DTx Product Profile

Freespira®

Product Highlight

Condition targeted:

Post-traumatic stress disorder (PTSD), panic disorder, and panic attack

How it works:

The Freespira FDA-cleared digital therapeutic incorporates a proprietary sensor, physiological feedback display, and coaching to train patients over 28-days to normalize the respiratory irregularities underlying a key physiological driver of anxiety attacks and PTSD symptoms (carbon dioxide hypersensitivity).

Impact:

Panic disorder and panic attack: 86% panic attack free immediately post-treatment and 73% panic attack free at 12 months post-treatment.
PTSD: At 6-months post-treatment, 89% reported significant decrease in symptom based on CAPS-5 Score (validated PTSD assessment) and 50% were in remission.

 

Product Overview

Medical conditions:

Post-traumatic stress disorder (PTSD), panic disorder, and panic attacks

Target patient population:

Patients over 13 years old with PTSD, panic disorder, or suffering from panic attacks associated with other medical or behavioral health conditions

What to expect:

Significant reduction or elimination of panic and/or PTSD symptoms

Clinical Overview

Indications for use:

Freespira is indicated as an adjunctive treatment for symptoms associated with panic disorder (PD) and/or post-traumatic stress disorder (PTSD), to be used under the direction of a healthcare professional, together with other pharmacological and/or non-pharmacological interventions

Outcomes:

Panic: 86% panic attack free immediately post-treatment; 73% panic attack free 12 months post-treatment; 94% clinically significant reduction in panic symptoms at 12 months post-treatment; and 85% treatment adherence

PTSD: At 6-months post-treatment, 89% had significant reduction in symptoms based on CAPS-5 Score (validated PTSD assessment); 50% of patients were in remission; and 77% treatment adherence

Directions:

After receiving training by a clinician or Freespira coach, patients complete an at-home 28-day protocol with two 17-minute breathing sessions each day, for one month. Four weekly virtual coaching sessions are also included.

Risks & warnings:

Not indicated for patients who are younger than 13 years old, are pregnant, or have chronic obstructive pulmonary disease (COPD) or emphysema

Place in therapy:

Freespira is adjunctive to current treatments for PTSD and panic. However, neither psychotherapy nor medications are required for patients using Freespira.

Product Access

Product description:

As an FDA-cleared digital therapeutic, Freespira is authorized by a licensed healthcare professional, including Freespira-contracted clinicians. 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 carbon dioxide (CO2) and respiratory rate, wirelessly connected to a dedicated tablet computer pre-loaded with an app that guides them through treatment. The patient’s 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 regular breathing at different rates. Visual graphs of their respiratory rate and exhaled CO2 levels prompt them to adjust their breathing volume to achieve 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’s home, a clinically supervised 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 and how they are trending. Coaches can also see how often and for how long patients use Freespira. This information enables personalized and 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 ward off and prevent panic attacks and PTSD symptoms.

Prescription status:

Authorization from a licensed healthcare provider is required. A prescription from a physician is not necessary.

Patient access:

Patients may self-refer into the program or are referred by a healthcare provider. The Freespira Patient Care Team determines any necessary copay/coinsurance payments, collects payments or creates a flexible payment plan, then ships devices to the patient’s home and schedules training. The Freespira device is self-contained and does not require additional equipment.

Provider access:

Healthcare providers may refer a patient to Freespira via website, phone, or fax. Providers, including behavioral health, primary care, psychiatry, and case management can receive post-treatment reports for their patients. Veterans Administration healthcare providers receive additional clinician support via Freespira field teams and approved government contractors.

Coverage options:

Coverage examples include the Veterans Administration, Highmark Health, and Children’s Community Health Plan, who offer Freespira as a covered benefit for eligible members with panic disorder, panic attacks, or PTSD symptoms. For patients who receive Freespira through employers, Comcast for example, there are no out-of-pocket costs associated with product use. Freespira is also offered as a self-pay product if insurance companies do not offer coverage.

Product availability:

Freespira is available in:

Unique Features

Freespira is the only FDA-cleared, evidence-based, medication-free digital therapeutic that can reduce or eliminate the symptoms of panic disorder, panic attacks, and PTSD by addressing the underlying physiologic factors related to these conditions.

Clinical Trials

05386 Rev A
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