ONWARD, Eindhoven (2025)

17/11/2025

We are pleased to announce that we have received clearance to expand the ARC-EX System indication for home use in the US. The Food and Drug Administration has cleared the ARC-EX System for use in conjunction with functional task practice in the clinic and take-home exercises in the home to improve hand strength and sensation in adults with spinal cord injury.

“For people with limited mobility who navigate daily logistical challenges, having the option to use this therapy at home can make a meaningful difference. Integrating in-clinic and at-home therapy may help support and maintain improvements in hand strength and sensation, contributing positively to overall quality of life,” said Dr. Candy Tefertiller, PT, DPT, PhD, NCS, Executive Director of Research and Evaluation at Craig Hospital in Denver, Colorado.

“For more than 40 years, the Christopher & Dana Reeve Foundation and our community have invested boldly in high-risk, high-reward science, pairing funding and leadership with the lived experience of those living with and those who care for them. Today’s achievement demonstrates that we are now seeing breakthroughs once thought impossible,” said Marco Baptista, Ph.D., Chief Scientific Officer of the Christopher & Dana Reeve Foundation.

The ARC-EX System is non-invasive and delivers programmed, transcutaneous electrical spinal cord stimulation. It is intended to be operated in medical centers by rehabilitation professionals and at home by patients and persons providing assistance to patients, as needed.

ARC-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 and with take-home exercises in the home to improve hand sensation and strength in individuals between 18 and 75 years old that present with a chronic, nonprogressive neurological deficits resulting from an incomplete spinal cord injury (C2-C8 inclusive). The ARC-EX System is intended to be operated in medical centers by rehabilitation professionals and at home by patients and persons providing assistance to patients, as needed.

11/11/2025

"I always wanted to join the military. I've traveled the world and done all sorts of things. You've got to always be optimistic and find the good in whatever situation you're in. I may not be able to walk again, but there are always new things to learn to make my life easier. Since using the technology, I've noticed many minor things that, to me, are major. I like playing spades. Now I can hold the cards up with one hand or with both hands and pull them out without worrying about dropping them. Little things like that make a big difference."

AJ Walker is a US Navy veteran living with spinal cord injury, and a user of our technology designed to improve hand sensation and strength after . This Veterans Day, we honor all who have served and recognize their courage and resilience. Our team is dedicated to helping people living with SCI enjoy life in the ways that matter to them. Thank you, AJ, for your service and for sharing your motivating outlook and drive!

Patient testimonials reflect individual experiences and outcomes, which may vary. Please review the full product label and clinical study data.

28/10/2025

We’re happy to announce that long-time ONWARD Medical partner Scott Chesney has received the Mike Lione Accessibility Award!

This award is given to pioneers and visionaries in accessibility who have performed exemplary work as advocates for people living with disabilities. Scott is a long-time champion and advocate for the spinal cord injury community, and has offered us an invaluable perspective as we work together to raise awareness on the importance of accessibility and empowering movement.

Congratulations, Scott, on this well-earned recognition! 🏆

17/10/2025

"Without blood pressure, blood doesn’t flow through your body. It’s like a garden hose that’s not watering the plants. Your organs don’t get the oxygen and blood they need. Blood pressure is central to everything."

That is how Nuno Abreu, a general surgeon in Lisbon, Portugal, living with spinal cord injury (SCI), describes the need for improved blood pressure regulation.

After , many people experience symptomatic blood pressure instability, where disruptions in the autonomic nervous system cause blood pressure to fluctuate between abnormally low and high levels. Blood pressure instability and persistent low blood pressure can threaten neurological recovery and negatively impact cardiovascular health and overall quality of life.

“I had severe hypotension after my SCI. I wasn’t able to be upright for a long time, and I fainted multiple times a day,” explains Julie Verlinden.

In collaboration with the Christopher & Dana Reeve Foundation, we recently hosted a webinar ahead of the initiation of Empower BP, a global pivotal study to assess the safety and effectiveness of our implantable neurostimulation technology in addressing blood pressure instability following SCI.

