Latest news with #ARC-EX
Yahoo
01-07-2025
- Business
- Yahoo
ONWARD Medical Files 510(k) with US FDA for ARC-EX System Home Use and Submits CE Mark Application
FDA 510(k) application submitted to allow marketing of the ARC-EX® System for home use in the United States CE Mark application filed with notified body to enable commercialization of the ARC-EX System in the European Union and other countries EINDHOVEN, the Netherlands, July 01, 2025 (GLOBE NEWSWIRE) -- ONWARD Medical N.V. (Euronext: ONWD and US OTCQX: ONWRY), the leading neurotechnology company pioneering therapies to restore movement, function, and independence in people with spinal cord injury (SCI) and other movement disabilities, today announced the submission of two major regulatory applications for its ARC-EX System. The Company has submitted a 510(k) application to the US Food and Drug Administration (FDA) seeking clearance to expand its indication for home use. In parallel, ONWARD has filed an application with the notified body for CE Mark certification in accordance with the European Union Medical Device Regulation (MDR) to enable commercialization of the ARC-EX System in the EU. Completed in June, these submissions represent significant milestones as the Company advances its mission to bring breakthrough therapies to people with SCI around the world. The ARC-EX System is the first and only FDA-cleared technology indicated to improve hand sensation and strength after SCI. Following the successful initial phase of its US launch to clinics, ONWARD is pursuing FDA clearance to expand marketing of the ARC-EX System for use at home. Strong early demand and positive feedback from users suggest the Company is on track to meet its 2025 expectations. Clearance for home use would significantly broaden access to this innovative technology. Simultaneously, ONWARD is preparing for the commercialization of the ARC-EX System through its CE Mark submission. Once approved, the ARC-EX System would be available in the European Union and other countries recognizing CE Marking. 'These two submissions are further evidence of our ability to execute against our innovation roadmap,' said Dave Marver, Chief Executive Officer of ONWARD Medical. 'Gaining regulatory authorization for ARC-EX in Europe and broadening the ARC-EX label in the US will greatly expand the market while offering improved and more convenient access for those with SCI.' Earlier this year, ONWARD also announced the publication of positive results from the investigator-sponsored Pathfinder2 Study in Neuromodulation: Technology at the Neural Interface. This peer-reviewed paper further expands the body of clinical evidence supporting the ARC-EX System. The one-year trial demonstrated that ARC-EX Therapy combined with activity-based rehabilitation delivered significant functional improvements when administered to people with SCI in community-based rehabilitation centers. Participants experienced continued gains in upper body strength, trunk control, and balance after one year of treatment, with no plateau in therapeutic benefit1. About ONWARD Medical ONWARD Medical is the leading neurotechnology company pioneering therapies to restore movement, function and independence in people with spinal cord injury and other movement disabilities. Building on more than a decade of scientific discovery, preclinical research, and clinical studies 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 FDA. The Company's ARC-EX System is cleared for commercial sale in the US. In addition, the Company is developing an investigational implantable system called ARC-IM with and without an implanted brain-computer interface (BCI). Headquartered in the Netherlands, the Company has a Science and Engineering Center in Switzerland and a US office in Boston, Massachusetts. The Company is listed on Euronext Paris, Brussels, and Amsterdam (ticker: ONWD) and its US ADRs can be traded on OTCQX (ticker: ONWRY). For more information, visit and connect with us on LinkedIn. To be kept informed about the Company's technologies, research studies, and the availability of therapies in your area, please complete this webform. For Media Inquiries: Sébastien Cros, VP communications media@ For Investor Inquiries: investors@ 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. Trademarks: 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. 1ARC-EX Indication for Use (US): The ARC-EX System is intended to deliver programmed, transcutaneous electrical spinal cord stimulation in conjunction with functional task practice in the clinic to improve hand sensation and strength in individuals between 18 and 75 years old that present with a chronic, non-progressive neurological deficit resulting from an incomplete spinal cord injury (C2-C8 inclusive). Other Investigational Products: All other ONWARD Medical devices and therapies including ARC-IM and ARC-BCI are investigational and not available for commercial in to access your portfolio
Yahoo
09-04-2025
