Freedom from panic attacks and PTSD in 28 days
Millions of Americans suffer from repeated panic attacks (panic disorder, or PD) and post-traumatic stress disorder (PTSD), which is often accompanied by panic attacks. Among the most life-impairing behavioral health conditions, PD and PTSD are the top two causes of missed workdays, according to the World Health Organization. Existing treatments—generally psychotherapy and medications—are often ineffective and pose obstacles to access, affordability, and adherence over time. Moreover, they fail to address the underlying physiological component of these conditions. Numerous peer-reviewed studies have shown that chronic dysregulated breathing, due to an underlying hypersensitivity to carbon dioxide (CO2) in some people, sets the stage for panic attacks, which can appear suddenly or during exposure to stress or triggering situations. The disconnect between this fact and existing treatments means that potentially millions of patients are left without effective treatment for their condition. Freespira’s FDA-cleared digital therapeutic has been proven to reduce or eliminate the symptoms of PD and PTSD through a single 28-day at-home treatment protocol. The combination of a device, tablet-based app, and telehealth consultations with a credentialed coach helps patients to normalize their breathing when exposed to stress or triggering stimuli, resulting in clinically significant reduction or elimination of PD and PTSD symptoms. Delivered as an adjunctive therapeutic to medications and psychotherapy, our clinically validated treatment is proven to deliver significant health outcomes, while lowering overall medical costs, as shown in a Highmark clinical and economic study.
As an FDA-cleared digital therapeutic, Freespira is authorized by a licensed healthcare professional. Patients receive a complete system in a small, portable case: the world’s first low-cost, commercial-grade portable sensor able to measure real-time CO2 and respiratory rate, wirelessly connected to a dedicated tablet computer pre-loaded with an app that guides them through treatment. The patients breath is sampled through a nasal canula connected to the Freespira sensor and patients breathe in synch with rising and falling audio tones, which teaches paced breathing. Visual graphs of their respiratory rate and exhaled CO2 levels prompt them to adjust their breathing volume to hit normal CO2 targets. Freespira is used at home for 17 minutes twice a day for 28 days, raising awareness of irregular breathing patterns so users learn how to shift to the new breathing style, which is strongly associated with long-term improvement or remission. Once the Freespira system is delivered to the patient, a credentialed coach trains, guides and supports patients via telehealth on use of the therapeutic and best practices over the course of 28 days, ensuring engagement and adherence. Physiological data from the app is uploaded and lets coaches see the user’s respiration and CO2 levels. Coaches can also see how often and for how long patients use Freespira. This information enables personalized, specific coaching to help patients maintain adherence and build on symptom reductions over time. As a result, Freespira helps patients to develop the self-management skills they need to prevent panic attacks and PTSD symptoms.
Freespira is a breakthrough technology—the only solution on the market that addresses the underlying physiological components of PD and PTSD. Existing treatments for these conditions—generally psychotherapy and medications—fail to address the respiratory dysrhythmia arising from hypersensitivity to CO2 that studies reveal are key contributors to PD and PTSD symptoms. Moreover, existing treatments are often ineffective or difficult to access for many people. 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. The most used medications, particularly the 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. By contrast, Freespira’s at-home medication-free treatment reduces access barriers, is short in duration, and has no post-session side effects. While a number of apps are marketed as aids for anxiety relief, they tend to rely on meditation or mindfulness techniques to help patients self-regulate their anxiety. By contrast, Freespira uniquely collects physiological data so our credentialed behavioral health coaches can see user’s respiration and CO2 levels and provide personalized and specific coaching to maintain adherence and reduce symptoms over time.
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 for PD and PTSD than 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 finding that 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, and their functional impairment in work, school, and social and family life decreased from moderate to mild post- treatment and decreased further six months later. No significant side effects or adverse events were reported. A 2020 study conducted as part of the Highmark Health / Allegheny Health Network VITAL Quality Improvement Program 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.Both studies are attached to this application. Additional Freespira studies are referenced in this white paper: https://freespira.com/download-our-white-paper/
Freespira’s novel therapeutic is the only one that addresses the common physiological factors underlying the most life impairing anxiety disorders. It comes at a critical time, when Kaiser Family Foundation reports over 40% of adults are experiencing symptoms of anxiety. We can improve access and help people unlock happiness again!