Nature Medicine highlights significant improvement in hand and arm function after spinal cord injury through ONWARD® ARC-EX® therapy

ARC Therapy™ has been proven safe and effective in a global approval study*

90% of participants improved either upper limb strength or function*

Improvement demonstrated in participants up to 34 years after injury*

87% of participants also reported an improvement in overall quality of life*

EINDHOVEN, Netherlands, May 21, 2024 (GLOBE NEWSWIRE) — ONWARD Medical NV (Euronext: ONWD), the medical technology company developing innovative spinal cord stimulation therapies to restore movement, function and independence to people with spinal cord injury (SCI), today announces the publication of the results of the global Up-LIFT pivotal study in Natural Medicine The study met all primary safety and efficacy endpoints, and ARC-EX therapy demonstrated significant improvements in upper limb strength, function, and sensation in people with chronic quadriplegia due to cervical spinal cord injury.

At the end of the study, 72% of study participants were classified as responders to noninvasive ARC-EX therapy* based on a conservative definition that requires responders to meet criteria for improvement in both strength and function compared to standard rehabilitation alone. Notably, the number of participants responding to the program increased to 90% when the definition included participants with improvements in at least one strength or function outcome*.

“The study results far exceeded our hypothesis of a 50 percent response rate to ARC-EX therapy and offer new hope to people with spinal cord injuries and rehabilitation providers,” said Dr. Chet Moritz, lead author of the paper, co-lead investigator of the clinical trial, and professor of electrical and computer engineering and rehabilitation medicine at the University of Washington. “After just two months, more than half of the Up-LIFT participants achieved an average improvement in grip strength greater than the force required to lift full cups and grip strength equivalent to the force required to pick up an object with a fork or insert a key.^1.2 This indicates not only improved strength and function, but also the potential for greater independence with ARC-EX therapy.”

Study participants also reported reduced seizure frequency, better sleep, and improved upper body sensation, including touch*. 87% of participants reported that ARC-EX therapy improved overall quality of life*. Self-care, a key component of independence after spinal cord injury, also improved significantly*.

“Improving arm and hand function is one of the highest priorities for people with tetraplegia³who have been without effective therapies for functional restoration for far too long,” said Dave Marver, CEO of ONWARD Medical. “The Natural Medicine published results provide crucial and compelling evidence that ARC-EX has the potential to restore independence in daily activities and improve quality of life. We are committed to making this unique technology available to the SCI community as soon as possible.”

“We are proud that ONWARD has developed this first therapy proven to improve strength and function after chronic incomplete tetraplegia,” said ONWARD Medical co-founders Dr. Grégoire Courtine, Professor of Neuroscience and Neurotechnology at the Swiss Federal Institute of Technology in Lausanne (EPFL), and Dr. Jocelyne Bloch, Head of Functional Neurosurgery at the University Hospital of Lausanne and Professor of Neurosurgery at EPFL. “We commend the outstanding researchers and study participants who contributed to this groundbreaking study.”

ARC-EX therapy is an external, programmed electrical stimulation that non-invasively acts on the spinal cord and is intended to support functional recovery after traumatic brain injury. The Up-LIFT study was a prospective, single-arm registration study to evaluate the safety and efficacy of the ARC-EX system in treating upper extremity functional deficits in people with chronic quadriplegia. The global study was conducted with 65 participants at 14 leading SCI centers in the United States, Europe and Canada.

At the end of the first quarter, ONWARD Medical submitted a de novo application to the US Food and Drug Administration for marketing authorization of the ARC-EX system. The company plans to follow the US application with a marketing authorization application in Europe.

On Thursday, May 23, at 2:30 p.m. CET/8:30 a.m. ET, following a brief Q1 business update, CEO Dave Marver will lead a discussion of the Up-LIFT pivotal trial results with a panel of investigators and study participants.

To join the webcast via Zoom, please register using this link.

Participants can also dial in by telephone:

32 2 290 9360 (Belgium)

33 1 7037 2246 (France)

49 69 3807 9884 (Germany)

31 20 794 0854 (Netherlands)

41 22 591 0156 (Switzerland)

44 203 481 5240 (United Kingdom)

1 346 248 7799 (US)

Additional phone numbers are available.