- Health
- Yahoo
Non-invasive stimulation device shows promise in treating spinal cord injuries
WILLOW SPRINGS, Ill. (WGN) — There has been an extraordinary step forward in the treatment of spinal cord injuries. For the patients who come through the door of the Next Steps clinic in southwest suburban Willow Springs, it takes tremendous effort. But it's worth it. 'We are really living out our mission here at Next Steps, which was to provide access to technology at a community level,' physical therapist and clinic director Mary Jones said. Bari Rubenstein has been living with quadriplegia for 14 years – the result of an infection and subsequent hematoma that damaged the nerves in her spine. 'I never thought in my lifetime I would get this opportunity,' she said. It's access to a device called ARC-EX that's giving Rubenstein some hope. 'It is able to bridge an electrical gap and cover that injury so new pathways within the spinal cord can create movement,' Jones said. Electrical nerve stimulation is not new, but the ARC-EX is non-invasive – it delivers pulses from electrodes placed on the skin that amplify weakened signals from the brain. The stimulation helps restore muscle activation below the site of injury, which is often blocked. An electrode is placed above Rubenstein's injury and another is placed below. 'So the stimulation bridges that area of the injury,' Jones said. Once the leds and electrodes are all connected, Jones starts the stimulation and gradually ramps it up. As the stimulation activates the muscles, clinic director Jones reinforces the movement. 'We pair that with retraining, learning how to re-move for those persons with spinal cord injury, and that device helps make that connection that was once lost with spinal cord injury,' she said. 'I have better breath support, which is huge because a lot of times people can't hear me, so I'm trying to amplify my voice more,' Rubenstein said. 'Even people with chronic injuries are seeing gains with this,' Jones said. 'People 14 years out, you think, 'At 14 years what is out there for me?' This device could be that device.' At Next Steps, patient Trevor Hayden takes steps without the device. It's a significant struggle. 'It's so choppy because it's like three separate motions,' he said. More News, Weather and Headlines at The 33-year-old, paralyzed in a truck accident eight years ago, travels nearly three hours twice a week so he can access the new stimulation system. 'The pulse that it delivers is almost you can feel it kind of spreading, and it's not just directed right where the pad placement is,' he said. 'This feeling of kind of waking things up in a way.' The steps with the device are more fluid and take less effort. '(It is) much easier. It just feels like everything is kind of pulled together,' Hayden said. The care provided at Next Steps is a labor of love born from loss. Jon O'Connor was 30-years-old when he hit his head after jumping off a dock. 'He got paralyzed C4-C5. Very high level. All he had was use of his right bicep,' his father John O'Connor said. But the injury did not deter his tenacity. In the years following his accident, Jon worked tirelessly to build a non-profit clinic that offered fellow patients the most promising treatments to improve movement and strength. 'Even though some things wouldn't benefit himself, he saw the value that it would have for others and fought for that,' his sister Kelly Heneghan said. Now his family continues the fight. Jon passed away in 2013 – 12 years after his injury – due to the secondary effects of his paralysis. More Coverage: WGN's Medical Watch 'We really want to be able to give our patients the most technologically advanced equipment, and at that time and still to this day, a lot of those things are reserved for clinical trials,' said Heneghan. Not at Next Steps, where technology like the Onward device is up and running for all those who may benefit. 'To me it feels like my muscles are waking up,' Rubenstein said. 'For a long time it was nothing.' 'I wish Jon could be here to see this. This is exactly what he would have fought for, and the fact that we have it now is really exciting for our patients,' Heneghan said. 'I get emotional about it because there are brilliant people, brilliant scientists out there coming up with these type of devices, and to see it come and change peoples' lives and being part of that is a really big gift,' Jones said. An at-home unit is in the works. The device makers hope to have that available in 2026. Sign up for our Medical Watch newsletter. This daily update includes important information from WGN's Dina Bair and the Med Watch team, including, the latest updates from health organizations, in-depth reporting on advancements in medical technology and treatments, as well as personal features related to people in the medical field. Sign up here. Copyright 2025 Nexstar Media, Inc. All rights reserved. This material may not be published, broadcast, rewritten, or redistributed.
