Zynex submits NiCO pulse oximeter technology for FDA clearance - ICYMI

Zynex Inc (NASDAQ:ZYXI) CEO Thomas Sandgaard talked with Proactive about the company’s recent FDA submission for a new non-invasive pulse oximeter.

The device, according to Sandgaard, offers improved accuracy in measuring oxygen levels, particularly for individuals with darker skin tones or conditions like carbon monoxide poisoning.

He explained that current market devices often return inaccurate readings under such conditions, prompting the medical community and regulators to seek better solutions.

Proactive: All right, welcome back inside our Proactive newsroom. And joining me now is Thomas Sandgaard. He is the CEO of Zynex. And Thomas, it's great to see you again. How are you?

Thomas Sandgaard: Yeah. Good morning. Good to see you.

So the company has put out a news release saying that you've officially submitted to the US FDA the non-invasive oximeter device. Maybe let's start there. Tell everyone a little bit about what this device is, and more importantly, what the FDA has to do with it.

Yes. We've been waiting a long time for this one. This device is very unique in that it can make a very significant and meaningful difference. Pulse oximetry is one of the biggest markets for medical devices worldwide, and devices on the market today are not exactly perfect.

For instance, they read significantly wrong when someone has dark skin. Also, if someone comes into the emergency room with carbon monoxide poisoning, current devices won’t pick that up — they’ll read as if there’s plenty of oxygen in the blood. So typically, if the condition is in doubt, a blood sample is taken and they wait for the results to determine the actual oxygen levels or presence of carbon monoxide.

Our technology can read that non-invasively with a finger clamp, regardless of skin tone or even nail polish. It reads oxygen levels accurately and gives instant information if there’s carbon monoxide poisoning or reduced hemoglobin. That makes a big difference — it can probably save lives.

Yeah. That was a huge problem during COVID, especially for people with darker skin. The data wasn’t being collected accurately.

Exactly. We hope this will have a massive impact. It’s now nearly two weeks since we submitted the application and we’ve had initial dialogue with the FDA about the product. We're very hopeful for a quick process, but conservatively we say it will take six months.

And just to clarify — it goes through the FDA for clearance because it’s considered a medical device, right?

That’s correct. It’s a Class II device. So not historically dangerous, but medium to low risk in terms of clinical impact. We’ve conducted multiple clinical studies that are up-to-date and required by the FDA.

You mentioned your device addresses flaws in what’s currently available. Has there been much advancement in this area?

Not really. The technology was developed around four decades ago and has become an industry standard. It’s used across hospitals and other settings, including at home. Our initial product will target the hospital market, which is worth about $1.00 billion in annual revenue.

There have been small improvements — one company focused on reducing sensitivity to movement — but detecting other hemoglobin species accurately and non-invasively has not been solved. Competitors have tried, but they often add disclaimers. We believe our approach solves it properly.

And this is something the FDA and medical community were actively looking for, right?

Yes. They were prompted by members of Congress and some media reports, especially during COVID, which showed higher mortality rates for people with darker skin. The FDA set up a panel to investigate this, and even considered whether some currently cleared devices should no longer be sold.

We’ve had a lot of conversations with the FDA over the past couple of years about our technology. They’ve shown a lot of interest in how we’ve achieved this accuracy. A key part of it is using laser diodes with precise wavelengths, unlike regular LEDs. The company we acquired three and a half years ago had been working on this for about a decade.

Quotes have been lightly edited for clarity and style