Rich Yang

Yeah.

The most profound, I mean, CGM has been around for a few decades, so there's a lot of rigor around the clinical evidence and performance data you have to show.

But a new layer of manufacturing controls, this is a big one.

The manufacturing controls are really profound.

It's a very high bar to meet.

Not only did Amy execute on the fastest pivotal in our domain, and it was one time.

We had one shot at doing it.

We didn't have enough working capital to repeat the pivotal trials if we didn't meet the endpoints.

But this was also one of the fastest approvals by the FDA for a new CGM category.

So PMAs, as you know, take a very, very long time when there's a new category, if there's no predicate.

So 270 days.

So for something this dramatically different from conventional sensors to be approved in under a year was also an extraordinary feat.

And we're very grateful to the FDA for their collaboration, because without their long hours and guidance and support, this would not have happened.

Sure.

So this is the first fully autonomous bio-wearable for continuous glucose monitoring.

And what that means is because we show glucose excursions through an LED light that tells you what range you're in, this is really a time and range sensor.

So for metabolic health, time and range is becoming one of the most important metrics

above and beyond A1c.

And the only way you get time and range information is if you have a sensor on that's measuring continuously so you can see how much time you are in target range and how much time you're above and below.

So we just happen to have it in a fully autonomous nature.