Yahoo
07-03-2025
- Politics
- Yahoo
Afternoon Briefing: Illinois clinic offers new device to spinal cord injury patients
Good afternoon, Chicago. Eliazar Rodriguez was running errands in Roscoe Village when he was stopped by two men with a laminated flyer outside a Starbucks. They said they were raising money for their little brother who was killed in a drive-by shooting and told Rodriguez that they were struggling to gather funeral funds. He gave the men $15 through Apple Pay and wrote his name down on a sheet pledging his donation. One of the guys took Rodriguez's phone to make the transaction, showed him the screen to confirm that Rodriguez donated $15 and the two men went on their way. Next thing Rodriguez knew, he got an instant notification from his bank telling him he had a $3,000 charge for a carpet purchase. 'I was just blinded by my naivety and my wanting to do good and be kind to others, only to be kind of slapped in the face,' Rodriguez said. Rodriguez is not alone — he is one of dozens who have recently lost thousands of dollars to a scam going around Chicago where con artists will use a sad story to lure victims into paying them thousands of dollars when the victim thinks they are only paying a small amount of money. Here's what else is happening today. And remember, for the latest breaking news in Chicago, visit and sign up to get our alerts on all your devices. Subscribe to more newsletters | Asking Eric | Horoscopes | Puzzles & Games | Today in History If Mayor Brandon Johnson had reacted as antagonistically to Republican congressmen hoping to goad him into an argument Wednesday as he at times has, the mayor's appearance at the House Oversight Committee could have gone south fast. But a different Johnson appeared on Capitol Hill to testify in the hotly anticipated hearing on sanctuary policies for immigrants. Read more here. More top news stories: Protests have taken over Chicago. Here's what to know. Federal subpoena seeks Dolton records for bar and grill subject of Tiffany Henyard lawsuit The ARC-EX is not the first device to deliver electrical stimulation through the skin to help people with spinal cord injuries. But unlike other commercially available devices, the ARC-EX delivers stimulation directly to the spine, rather than to other parts of the body that a person wishes to move, such as to an arm or a leg. Read more here. More top business stories: Homeland Security ends collective bargaining rights for transportation workers 40-day boycott of Target during Lent kicks off The 25-year-old Joe Veleno, a left-handed shot, was a first-round draft pick (No. 30) by the Red Wings in 2018. The 6-foot-1 fourth-liner has five goals and five assists in 56 games this season. Read more here. More top sports stories: Column: Chicago Bulls are destined for the play-in tournament — again. Embrace it, ignore it, but don't fight it. A flag football first in Illinois: History will be made Saturday as sport continues to grow nationally Chicago Symphony audiences expected to hear an American composer's clarinet concerto, written for CSO principal clarinetist Stephen Williamson, last season. Unexpected quadruple bypass surgery forced Williamson to postpone the performance to this week, in concerts conducted by Gustavo Gimeno. Read more here. More top Eat. Watch. Do. stories: Illinois Holocaust Museum will close for renovations, with a temporary location opening downtown 'Seven Veils' review: The operatics are everywhere in this backstage melodrama The disposal of what Paris police called an 'excessively dangerous' unexploded World War II bomb caused hours of transportation chaos Friday on rail and road networks in the French capital, including the suspension of high-speed train links with London and Brussels. Read more here. More top stories from around the world: Frustration grows inside the White House over pace of deportations President Donald Trump says he sent a letter to Iran's supreme leader over country's advancing nuclear program
Chicago Tribune
07-03-2025
- Politics
- Chicago Tribune
Afternoon Briefing: Illinois clinic offers new device to spinal cord injury patients
Good afternoon, Chicago. Eliazar Rodriguez was running errands in Roscoe Village when he was stopped by two men with a laminated flyer outside a Starbucks. They said they were raising money for their little brother who was killed in a drive-by shooting and told Rodriguez that they were struggling to gather funeral funds. He gave the men $15 through Apple Pay and wrote his name down on a sheet pledging his donation. One of the guys took Rodriguez's phone to make the transaction, showed him the screen to confirm that Rodriguez donated $15 and the two men went on their way. Next thing Rodriguez knew, he got an instant notification from his bank telling him he had a $3,000 charge for a carpet purchase. 