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

Yep.

And I think at least with the BioAccess team, we were working with clinicians on the team, you know, people trained as medical doctors.

And I think that helped where we, XSOFT had some consulting neurosurgeons on our team.

So being able to have like a surgeon to surgeon conversation was,

or a surgeon-to-doctor conversation if they were outside of that particular specialty was really helpful in conveying what it was we were doing in medical terms and then having their medical knowledge be able to translate that both language-wise and concept-wise into something that the clinical teams at the sites could understand and respond to was extremely helpful.

I think, uh, for all things that are new, the first in human being a very new experience for the device, for the team, for the clinical side, for the CRO, for pretty much everybody involved, um, that the things are never going to go perfectly to plan.

And so being able to be flexible and adaptable as we go through these things, uh, was, uh, definitely the type of thinking that everybody on the team needed to bring to such a project.

Um,

I think certainly schedule-wise that being able to schedule, identify patients who would qualify for the study as study subjects, understanding their specific medical requirements, how they met the inclusion criteria and how they did make sure that they didn't meet any of the exclusion criteria, being able to obtain consent and get their procedure scheduled.

And do all of that in a short time was definitely challenging.

And I think some of that challenge was mitigated by the fact that we did have a direct flight and were able to come over relatively quickly once we had a patient scheduled.

So certainly there are things related to scheduling that were challenging, but I think the team was able to be flexible and manage that expectations of the clinical team, expectations of the CRO, and likewise for them to manage our expectations of, you know,

what this is like.

Sometimes surgeries get rescheduled, get moved to later, and here's how that was communicated back to us and gave us enough time to replan and manage timelines and things like that.

I think also challenging was...

just the things that happen in a clinical trial after the base procedure itself.

So that was something where BioAccess as a CRO really took over and drove that because there were things that the site was required to do to maintain case report forms and documentation.

And it's challenging when you're not on site to stay on top of that information.

On the day to day, you know, as they see patients for follow up visits and things like that.

So one of the strategies we saw that bioaccess employed was to have a member of the CRO team on site doing kind of like a.

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