#StartupsEverywhere: Indianapolis, Ind.

#StartupsEverywhere: Izzy Branam, Co-Founder & CEO, RelateXR

This profile is part of #StartupsEverywhere, an ongoing series highlighting startup leaders in ecosystems across the country. This interview has been edited for length, content, and clarity.

Harnessing VR for addiction treatment

RelateXR is an addiction recovery software that has been making waves at Indiana University since it was founded three years ago. Izzy Branam is the CEO and co-founder of RelateXR. We sat down with him to talk about his company, RelateXR’s experience with Small Business Technology Transfer (STTR) grants, and more.

Tell us about your background. What led you to RelateXR?

The company was formed when two academics, Dr. Brandon Oberlin and Andrew Nelson, at Indiana University, came together for a pilot program to help patients recovering from addiction. I came along a little while later shortly after their pilot study published. Their results looked promising to me, and I jumped in and, with no regulatory experience, started working on our Food & Drug Administration (FDA) strategy. That was about three years ago, and now RelateXR is proposed as a Prescription Class II Medical Device.

What is the work you all are doing at RelateXR? Who are your users/customers?

One of the big problems with addiction recovery is that patients get really great care in a treatment center, but they can only be there so long, and there’s a common trend of relapse after discharge. It’s challenging when the patient returns to the same environment, people, and triggers that led them to substance use in the first place. We’re trying to bridge that gap with our technology. 

RelateXR is a take-home adjunctive therapy device for people in early recovery from substance use disorders, which is a fancy way of saying we’re helping people who’ve recently gone clean keep away from the drugs (particularly stimulants) they used to depend on. People using RelateXR create digital avatars of their future selves and interact with them to help them visualize potential futures based on their current choices. We’ve built this system with the provider in mind so that they can see how their patients are recovering, and hopefully, more readily identify and intervene in a relapse.

RelateXR received a Phase I Small Business Technology Transfer (STTR) grant from the National Science Foundation (NSF). What did STTR funding mean for your startup?

The STTR program has been absolutely vital for us. It would have been impossible for us to raise the funds we needed for a clinical trial for what was functionally, at the time,  a video game. Our pilot study looked encouraging, but the sample size was only 21, investing in a technology that early would have been illogical to a private investor. The money we got from our STTR grant at the NSF helped us crest this valley of death between knowing we had something valuable and being able to demonstrate that to investors with reliable, statistically significant data. 

RelateXR’s Phase I grant ended just as the funding for SBIR/STTR was frozen. How did that six month freeze in access to further federal applications and funding impact RelateXR? 

RelateXR would have struggled to exist without STTR funds in the first place, and during that months-long freeze of federal funding, we had to be very careful; we were treading water, and getting our ducks in a row. Because of how the reauthorization shook out, we need to wait until next September to apply for Phase II. Policymakers need to recognize that a disruption of only a few months can have considerable downstream effects for years to come. 

How has working in the virtual reality (VR) space intersected with government regulations at the Food & Drug Administration (FDA)?

FDA compliance takes up a lot of our time. The way they have set things up historically has not evolved with the needs of today’s technology. The device is a combination of software and hardware, making the regulatory burden much more challenging than other digital-therapeutics that leverage off the shelf hardware such as a smartphone. The hardware isn’t even our proprietary technology; the headsets we've been using are just Meta Quests so far. 

Even so, the FDA wants presentations on how we’re using them and demonstrating how our product is not going to harm users. It’s the same thing going forward with any and every headset we use to run our software on. We have to go back to the FDA and declare a change in our hardware.

Since you’re using off the shelf VR headset models, what extra steps do you have to take to make RelateXR a legal medical prescription?

 So this is another funny wrinkle in things.  The headset would likely not be reimbursable if we didn't lock it down to run only our software.  So that's what we have to do to make sure that this is reimbursable because otherwise the insurance companies would say, ‘we're not going to pay for someone to play Beat Saber all day.’ The hard part of all of this is that as this space in medical technology expands, if the rules aren’t updated for this day and age, a patient might have six different headsets for six different programs, and each of these headsets ranges in cost from $300 to $600. It’s just short-sighted, but those are the rules for now.  

Are there any local, state, or federal startup issues that you think should receive more attention from policymakers?

The FDA needs to update its regulations for the modern age. So many of the friction points we hit are because of severely outdated policies. In the substance use space, the FDA rejects any clinical trial data that isn’t substantiated by urine analysis. Our clinical trials were conducted with what is considered the gold standard in substance use research, with multi-verification factors including urine analysis, fingernail tests, breathalyzers, and self-reporting. All of our end data was unidirectional (if any of the participants tested positive for drug use in one or more of the tests, they were counted as a relapse). 

Despite using the industry standard, the FDA guidance is still only for urine analysis. We had participants who self-reported as using substances outside of the 72-hour detection window for urine analysis, and the FDA wanted us to count them as clean instead of relapse. The government needs to catch up with the times and create new standards for digital therapeutics for substance use.

What are your goals for RelateXR moving forward?

I hope we get cleared by the FDA as soon as possible so we can get our technology into as many treatment centers as possible, positively impacting as many lives as possible. It’s hard to quantify that with numbers because it’s each and every life that we change for the better that we care about.

All of the information in this profile was accurate at the date and time of publication.

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