'I was just blinded by my naivety and my wanting to do good and be kind to others, only to be kind of slapped in the face,' Rodriguez said. Rodriguez is not alone — he is one of dozens who have recently lost thousands of dollars to a scam going around Chicago where con artists will use a sad story to lure victims into paying them thousands of dollars when the victim thinks they are only paying a small amount of money. Here's what else is happening today. And remember, for the latest breaking news in Chicago, visit and sign up to get our alerts on all your devices. Chicago observers relieved a reserved Mayor Brandon Johnson achieved 'a draw' with congressional Republicans If Mayor Brandon Johnson had reacted as antagonistically to Republican congressmen hoping to goad him into an argument Wednesday as he at times has, the mayor's appearance at the House Oversight Committee could have gone south fast. But a different Johnson appeared on Capitol Hill to testify in the hotly anticipated hearing on sanctuary policies for immigrants. Read more here. Protests have taken over Chicago. Here's what to know. Federal subpoena seeks Dolton records for bar and grill subject of Tiffany Henyard lawsuit Illinois clinic one of first places in the country to offer new device to spinal cord injury patients The ARC-EX is not the first device to deliver electrical stimulation through the skin to help people with spinal cord injuries. But unlike other commercially available devices, the ARC-EX delivers stimulation directly to the spine, rather than to other parts of the body that a person wishes to move, such as to an arm or a leg. Read more here. More top business stories: Chicago Blackhawks trade Petr Mrázek and Craig Smith to Detroit Red Wings for forward Joe Veleno, 25 The 25-year-old Joe Veleno, a left-handed shot, was a first-round draft pick (No. 30) by the Red Wings in 2018. The 6-foot-1 fourth-liner has five goals and five assists in 56 games this season. Read more here. Column: Chicago Bulls are destined for the play-in tournament — again. Embrace it, ignore it, but don't fight it. A flag football first in Illinois: History will be made Saturday as sport continues to grow nationally Chicago Symphony audiences expected to hear an American composer's clarinet concerto, written for CSO principal clarinetist Stephen Williamson, last season. Unexpected quadruple bypass surgery forced Williamson to postpone the performance to this week, in concerts conducted by Gustavo Gimeno. Read more here. More top Eat. Watch. Do. stories: Unexploded WWII bomb in Paris halts Eurostar travel connecting it to London and Brussels The disposal of what Paris police called an 'excessively dangerous' unexploded World War II bomb caused hours of transportation chaos Friday on rail and road networks in the French capital, including the suspension of high-speed train links with London and Brussels. Read more here.
Yahoo
07-03-2025
- Health
- Yahoo
Illinois clinic one of first places in the country to offer new device to spinal cord injury patients
With electrodes stuck to different parts of his back along his spine, Shane Callahan practiced walking on a recent day — with help from an exercise specialist and a harness that helped hold him upright. Callahan has a spinal cord injury, so he wasn't supporting all of his own weight or moving his legs by himself. But something had changed. He had a little bit of sensation in his feet. 'It's pretty strange,' said Callahan, 22, of Lockport, who was injured as a passenger in a car accident 1 1/2 years ago. Since he started using the device with the electrodes, he said, he can feel his feet touching surfaces, though they still can't feel pain or temperature. 'I think there's definitely noticeable progress.' The device, called the ARC-EX, delivers electrical pulses to his spine during his sessions at Next Steps Chicago, a neurological rehabilitation clinic in Willow Springs. The device was approved by the U.S. Food and Drug Administration in December, with some experts hailing it as a milestone in therapy for people with spinal cord injuries. Next Steps is one of the first two clinics in the country offering it. 'It's pretty miraculous,' said Mary Jones, a physical therapist and director of operations at Next Steps Chicago. 'I spent my career working toward this and to see it come to fruition is nothing short of amazing.' Now, during Callahan's appointments at Next Steps, neuro-adaptive exercise specialist Creighton Goss attaches electrodes to the back of Callahan's neck along his cervical spine and then midway down his back, near his thoracic spine. Thin electrical cables connect the electrodes to the ARC-EX device, which delivers continuous electrical pulses throughout Callahan's appointment. The stimulation doesn't hurt, but 'It definitely wakes you up,' Callahan said with a smile. The ARC-EX is not the first device to deliver electrical stimulation through the skin to help people with spinal cord injuries. But unlike other commercially available devices, the ARC-EX delivers stimulation directly to the spine, rather than to other parts of the body that a person wishes to move, such as to an arm or a leg. The idea is to restore hand strength and sensation even when stimulation is no longer used. The device is supposed to be used for up to an hour a day, alongside therapy or training, to help improve hand strength and sensation for people with incomplete spinal cord injuries. About two-thirds of people with spinal cord injuries in the U.S. have incomplete injuries, meaning that though their movement may be extremely limited, their spinal cords have not completely lost the ability to transmit messages to and from the brain. 