CEO Stories: Keeping an eye on Oculogica

Rosina Samadani, Ph.D.
CEO and Board of Advisors

All eyes are on Oculogica. Late in 2018, the company received FDA approval to market the EyeBox. The non-invasive, baseline-free tool offers both efficiency–analyzing more than 100,000 data points around patient eye movement in less than four minutes–and accuracy in diagnosing concussions, one of the most common forms of brain injury. Until now, diagnosis of concussion has been highly subjective, and tests that rely on a baseline evaluation may be unreliable because people can “game” their results through memorization.



ADDITIONAL APPLICATIONS
The eye-movement technology on which the EyeBox was based was developed by Dr. Uzma Samadani in 2011; sister of CEO Rosina Samadani, a former management consultant who joined Oculogica as CEO in 2015. According to Rosina, who has a Ph.D. in biomedical engineering, the eye-movement-tracking technology could have other applications and will likely be the foundation for additional devices. The next hurdle: getting it to a price point where it can be widely used.

GAME CHANGER
Oculogica has caught the eye of professional sports leagues as well as team doctors. Given that the leagues tend to favor baseline tests, the EyeBox could be a game changer in diagnosis and treatment. However, potential uses go beyond athletes: sports injuries account for only 18 percent of concussions. Rosina estimates the market as being in excess of $1 billion. In October of 2018, Oculogica was honored by the Angel Capital Association with its Louis Villalobos Award for “outstanding ingenuity, creativity, and innovation.”

The following is a transcript of an interview done by Ray Hoffman (RH) with Rosina Samadani (RS) for Stephens’ “This is Capitalism” podcast series.

RH: This is Capitalism, I’m Ray Hoffman. For Rosina Samadani, New Year’s Eve, the fireworks, the ball drop, the champagne came on December 28, 2018. That’s when her company, Oculogica, received FDA approval to market a major tool, a breakthrough algorithmic neuro diagnostic tool for determining whether a person has had a concussion.

Oculogica’s EyeBox does that by a modern variation on what doctors used to do as a matter of course in head injury cases. The EyeBox looks into the patient’s eyes to see how they move–only the EyeBox can do that and analyze over 100,000 data points in the space of less than four minutes. That’s a breakthrough, and that’s what Rosina Samadani’s company Oculogica has done.

RS: When we talk to physicians about diagnosing concussion, there is a dire need for an objective diagnostic. And we do feel that this is an inflection point in the market. From now on, people will really need to say, okay, does the device have FDA authorization as an aid and diagnosis of concussion? Is it objective or is it subjective?

We’re hoping that this is a new era in concussion diagnosis. We don’t think that we’re going to be the only. We actually think that we are a part of a multi-modal assessment of concussion and that there should be multiple objective assessments that are performed simultaneously to really understand your concussion.

RH: How did you get the word from the FDA? That was about a month ago, right?

RS: Yes, it was almost exactly four weeks ago. And the way that they told us was that they first sent us an email and said, we’d like to talk with you in about 11 minutes. And I thought, “well, that’s very unusual.” And we knew that they were working on something. And I actually thought “well, they found something wrong,” ’cause it’s a 950-page submission.

And they said to us, “well, we actually are going to be giving this to you. We’d like to do it today. We need to make one change to a comma or a period here.” They did that and then we got email with the official letter that is signed and states that we’ve got the authorization. And that happened several hours later.

RH: And yours is the only device, such device, that has FDA clearance, correct?

RS: So we are the only non-invasive, baseline free aid in diagnosis of concussions. There is another test that’s called the impact test that has authorization from FDA as an aid in diagnosis of concussion. It requires a baseline and it’s mostly used on sports teams, so teams that can go at the beginning of the season, get their baseline testing, and then proceed on with a concussion diagnosis later.

What we can do with ours, we can use it in the clinic, we can use it in the emergency room–and it’s a lot faster than the impact test as well.

RH: You know, despite all the ways that we can see into the brain, why is diagnosing a concussion in a patient such a subjective thing? Why is it that one doctor will look at this patient and say, “no, he doesn’t have a concussion”? And the next doctor will come in, “this patient has a concussion.”

RS: Yes. So we’ve learned some very interesting things about concussion and physicians. So there’s a joke that if you get three neurologists in a room, you’ll get four opinions on whether or not the person has a concussion. The other thing that we’ve heard–and this is not a joke–that physicians say they know it when they see it. So they look at a patient and based on their years of experience, and their assessment that they conduct, they have a gut feeling that this person has a concussion.

