THIS PRESS RELEASE CONTAINS INSIDE INFORMATION WITHIN THE MEANING OF ARTICLE (7)(1) OF THE EUROPEAN MARKET ABUSE REGULATION (596/2014)

ARC-EX System is the primary and solely FDA authorized expertise proven to enhance hand energy and sensation after power spinal wire harm

ARC-EX System is an FDA Breakthrough Gadget and 2024 TIME Journal Greatest Invention

EINDHOVEN, the Netherlands, Dec. 19, 2024 (GLOBE NEWSWIRE) — ONWARD Medical (TASE:) N.V. ( Euronext (EPA:): ONWD), the medical expertise firm creating revolutionary therapies to revive motion, operate, and independence in folks with spinal wire harm (SCI), immediately introduced that it has obtained de novo classification and authorization to market its ARC-EX System from the US Meals and Drug Administration (FDA).

With immediately’s FDA de novo classification and authorization to market the ARC-EX System within the US, a brand new period begins for folks with power spinal wire harm. For the primary time, there’s an authorized remedy proven to enhance hand energy and sensation after power SCI, mentioned Dave Marver, CEO of ONWARD Medical. Now not will folks be despatched dwelling and informed nothing may be accomplished to assist them regain these skills after their harm. We hope that is the primary of many therapies we’ll introduce to assist folks regain independence from paralysis and different motion disabilities.

The ARC-EX System delivers programmed electrical stimulation by means of the pores and skin to the spinal wire through electrodes positioned on the again of the neck. The machine is non-invasive and doesn’t require surgical procedure like different spinal wire stimulation gadgets.

Regaining hand capacity is the best remedy precedence for folks with paralysis, five-fold increased than regaining all different skills misplaced to harm, mentioned Chet Moritz, PhD, Professor of Rehabilitation Drugs on the College of Washington. I imagine the ARC-EX System could have an amazing influence on the standard of life of individuals residing with SCI. My medical and analysis colleagues within the US are keen and excited to have entry to this necessary breakthrough expertise.

Outcomes of the Up-LIFT medical research printed in Nature Drugs confirmed that 90% of research members improved energy or operate, 87% reported enchancment in high quality of life, and advantages have been noticed as much as 34 years post-injury. The research additionally reported much less spasm frequency, improved sleep high quality, and improved higher physique sensation and sense of contact.1

This approval represents a watershed second for the SCI Neighborhood. For these residing with SCI and paralysis, the await even a single remedy to boost their well being and high quality of life has been lengthy and arduous. Now, we imagine this milestone alerts the opening of the floodgates for future developments, says Maggie Goldberg, President & CEO of the Christopher & Dana Reeve Basis. The Reeve Basis, together with our donors and supporters, has been steadfast in our dedication to this trigger. Practically 20 years in the past, we acknowledged epidural stimulation as probably the most promising avenues in SCI analysis. In the present day, this historic approval affirms our perception that it’s the starting of extra to return.

In the present day’s FDA market authorization is to be used of the ARC-EX System in clinics; dwelling use authorization is anticipated in mid-2025. The Firm plans to hunt CE Mark certification to commercialize the ARC-EX System in Europe in early 2025, with authorization anticipated 2H 2025. The Firm is growing a pipeline of applied sciences, together with its investigational implantable ARC-IM System and its investigational ARC-BCI System, an implanted platform that makes use of a brain-computer interface (BCI) powered by synthetic intelligence (AI).

For questions in regards to the ARC-EX System and its availability within the US, go to survey.onwd.com/help.

About Spinal Wire Harm (SCI)

Spinal wire harm impacts roughly seven million folks worldwide, together with greater than 300,000 in america. Half of accidents end in tetraplegia, affecting operate of all 4 limbs, and making on a regular basis duties like consuming, grooming, or utilizing a telephone terribly difficult. Past the speedy lack of motor and sensory operate, people with SCI face quite a few secondary issues comparable to incontinence, poor blood strain regulation, and lack of sexual operate. The financial influence is equally important, with lifetime remedy prices for tetraplegia exceeding $5 million.2 Traditionally, these accidents have been thought-about everlasting with restricted choices for purposeful restoration, significantly for these greater than one-year post-injury.