'Some instruction from the brain gets through but not enough to create a movement, so we're providing an amplification of that signal from the brain,' said Dave Marver, CEO of Onward Medical, the company that sells the device. Dr. Arun Jayaraman, executive director of the Technology & Innovation Hub at Chicago rehabilitation hospital Shirley Ryan AbilityLab, who is not involved with Next Steps, called the device 'an additional tool' that can be used to improve spinal cord signals to the limbs. He said it's the first device of its kind to be FDA-approved and available for everyday use by clinicians, rather than just for research purposes. The AbilityLab has an agreement to use the device for its research studies in stroke and other medical conditions later this year. The device's FDA approval is 'huge' for the spinal cord injury community, said Marco Baptista, chief scientific officer with the Christopher and Dana Reeve Foundation, which helped support the device's development with an investment in Onward. Philanthropic venture fund SCI Ventures, which was co-founded by the foundation and other nonprofits, now holds that investment, and any revenue received from the investment will go toward supporting more research, Baptista said. 'One, this can be a device that can help people, and, two, it provides this path forward that other therapies can then follow,' Baptista said. Next Steps Chicago, a standalone nonprofit, helped test an earlier version of the device and has always felt it's important to bring cutting-edge technologies into the community, Jones said. 'This is a catastrophic lifelong condition,' Jones said of spinal cord injuries. 'To make somebody's life a little bit easier, to give them 10% improvement, that's a big deal for someone who hasn't moved their arm or is dependent on someone else for round-the-clock care.' The device costs clinics about $40,000, Marver said — not a small price tag, but also not the most expensive piece of equipment a clinic like Next Steps uses. In a study funded by Onward and published in May in the peer-reviewed journal Nature Medicine, 72% of participants saw improved strength and function in their hands and arms after using the device. The FDA specifically approved the device to be used to improve hand sensation and strength. Improving hand function is a priority for many people with spinal cord injuries, Marver said, sometimes even more so than regaining the ability to walk. 'They need their hands to get through activities of daily living, to feed themselves, to clothe themselves, to go to the bathroom,' Marver said. 'These are all things that introduce independence, dignity, quality of life.' The device doesn't work for everyone, but so far Next Steps has seen about a dozen patients have positive results, including Callahan, Jones said. Though Callahan still has hand function, the device has helped with other areas of his body, Jones said. Callahan said he'd been a patient at Next Steps for about a year when Jones asked him if he wanted to try the ARC-EX device. 'She was explaining the research behind it and the possible benefits of using it, and it seemed it was applicable to my injury, so I thought why not,' Callahan said. Callahan uses a wheelchair and is paralyzed from the diaphragm down. After his accident, he spent about two months as an inpatient at AbilityLab and then another six months doing outpatient rehab with the AbilityLab. Now, he goes to Next Steps about three times a week, for two hours at a time, where he practices movement in the treatment gym. At a recent appointment, Goss had him kneel in front of a low table, which he used to brace himself, using his arms. Goss then slowly helped Callahan move his legs back and forth, an exercise designed to help him practice shifting weight from one leg to the other. Callahan isn't sure how much strength, movement or sensation he'll ever regain. Everyone and every injury is different. 'Nothing is guaranteed,' Callahan said, but he's trying to recover as much as he can. 'It would definitely improve my quality of life, not just for me, but for my family,' Callahan said of the prospect of regaining more function. 'We're hoping you walk in one day and say, 'Peace out, I'm done,'' Goss said. 'That would be the goal.' 'That would be the goal,' Callahan agreed.
