ONWARD® Medical Announces Publication Highlighting Evidence-based Programming for ARC-EX® Therapy

Framework to determine stimulation parameters for ONWARD ARC-EX Therapy are published in the journal Neuromodulation: Technology at the Neural Interface

Peer-reviewed publication is based on results from the Up-LIFT and LIFT Home studies

EINDHOVEN, the Netherlands, July 09, 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), today announces a publication in Neuromodulation: Technology at the Neural Interface, summarizing effective stimulation parameters from the Up-LIFT and LIFT Home studies and providing a decision-making framework for clinical implementation of ONWARD ARC-EX Therapy created by study investigators.

Investigational ARC-EX Therapy is non-invasive, programmed spinal cord stimulation designed to improve upper limb function after incomplete cervical SCI. The publication in Neuromodulation: Technology at the Neural Interface provides an evidence-based framework to determine stimulation parameters for ARC-EX Therapy based on analysis of device parameters, usage data, and clinician and participant feedback from the Up-LIFT pivotal trial and follow-on LIFT Home study.

The Neuromodulation publication references observations and results from the Up-LIFT pivotal trial, which were published in May 2024 in Nature Medicine, and which demonstrated significant improvement in hand and arm function after SCI with use of ARC-EX Therapy. At the end of the trial, 72% of participants were considered responders to non-invasive ARC-EX Therapy* based on a responder definition for participants to meet improvement criteria in both strength and functional domains. Notably, the number of responders increased to 90% when the definition included participants with improvements in at least one strength or functional outcome* and 87% of participants reported improvements in quality of life with ARC-EX Therapy*. There were no serious device-related adverse events observed during either the Up-LIFT trial or LIFT Home study.

Up-LIFT and Lift Home study investigators recognized the importance of simplifying programming processes for their peers. “We are very excited to share the insights we gained through the first large-scale study of transcutaneous spinal stimulation with clinicians” said Chet Moritz, PhD, co-Principal Investigator of the Up-LIFT trial, publication co-author, and Professor of Electrical & Computer Engineering and Rehabilitation Medicine at the University of Washington. “These programming insights were developed based on our experience with 60 participants in the Up-LIFT trial, and we expect them to be very helpful in determining the optimal parameters for stimulation for a wide range of patients in the clinic.”

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.

*Moritz, Chet, et al. “Non-invasive spinal cord stimulation for arm and hand function in chronic tetraplegia: a safety and efficacy trial.” Nature Medicine. 2024.

Note: Unless otherwise noted, statements herein are based on the publication discussed: Gelenitis, Kristen, et al. “Non-invasive Transcutaneous Spinal Cord Stimulation Programming Recommendations for the Treatment of Upper Extremity Impairment in Tetraplegia” Neuromodulation. 2024.

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 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, 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.