It really is tough. Concussion manifests in many different ways. Not every single person’s concussion is the same. The symptoms are subjective. It’s dizziness, nausea, fatigue. You can feel that way after a long day. You can feel that way just by being in the emergency room because you’re freaked out for being in the emergency room and seeing lots of white coats and thinking, “okay, how did I get here?” You may or may not actually have a concussion.

So those subjective symptom lists are really challenging, especially under stressful environments. And so there has not been a great test, an objective diagnostic for concussion until now.

RH: Which is the more important aspect: the way you don’t need a baseline with EyeBox, or the way the test only takes four minutes?

RS: The speed of the test is great and we actually believe that we can get even to a faster test. But the fact that you don’t need a baseline means that you can’t game the test.

What that means is that at the beginning of the season, sometimes professional athletes will actually game the test or in the military they’ll memorize the baseline test, so that when they actually get a concussion, they either match the gamed test and they are not pulled out of the game, or they’ve memorized the answers so you can’t really tell because they want to be in there. They want to be deployed, they want to be on the field. And that lack of a baseline removes that ability for them to do that.

RH: Now it was your sister who now is a professor of neurology at the University of Minnesota who landed on this idea. And as I understand it, basically she went back to a very fundamental original case-diagnosis of concussions, right?

RS: Yes. So first of all let me just correct. She’s a professor of neurosurgery. Her name is Dr. Uzma Samadani. She is a professor of neurosurgery. And what she did was she was looking at cranial nerve palsies, so very, very basic palsies in the brain. And what she did was correlate eye movements to those cranial nerve palsies in cranial nerve three and cranial nerve six.

And she knew that these nerves are implicated in concussion and then said, “okay, let’s go out and prospectively do that study and see if my hypothesis is correct.” And it was correct. And she then was able to correlate eye movements with a concussion diagnosis.

RH: Fifty years ago you would have looked mainly at eye movement, I’m assuming.

RS: Yes, even less than 50 years ago you would do this. You would say, “follow my finger” and you could even do that today. People are still doing that and that’s how… they’re just checking your eye movements and seeing if you’ve got a concussion.

RH: So she started the company in 2013.

RS: Yes. So she discovered the technology, or this connection, in 2011 and wrote up the patents, had a couple of publications, licensed those patents into a company that she founded in 2013. And then I joined as CEO in 2015.

RH: Now before we get any deeper into the operations of this company, I’m wondering if the idea of being the CEO of a medical device company founded by your sister is anywhere close to where you thought you were going to be at this point in your career?

RS: So half of that, yes, the other half, no. I have always thought I would like to run something, and I would like to take something real to the FDA, take it through that process. I want to roll up my sleeves and really get in there and understand everything that happens during this process and to do it myself.

So I knew that I wanted to do this. I’ve been a management consultant for a very long time, giving advice to other people that were doing this. But there’s something very, very different about doing it yourself. I did not think that I would be doing this for a company which was based on technology that my sister had developed. That was not expected.

RH: You studied mechanical engineering and you earned a doctorate in biomedical engineering.

RS: That’s right.

RH: And you spent a number of years at that great professional school of immersive experiences, McKinsey & Company.

RS: That’s right.

RH: Now do you have an idea, in terms of the number of companies, different medical companies of one kind or another, that you were involved with, and really looked inside during the time you were with McKinsey?

RS: I was at McKinsey for just under seven years, I think it was six and a half years. And when you first start at McKinsey as a young associate, or an engagement manager, what you do is, you work on one company at a time. And so for the first several years, that’s what I did. And maybe I would do six engagements or four to six engagements a year.

And then as you become more senior, you’re working on multiple clients at one time, and you’ve got more junior teams that are working with you. And so as I became more senior I would do maybe 12 engagements a year. So over the course of 6 years, maybe 40, maybe 50.

The thing is also that you go back to the same clients. And so if you’re working with a Johnson & Johnson, that’s a very large company. So I don’t know if you count that as one company, or multiple companies. But you can certainly do multiple engagements even for the same company. So yes, you definitely a vast array of opportunities. It was really a privilege to serve and to be invited in and to serve those companies. Not everybody can afford McKinsey so you don’t get to see start-ups and these very, very tiny companies. But certainly the larger companies, you absolutely get a good sense of them.

RH: The one learning experience that stands out among those?

RS: That’s a very tough question. I think just overall, from an entrepreneurial perspective more so than really from a McKinsey perspective, is that you really can learn anything and you can enter into any field and figure out the toughest problems. Getting this authorization from FDA was extremely tough. I was with the company three and a half years before it happened. It was every single day, weekends included, working extremely hard to make it happen. And it was not only executionally tough but strategically tough and required our full brainpower.

