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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 neurodiagnostic 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. Key Takeaways: [:18] Ray Hoffman introduces the guest, Rosina Samadani, CEO of Oculogica. [1:06] There is a dire need for an objective diagnostic. Rosina hopes we are entering a new era in concussion diagnosis. Oculogica sees itself as part of a multi-modal assessment of a concussion. There should be multiple objective assessments that are performed simultaneously to understand your concussion. [1:45] Rosina tells how the FDA informed Oculogica of authorization to market the EyeBOX®. Oculogica’s 950-page submission needed one punctuation change, and then it was officially approved and authorized. [2:27] Oculogica’s EyeBOX® is the only non-invasive, baseline-free aid in diagnosis of concussion. One other test, the ImPACT® Test, is authorized as an aid in diagnosis of concussion but it requires a baseline and is mostly used on sports teams. [2:59] The EyeBOX® can be used in the clinic and emergency room, and it’s a lot faster than the ImPACT® test. [3:06] Rosina discusses what Oculogica has learned about concussion and physicians. Concussions manifest in many different ways. Not every person’s concussion is the same. The symptoms are subjective. Rosina lists symptoms that can mimic other conditions under stressful environments. [4:26] There has not been an objective diagnostic for concussion until now. [4:33] The speed of the test is great. Oculogica wants to get to an even faster test. A test where you don’t need a baseline means that you can’t game the test. Rosina describes how athletes and military personnel have been able to game previous tests to get back into action. EyeBOX®, with no baseline, removes the ability to game the test. [5:22] The idea was developed by Rosina’s sister, Uzma Samadani, M.D., Ph.D., a professor of neurosurgery at the University of Minnesota. Dr. Samadani was looking at cranial nerve palsies, and she correlated eye movements to the cranial nerve palsies of cranial nerve three and cranial nerve six. [6:01] Dr. Samadani knew that these nerves are implicated in a concussion. She had a hypothesis that eye movements correlate to a concussion diagnosis. She did a study to test the hypothesis and it was shown to be correct by the data. [6:18] Before an objective test, the main test was to observe eye movements following a finger. [6:37] Dr. Samadani discovered this connection in 2011 and wrote up patents, did a couple of publications, and licensed the patents into a company that she founded in 2013, Oculogica. Rosina joined the company as CEO in 2015. [7:04] Rosina had always thought she would like to run something and take something to the FDA through the authorization process. She has been a management consultant for a very long time and wanted to get into the work of it. She did not think she would be doing it for a company based on technology that her sister had developed. [7:58] Rosina studied mechanical engineering and earned a doctorate in biomedical engineering. Then, she went to McKinsey & Company for six-and-a-half years, where she worked on engagements for a number of larger companies. [9:42] Rosina talks about the learning experience of spending every single day and weekends working extremely hard for two-and-a-half years on getting the FDA authorization to market EyeBOX®. [10:34] The execution requires you to go to the FDA with a discussion of what you are going to do, and then, go out and do that by a study, finding four to six medical 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. [11:03] You have to make sure the data is collected in a fully FDA-compliant manner. When you are a small company, everybody is engaged in the process. They had just a handful of people and they all had to make sure it was happening. [11:19] The strategic element came on top of the execution. There is not a definitive diagnosis of concussion, so when you’re setting up a clinical trial, what do you compare it to? That is a separate discussion with the FDA. The clinical reference standard is a full-on set of multiple discussions with the FDA. [11:44] There is an FDA review team for these discussions. Ideally, the team is steady, but people come and go with job changes. Rosina found the FDA to be very reasonable and logical in their requests. Everything they asked for made sense to her. Oculogica was very transparent with the FDA and they saw that and appreciated it. [12:26] How did Rosina come to be CEO of Oculogica? She explains the history. Rosina was helping them look for a CEO. When Uzma offered the position to her, at first, Rosina resisted because of the family relationship. That made Uzma even more sure Rosina was right for the position. They talked seriously for three days before she accepted. [13:43] The full company team is six people, working as a virtual company scattered around the country. There is a Minnesota office that serves three of them. There is a New York office for one. Rosina works from home, and another person works from San Francisco. [14:07] Oculogica found