“Innovation has no boundaries. The same is true for trauma.”
Those were the opening remarks of a brief acceptance speech given by Oded Kraft at the Galien Forum in New York City last week.
Kraft was there to accept the Prix Galien USA award for best startup on behalf of his company, Israel-based GrayMatters Health.
Judges lauded the company’s FDA-cleared, adjunct digital therapy for PTSD, known as Prism. The therapy combines state-of-the art technology to help down-regulate the impact of the amygdala — the part of the brain involved in emotions — with a program designed to help patients (under medical supervision) work on alleviating their PTSD.
The approach helps patients take an active role in managing their PTSD which, as Galien jury chair Bernard Poussot noted, can reduce pressure on mental health providers, who find themselves stretched thin given the millions of people suffering from mental illness the world over.
Life science CEOs often talk about the effects of geopolitical risks in terms of their disruption to supply chains and overall global equilibrium.
Yet in GrayMatters’ case, we wondered whether the effects of the Israel-Hamas conflict would have a different impact.
Given the pressing need for trauma care in the wake of October 7 — when terrorist group Hamas carried out a surprise attack that claimed the lives of 1,400 Israelis, many of them women and children — the startup’s mission seems more critical than ever.
MM+M spoke with Kraft, co-founder and CEO/president, about how the invasion and ongoing war against Hamas have impacted his company’s ability to fulfill its mission. He expressed the resilience – and skill in navigating through difficult times – for which Israeli entrepreneurs are known.
This interview has been edited lightly for length and clarity.
MM+M: Let’s start with your technology. How is the tech used? Is it an app on a phone, or a special device?
Kraft: It’s a special device. We are a software-as-a-medical device that’s installed on an off-the-shelf laptop and an off-the-shelf monitor that presents the simulation that the patient learns how to control and regulate by identifying specific personal mental strategies. The software receives its inputs from an EEG device, which too is an off-the-shelf device commercially available from a third party. This is to be used at an out-patient clinic under the direction of a healthcare professional.
[Editor’s note: GrayMatters Health’s core technology and treatment are based on a digital biomarker of brain activity associated with mental health disorders. The proprietary EEG-fMRI-Pattern (EFP) digital biomarker was developed by applying advanced statistical models to register amygdala fMRI data to EEG. During Prism for PTSD treatment, the patient watches a crowded and noisy simulation wearing an EEG headset that measures the patient’s brain activity. As patients tune down their amygdala-based EFP biomarker, the simulation changes and the avatars sit and quiet down.]
MM+M: Most founders have a personal reason for doing what they do. I’m sure that’s no different in your case, so what drove you and your partner to start this company?
Kraft: I’ll divide my answer in two parts.
First, Professor Talma Handler, who’s the inventor of the technology, experienced her late husband living with PTSD for a few decades. That, as well as her being a psychiatrist and also a scientist, drove her into this field and into this application in particular.
[I don’t suffer from] PTSD, but I do like people and science. I find them both fascinating. So when I was first introduced to Professor Handler’s technology through one of my co-founders [Rani Cohen], the idea seemed just amazing to me.
I saw it as a true, real, unique and natural way to combine people and science, as well as my own experience with GE Healthcare, machine learning, and [desire to] introduce new products into fields that have not seen innovation for a while.
(Editor’s note: Kraft spent six years at GE Healthcare as a segment manager, system architect and project lead)
MM+M: You mentioned Rani Cohen, co-founder and executive board chairman, who I understand is a former F-16 fighter pilot. There is a third co-founder, Shai Attia, VP of R&D. How did the three of you explore development and access through the lens of the end-user?
Kraft: The three of us are fairly different. We bring different perspectives into whatever we do as individuals and also as a team. The way we view each of our perspectives is what we call a “statistic of one,” commonly known as an anecdote.
What we’ve done for the past seven years is speak with people who know more than we do, collecting the voice of the customer all of the time. Even now, as we have the product which is FDA-cleared and making its first steps in the market, we continue to collect voice-of-customer information.
MM+M: How is the terrible situation in your region elevating the importance of PTSD in Israel – in the shadow of the horror in Maine, which we’re now dealing with in this country – and other events that leave deep psychological scars?
Kraft: The recent events – the horrific October 7 [invasion] and then the Maine shooting in the U.S., they highlight trauma, they highlight cruelty and they expand the circles of those that live with trauma.
