Actuated Medical is making electrode placement for deep brain stimulation easier and less traumatic.
Nearly 16 years ago, Actuated Medical co-founder, President and CEO Maureen Mulvihill was working for a company making actuators that were the size of a grain of rice. While the company was focused on components, she wanted to help patients more.
“I was actually sitting in a doctor’s office and I was showing him the little actuators. He’s like, ‘Maureen, I don’t need that. I need the whole system FDA approved,'” she told Medical Design & Outsourcing.
Mulvihill understood that sentiment and went on to start Actuated Medical with the idea of putting motion into medicine.
Bellefonte, Pennsylvania-based Actuated Medical is a medical device product development company with devices that have some kind of motion built in. It has three commercial devices, including the NeuralGlider neural implant inserter that reduces tissue deformation during trans-pial insertion of deep brain stimulation electrodes, TubeClear feeding tube clearing system and GentleSharp blood sampling system.
The company also has eight products in its pipeline: the GripTract GI endoscopic tissue manipulator, Baby GentleStick heel stick helper, IntelliNeedle for epidurals, OsteoAccess that enables angled bone entry, TumorSite CNB tissue edge identifier, BleedClear endoscopic clot clearing system, GentleClear endotracheal suction catheter and GentleDispense for needle-free drug delivery.
Actuated Medical received funding through a National Institute of Health Small Business Innovation Research (SBIR) grant, which is the biggest source of seed funding for medical device startups in the product development and proof-of-concept stages.
I caught up with Mulvihill at the Life Science Women’s Conference in September to discuss some of the innovations her company is working on.
MDO: I sat in on an NIH funding session in which they talked about their (SBIR) grant, and they specifically mentioned the success Actuated Medical has had in the program. They touted the company’s NeuralGlider in particular. Is that your only device for which you received that NIH grant?
Mulvihill: We’ve received several grants from the NIH. We have three products that are on the market that have been developed with SBIR grants. The first one is a device called the TubeClear System. The TubeClear System is a device that clears feeding tubes while the tube stays in the patient. It’s critical care. When people can’t self-feed, they put a tube through the sinus passage, down the esophagus and into the stomach or below into the pylorus. These tubes are very narrow and they clog at about a 25% clog rate. That technology is in about nine hospitals across the country, and it’s a critical care device. It’s in a lot of ICUs and a lot of ERs.MDO: I know with the NeuralGlider neural implant inserter, it’s really hard to make or it’s just a difficult device to successfully achieve, and your company has done it because it’s a commercial product now, right?
Mulvihill: It is a commercial product for preclinical research. It is not for human use yet. Under NIH SBIR grants, we developed the device to be compatible with many electrodes. There are researchers across the country and the world that are studying the brain. 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 FDA-cleared. 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 sampling of rodents. That did not require FDA. The NeuralGlider inserter, we’re in the preclinical market, so we did not need to go to the FDA. But we right now are interacting with the FDA to see what is the regulatory path for it. The Blackrock NeuroPort is FDA-cleared for their specific electrode. We know there is a path forward. It could be a 510(k) pathway.
MDO: What are some of the challenges of designing, especially for the NeuralGlider?
Mulvihill: You do have to consider the tissue you’re going into. Then our device, which is a piezoelectric actuator, has to have a coupling mechanism to couple to the electrode because everyone’s electrode design is different. That mechanism that does the coupling is definitely our intellectual property. That would be one of the things to think about.
Then the other part is we do want to get this into the human clinical stage. Now we have to look at verification validation testing. Actuated Medical is ISO 13485-certified, which means that we can manufacture medical devices. We’re compliant with the FDA. We’re now looking at getting NeuralGlider FDA cleared, getting all the data ready so that we can go quickly to a clearance once we have the safety and efficacy data.
MDO: What’s next for Actuated? What are you excited about?
Mulvihill: The future for it is this neural device space. We also have three other products that are very close to FDA [review]. We have a regulatory submission going in for an endoscopic tool. That should be going through the FDA in the next couple months.
GripTract will be going to the FDA before the end of the year. Then we have another product called Baby GentleStick, and it will be going to the FDA probably in the first quarter or second quarter of 2023. We have a clinical study going on for the Baby GentleStick. We’re waiting for that data. Once that data’s in, then we’ll go to the FDA because everything else is done. We’re just waiting on clinical data. GripTract, for which we’re receiving additional SBIR funding that’ll support two clinical studies. We have these three products and TubeClear — we continue pushing TubeClear.
MDO: Which one are you most excited about?
Mulvihill: Probably NeuralGlider, right? Each one is so different. Each one has a different application area, clinical need. Each one gets me excited about different things. One of the great things with TubeClear is when you have a feeding tube, and it’s clogged — you can’t get your food, your medication and nutrition — our device clears that so they don’t have to have a surgical procedure. During COVID, we had a doctor call us. He had a patient that hadn’t eaten in eight days. They used our device. That patient avoided having surgery. That’s a great day. NeuralGlider — I have family members that have had Parkinson’s. Can we help them? Rather than the drugs that have cerebral side effects, can we do a minimally invasive procedure and make their quality of life better? And then GripTract, anyone over 50 that has had a colonoscopy, we all know how serious it is, right? Our device gives doctors a third hand, gives them fingers, and then they can manipulate tissue, and they can do better procedures faster for patients and make outcomes better.