Matt DeNardo

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183 appearances 1 recordings 1 series first heard Jul 2026 last heard 11 Jul

Matt DeNardo’s voice in public audio — every appearance, attributed to the second.

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Global Trial Accelerators™: Fast-Tracking First-in-Human Trials, Anywhere · Matt DeNardo, Chief Product Officer at Axoft · 11 Jul 2026 podcast

auditing and monitoring in person and then also remotely sometimes with the clinical team so that we could be sure that the clinical team was providing the data and documentation that we needed from the trial and was sticking with the clinical plan that we had all agreed on.

I think strategically that...

What we saw from the first in human trial that we conducted was a validation of that approach and technology as being a viable solution for the clinical need that we're trying to meet.

I would say that the things that we learned from the trial that have redirected us a bit came directly from the clinicians themselves, where we learned some feedback on the setup for the procedure, how the procedure itself is conducted, and their preferences for how they like to use the tools that they have and the tools that we provided to conduct such a procedure.

And so I think that's the kind of thing that you really don't learn unless you're hands on with a clinician in the procedure where they can give you feedback as real time, like as they're doing it.

Here's what is and isn't working about this or, you know, here's how they would prefer to do this particular step.

And getting that feedback has influenced our device development pathway.

So as we look to expand and continue our technology development and improve the usability, having that feedback directly from the neurosurgeons has been and will continue to be extremely helpful.

Sure.

And to answer that, I'll talk a little bit about how the technology has gotten to where it is today so that you can have a vision of how that's going to shape what the future path is.

I'll say that

The core material technology, which X-Office is calling Flodon, is the soft elastomer that serves as the base material for the neural probe that we're developing.

And at the level of first in human study, that the key finding is the safety of using such a material in a human patient population.

And then does this actually work to read the neural signal that's so important to the underlying things that we want to develop as part of a medical device?

And I'm happy to say that we learned through the first in-human study that the answer to both of those was yes, that it is safe and yes, that we can record that neural signal.

And I think that gives us kind of a step change in the direction of our company where that lets us go and start to imagine what the specific use cases are for a neural probe made with this material and less about

You know, can we do this at all?

Because that really is kind of the first hurdle for any startup is you get to a point where you say, we think we've got it, but does it really work?

Will clinicians accept this?

Is it going to be useful for patients?

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