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Never Before: Spinal Cord Therapies by Onward Medical

Never Before: Spinal Cord Therapies by Onward Medical
Onward Medical continues to advance in technological breakthroughs for SCI patients. In 2023, Onward Medical demonstrated a digital bridge between Wimagine brain implants and a neurostimulator positioned on the spinal cord. Courtesy of Onward Medical.

Onward Medical’s press conference highlighted the imminent approval of its ARC-EX® therapy for spinal cord injuries, its achievements in 2024, and plans for global expansion and further clinical advancements in 2025.

On December 19, ONWARD Medical was authorized to release the ARC-EX system to the American market.

Onward Medical, a pioneering company in medical technology, held a press conference on December 17, 2024, at Les Jardins du Presbourg in Paris, highlighting its advancements in therapies for spinal cord injuries (SCI). With an impressive track record of over a decade of scientific and clinical research, the company is on the brink of a major milestone—the anticipated regulatory approval of its non-invasive ARC-EX® therapy in the United States by the end of the year. 

This external stimulation device has already demonstrated significant improvements in upper limb function for SCI patients, as showcased in the pivotal Up-LIFT study, recently published in Nature Medicine. Onward Medical also discussed its plans to expand to Europe in 2025, reflecting its commitment to restoring movement and independence to individuals affected by SCI worldwide.

Led by CEO Dave Marver and Director of Strategy Alexandre Casteau, the conference offered a glimpse into Onward’s ambitious roadmap for 2025. The agenda included a review of 2024’s achievements, such as the recognition of ARC-EX® as one of TIME Magazine’s Best Inventions, and outlined future clinical trials for the ARC-IM® therapy, which shows promise in regulating blood pressure for SCI patients. With innovation at its core, Onward Medical is poised to transform the lives of countless individuals while reinforcing its position as a leader in medical breakthroughs.

“We are a team of scientists, engineers, and physicians, collectively driven to create therapies that change lives.”

The Upcoming Launch of ARC-EX®

Onward’s ARC-EX® system is set to redefine SCI treatment as the first FDA-approved therapy proven to restore movement. This non-invasive device delivers targeted electrical stimulation to the spinal cord through electrodes placed on the skin, enabling patients to regain control over their arms and hands. The device consists of a compact control unit connected to electrodes placed on the skin near the spinal cord area associated with the desired function, such as arm and hand movement. Patients use the system for approximately an hour a day, with the electrical stimulation activating spinal circuits to facilitate movement that was previously impossible.

“The results are immediate for some patients,” Marver explained, “while for others, consistent use over several weeks leads to significant improvements.”

Clinical trials have demonstrated that ARC-EX® benefits patients with injuries spanning from one year to an astonishing 34 years post-trauma, shattering previous assumptions about the limits of rehabilitation. One pivotal study revealed that 90% of participants experienced measurable improvements in upper limb strength or function, and these benefits persisted even after stimulation ended. 

“This isn’t just about temporary effects—it’s about long-lasting recovery,” Marver noted.

The ARC-EX® device will soon be available in rehabilitation centers and eventually for at-home use, with a recommended usage of one hour per day. 

“We’re starting with specialized rehab clinics, but the goal is to make it accessible for home use,” said Marver. 

Certainly! Here’s the updated paragraph to close the section about ARC-EX®:

ARC-EX® has also demonstrated potential for addressing other medical conditions, such as Parkinson’s disease, with studies already indicating improvements in mobility for this population. While further testing is needed to expand its regulatory label, ARC-EX® has undergone the most extensive clinical trials among Onward’s technologies, reinforcing its versatility and potential to benefit a wider range of patients beyond those with SCI.

ARC-IM® and Onward’s Expanding Pipeline

Onward’s ARC-IM® technology builds on the principles of ARC-EX® but offers an implantable solution aimed at addressing more complex issues. This system has shown promise in early trials for improving blood pressure regulation and mobility in SCI patients. The small device is surgically placed beneath the skin, similar in size to a pacemaker, with leads positioned near the spinal cord. Unlike the external ARC-EX®, ARC-IM® operates continuously. Marver explained the company’s timeline: 

“We plan to launch a global pivotal study for ARC-IM® early next year and aim for commercialization within three years.”

In addition to SCI, the ARC-IM® system also holds the potential for treating conditions such as Parkinson’s disease.

“While our primary mission is focused on spinal cord injuries, these therapies have also shown promise for other populations, including Parkinson’s patients,” said Marver.

The company has received support from organizations like the Michael J. Fox Foundation to further explore this avenue, including a clinical feasibility study that has already produced encouraging results.

Innovation remains a cornerstone of Onward’s strategy, supported by a robust intellectual property portfolio comprising nearly 280 patents.

“What’s exciting is that about half of these are licensed from top institutions like Caltech and EPFL,” Marver shared.

Among its most significant partnerships is Onward’s agreement with CEA-Leti, which has brought critical brain-machine interface technology into its fold.

Joining Forces with CEA, Neuroprosthetics Experts

The collaboration between Onward and CEA-Leti is central to the company’s ambitious plans for SCI treatment. The CEA has developed an advanced brain-machine interface (BCI) that interprets brain signals, decodes movement intentions through artificial intelligence, and uses these signals to stimulate spinal activity. Guillaume Charvet, Head of CEA-Leti’s Medical Devices Development lab, detailed the partnership’s origins and progress. 

“This partnership began in 2019, combining Onward’s spinal stimulation expertise with our work on neuroprosthetics,” Charvet explained.

Charvet described a breakthrough demonstration in which a tetraplegic patient controlled an exoskeleton for both arm and leg movements using CEA’s BCI technology

“What we’ve achieved is the integration of brain activity with spinal stimulation, allowing patients to regain control over lost functions,” Charvet said. 

He explained how these technologies work in tandem: 

“The brain implant records the patient’s movement intentions, and our algorithms decode this data to trigger spinal stimulation at the appropriate moments.”

The collaboration has already achieved significant milestones, including the publication of results in Nature Medicine. Moving forward Onward will lead efforts to transition these technologies from clinical trials to commercial products. 

“Our goal at the CEA is to focus on research and development, then transfer these innovations to industrial partners like Onward,” Charvet emphasized. 

He projected that these technologies could reach broader patient populations within five to seven years, pending successful large-scale clinical trials.

“This partnership is about making life-changing technology accessible to those who need it most,” Charvet stated.

Looking ahead, Onward’s innovative pipeline and strategic alliances position it as a global leader in SCI treatment. 

“We’re entering a new era for people with spinal cord injuries—one where therapies can finally reach the clinic and profoundly impact lives,” Marver concluded.

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