Some of them will develop PTSD later on – those directly affected, their friends and families, their community and so on. As we’ve learned, it does not stop here; trauma travels. The American Psychological Association came out with a short statement talking about how the events that we’ve seen on October 7 propagate and affect people all around the world.
I’m seeing it in conversations here with people. I hear it from colleagues in Europe and Japan. What we do matters, it always did, but mental health in general and PTSD in particular, has not always gotten adequate attention. Now it does.
MM+M: How many employees do you have in Israel?
Kraft: We have 22 employees in Israel.
MM+M: Oftentimes in the wake of a geopolitical crisis, corporations speak about disruption to supply chains and the like. Employee morale can obviously take a hit. You told me that the attitude among Israeli entrepreneurs – a community which has been providing innovation to the world for many years – has been quite the opposite. Talk about that resilience.
Kraft: I’ll start small with us, with our company. As I mentioned, we’re a small group of 25 in the U.S. and Israel. Some of us are on reserve [IDF] duty. Some of us are at home because their partner is on reserve duty. However, we still have a business to operate. None of the people in our company was directly affected by [the October 7 attack], depending on the term “directly,” of course.
Still, everybody was affected in one way or another, we all know people. I won’t lie, the morale is affected. We are a company that deals with stress and resilience, so we do try to set an example.
I just talked about this with the team. When I travel, I try to send short clips with some information and messaging so they know what’s happening and what the big picture is, because we cannot meet in-person due to the time differences.
Now, generally speaking, Israel and Israeli entrepreneurs – because of the ecosystem, our education and everything that has to do with being an Israeli – I think we are resilient. By that, we’re not different from any entrepreneurs globally [who] also tend to be resourceful. We always look for the silver lining and for what can be done to move forward.
As a certain prolific and successful entrepreneur once said, “A thousand more startups will come to life after this war.” We will overcome and prevail. That’s the way that we’ve always done this and that’s the way we’re going to do it now.
We mourn those that have been lost. None of this will undo the damage and the pain that was inflicted. However, we will continue to innovate and we will continue to deliver. That’s a promise.
MM+M: Given your mission to help people with mental health disorders, one would think that the pressing need for mental health care and grief counseling after what happened on October 7 and the ongoing war would serve to galvanize your company’s mission. Would you say that’s been the case?
Kraft: Unfortunately, I would say that I think it did.
A couple of years after we started, we decided to focus on PTSD. That was a strange decision to make. We’re not prophets. We could not have seen what would come to be with COVID-19 and the trauma that was associated with it, natural disasters, the war in Ukraine, October 7 and so on.
What also helps to galvanize the mission is the fact that public opinion in general and also decision-makers’ understanding of the importance of mental health has by itself had a galvanizing effect. That process is not going to be true just for us, but for any company whose mission is to help people with this or that mental disorder.
MM+M: You mentioned the pandemic. In this country, many of the digital therapeutics startups were able to gain traction during the early days of COVID-19 when it was harder to see a clinician in person. In some cases, the pandemic helped them soft-launch their products as they went directly to consumers for the first time. Those firms collected a lot of learnings during that process. Do you expect that to happen with your company?
Kraft: We have a go-to-market plan, which is structured and involves working with clinicians who treat people with PTSD. That’s what we’re following, regardless of these events which sometimes are unfortunately forgotten.
MM+M: Where are you in that go-to-market plan?
Kraft: So the time is now. We received FDA 510(k) clearance earlier this year, as well as the Israeli equivalent three weeks ago.
We’ve installed two sites in Israel as a part of the Tranquility Dome project aimed to assist all those affected by the October 7 massacre and the events that followed.
We’re installing our first site in the U.S. this fall and number two is going to follow shortly. Two or three more are expected later on this year. These are commercial installations in customer sites, in outpatient clinics or private clinics.
MM+M: And you have some large-scale clinical trials running in hospitals, correct?
Kraft: We have a large-scale PTSD study running in Germany in six highly-regarded medical centers, with whom we are extremely fortunate to be working. We also have a depression study with another product called Prism for Depression, which is not yet FDA-cleared, running at McLean Hospital in Boston. We have a few more, smaller studies on other indications.
MM+M: Is there anything else you’d like to share in terms of how the company is pressing on with its extremely vital work of helping people to recover from PTSD?
Kraft: I’d like to thank my team back home, the team here in the U.S., my family and everybody who’s involved with the Tranquility Dome project. I’m also truly thankful for our first customers here in the U.S. We promise to deliver and we will continue to do so.
This Q&A has been updated with additional information on how PRISM works.