RH: Can you take me into execution a little bit?

RS: So the execution requires you to go to the FDA, have a discussion about you’re going to do and then going out and doing that. And doing that means it’s multi-center, so you have to go out and find four to six different centers that are willing to do this study. You have to design the study. You have to get IRB approval. You have to get your patients enrolled and you have to make sure the date is collected in a fully FDA-compliant manner, every little detail. When you’re a small company, everybody is engaged in doing that. We were just a handful of people and we all needed to make sure that that was happening.

RH: And there’s the strategic element on top of that.

RS: Yes, and then there’s strategic element. Concussion is very tough. There is not a definitive diagnosis of concussion. So when you’re setting up a clinical trial, what do you compare to? That is a discussion with FDA all by itself. The clinical reference standard is a full-on discussion with FDA that is not just one discussion. It’s multiple discussions.

RH: And I assume you’re dealing with different people at the FDA in that matter.

RS: Yes. So your review team is supposed to be steady but people come and go. You know, people leave their jobs. You have a discussion with somebody and then that person is no longer there. The FDA with us, I found them to be very reasonable, very logical in their requests. I thought that everything they asked us for made sense. If I were them, I would have asked for that as well. We were very transparent with them. And I think that they saw that and they appreciated it. So we had a very good relationship and we have a very good relationship.

RH: No, you came to be CEO of Oculogica in 2015.

RS: Yes.

RH: Can you give me a sense of the circumstances and did your sister have to twist your arm to get you to take the job? That’s what I want to know.

RS: So they were looking. Oculogica had some friends and family investors, six investors, and they were on the search of a CEO. And I had been giving a little advice in between everything else that I was doing. I was busy but I knew something about this area, not so much about concussion but about medical devices, and so I was giving them advice.

And then they said, okay, we now need to get serious about this company and we need a CEO and we when we have a pre-submission with FDA, we actually need to do something with that meeting. And so I was helping them look for a CEO.

And during that process, one person on the board and my sister said to me, “well, maybe you should do it.” And my first answer we actually “no, I don’t think I should do it” and it was mostly because of the family relationship. And that’s when my sister said, “well, now I know you should really do it because you’re telling me no.”

And we talked about it very seriously over the course of three days. We knew that there’s a danger anytime you do something like that. So we took it pretty seriously. And we had a very serious discussion about it and then I decided to do it.

RH: How small is your team?

RS: The team is six people total including myself.

RH: And you’re not even together, you’re scattered around the country.

RS: Yes, we are a virtual team. There are three of us in Minnesota but in different locations. We do have an office there. We have one office here in New York but it’s only for one person and that person is not me. So I work from home and then we’ve got another person working out in San Francisco.

RH: Now is that by choice? Or maybe that’s optimal given you different research locations or is it more of a bow to modern lifestyles?

RS: So I think both. So we found the people where we found them. Our engineers are in Minneapolis and they found other engineers. They don’t want to move to New York and I certainly don’t want them to move to New York because the cost of living here is so high. We found a clinical operations manager here. We found an analyst out in San Francisco. The tools that are available today to help people work virtually are phenomenal. Zoom and Slack, it’s like you’re in the next room. It may be even more efficient than if you were in the office together. [Laughs]

RH: And how often do you meet virtually?

RS: Every single day on purpose over video, it’s over a Zoom call. I have told the team that whenever they can, they should get on Zoom. Everybody has their own Zoom room. I much prefer that over a phone call. And we try to do that with all of our physicians, our partners, everybody. Because looking at somebody is so different than just being on the phone with them. It’s night and day.

RH: Now, in October, 2018, just a couple months ago, you received the Louis Villalobos Award from the Angel Capital Association for outstanding ingenuity, creativity, and innovation. One of the members of the selection committee said, “It is hard not to get excited about Oculogica. This is a company that has done everything right,” end quote. Now from your vantage point, on the inside of the company, how many things do you get wrong before you get things right?

RS: Yeah, you definitely. First of all, that seems like a lifetime ago. October 2018 seems like a very, very long time ago given everything that’s happened.

RH: The FDA in the middle…yeah, right.

RS: Yes, the FDA in the middle. It’s always helpful to look at things in hindsight. I think that we have made a few mistakes. My sister and I have actually talked about this. And we know that you can make mistakes, they just can’t be fatal mistakes. And so the mistakes were tiny enough that we could overcome them.

My dad is a physician and when we got the FDA authorization, he said, “the biggest accomplishment is that you have made a difference for patients that will always be there.” This change will not go away, and we can build from here. And that is such a fantastic thing that we’re actually making a difference to people. Everywhere I go, investors, everyone, they all say, I know somebody who has a concussion and this is going to make a difference.