About ARC-EX System

The ARC-EX System is a non-invasive neuromodulation expertise consisting of an exterior stimulator and wi-fi programmer which stimulate the spinal wire through electrical pulses from electrodes positioned on the again of the neck. The system parameters may be optimized for every affected person’s distinctive wants. The ARC-EX System is the primary and solely authorized expertise indicated to enhance hand sensation and energy after power spinal wire harm. It was chosen as a TIME Journal Greatest Invention in 2024.

About ONWARD Medical      

ONWARD Medical is a medical expertise firm creating therapies to revive motion, operate, and independence in folks with SCI and different motion disabilities. Constructing on greater than a decade of scientific discovery, preclinical analysis, and medical research performed at main hospitals, rehabilitation clinics, and neuroscience laboratories, the Firm has developed ARC Remedy, which has been awarded ten Breakthrough Gadget Designations from the US Meals and Drug Administration (FDA). Along with the ARC-EX System, which is now cleared for business sale within the US, the Firm is growing an implantable system referred to as ARC-IM with and with out an implanted brain-computer interface (BCI).

Headquartered within the Netherlands, the Firm has a Science and Engineering Middle in Switzerland and a US workplace in Boston, Massachusetts. The Firm is listed on Euronext Paris, Brussels, and Amsterdam (ticker: ONWD).

For extra info, go to ONWD.com and join with us on LinkedIn and YouTube. If you’re a clinician or individual with a spinal wire harm, go to survey.onwd.com/help.

Sure statements, beliefs, and opinions on this press launch are forward-looking, which mirror the Firm’s or, as acceptable, the Firm administrators’ present expectations and projections about future occasions. By their nature, forward-looking statements contain a number of dangers, uncertainties, and assumptions that would trigger precise outcomes or occasions to vary materially from these expressed or implied by the forward-looking statements. These dangers, uncertainties, and assumptions might adversely have an effect on the end result and monetary results of the plans and occasions described herein. A mess of things together with, however not restricted to, delays in regulatory approvals, modifications in demand, competitors, and expertise, could cause precise occasions, efficiency, or outcomes to vary considerably from any anticipated improvement. Ahead-looking statements contained on this press launch relating to previous developments or actions shouldn’t be taken as a illustration that such developments or actions will proceed sooner or later. Consequently, the Firm expressly disclaims any obligation or enterprise to launch any replace or revisions to any forward-looking statements on this press launch on account of any change in expectations or any change in occasions, circumstances, assumptions, or circumstances on which these forward-looking statements are based mostly. Neither the Firm nor its advisers or representatives nor any of its subsidiary undertakings or any such individual’s officers or workers ensures that the assumptions underlying such forward-looking statements are free from errors nor does both settle for any duty for the longer term accuracy of the forward-looking statements contained on this press launch or the precise prevalence of the forecasted developments. You shouldn’t place undue reliance on forward-looking statements, which communicate solely as of the date of this press launch.

ARC-EX Indication for Use (US): The ARC-EX System is meant to ship programmed, transcutaneous electrical spinal wire stimulation  together with purposeful process apply within the clinic  to enhance hand sensation and energy in people between 18 and 75 years outdated that current with a power, non-progressive neurological deficit ensuing from an incomplete spinal wire harm (C2-C8 inclusive).

Different Investigational Merchandise: All different ONWARD Medical gadgets and therapies together with ARC-IM and ARC-BCI are investigational and never accessible for business use.

Emblems: ONWARD, ARC-EX, ARC-IM, ARC-BCI, and the stylized O-Emblem are proprietary and registered emblems of ONWARD Medical. Unauthorized use is strictly prohibited.

1 Moritz, Chet, et al.  Non-invasive spinal wire stimulation for arm and hand operate in power tetraplegia: a security and efficacy trial.  Nature Drugs. 2024.2 NSCISC Traumatic Spinal Wire Harm Details and Figures at a Look (2023 SCI Information Sheet) and Firm evaluation.

Supply: ONWARD Medical NV

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