Palo Alto Health Sciences Obtains FDA-Clearance for Freespira in Treating Post-Traumatic Stress Disorder

KIRKLAND, Wash., Dec. 18, 2018 /PRNewswire/ -- Palo Alto Health Sciences, Inc. (PAHS) announced today that its flagship digital therapeutic, Freespira®, has been cleared by the FDA as a treatment option for patients diagnosed with post-traumatic stress disorder (PTSD).  

PTSD is serious and devastating, occurring after a traumatic event such as combat, an accident, a violent personal assault or a physical trauma such as an explosion. Annually, close to eight million adults are diagnosed with PTSD and it is estimated that 7-8% percent of the US population will experience PTSD in their lifetime. Sixty-seven percent of those exposed to mass violence have been shown to develop PTSD symptoms. 

A clinical trial was conducted at the Veterans Administration Palo Alto Health Care System to demonstrate the efficacy of Freespira for veterans and non-veterans suffering from PTSD. The primary endpoint of this study was to determine if treatment with Freespira could reduce the patient's CAPS-5 score.  CAPS-5 is a standardized in-person validated clinical assessment tool for measuring the severity of PTSD.^[1] Response was defined as a reduction of six or more points. Remission was defined as response plus no longer meeting clinical symptom criteria and having a CAPS-5 score < 25.

The study met its primary endpoint with a large majority of subjects achieving the specified 6-point reduction in the CAPS-5 score at two months and six-months post-treatment (93% and 91% respectively).  Importantly, 86% of patients had a 13-point reduction in the CAPS-5 score at 6 months. In addition, 50% of the patients no longer met the diagnostic criteria for PTSD, thus providing them with a sustained remission of their PTSD until at least six months post-treatment.  Patient satisfaction was 90% at six months post-treatment. Furthermore, mean patient adherence to the treatment protocol was 77%. Based on these results, FDA-cleared Freespira to treat PTSD.

The most common treatments for PTSD are exposure-based psychotherapeutic methods and/or medication, both of which have significant limitations. Medications have adverse effects and limited efficacy, and are no longer recommended in the VA/DOD Clinical Practice Guidelines for Management of PTSD as a first line treatment. In contrast with exposure-based treatments, treatment with Freespira allows patients to avoid the revisiting of traumatic memories common in treatment with exposure therapy while at the same time decreasing the need for highly trained specialists and a long-term time investment to deliver this type of therapy. 

"PTSD is extremely difficult to treat. The availability of an effective, four-week, drug-free intervention is a game changer for people suffering from PTSD. Freespira offers hope for people who otherwise experience a significantly diminished quality of life," said principal investigator Michael Ostacher, MD, MPH, MMSc, Staff Psychiatrist at the VA Palo Alto and Associate Professor of Psychiatry and Behavioral Sciences at the Stanford University School of Medicine.

About Freespira®
Freespira is an FDA-cleared, drug-free, treatment for PTSD, panic disorder, panic attacks and other panic symptoms. Treatment entails two 17-minute in home sessions daily for four weeks and is authorized and completed under the supervision of a licensed healthcare provider. Freespira is clinically proven to reduce or eliminate panic attacks and other symptoms of panic disorder, and significantly reduce the symptoms of PTSD.  Freespira corrects the abnormal respiratory patterns associated with these conditions by training the user to stabilize and normalize their breathing rate and exhaled CO₂ levels.

About Palo Alto Health Sciences, Inc.
Palo Alto Health Sciences, Inc. is a privately held digital therapeutic company revolutionizing behavioral healthcare with evidence-based, non-invasive, drug-free solutions to treat mental health conditions. Their first product, Freespira, is an FDA-cleared treatment for individuals suffering from panic disorder, panic attacks and other symptoms of panic. In the United States, over 6.7 million adults annually suffer from panic disorder; panic attacks affect a total of 27 million adults in the U.S. every year and are a common component of other anxiety disorders.  The latest FDA-clearance for PTSD allows Freespira to be marketed to treat this debilitating condition, which impacts about 8 million Americans annually.

Freespira is currently commercially available for panic throughout the U.S. and will be available for PTSD in the second half of 2019. To learn more, visit http://www.freespira.com or contact [email protected].

Press contact: Christopher S. Lento, Chief Commercial Officer: [email protected]

1. Weathers, F.W., Blake, D.D., Schnurr, P.P., Kaloupek, D.G., Marx, B.P., & Keane, T.M. (2013). The Clinician-Administered PTSD Scale for DSM-5 (CAPS-5). Interview available from the National Center for PTSD at www.ptsd.va.gov.

SOURCE Palo Alto Health Sciences, Inc.