Neuropace, Inc. Common Stock 12th Annual Cantor Fitzgerald Global Healthcare Conference

Thank you. Excited to be here.

Yeah. Just to sort of maybe give a little bit of background, we have submitted a PMA supplement to get the expanded indication for what we call another disease state for epilepsy called idiopathic generalized epilepsy. It will likely open up another 20% of the overall epilepsy market for us. Clearly, a nice driver of TAM expansion. With the approval, upon approval, we would be the only company that has a neuromodulation device approved for IGE. With all that said, we have had a few bumps in the road to get here. The most recent one was we did receive from the FDA what is known as a not approvable letter. We can certainly talk about that a little bit more, but what we are doing right now is going through a process, as you mentioned, called the SIR, or submission issue request, on behest, actually, of the FDA.

They said, "We strongly recommend that you go through this process." To give a little bit more background on it, the letter went through and talked about each of our different submissions that we had and some of the questions that they had, and we can dive into it. The takeaway for everyone is that on our last earnings call, we talked about we were in the process of resubmitting. It is not a denied letter. I think that's very important, and the FDA made that clear to us, as well as we've been very thoughtful about the words we picked. We've been saying consistently the FDA strongly recommended we go through this SIR process. What the SIR process is, you can almost think of it as kind of like a mini panel.

We'll have the ability to have the voice of the patient, the voice of the physician. We think that this is an unmet population that definitely needs the RNS System device. It is the same device that we use today that's approved. We met all the primary safety endpoints.

You can certainly look at the MAUDE database and see that we have very pristine results when it comes to adverse events, very minimal. We have submitted the SIR. We did that recently. The FDA then has 21 days to respond and set up a meeting with us. We expect that meeting to happen in early to middle of Q4. Then we can talk about, we'll have a meeting with them. We do have what's called a Breakthrough Device designation, and so that allows for a very collaborative back and forth with the FDA. They may require that when we amend it could be deemed a major amendment, and if that is the case, you would add a 180-day clock on that. Thus far, again, that could happen.

It may not happen, and so people start doing the math, "Well, when do you think you'll get approval?" You start doing the math on that, and the calendar would say 180 days would push you, depending on when the meeting is, kind of in that Q2 timeframe of next year. That's where we're at, and we're excited to meet with the FDA and move this forward for the patients.

Yeah, I am going to let Scott kick that off, and then I will hit it. Scott heads not only our investor relations, but helps out on many fronts with biz dev and finance, but he is quite versed in this, so I am going to let him- Sure take it.

What Sarah is referring to is the recognition from the FDA that they do see a clinical benefit across the study population. What they have focused on is whether or not that is being driven by any subgroup analysis. Mostly driven by seizure frequency. Just give an example, if someone is having two or fewer or two or greater, does one of those specific subgroups drive the disproportionate impact? We do not think so. The data that we have within the NAUTILUS trial, we do not need any new clinical data to be generated. It is all stuff that we already have. We will provide them to that subgroup analysis, as well as other things that Patrick mentioned, which is physician and patient testimonials, also real-world data and evidence. We continue to believe that there is a pathway to approval based on the existing clinical data.

Yeah, maybe a couple of things to add on that is, one of the things that we've talked about and the FDA requested us to elaborate on further would be clinical meaningfulness. What does that mean at the end of the day? That's the totality of evidence, the importance of an unmet population that needs a device. As Scott said, one of the interesting things that they talked about is, they asked for our 24-month data. Our 18-month data, which has actually been published in Epilepsia, showed a 77% median seizure reduction at 18 months. We recently, as part of this, submitted 24-month data. The 24-month data improved dramatically. It's at 100% median seizure reduction at 24 months, 23 to 24 months of stimulation. We really believe that the data's on our side.

We are not at the point where we're looking to parse out the population groups. We believe that all patients that have IGE should get this, and so we're not quite at the point of a narrowed indication that some people are asking. The one thing I would point out is another thing that the FDA said, the protocol allowed us to enroll patients above the age of 12. We did not get a lot of enrollees above the age of 12, unfortunately. Some of that has to do with the disease state. Idiopathic generalized epilepsy tends to present later on in your teens, and by the time you go through the evolution of healthcare, you probably don't get a medical intervention until you're an adult. Hindsight being 2020, it kind of makes sense we probably didn't get a lot of people.

The FDA did come back and said, for that population, there was limited representation.