Dr. Kevin Tracey

And the answer was yes.

When we implanted the device, measured, collected blood before the implant and after the implant, but before it was turned on,

and then collected blood again after the implant was turned on, there was a statistically significant reduction in the TNF ability of the white blood cells of those patients to make TNF in response to endotoxins.

So that was really important.

And then the open-label trial had a positive signal in rheumatoid arthritis.

That laid the groundwork for the FDA to grant

set point, a breakthrough designation, which turns out now to be very important, as you know, in these regulated times, and laid the groundwork for the labeling trial.

If you're in the drug business, you would call it a phase three equivalent trial.

This is a device, so it's the definitive trial that

That was set up, as you describe.

That trial, I was not a co-author on that trial.

That was an independent trial done at 40 sites across the United States.

It was led by John Tesser from Arizona and by Dave Chernoff from the chief medical officer at Setpoint.

The study enrolled, as you said, 242 patients, and all of them had refractory rheumatoid arthritis, which means they were having serious signs and symptoms despite the fact that they tried these powerful immunosuppressive drugs we talked about, the biologics or the JAK inhibitors.

So these people were sort of out of options, and they enrolled in the trial.

Now, there's a really important point about this.

242 patients made it into the trial.

Guess how many created a portal, logged in, and put their information in trying to get into the trial?

Probably 1,000, right?

It's 30,000.