Adam Torres and Ken Mariash discuss Octane’s Medical Innovation Forum.
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Show Notes:
Listen to Octane’s Medical Innovation Forum coverage. In this episode, Adam Torres interviews Ken Mariash, CEO at Sinaptica Therapeutics. Explore Sinaptica Therapeutics and Octane’s Medical Innovation Forum.
Watch Full Interview:
About Ken Mariash
As CEO of Sinaptica, Ken is leading the team to advance their personalized closed-loop neuromodulation therapy for Alzheimer’s, which has generated unprecedented Phase 2 sham-controlled clinical data that was recently published in the Oxford journal, ‘Brain.’ Sinaptica has FDA Breakthrough status for its novel proprietary approach which combines rTMS, EEG, and Neuronavigation with a sophisticated ML-derived personalization engine based on a novel brain target– the precuneus, the central hub of the Default Mode Network, a brain network involved in episodic memory. The company has completed all clinicals to date with non-dilutive funding, and is now in-process on a financing to complete the clinical product (SinaptiStim™️ – AD) and prepare to initiate a pivotal study in 2025.
Previously to Sinaptica, Ken has 20+ years leading and growing new business ventures on both the ‘Buy Side’ and the ‘Build Side.’ He started his career in management consulting at Charles River Associates, then jumped to industry at CSL, then Baxter BioScience (now Takeda), and Boston Scientific, with leadership roles in marketing, strategy, and corporate development.
At Boston Scientific’s nearly $1B Neuromodulation division, he was the global commercial lead for the highly successful Cosman RF ablation business he helped acquire. He also built the division’s Strategy function, providing leadership in areas including strategic planning, BD assessment, R&D portfolio management, digital strategy, and investments in next-gen platforms & new indications. In 2019 he joined EBT Medical, a venture-backed, clinical-stage startup developing a disruptive neuromodulation device for overactive bladder, where he oversaw all commercial aspects.
Full Unedited Transcript
Hey, I’d like to welcome you to another episode of Mission Matters. My name is Adam Torres, and if you’d like to apply to be a guest in the show, just head on over to missionmatters. com and click on Be Our Guest to Apply. All right, so today I’m at the Medical Innovation Forum powered by Octane in Irvine, California, and my guest is Ken Mariash.
Ken, welcome to the show. Thanks so much for having me. Alright, so how you liking the conference so far? I know we’re about midway in the first day. So far, so good? Yeah, it’s a great turnout. I mean, for the for the Irvine area, this is fantastic. I mean, people are flying in from all over the country.
I only drove down from Los Angeles, so not a big deal for me, but I’ve been to many of these conferences, and it’s all about the quality of the attendees. I mean, the presentations matter too, but who you meet and who you interact with is absolutely key. And we got a great, a great turnout. All right, Ken.
So you mentioned been to many conferences, many medical conferences or many octane conferences. I just, just curious. Been to a number of med tech conferences across the world. And octane is one of those ones that’s special because there’s a home grown feel to it because these are the local companies that I personally interact with on a regular basis, but people fly in from all over the country.
So it has an international feel as well. Yeah, this is only, this is only my second conference for Octane specifically, and I’m hooked. I’m like, what are some of those things that you feel, I know you’re local, so it’s, that’s one thing, but what are some of those things that you feel make it special?
Yeah, like I said, it’s all about the people you interact with. So, I mean, the topics that are presented are great and you learn a lot. But it’s also the sidebar conversations, it’s people coming up to you, unexpected connections with people in your industry, people who are funders, people who are clinical trial participants, for example.
You know, those are the kind of things I like because those are things you can’t plan for. Yeah. Yeah. I get that. And I see that like during lunch, I saw the, they had some round tables, some investor talks or doing a bunch of different things. And I’m like, I could just, I don’t know how to explain it, but I can just smell, I’m like business is happening here.
I feel it. Like Irvine’s on fire, deals are being done. Right. Yeah, that’s right. And we’re all here seeking capital. Yeah. I mean, all of us have an innovation that we think is special. And so, we’re looking for connections to capital, but, You know, it’s also the people that you meet who can help you along the way.
So it’s the vendors, it’s the lawyers, it’s the doctors, the physicians, the clinical trial experts. It’s a whole ecosystem that does revolve in some ways around these conferences. Yeah, talk a little bit about your company. Tell us a little bit more about what you do. It’s really exciting. So Synaptica is developing a nondrug neuromodulation approach for Alzheimer’s.
