Helius, a neurotech company, announced that the U.S. Food and Drug Administration has completed its review of the its request for De Novo classification and 510(k) clearance of the Portable Neuromodulation Stimulator (PoNS™) device and has declined the company’s request. The company’s CEO Phil Deschamps joined Cheddar to discuss how Helius will regroup after the defeat and submit a new request.
Cheddar: With us now is Phil Deschamps. He’s the Chief Executive Officer at Helius, a publicly traded company. Phil, we’re happy to have you here.
Phil Deschamps: Thank you.
Cheddar: It is a bit of a tough day, not getting the FDA clearance for your latest treatment. So where does your company stand now?
Deschamps: Let me explain to viewers actually what happened today. Our device is called the Portable Neuromodulation Stimulator. When you take this device and combine it with physical therapy or cognitive therapy, the combination of the two seems to put the brain into a plastic state, which allows it to recover from neurological symptoms of disease or trauma.
We were seeking an indication for balance deficit tied to traumatic brain injury. About 1.5 million people in the US that have this condition have no other option. We’re disappointed for them today mostly. Obviously [for] our employees and shareholders also, but it’s really about them I’m thinking about today because they’ll have to wait a little longer to potentially get our treatment.
Cheddar: What did the FDA have issue with?
Deschamps: As I mentioned, the treatment is a combination of [neuromodulation and physical therapy], and our clinical trials were designed for a treatment where both would be provided at the same time. The FDA wants us to give them information to determine what contribution both the physical therapy and the neuromodulation made so that they can make a scientific discussion on what contributions came from [which aspect]. That’s really the issue, and we’re very pleased to continue to work with FDA. We have a wonderful relationship with them and I think that everyone is invested in trying to find a solution for these patients that don’t have other options. We’re looking forward to working with them in getting them the information they need to clear this technology.
Cheddar: Who are these patients typically?
Deschamps: Think about traumatic brain injury as falls, car accidents, bar fights…
Cheddar: A lot of people may think of athletes, head injuries.
Deschamps: Exactly, concussive sports injuries. All of that is mild to moderate traumatic brain injuries. That’s what we were seeking clearance for. Believe it or not, in the US, 5 million people live everyday with chronic symptoms of a traumatic brain injury. About 30% of those, or about 1.5 million, actually have a balance deficit. That’s their primary symptom.
That’s what we focused on because it tends to be the most troublesome symptom for people. Unfortunately today we’ll have to generate more data for FDA, but we’re certainly on our front foot and looking forward to doing that for patients.
Cheddar: So what does that look like? What’s the time table to get there, what data do you have to give them, and then how confident are you [that with] another time around they will give clearance?
Deschamps: Like most things in life, you take two steps back, but there’s definitely one step forward here. As we go through the process, we were able to work with FDA quite significantly so we really understand what they do. They’ve even asked us…[to] come back and talk — it’s called a pre-submission meeting — and let’s discuss exactly how to generate the data so that they’ll be able to evaluate it and potentially clear it. It’s really impossible for me to tell you until we have that discussion how long it’s going to take us. It could be as little as six months but it could be longer if ultimately the data that they’re generating will require a little more work.
Cheddar: What kind of capital will it require to run additional tests to do the additional due diligence to make sure that you’re having that flow of conversation and data?
Deschamps: It’s unfortunately the same answer. We won’t know until we really understand what FDA is going to require. Within the next 75 days, we’re going to have that pre-submission meeting with the FDA and we’ll be able to know precisely what that is.