📺 Watch the full webinar to learn more about Nuno's and Julie’s experiences, and about the Empower BP global pivotal study: https://www.youtube.com/watch?v=5mW8TlLnnak

For more details about the study, please visit: https://www.onwd.com/empower-bp/

ARC-IM® is investigational and not available for commercial use. Limited by United States law to investigational use. To stay informed about ONWARD’s technologies, research studies, and future availability in your area, please complete the web form linked in the comments below.

24/09/2025

Reminder: Webinar is Tomorrow!

Join us tomorrow, September 25 at 12:00 PM ET, co-hosted with the Christopher & Dana Reeve Foundation, and learn more about Empower BP, a global pivotal study to evaluate the ARC-IM System, an implantable neurostimulation therapy for blood pressure instability after spinal cord injury ( ). Hear directly from ONWARD, study investigators, and SCI community members who have participated in prior ARC-IM studies.

👉 Register now: https://bit.ly/4mkietd

More info: https://www.clinicaltrials.gov/study/NCT07147296

We look forward to seeing you there!

19/09/2025

We recently announced that the US FDA has approved an investigational device exemption (IDE) for the ONWARD ARC-IM System. This approval allows the initiation of Empower BP, a global pivotal study to assess the safety and efficacy of the implantable neurostimulation technology in addressing blood pressure instability following spinal cord injury.

Many people living with experience symptomatic blood pressure instability, where disruptions in the autonomic nervous system cause blood pressure to fluctuate between abnormally low and high levels. This under-appreciated and unmet need has a significant impact on both cardiovascular health and quality of life.

Join our webinar in collaboration with the Christopher & Dana Reeve Foundation to learn more about the global Empower BP pivotal study. It will feature speakers from ONWARD, study principal investigators, and SCI community members who participated in past studies investigating ARC-IM Therapy to treat symptomatic blood pressure instability.

When: September 25 at 12:00 PM ET
Register here: https://us02web.zoom.us/webinar/register/8317580514853/WN_bUdVrPSvQgmXjUwYDJf7sw #/registration

We look forward to engaging with you during this session!

For more details about the study, please visit: https://www.clinicaltrials.gov/study/NCT07147296

ARC-IM® is investigational and not available for commercial use. The safety and effectiveness of this therapy are currently being evaluated in clinical studies and are under review by the US Food and Drug Administration (FDA). Limited by United States law to investigational use.

18/09/2025

We are proud to announce the simultaneous publications of two articles in the highly respected academic journals Nature and Nature Medicine. They highlight advances in blood pressure regulation after spinal cord injury (SCI) and add to the compelling body of scientific and clinical evidence supporting the investigational ARC-IM® System, our implanted neuromodulation platform designed to deliver targeted and personalized spinal cord stimulation.

Both publications support our commitment to introducing therapies that address critical autonomic functions impacted by . These results demonstrate the potential of ARC-IM Therapy for managing blood pressure instability in advance of the planned initiation of the Empower BP global pivotal study later this year.

Read the full press release: https://lnkd.in/eahW9SSt
Nature article: https://lnkd.in/gvvJ2Mvi
Nature Medicine article: https://lnkd.in/gMf8YAyj

ARC-IM® is investigational and not available for commercial use. To stay informed about ONWARD’s technologies, research studies, and future availability in your area, please complete the webform linked in the comments below.

08/09/2025

We are pleased to announce that we have received CE Mark certification for the ARC-EX® System, enabling commercialization of our breakthrough spinal cord stimulation system in the European Union and certain other countries. This certification enables us to promote its use to improve hand strength and sensation after spinal cord injury, both in the clinic and at home.

The ARC-EX Therapy opens new doors for the European community, offering opportunities for recovery and care that were previously unavailable. It gives us great satisfaction to bring this important new therapeutic option to people living with paralysis in Europe.

