Onward Medical's no-predicate bet wins first FDA approval for non-invasive spinal therapy

Onward Medical, a Netherlands-based publicly traded medical device company, sells the ARC-EX System: an external stimulator and wireless programmer that deliver programmed electrical stimulation through electrodes placed on the back of the neck, improving hand strength and sensation after spinal cord injury without surgery.

That a non-invasive spinal stimulator could win US approval with no predicate device, and that proving it in clinics would open a home-use market patients run themselves.

Traditional spinal cord stimulation devices require surgery to implant electrodes, leaving a gap for the far larger population living with chronic spinal cord injuries who could benefit from non-invasive therapy. Because no predicate device existed for that approach, Onward could not file a routine 510(k) showing equivalence; it had to pursue FDA's de novo classification, which demands clinical evidence that a novel device is safe and effective enough to create a new regulatory category.

Onward ran the Up-LIFT study, published in Nature Medicine, which reported that 90% of participants improved in strength or function and 87% reported higher quality of life, with benefits including reduced spasm frequency and improved sleep observed in people whose injuries dated back as long as 34 years. On 2025-01-06 the FDA granted de novo classification and market authorization for ARC-EX as the first technology approved to enhance hand strength and sensation after chronic spinal cord injury. Eleven months later, on 2025-11-17, a 510(k) clearance expanded the indication so adults with incomplete spinal cord injuries at levels C2-C8 could use the system for functional task practice in the clinic and take-home exercises at home.

Two regulatory approvals in eleven months converted ARC-EX from a breakthrough device into a reimbursable, repeatable therapy: the de novo authorization opened US commercial sales, and the home-use clearance let Onward widen from clinic-administered sessions to therapy patients continue themselves, with more than 60 US clinics offering the system within its first year.

Non-invasive therapy had no predicate, so Onward's only route to the US market was FDA's de novo pathway, which required the company to prove the device safe enough to define a new category.

The Up-LIFT trial supplied the evidence: published results — 90% of participants improved, 87% reported better quality of life — gave regulators a basis for authorizing a novel device class.

A clinic-first launch was deliberate: supervised sessions generated real-world use and reimbursement traction, creating the track record Onward needed to argue for a broader home-use indication.

Expanding from clinics to homes multiplied the market, letting people continue functional-task therapy daily instead of only during visits — turning a specialty procedure into an ongoing product.

When no device exists, the regulator defines the market: the de novo win created a category, and the home-use clearance showed that winning a new label is only the first step of scaling it.

As of 2025-11-17 Onward Medical held two FDA approvals for ARC-EX in eleven months: a de novo market authorization from January 2025 that made it the first FDA-approved non-invasive technology for improving hand strength and sensation after chronic spinal cord injury, and a November 2025 510(k) clearance allowing home use. CEO Dave Marver called the first authorization the beginning of a new era for people living with chronic spinal cord injuries, and the company was scaling commercial availability beyond the more than 60 US clinics already offering the system.