RH: In terms of numbers, traumatic brain injury is the leading cause of disability and leading cause of death for young adults.

RS: Yes.

RH: There’s one estimate I saw, I believe it was on your website: undiagnosed and diagnosed incidences may be as high as 10 million a year in this country. And your sister was quoted as saying that almost half of all people in society will incur a brain injury at some point in their life. Almost half?

RS: Yeah, yeah. Well, I had not heard the almost half but she must be talking about from very mild to severe. So I will tell you that every person I talk with knows somebody who has had a blow to the head of some sort. So you know somebody, I know somebody, that was actually me.

RH: That was actually me too, yes.

RS: Yes, and so there you go. The two of us, random. I did not know that about you before I sat down that you’ve had a blow to the head. I’ve had one too. It’s so easy. Mine was sitting on a beach and got hit by an umbrella. I don’t know how yours happened.

RH: I fell on a pile of bricks.

RS: The other interesting thing is that all the headlines, a 100 percent of the headlines are about sports, only 18 percent of the concussions are related to sports.

RH: And there are other possible uses out there for the EyeBox technology.

RS: Yes, so our next indication that we’re going after is elevated intercranial pressure. And then there are the various sub types of concussion, which we’re also exploring, and then obviously the cranial nerve palsies. There are a number of other areas that are of interest to us and to other companies.

RH: Now, can EyeBox be priced at a level that would allow it to benefit as many people as possible considering how widespread the incidences of brain trauma are?

RS: Yeah. We will get there, we’re not there yet. But we are very much dedicated to getting there, to an accessible solution for everybody.

RH: Now Golden Seeds, and we’re at the Golden Seeds Summit right now, Golden Seeds got interested in you. What did they want to know from you when you met with them?

RS: Very early on. I mean Golden Seeds is very thorough in their diligence. The advice I would give to any company, if you were to come and pitch to Golden Seeds, is to be prepared, to have really thought through your market, what you’re trying to do, how you’re going to go to market.

Even way back then, you certainly need to understand your technology, how your IP lines up against the competitors, what is the licensing arrangement that you have, the number of people that are affected by this, the unmet need. They really want to know everything. And they talked with us, they talked with everybody they could get their hands on. They talked with our regulatory folks, physicians, patients, whoever they could. They’re pretty thorough.

RH: But in the end you had an investor and a network of related people.

RS: Yes, they’ve been really great to us. I would say it’s almost 50-50. The investment is fantastic but they’ve also really opened up their networks to us. And we’re still benefiting, even as we progress. Today, I’m meeting with people because of Golden Seeds. They’ve been very generous.

RH: Now, I understand that the NFL and Major League Baseball like to do tests based on the baseline. But have you heard from the NFL, have you heard from Major League Baseball or any sports leagues?

RS: Yes, we have. We’ve been in touch with sports leagues and teams even before we got authorization. They’re all aware of what’s going on. Some of them have even visited the lab. After the authorization, we’ve had some discussions with major sports leagues but also some of the individual team doctors. So I’m assuming they’re very interested.

RH: And you did extensive testing with some high school teams, right?

RS: Yes, we did. In Wisconsin–and actually from a very small town in Wisconsin, Beaver Dam, Wisconsin. There were two high schools there. And we studied their entire football team over the course of a season, the two football teams over the course of the season.

RH: What did you learn?

RS: Well, we learned two things. We learned about our false positive rate in kids before the season started. But we also learned a little bit about concussions, that they actually get a little worse before they get better.

RH: Explain that please.

RS: So you can get a concussion and you can come in that day and you can be pretty fuzzy and things aren’t going well. You eventually will get better but three to seven days after your original hit, you’ll be a little bit worse before you get better. That’s what I mean.

RH: Let’s take a look at your company in January, 2024, five years from now. What do you think I’m going to see?

RS: Oh my gosh, okay. Hopefully you will see us being in multiple indications. I anticipate that we’ll have two products in concussion, a product that is very much our current product, which also provides therapeutic implications. And then a second product, which is triage device which just does the “yes/no, you’ve got a concussion” and can be used pretty much anywhere, a very portable version. We may have a version that is even more portable than the one that I have in mind. Depending on how the technology of phones and tablets progresses, we may be able to move on to that.

RH: Any numbers on how big of a market this might be addressing?

RS: It’s over a billion-dollar market. It’s very large, it’s a very large market.

RH: But then it’s a very large development.

This is Capitalism, I’m Ray Hoffman.


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