Dean Sawyer, CEO of Freespira, offered an overview of how his company is treating anxiety disorders with an FDA cleared digital therapeutic, in response to emailed questions.
Why did you start this company?
The founders of Freespira are Beth and Russell Siegelman. The idea for the company was born of Beth’s experience as one of the subjects in a Stanford University research study testing a new approach to treating patients diagnosed with repetitive panic attacks, known as panic disorder. The standard approach at the time was to treat panic disorder and related conditions like post-traumatic stress disorder (PTSD) with psychotherapy or medications, or both. That’s still the standard treatment today. The Stanford researchers took a different approach. They theorized that panic disorder sufferers have an underlying physiological condition — chronic dysregulated breathing, from an underlying hypersensitivity to carbon dioxide (CO2) and that these physiological risk factors set the stage for panic attacks, which sometimes seem to come ‘out of the blue’ or when the person is exposed to stress or triggering situations. The study tested the hypothesis that normalizing the dysregulated breathing by teaching subjects to regulate their CO2 and respiration rate would reduce or eliminate the panic attacks. The researchers developed a treatment protocol calling for short, twice-daily physiological feedback sessions using hospital-quality measurement devices and an audio tape player providing paced breathing tones.
It worked. The experience of participating in that study was life changing for Beth. She was thrilled to be free of the debilitating panic attacks and determined to launch a company to help other people suffering from recurring panic attacks. Her goal was an ambitious one – to develop and manufacture the world’s first low-cost, commercial-grade portable sensor that could be used by patients in their own homes to measure, monitor and ultimately normalize their breath-to-breath exhaled CO2 levels and respiration rate (i.e., normalize their dysregulated breathing pattern). Beth’s husband, Russell, who was then a partner at the legendary venture capital firm Kleiner Perkins Caufield & Byers, joined her in launching the company. He currently serves as Freespira’s Chairman. The Siegelmans launched the company with angel funding and built the team that developed and patented the Freespira system and received FDA clearance for panic disorder and PTSD based on clinical studies reporting significant and enduring clinical benefit. Dean Sawyer was hired as CEO in December 2019 to lead the growth phase of the company.
What need/problem are you seeking to address in healthcare?
Behavioral health conditions in general are extremely disruptive to Americans as well as their employers. Overall, 200 million workdays per year are lost to behavioral health conditions, costing employers up to $44 billion annually. Public awareness of the most prevalent behavioral health condition – anxiety disorders – has increased recently thanks to studies showing a dramatic upsurge in cases during the Covid-19 pandemic. Less well known is the fact that panic disorder and PTSD are among the most common types of anxiety disorder and two of the most debilitating behavioral conditions of any kind. According to the World Health Organization, panic disorder and PTSD are the No. 1 and 2 causes of ‘Days out of Role’ in high-income nations, a term that means the inability to work or carry out normal activities. People with panic disorder average 45.6 days out of role per year, compared to 31.5 days for cancer patients, and 32.3 days for those with migraine headaches.
These life-impairing conditions have been significantly exacerbated by anxiety and trauma from the Covid-19 pandemic. A recent Kaiser Health Foundation survey found 40% of U.S. adults had symptoms of anxiety and depressive conditions during the Covid-19 pandemic, up from 10% before the pandemic. Healthcare professionals, especially those in front line settings, are especially at risk for developing PTSD related to Covid-19 , with prevalence as high as 35%. I think we will see those rates increase. Once someone is exposed to trauma, PTSD usually occurs six months later, so I expect a really big spike is ahead of us. That spike will likely include people with the coronavirus who are admitted to the hospital, 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.
