The medtech company Onward, listed on Euronext Brussels, has launched its commercial rollout in the U.S. and is now attracting significant interest. Sales of its ARC-EX system are expected to accelerate, following the sale of 10 systems in the first quarter. Meanwhile, the company continues to develop new applications and is preparing for the introduction of ARC-EX to the European market. CEO Dave Marver shares his vision and explains how he plans to manage this growth.
Hope for Spinal Cord Injury Patients
At the heart of Onward’s efforts is the ARC-EX system, a unique non-invasive device that improves hand function and sensation in people with spinal cord injuries. It was approved by the FDA in December 2024. This system externally stimulates the spinal cord using electrodes that deliver small electric impulses, without the need for surgery. For many people, even slight improvements in hand function can greatly increase their independence and quality of life.
“This is the first FDA-approved therapy proven to deliver these kinds of results. Since beginning our commercial rollout in the U.S. after approval, we’ve barely been able to keep up with demand,” says Marver. According to him, more than 3,000 people have reached out to learn more about the device—clear proof of both the need for and demand for such solutions. Onward is becoming increasingly well-known in the U.S. The company was recently featured on CBS’s 60 Minutes, bringing their story into millions of households and further boosting interest among investors and patients.
Early-Stage Rollout
Marver emphasizes that the U.S. launch is being handled methodically. “We deliberately phased the launch,” he explains. “Our goal in the first quarter was to sell 10 devices to different clinics so we could learn how to provide training, collaborate with clinics, fit the device into patient workflows, and ensure our sales team—composed entirely of physiotherapists—mastered the therapy.” Following this initial phase, sales are expected to significantly accelerate in the second quarter.
“Most of the clinics we work with already have 15 to 20 patients using the therapy, and many have long waitlists due to capacity limitations. That’s exactly what we hoped for when we launched the product.” Currently, Onward has a commercial team of six people supporting clinics and conducting evaluations. That number will soon double to 12 as demand grows. “In the first half of 2025, we expect to have sold 30 systems as our commercial build-out and market penetration increase. The consensus for the full year is sales of 150 systems.”
Connecting the Dots
Dave Marver clearly enjoys this new phase for Onward. “Now that I’ve been with the company for five years, it’s exciting to finally bring a product to market. For me, shifting from being a purely therapeutic development company to one that also has a commercial side is no problem. I spent years at Medtronic and know what it takes to bring a product to market.”
He believes Onward has taken a smart approach: “The challenge with commercializing a therapy like ARC-EX is connecting patients with care providers. We’ve addressed this by developing a referral system. Interested patients fill out a simple online form, giving Onward permission to share their details with local clinics. In turn, clinics can directly reach out to patients in their area. It’s a win-win,” says Marver. “Clinics receive a list of motivated patients, and patients are informed when therapy becomes available near them.”
Product Pipeline
While the U.S. launch is gathering momentum, Onward is also preparing for European approval. The company is working on obtaining the CE mark, which will allow sales across the EU. “We expect to achieve this by the end of the year,” Marver states. “Preparations are already well underway. We’ve appointed a European sales manager, are hiring reps for key countries, and are about to finalize distribution partnerships. The commercial approach will vary by country, combining direct sales with partner efforts to ensure deep market penetration.”
At the same time, Onward is pursuing approval to market the ARC-EX system for home use. “We also expect a green light for that application by the end of the year.”
Additionally, Onward is developing ARC-IM, an implantable device with more advanced functionalities, along with a brain-computer interface platform designed to give people with severe neurological conditions a new level of control. Even more exciting are potential applications beyond spinal cord injuries. “We’re exploring its use for people with Parkinson’s disease, stroke, and conditions such as blood pressure instability or mobility issues,” says the CEO. He adds that Onward has received a record 10 Breakthrough Device Designation Awards from the FDA—more than any other company in the world. “These awards help speed up regulatory processes and show the FDA’s confidence in Onward’s innovation.”
Sufficient Funding
With $50 million in the bank and no direct competition, Onward is in a strong financial position. “We don’t need to raise additional capital in the short term,” says Marver. “We have enough resources to support the rollout of ARC-EX in both the U.S. and Europe.”
In a strategic move to attract U.S. investors, the company recently launched an ADR program, allowing American investors to buy shares in USD. “It’s about making it easier for U.S. investors to access the stock and increasing liquidity,” the CEO explains.
And what’s the dream scenario for Onward? “By 2030, I’d like to see all three of our platforms approved, on the market, and making a positive difference in people’s lives,” emphasizes Marver. He also expects Onward to be listed on Nasdaq by then.