the people where they already were. Three engineers were in Minneapolis and they found other engineers. None of them wanted to move to New York, so they found a clinical operations manager there and an analyst in San Francisco. [14:36] The tools that are available today to help people work virtually are phenomenal. Zoom and Slack are maybe even more efficient than being in the next room. [14:49] Every single day, the company has a Zoom video call. Rosina has asked the team to get on Zoom rather than a phone call whenever they can. Everyone has their own Zoom room. They use Zoom with all of their physicians and partners. Looking at somebody is so different than just being on the phone with them. [15:13] In 2018, Oculogica received the Luis Villalobos Award from the Angel Capital Association for outstanding ingenuity, creativity, and innovation. One of the members of the selection committee said “This is a company that has done everything right. … It is hard not to get excited about Oculogica.” [15:38] Rosina talks about receiving the award, which seems like a lifetime ago. Uzma and Rosina have talked about mistakes they have made. You can make mistakes; they just can’t be fatal mistakes. The mistakes were tiny enough that Oculogica could overcome them. [16:11] Rosina talks about her father, a physician, who told her, when they got the FDA authorization, “The biggest accomplishment is that you have made a difference for patients - that will always be there. This change will not go away.” Oculogica can build from here, making a difference to people. [16:31] Everywhere Rosina goes talking to investors, they know someone who has had a concussion, and this will make a difference. [16:37] Traumatic brain injury is the leading cause of disability and the leading cause of death for young adults. Undiagnosed and diagnosed incidences may be as high as 10 million a year in the U.S. [16:55] Almost half of people will incur a brain injury at some point in their life, according to Dr. Uzma Samadani. Every person Rosina talks to knows someone who has had a blow to the head. Rosina and Ray exchange their own stories of blows to the head. It’s so easy to happen. [17:44] 100% of the concussion headlines are about sports. Only 18% of concussions are related to sports. [17:51] Rosina mentions upcoming uses for the EyeBOX® technology. Oculogica will go after elevated intracranial pressure next, Then, they will go after the various subtypes of concussion they are also exploring, and cranial nerve palsies. There are a number of other areas that are of interest to Oculogica and other companies. [18:14] Ray and Rosina discuss pricing. They will get to an accessible price solution to benefit more patients, but it will take time. [18:33] This interview is being held at the Golden Seeds Summit. Golden Seeds had expressed an interest in Oculogica. Rosina recommends that if you are going to pitch to Golden Seeds, be thoroughly prepared and know your market — what you are trying to do, and how you will go to market. [19:04] You need to understand your technology, how your IP lines up against your competitors, your licensing arrangement, the number of people that are affected, and the unmet need. Golden Seeds wants to know everything. They will talk with you and with regulatory folks, physicians, and patients. [19:33] In the end, Oculogica had an investor and a network of related people. Half of the benefit from the arrangement has been having access to Golden Seeds’ network. On the day of this interview, Rosina was meeting with people because of Golden Seeds. Golden Seeds has been very generous. [19:57] Oculogica has been in touch with sports teams and leagues even before they received FDA authorization to market EyeBOX®. Since the authorization, they have had some discussions with major sports leagues and also with some of the team doctors. [20:28] Oculogica did some extensive testing with two high school teams in Beaver Dam, Wisconsin over the course of a season. They did find a false positive rate in kids before the season started. They also found out that concussions get a little worse before they get better. [21:01] You can be tested on the day of a concussion and be a little fuzzy. Three to seven days after the hit, you will get a little worse, before you get better. [21:20] What is planned for Oculogica by January 2024? Rosina anticipates they will have two products dealing with concussions; one with therapeutic implications and one as a portable triage device. There may be a version that is more portable than the one they are planning now, depending on how the technology of phones and tablets progresses. [22:07] The products address a market of over $1 billion. It’s a very large market. [22:16] It’s a very large development! This is capitalism. Mentioned in This Episode: Stephens.com This Is Capitalism Rosina Samadani, Ph.D. Oculogica/EyeBOX® FDA The ImPACT® Test Uzma Samadani University of Minnesota McKinsey & Company American Public University System (APUS) Institutional Review Board (IRB) Zoom Slack “Oculogica receives Luis Villalobos Award for Innovation", by Marianne Hudson Golden Seeds NFL MLB