The increasing prevalence of the conditions is compounded by the fact that existing treatments—generally psychotherapy and medications—are often ineffective or difficult to access for many people. They also fail to address the underlying physiological component of these conditions. While psychotherapy is useful for some patients with panic attacks and PTSD, the long duration of treatment (12 weeks is recommended) can pose obstacles for access, affordability, and adherence over time. Talk therapy has high dropout rates, particularly for the exposure-based therapies commonly used to address PTSD as well as panic. The most commonly used medications, particularly antidepressants, often produce side effects that lead to adherence problems and high dropout rates. Benzodiazepines, for instance, are not recommended for extended use and carry risk for abuse and dependence. As a result, hundreds of thousands and maybe millions of patients are left without effective treatment for their condition.
The cost to society is significant. The annual cost of anxiety disorders of all types is estimated to be more than $42 billion in 1990 dollars, surely a huge understatement of today’s costs. Of the anxiety disorders, panic disorder and PTSD are the most expensive to treat – and they are also both among the top five medical causes of missed work days. The annual healthcare cost of an average patient with panic disorder is $6,812, more than six times the cost of treating an average patient in a medically matched control group. For PTSD it’s more than $10,000 per year. Our nation desperately needs better digital, at-home therapies for panic disorder and PTSD to add to the therapeutic toolbox.
What does your product do? How does it work?
Researchers have concluded that most patients with panic disorder or PTSD have underlying physiological factors (respiratory dysrhythmia) that make them much more likely to develop panic attacks or PTSD symptoms due to underlying CO2 hypersensitivity. Freespira helps these individuals normalize their CO2 and respiration rate using physiological feedback. The approach closes the gap for patients who have failed on other therapies, need to augment their current treatment, or who are currently untreated for their condition. It also removes current barriers to accessing care by enabling patients to conduct the treatment in their homes, with the support of telehealth coaching.
Freespira is the first FDA-cleared digital therapeutic proven to significantly reduce or eliminate symptoms of panic attacks, panic disorder, and PTSD, in a single, 28-day treatment episode. Freespira represents a breakthrough in the treatment of these common conditions with its medication-free (or medication adjunctive) approach that is the first to address the underlying physiological factors related to panic, rather than addressing cognitions and emotions or neurotransmitters.
As an FDA-cleared digital therapeutic, Freespira is prescribed/ordered by a licensed healthcare professional, including Freespira-contracted clinicians who follow an evidence-based evaluation process. Patients receive a complete system comprising a sensor that measures real-time exhaled CO2 level and respiratory rate, wirelessly connected to a dedicated tablet computer pre-loaded with an App that guides them through treatment. The task for the patient is extremely straightforward but requires committed engagement to alter lifelong habits. The user breathes in sync with a rising and falling audio tone, which teaches paced breathing. At the same time, the user sees graphs of their respiratory rate and exhaled CO2 levels, prompting them to adjust their breathing volume to hit normal respiration targets. It’s almost like playing a video game. The treatment protocol specifies using Freespira at home for 17 minutes twice a day, and over the 28-day treatment the new breathing skills become a kind of muscle memory. With improved awareness of irregular breathing, users learn how to shift to the new breathing style, which is strongly associated with long term improvement or even remission.
Once the Freespira system is delivered to the patient’s home , we use telehealth to connect users with credentialed coaches who work with the patient over the 28 days to train them how to use the system, what to expect, and make sure they’re getting the results they want. Unlike app-based solutions, we collect physiological data so our coaches are very informed; they can see the user’s respiration and CO2 levels from all previous sessions and how they’re trending. They can also see whether a user has conducted their sessions each day and for how long. That information lets them provide personalized and specific coaching back to members to maintain adherence and build on symptom reductions over time. As a result, Freespira helps patients to develop the self-management skills they need to ward off and prevent panic attacks and PTSD symptoms.
Is this your first healthcare startup? What’s your background in healthcare?
