Health Evolution | March 3, 2021
Freespira is in a position akin to rarified air: an FDA-cleared digital therapeutic. In this case, the combination of an at-home device, software and tele-health coaching that helps people with panic disorder and PTSD reduce their symptoms — or even achieve full remission.
Health Evolution interviewed Sawyer about the theory and subsequent research that inspired a research subject to start the company and a veteran Kleiner Perkins venture capitalist to invest in the technology, how it helps patients with panic disorder and PTSD normalize breathing, cost-savings health plans have earned using it, and more.
What’s the origin story or the inspiration fueling Freespira?
Sawyer: The origin story is that the product is based on research at Stanford University about a theory that there is an underlying physiological cause of panic disorder (and later PTSD), which was that chronic hyperventilation and hypersensitivity to carbon dioxide (CO2) serves as a trigger for patients exposed to trauma or stress. To test that hypothesis researchers brought subjects into the lab who were having multiple panic attacks per week and gave them a single gulp of CO2 enriched air and almost all of the subjects had a panic attack on the spot. That confirmed their hypothesis and led to a clinical study to see if normalizing CO2 and respiratory rate would make a difference. The study was very successful with 68% of subjects becoming panic attack free. One of the subjects in the study, Beth Siegelman had such a life-changing benefit from the treatment, she decided to start a company with the goal to make a low cost, easy-to-use commercial product that could be used at home. Beth convinced her husband, Russell Siegelman at Kleiner Perkins to invest in the company and he continues to serve as Board Chairman to this day. Beth and Russell’s goal is to get Freespira out to as many people as possible — which is very inspirational and motivational for me.
Freespira says the digital therapeutic works in 28 days. What exactly is accomplished in that timeframe?
Sawyer: The digital therapeutic is a combination of an at-home device, which is a sensor that measures real-time CO2 and respiratory rate that patients use twice a day, connected to a tablet computer with an algorithm that they watch. Essentially, the patient is seeing an inhaling index with an audio tone and looking at graphics on the screen. It’s almost like playing a video game. So after doing this twice a day, for 28 days it becomes muscle memory in that people learn how to reach and maintain a normalized respiratory rate and CO2 level. And that really makes all the difference in the world in terms of when they start feeling anxious or start feeling a panic attack coming on or begin feeling stressed, they remember how to breath normally. In addition to the equipment at your home and the proprietary algorithms, we also use coaches who work with the patient over the 28 days to train them on how to use the equipment, what to expect, and they make sure members are getting the results that they want. We’re actually collecting records of every session so our coaches are very informed, they can see what the previous sessions CO2 levels are and what the trend is. They can see the respiratory rate and then they can of course also see whether a member has conducted their sessions each day and for how long. So they can provide personalized coaching back to members for good results.
What typically happens at the end of the 28 days, are they done using the equipment or do they continue with the sessions?
Sawyer: At the end of the treatment, 80 to 90 percent of patients have normalized CO2 and respiratory rates and have a very significant reduction in symptoms and a large percentage actually go into full remission. So they return the equipment, which is actually reused except for disposables like the nasal sampling cannula. But the sensor itself and the tablet computer is reusable so they send those back. And we’re now developing an app that a lot of folks have asked for to use if they want to practice breathing but there doesn’t seem to be a benefit for keeping the equipment longer than 28 days. If it’s going to work, it will happen within that 28 days.
What have you seen relative to increases in panic attacks, panic disorder and even PTSD as a result of the COVID-19 pandemic? And what are you anticipating the long-term impact of COVID-19 to be in terms of those areas?
Sawyer: Panic attack and PTSD have come up significantly. There’s a study that was done by the Centers for Disease Control and Prevention showing that in June of 2020 there was a 30 percent increase in Americans suffering from panic disorders compared to June 2019. I would expect that has even gone up since. There has been a significant rise in PTSD especially with front-line health care workers. A meta-analysis study completed in October showed that about 35 percent of frontline health care workers will suffer or are suffering from PTSD symptoms. I think we will see those rates increase because once someone is exposed to trauma, PTSD usually occurs six months later and so I expect the really big spike is ahead of us—and that spike will likely include people with COVID that get admitted to the hospital and especially if they are placed on a ventilator as well as their close family members who are unable to visit their infected loved ones in the hospital.
Dean Sawyer, Freespira
Since there are already treatments for panic disorder and PTSD, why is Freespira such an important new option for patients?