Meeting ID: 879 5741 2479

A replay of the webcast will be available on the Company’s website following the live event.

Note: All medical devices and therapies from ONWARD^®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 developing therapies to restore movement, function and independence for people with spinal cord injury (SCI) and movement disorders. Based on more than a decade of scientific discovery, preclinical and clinical research at leading hospitals, rehabilitation clinics and neuroscience laboratories, the company has developed ARC Therapy™, which has been awarded ten Breakthrough Device Designations by the U.S. Food and Drug Administration (FDA).

ONWARD ARC therapy is a targeted, programmed stimulation of the spinal cord, which is delivered via the external ARC-EX^®– or implantable ARC-IM^®platforms. ARC therapy can also be delivered using the Company’s ARC-BCI™ platform, which combines the ARC-IM system with brain-computer interface (BCI) technology to restore movement after spinal cord injury using thought-based control.

The use of non-invasive ARC-EX therapy significantly improved upper limb function after spinal cord injury in the global, pivotal Up-LIFT study; results were published in May 2024 in Natural Medicine The company has submitted a New Drug Application to the FDA for the ARC-EX system in the US and is preparing for submission in Europe. In parallel, the company is conducting clinical trials with its ARC-IM therapy, which has demonstrated positive interim clinical results for improved blood pressure regulation following spinal cord injury. Additional ongoing clinical trials focus on the use of ARC-IM therapy to improve mobility following spinal cord injury and gait disturbances in Parkinson’s disease, as well as the use of the ARC-BCI platform to restore mind-controlled movement of the upper and lower limbs following spinal cord injury.

ONWARD Medical is headquartered in Eindhoven, the Netherlands, with a science and development center in Lausanne, Switzerland, and a U.S. office in Boston, Massachusetts. The company is listed on Euronext Brussels and Amsterdam (ticker: ONWD).

For more information, visit ONWD.com, LinkedIn, and YouTube.

For media inquiries:
Aditi Roy, VP Communications
[email protected]

For investor inquiries:
Amori Fraser, Finance Director
[email protected]

Disclaimer

Certain statements, beliefs and opinions in this press release are forward-looking and reflect the current expectations and projections of the Company or the Company’s directors with respect to future events. By their nature, forward-looking statements involve a number of 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 affect the outcome and financial impact of the plans and events described herein. A variety of factors, including, but not limited to, changes in demand, competition and technology, could cause actual events, performance or results to differ materially from those anticipated. Forward-looking statements in this press release that address past trends or activities are not representations that such trends or activities will continue in the future. As a result, the Company expressly disclaims any obligation or undertaking to release any updates or revisions to the forward-looking statements contained in this press release to reflect any change in expectations or any change in events, conditions, assumptions or circumstances on which the forward-looking statements are based. Neither the Company, nor its advisors or agents, nor any of its affiliates, nor the officers or employees of any of these persons warrant that the assumptions underlying such forward-looking statements are error-free, nor do they assume any responsibility for the future accuracy of the forward-looking statements contained in this press release or the actual occurrence of the forecast 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 medical devices and therapies mentioned herein, including but not limited to ARC-IM^®ARC-EX^®ARC-BCI™ and ARC Therapy™, are in the investigational stage and are not available for commercial use.

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* Moritz, Chet, et al. “Non-invasive spinal cord stimulation for arm and hand function in chronic tetraplegia: a safety and efficacy trial.” Natural Medicine. 2024.
¹ Feingold-Polak, Ronit, et al. “The effects of an object’ s height and weight on force calibration and kinematics when post-stroke and healthy individuals reach and grasp.” Scientific Reports. 2021.
² Smaby, Niels, et al. “Identification of key pinch forces required to complete functional tasks.” Journal of Rehabilitation Research Development. 2004.

³ Anderson, K.D. “Targeting recovery: priorities of the spinal cord-injured population.” Journal of Neurotrauma. 2004.

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/c9a3a475-7e21-41aa-ad6d-ea15e8cc7dae

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