I have more than 20 years of experience as a Founder, CEO and leader for venture-backed startups and early stage companies in the digital health, medical device, AI, behavioral health and electronic health record spaces. I co-founded my first startup, MyDrugRep.com (now Lathian Health) where we won the largest business plan contest in the world, a $5 million investment by Hummer-Winblad Venture Partners. After MyDrugRep, I was hired by Glen Tullman at Allscripts where I was one of the first 200 employees and rose to become vice president of sales and helped grow revenue from zero to $180 million during the early adopter phase of the e-prescribing and EHR industry. After that I was Chief Revenue Officer at Aptus Health (acquired by Merck) where I helped to commercialize one of the first mobile decision-support tools for medical professionals and one of the first digital sales channels in the pharmaceutical industry. Most recently, I was Co-founder and CEO of Sentrian, an artificial intelligence company in the remote patient monitoring space that predicts hospital admissions for chronic heart failure (CHF) and COPD up to five days in advance. I was also a partner in a venture capital company and startup foundry where I helped create and advise big data startups.
What is your company’s business model?
We sell a 28-day panic disorder and PTSD treatment to health plans, self-insured employers and to the Veterans Administration. The program includes:
- Identification of both diagnosed and undiagnosed patients, and activation services;
- Treatment including use of a portable sensor that measures breath-to-breath exhaled CO2 and respiration rate, connected tablet computer with dedicated treatment algorithm app;
- Telehealth coaching, reporting and other services.
We package the hardware, software and services into a single, per-treatment bundle, which can be paid as medical benefit, EAP program or administrative expense.
Who is your customer?
Under Freespira’s B2B2C model, our primary customers are commercial and managed Medicaid health plans, as well as large self-insured employers and the Veterans Administration. Reference customers are: Comcast/NBCUniversal, Highmark Health, the nation’s third-largest Blue Cross Blue Shield health plan, and CCHP (Medicaid provider in WI).
We also serve the individual members, employees or veterans with panic and PTSD via a number of affordable payment options.
How do you generate revenue?
Essentially, a Freespira fully bundled case rate is usually paid as a medical benefit. It can also fall under an EAP, etc.
We think the market is ripe for adoption of Freespira. For instance, 44 percent of HR leaders say their organizations plan on increasing access to mental health services for their employees, according to a March 2021 report from Evernorth.
Do you have clinical validation for your product?
Yes. The clinical and economic efficacy of Freespira has been demonstrated in four published peer-reviewed clinical studies, with another study pending publication. These studies show Freespira has better clinical outcomes than virtually any other product on the market today, as well as significant, positive economic results.
In 2017, Dr. David Tolin, Director of the Anxiety Disorders Center & Center for Cognitive Behavioral Therapy at Hartford Healthcare, conducted a multi-site study to validate that individuals seeking treatment for their panic attacks have the same results as those in a formal research environment. Dr. Tolin’s results, in clinical practice, mirrored the results from the earlier academic trials: 85% of participants who completed the Freespira treatment had clinically significant improvement at the end of the 28-days, and 82% were improved one year after treatment ended. Seventy percent of participants were in remission a full year post-treatment.Their functional impairment in work, school, and social and family life decreased from moderate to mild post- treatment and decreased further at six months later. No significant side effects or adverse events were reported.
Another study, published last year and conducted as part of the Highmark Health / Allegheny Health Network VITAL Quality Improvement Program, looked at both the efficacy of the Freespira therapy as well as its impact on health care costs. That study found that 68% of treated patients were in remission one-year post-treatment and 91% had their symptoms significantly reduced one-year post-treatment. Overall medical costs declined by 35% for the year after treatment. Pharmaceutical costs fell by 68% and Emergency Department costs fell by 65% for participants. After completing the program, 90% of participants said they would recommend Freespira.
Freespira also consistently achieves an adherence rate of over 75%. A 2020 peer-reviewed study of Comcast/NBCUniversal employees treated with Freespira found they were highly engaged and adherent to the treatment. Earlier studies found high satisfaction rates (84%) and adherence rates (88%). Both are strong measures of engagement. The treatment is tolerable with minimal or no side effects.
At what stage of development is your lead product?
Freespira is in market, commercially available, and has FDA (510k) clearance for panic disorder and PTSD for adults, plus adolescents aged 13-17 under the FDA’s Covid-19 Waiver program.
Photo: SIphotography, Getty Images