Medical Design & Outsourcing – WOMEN IN MEDTECH 2022

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They want to understand what the brain's doing so they can treat neurological conditions, and most labs have their own electrodes that are really different. Our device has to mate or couple with each one of these. That's what our goal is under that NIH funding. We went from being compatible with one to 13 now. We have commercial sales of our NeuralGlider to about 12 research labs. Then we have other ones that are just participating in evaluating it to see if it works for their electrode. Then, under that SBIR are another six labs that are using it as part of the SBIR project. MDO: Neuromodulation and neurostimulation are a trend right now, so obviously, that's a really important innovation. How does the NeuralGlider work? Mulvihill: Right now, one way that researchers insert electrodes into the brain is by using high-force air. It forces

the electrode into the brain tissue, but the brain tissue dimples, and therefore it’s hard to achieve to a precise location. There’s also a lot of hemorrhaging, which then causes a foreign body response, where the body attacks the electrode and decreases its lifetime. NeuralGlider, our device uses ultrasonic energy — very frequent but short displacements. We’re vibrating those electrodes into the tissue with less dimpling, so we’re more precise and less tissue trauma, so lower body response. Then we believe that our electrodes will have a longer life. MDO: Could that kind of technology be used in another application like blood draws? Mulvihill: Correct. So we started actually looking at it for spinal insertions and epidural insertions and even bone biopsies. And it was when DARPA (Defense Advanced Research Projects Agency) saw what we were doing and said, "Can

you use that same technology to insert electrodes into the brain?" We started with the other application areas and really moved into the neural space. MDO: DARPA saw there was a need for it somewhere else, and so your team decided to shift toward that? Mulvihill: Yeah, pretty much. We're still doing other things. We actually have 21 employees, so we're not all doing neural devices. MDO: What is the regulatory status of NeuralGlider and your other two commercial devices? Mulvihill: The TubeClear system is FDAcleared. It has six 510(k)s behind it because there's different types of feeding tubes. With each different feeding tube, we had pretty much a new indication or a new FDA clearance. The other device we have is GentleSharp, and that device is for animal research or for more humane blood

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