Sawyer: There are a few reasons. One is that Freespira is the only product that addresses the underlying physiological cause of these conditions. We know that the vast majority of these patients have chronic hyperventilation and hypersensitivity to carbon dioxide (CO2) which is not addressed by current treatments. The second reason is that current treatments — such as talk therapy or medications have significant barriers to use. For example, with talk therapy, there are problems with access, the availability of therapists, a lack of therapists trained in evidence-based cognitive behavioral therapy and then there’s just all the time involved since it typically takes 12-18 sessions before a patient may see a difference. In addition, therapists often use exposure therapy for patients with PTSD and a lot of folks don’t want to re-live their trauma. And then there’s the cost.
With medications, the problem is side effects and abuse concerns. For example, studies show that 50% of patients prescribed SSRIs discontinue use within 6 months due to side effects. Other studies have documented relapse rates of 61% for panic disorder and PTSD when medications are discontinued. And for the small percentage of patients who benefit from medications, they often have to take these medications for life, which can lead to abuse and addiction issues, especially with benzodiazepines.
Now when you compare Freespira to talk therapy and medications there are some significant advantages. First, Freespira is medication free. Second, Freespira has little to no side effects. Some patients may experience a little dizziness during their first few breathing exercises. Third, Freespira works in only 28 days. One interesting aspect of our clinical trials was that the average duration the patients had panic disorders or PTSD was 10 years and they tried almost everything that was out there and nothing worked for them. And then they used Freespira for only 28 days and north of 80 percent had a significant reduction in symptoms and many no longer met the criteria for having panic disorder or PTSD. That’s pretty remarkable. Last, since Freespira is an at-home treatment and does not require the patient to see a doctor or therapist in person, adherence is very high.
What would you like health plans to know about how they can benefit from providing their members with Freespira?
Sawyer: First, the prevalence and cost of moderate to severe anxiety-related conditions like panic attacks, panic disorder and PTSD may be a lot higher than they realize. Second, there is almost an immediate reduction in utilization and costs. A study by Highmark Health documented a nearly $200 per-member per-month reduction in costs for treated members starting one month after treatment and going out 12 months. In a follow up, it appears these monthly cost savings go out to at least 24 months and probably longer. Third, Freespira can improve access to care since it is an at-home treatment that does not require a visit to a doctor of therapist. Last, Freespira has very high efficacy and remission rates so it makes a real difference in the lives of their members and their families. One fascinating issue, to me anyway, is that panic disorder and PTSD are more life-impairing than virtually any other condition, including people going through chemotherapy for cancer so it’s great that we can give these folks relief so quickly.
So in terms of Freespira but also the class of digital therapeutics for treating panic disorder and PTSD, what should CEOs expect in the next 18-24 months and beyond that?
Sawyer: Broadly, it’s about getting more clinical and economic evidence. Most of these digital therapeutics don’t have the evidence that pharmaceutical products do, for example. I think that you’re going to see more digital therapeutic companies undertaking clinical studies that document the clinical benefit and the reduction in utilization and costs and publishing them in peer reviewed journals like we have done.
The other thing we’ll see is a number of digital therapeutic formularies or platforms that will only include products that have the evidence I described above, making it easier for payers to sort through all the noise and provide “one-stop shopping”. Some of these platforms already exist, with Express Scripts and CVS Caremark coming to mind. Last, I think we’ll see consolidation with large telehealth and disease management companies acquiring the most promising, evidence-based digital therapeutics and plugging them into their already proven infrastructure.
Regarding our solution in particular, in the next year or so we’re wrapping other services around the product to make it more scalable. For example, we have an AI tool that allows us to analyze claims data to find patients who have high utilization and cost related to their diagnosis of panic disorder and PTSD and equally important, the tool can find undiagnosed patients with these same utilization and cost patterns. This is important because there are 3 to 10 times more undiagnosed panic disorder patients than diagnosed patients, but they are not being identified because they are showing up at the ER thinking they are having a heart attack. We can find them, get them treated and reduce the ER visits, specialists visits, diagnostic tests and medications usage.
2020 was obviously tumultuous. What are you anticipating in 2021? Any expectations or predictions for the year ahead?
Sawyer: Our assumption is that we’re still going to be in a relative lock down, either mandated or voluntary. People are still going to be cautious for the first half of the year and we think things are going to open up after that. Patients will begin going back to see their doctors in person, but telehealth and virtual-first medical practices will continue to have high adoption and become the norm. For Freespira, look for a number of exciting announcements of customer expansions, new customers and partnerships, two more published clinical studies and most importantly, a record number of patients suffering from severe anxiety related conditions having their lives changed by Freespira.
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