to be implanted with the ONWARD ARC-BCI System.

.NeuroRestore is a collaboration between the Swiss Federal Institute of Technology (EPFL) and Lausanne University Hospital (CHUV) and key research partner to ONWARD Medical.

“While other companies are using BCI technology to interface with computers, ONWARD is leading the pursuit of BCI-augmented movement restoration,” said ONWARD Medical CEO Dave Marver. “We are grateful to the Christopher & Dana Reeve Foundation for its support, which enables us to expand this important study.”

“This grant reflects our vision to facilitate rapid scientific advancement to address the unmet needs of individuals living with SCI,” said Marco Baptista, Ph.D., Chief Scientific Officer of the Christopher & Dana Reeve Foundation. “We look forward to working with ONWARD Medical in learning more about the potential for BCI technology to meet those challenges.”

The ARC-BCI System combines the investigational WIMAGINE® BCI from CEA-Clinatec with investigational ONWARD ARC-IM® Therapy (implanted targeted spinal cord stimulation) to form a DigitalBridge™ that enables thought-driven movement restoration. The WIMAGINE BCI is an epidural implant with 7 years of human safety data and ONWARD ARC-IM Therapy has been applied in more than 30 study participants. ONWARD Medical is also investigating the use of its ARC-BCI System to address lower limb mobility challenges after SCI in a separate early feasibility clinical study.

The first-in-human use of ARC-IM Therapy paired with an implanted BCI in a clinical study resulted in an individual gaining augmented control over when and how he moved his paralyzed legs. The results of this study were published in Nature in May 2023.

Earlier this year, ONWARD Medical announced that it was accepted into the US FDA’s new Total Product Lifecycle Advisory Program (TAP) for its ARC-BCI platform, which was also awarded FDA Breakthrough Device Designation (BDD).

To learn more about ONWARD Medical’s commitment to partnering with the SCI Community to develop innovative solutions for restoring movement, function, and independence after spinal cord injury, please visit ONWD.com.

*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.

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 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 Directorinvestors@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, 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.