In an exclusive interview with The Fly, NeuroOne (NMTC) CEO Dave Rosa talked about the company, its pipeline, upcoming data readouts, COVID-related delays and much more.
WHAT SETS NEUROONE APART: NeuroOne is developing new minimally invasive and high-definition electrodes based on its thin film electrode platform for diagnostic and therapeutic neurological applications. "Unlike a lot of technologies that are out there today and are one-trick ponies – only treat one condition, what we have at NeuroOne is a true platform technology. It's not only used for one indication but a variety of them. We really fit across a wide variety of indications. You will hear us talk about Parkinson's Disease, epilepsy, and back pain, but it can also apply to other conditions like depression, urinary incontinency, and pain management," CEO Dave Rosa told The Fly.
The executive believes three things set NeuroOne apart. "One is the technology. Because it's a very thin film, you have a better chance of placing these devices through smaller holes and even through needles. The second one is its multifunction capability. Most devices either record electrical activity, ablate tissue or stimulate and we're working on combining some of those functions into one device. If you're able to do that, you can cut down on the number of hospitalizations, the number of surgeries, the cost involved and hopefully improve outcomes. The last thing in terms of differentiation is the high-definition capability, which gives you clearer signals. When you're talking about removing brain tissue, you clearly don't want someone taking anymore or any less than they need to address whatever neurological problem you have. The more precise, the more accurate you can be, the better the outcome should be," Rosa explained.
"We have the capability of increasing the number of points of contact with the brain. If you think about pixels on the TV – the more pixels, the better the picture. We really feel thse type of electrodes could be used to help maximize the impact of using artificial intelligence. You've heard of Elon Musk and his company NeuraLink in the space and that's what they're looking to do as well," the executive told The Fly.
EARLY STUDY TESTING: Earlier this month, the company announced that it successfully completed initial pre-clinical long-term testing of recording capabilities on its platform thin film electrode technology. "Whenever you do early study testing, you always learn something new that you haven’t experience before. And that is just inherent in developing these technologies. In particular with electrodes, the design is critical but a lot of people don't realize that the manufacturing process is equally if not more important to really develop these devices. We learned that there are some things that we still want to work on to really fine tune the technology so that we can make them in high volume, with high yields and low cost. There are lot of devices that you can develop but at times it's very challenging or expensive to manufacture. You really need to be able to do both. While we're very excited by the results we saw for long-term recording, there's still work we need to do on the manufacturing of the device," Rosa said.
UPCOMING MILESTONES, DATA: NeuroOne expects results/completion of test data for therapeutic brain electrode technology and Food and Drug Administration 510(k) clearance on diagnostic brain electrode technology from 24 hours to 30 days in the near future. CEO Dave Rosa expects to hear from the FDA "by the end of this month" or "sometime next month." "This is major milestone for NeuroOne because this particular device represents the technology that is used in the majority of diagnostic procedures for patients with epilepsy. There are a few different ways of doing this diagnostic testing but this one is the least invasive way using devices like this. That's clearly an important milestone for us. Also, it will trigger a non-dilutive milestone from Zimmer Biomet [ZBH], which is our distribution partner. Zimmer Biomet will be the company that will actually launch the product in our behalf in the market. It has a lot of great synergy with the robots that they market for these procedures. It's a critical milestone because it triggers a payment to us," the executive told The Fly.
Regarding the long-term stimulation data, the executive told The Fly that the upcoming data is also "really key" as it "opens the door to be able to start looking more at therapeutic technologies, combination therapeutic technologies. We really need to be able to demonstrate that the electrodes can last a long period of time."
COVID-RELATED CHALLENGES: The ongoing pandemic has impacted a wide range of sectors worldwide and the biotech and pharmaceutical space hasn't been immune to COVID-related delays and supply shortages. Back in December, NeuroOne experience "supply chain shortages with many of the vendors" the company was working with. "They attributed to COVID," Rosa said. "COVID was having an impact but companies instead of having 6 months of inventory, they were placing orders for raw materials for 18 months of inventory. Everyone was trying to be overly cautious and that's what really cause, at least in our business, shortages in the supply chain. Luckily, we're working through this without major impact." The executive also noted that around the same time, NeuroOne also had issues with one of its vendors. "Half of their labor contracted COVID and were out for a few weeks. We had a few delays but expecting to have major impacts for us," CEO Dave Rosa added.
NOT A 'ONE-TRICK PONY': While the executive doesn't believe there are many misconceptions about NeuroOne, CEO Dave Rosa did point out that "there is a misperception that the technology is primarily for brain conditions." "People associated electrodes with brain and in reality, this is a technology that, for example in urinary incontinence, wouldn't be placed in the brain but it will stimulate the bladder or others parts of the anatomy to treat incontinence. The company is not a one-trick pony. We have broad applications. We just happen to be focusing in on epilepsy, Parkinson's and chronic back pain," he explained.
"Meet the Company" is The Fly's recurring series of exclusive short interviews with Executive Officers to offer a deeper look inside the company.