Matt DeNardo

speaker

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

It was also,

They are Axoft's CRO and are working on behalf of Axoft and have knowledge of the device, knowledge of the procedure, and knowledge of what we're trying to do and why this technology is ready for first in human.

And I think that made all the difference in developing relationships with clinical sites as we look to select one that helped the process go smoothly and quickly because it wasn't

a round trip of communication every time we got questions from a clinical site or had meetings with clinical sites.

I think the challenge that we saw came in the challenge that we see with any new technology is that explaining something that is so different than current technology is challenging.

And doing that across a language barrier can also add another layer to that challenge.

I'd imagine that, you know, the...

ideas behind what Axoff was specifically doing on the material side and how that led to the development of our brain computer interface is something that I think is hard to explain to anyone, even those familiar in the industry.

that it's really a specialty of neurosurgery in the first place.

Not all hospitals are familiar with or would have access to that technology because most of that technology is still at the clinical trial stage in some cases.

So it's not like there is a history of devices on the market where you can say, oh, yes, we're doing something like this, but here's our take on it.

You kind of have to build the understanding from the ground up of,

Here's what the clinical need is that we're addressing.

Here's how this trial helps us demonstrate the safety and efficacy of our solution.

Here's how our solution even works and what it's doing that's different than other folks and why that difference we think matters.

And so I think that was the most challenging bit was to build up the understanding of

with the CRO team and then convey that same understanding to clinical teams who have varying levels of experience with that type of neurosurgery.

So finding, you know, comparative devices and procedures that

the clinical teams were familiar with to help explain how our device works and how it's different from those things that they might be used to.

For each site, I think it was a different challenge depending on what types of procedures they do at that site and the devices and technologies that those clinical teams had been exposed to previously.

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