Read the full press release: https://ir.onwd.com/static-files/a535cfdb-3cdf-4e12-b0fb-a22805640da0

To stay informed about ONWARD’s research studies, technologies, and the availability of therapies in your area, please complete the webform linked in the comments below.

ARC-EX Indication for Use (EU): The ARC-EX System is intended to deliver programmed, transcutaneous electrical spinal cord stimulation in conjunction with functional task practice in the clinic and with take-home exercises in the home to improve hand sensation and strength in individuals between 18 and 75 years old that present with a chronic (>1 year post-injury), non-progressive neurological deficit resulting from an incomplete spinal cord injury (C2-C8 inclusive).

03/09/2025

We are heading to Philadelphia for the 2025 ASCIP Annual Meeting!

Organized by the Academy of Spinal Cord Injury Professionals (ASCIP), this conference is an opportunity for experts to connect, exchange ideas, and support new research. If you’re attending the conference, come visit us at Booth 201 to meet our team and learn about the ARC-EX® System, the first and only FDA-cleared technology to help improve hand strength and sensation in people with spinal cord injury.

We look forward to seeing you there!

ARC-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 who present with a chronic, non-progressive neurological deficit resulting from an incomplete spinal cord injury (C2-C8 inclusive).

23/08/2025

We are proud to return to the Paralyzed Veterans of America(PVA) Healthcare Summit + Expo 2025, supporting this important event for the , and communities as a Gold Sponsor.

Held from August 24-27 in New Orleans, the summit offers a unique opportunity to learn, share, and engage with clinicians and professionals across multiple disciplines, fostering an integrated approach to care.

If you’re attending the conference, mark your calendar: ONWARD will host an expert session and live Q&A on August 26 at 12:00 PM with Dr. Candace Tefertiller, PT, DPT, PhD, NCS, Dr. Jenny Kiratli, PhD, and Sean Sciara. We will discuss the early real-world experience with the ARC-EX® System, the first and only FDA-cleared technology indicated to improve hand strength and sensation after spinal cord injury.

Stop by Booth 303 in the conference hall to say hi to our team and learn more about our latest technologies. We look forward to connecting with you there!

ARC-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).

18/08/2025

We are pleased to announce that the US Food and Drug Administration has approved an investigational device exemption (IDE) for the ARC-IM® System, our implanted neuromodulation platform designed to deliver targeted and personalized spinal cord stimulation.

With this IDE approval, we can initiate the Empower BP global pivotal study to assess the safety and efficacy of the implantable ARC-IM System to address blood pressure instability after spinal cord injury. The study is expected to involve approximately 20 leading neurorehabilitation and neurosurgical research centers across the US, Canada and Europe, with first patient enrollment anticipated before the end of the year.

This is an important milestone for ONWARD and the community. Blood pressure instability is a major recovery target after spinal cord injury. It affects more than 50% of people with SCI, impacting neurological recovery, cardiovascular health, and quality of life.

Read the full press release: https://ir.onwd.com/news-events

ARC-IM® is investigational and not available for commercial use. To stay informed about ONWARD’s research studies, technologies, and the availability of therapies in your area, please complete the webform linked in the comments below.

13/08/2025

“There is a quiet dignity in needing less help.”

That is how Jessie Owen, an ARC-EX® Therapy trial participant, reflects on her journey with the device and her renewed confidence to complete daily tasks and live life independently. Our groundbreaking ARC-EX System is the first and only US FDA-cleared technology indicated to improve hand sensation and strength after a spinal cord injury.

We were proud to see Jessie’s experience with it recognized on Fast Company's list of World Changing Ideas 2025. 🌎💡

Fast Company’s annual World Changing Ideas Awards honor the businesses and organizations that are developing creative solutions to the most pressing issues of our time. Thank you for highlighting stories like Jessie’s as we advance our mission to bring breakthrough therapies to people with and other movement disabilities.

Read more about the World Changing Ideas 2025 at the link in our comments.

ARC-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).

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