So we’re stimulating the brain electrically using magnetic fields outside the head. And what that does is when you stimulate the brain in a very personalized way, you can induce neuroplasticity. What that means is that new nerves connections are forming. You’re strengthening the networks that drive human memory.
If we stimulate in the right way for these patients with Alzheimer’s, we can strengthen the networks and slow the disease progression of Alzheimer’s. And we have phase 2, 6 month data that’s been published in a peer reviewed journal that shows we can slow the disease by 82 percent on the primary endpoint.
And over 80 percent on all other secondary endpoints. Now we’re approaching our one year data, which we’re going to present, mark your calendars, October 31st, from the podium at a major conference. So 12 month data will now be presented, showing these spectacular results are durable to one year. What is some of the feedback you’ve received from the medical community on, on what you’ve already shared, I should say.
And obviously we’re not at the, at the one year yet. So really excitement. I mean, people have not been excited by something in a long time. The latest drugs that just got approved, they barely slowed the disease progression and they, They also come with a host of side effects. So to see something that’s noninvasive, that has no side effects, virtually no side effects and slows the disease by these kinds of levels across the board is really exciting.
Of course, there’s always, you know, some skepticism, some questions asked, but fundamentally, when you look at our data, it’s been peer reviewed. There’s a consistency across all of the markers. And what we’re showing too is imaging data that substantiates what we’re showing clinically. So when we look at fMRI, when we look at MRI, what we see is that stimulation of these brain networks is indeed causing new functional connections.
We see that with fMRI and then with structural MRI, what we show is that we can slow the rate of gray matter atrophy. We are literally preserving. The gray matter in the brain with our stimulation. So when you add up all of this together, the totality of the signal is really promising data. Yeah. So where are you at right now with rollout?
So like obviously you have the new study coming out that’s going to be presented, but in overall rollout adoption, like where are you at with the company? So we published our phase two results at six months. Now we’re going to present our 12 month data phase two. We’ve got a few little phase twos starting.
One is starting in Italy. It’s in early AD. The idea is get to Alzheimer’s early before it really progresses and see if you can bend the curve at the initial stages of the disease. I mean, after all, why wait till you have stage three cancer before you treat it, right? You want to treat it as early as possible.
So that study is starting in Italy now. And then a year from now, we’re planning our phase three study. That’ll be a landmark study, international multi center study, one year endpoint, you know, maybe up to 300 patients or so. And that’ll be where we really prove the use of the therapy in a broad population and then get FDA approval.
Man, that’s exciting. How are you feeling? I mean, I’m very grateful to be a part of this major breakthrough. Yeah, I’ve been, I’ve been in the neuromod space for about 15 years. I’ve had two phase previous phase three studies in Alzheimer’s, one drug, one device that I’ve been a part of and then I’ve also sold capital equipment.
So those three things in my background kind of made me the ideal fit for this role and I’m, I’m really lucky that I get to lead such a great company. Yeah, no, that’s awesome. And I’m, I’m, and I’m happy to have the interview so that when this comes out another year, Tim will be like, Ah, I remember Ken, he doesn’t have time to come to the show now, but hey, I’ll catch him at the next conference.
It’s not about me. I mean, it’s really about our scientific co founders. They are the brains behind the operation. This is their major patented breakthrough. Yeah. It’s amazing. Well, Ken, last question. If somebody’s watching this or listening to this and they want to continue to follow the journey of the company and the updates, like how do people get that?
Yeah. Please go to LinkedIn and follow Synaptica Therapeutics. You can see almost all of our news updates on, on that platform and interact with us. And then our website has a treasure trove of information that you can learn about our therapy and all the great results that we produced. Fantastic. And for everybody watching, just so you know, we’ll put the links in the, in the show notes so you can just click on it and head right on over and follow on LinkedIn as well.
And speaking to the audience, this is a daily show. If you haven’t hit the subscribe or follow button yet, we welcome you to do so. Again, daily show each and every day we’re bringing you new content, new ideas, and hopefully new inspiration that can help you along the way in your journey as well. So again, hit that subscribe button.
And Ken, thanks so much for making some time for us, man. Thanks for having me.