Most founders I meet want to launch on the biggest indication they can claim with a straight face. The math is seductive. A bigger label means a bigger patient population, so why aim small? This week offered a clean case against that instinct. Bioness cleared its PoNS device for stroke rehabilitation, a market of more than seven million Americans living with stroke-related gait disability. It reached that market by launching, five years earlier, on one of the narrowest indications it could have picked.
The expansion is the story, not the debut
PoNS is a home-use neurostimulation device. The patient places a mouthpiece on the tongue, which sends mild stimulation to branches of the trigeminal and facial cranial nerves, and uses it alongside a prescribed physical-therapy program. The stroke clearance rests on the Stroke Registrational Program, a three-study, 159-patient effort run across ten centers in the US and Canada. Active PoNS plus therapy produced a 45.5% higher response rate than therapy alone. By the study’s six-point gait-assessment threshold, 56.1% of treated patients responded against 11.1% of controls. It cleared as a 510(k), with Medicare coverage in place at launch.
None of that was the device’s debut. PoNS first reached the US market in 2021 on FDA De Novo authorization, for a much smaller group: gait deficit from multiple sclerosis. In the years since, it built commercial payer coverage with names like UnitedHealthcare, Anthem, and Aetna. The stroke market was always the ambition. MS was the beachhead.
Why launching narrow is a regulatory on-ramp, not a tax
Here is the mechanic most founders miss. The stroke indication cleared as a 510(k), not a second De Novo. That was possible because the 2021 De Novo created a new device type, and PoNS became its own predicate. Its next indication could clear against itself.
I make this point about De Novo constantly, because founders treat it as a punishment, a sentence to extra time and extra work. It is closer to the opposite. Being routed to De Novo means the FDA already views your device as moderate-risk. You write the safety story instead of inferring a competitor’s. And you become the predicate the rest of the category has to match. I took Galen through exactly that. We were routed to De Novo, drafted the proposed regulation ourselves, and the FDA adopted our wording almost verbatim. That language still governs the category.
Launching on a clean, defensible first indication is what earns that predicate position. The broad label you skipped on day one becomes a cheaper filing later, built against your own device instead of a stranger’s. If you are building neurostimulation, diagnostics, or anything with a novel mechanism and several candidate indications, that sequence is worth more than the wider claim you could fight for today.
The big market was the point all along
Launching narrow is not lowering your sights. The seven-million-person stroke market was the reason to build PoNS in the first place. You earn your way into a market that size by proving the smaller one, clinically and commercially, before you point the machine at a harder target. The evidence design, the payer relationships, the home-use workflow, all of it was rehearsed on MS first.
I say a version of this to first-time founders often. The billion-dollar ambition is not your opening move. You build the first small, real thing, and the appetite for the large outcome grows into you as you come to understand the product and the market. For a medical device, the narrow indication is that first real thing.
One honest caveat. Becoming the predicate helps only when the category rewards it. In a commoditized class with a line of fast followers, defining the standard can cost you more in clarifications and defense than it protects. Narrow-first is a strong default, not a law.
Dave’s take
A bigger first indication feels like ambition. More often it is impatience wearing ambition’s coat. The founders who reach the seven-million-person market tend to be the ones who were willing to win a smaller one first, cleanly enough that the regulator, the payers, and their own evidence all pointed the same way. Pick the indication you can genuinely defend, and let the market you actually want be the thing you grow into.
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Dave Saunders is the founder of Base Reality Group and a Fractional CPO for hard-tech founders. He was a founder and operator at Galen Robotics, where the surgical-robotics platform earned FDA De Novo authorization in 2023, and he managed a 35-patent portfolio licensed from Johns Hopkins. He wrote Founders Who Finish and publishes The Build. More about Dave →