DTx Product Profile


Product Highlight

Condition targeted:

Post-traumatic stress disorder (PTSD), panic disorder, panic/anxiety attacks

How it works:

Freespira is an FDA-cleared at-home treatment that addresses the symptoms associated with panic disorder, panic/anxiety attacks, and PTSD. With its unique mechanism of action, Freespira corrects dysfunctional breathing associated with CO2 hypersensitivity by training patients to stabilize their breathing. By combining hardware/software with personal coaching, Freespira has demonstrated its ability to reduce or eliminate panic attacks and PTSD symptoms in just 28 days.

The at-home Freespira system includes:

  • A compact breathing sensor which samples the patient’s breathing through a nasal cannula
  • A tablet that provides real-time feedback of the breathing pattern for the patient to act on


Freespira has delivered consistent clinical outcomes across 6 published studies. In clinical trials focused on panic disorder, ≥80% of patients treated reported significant reduction or elimination of symptoms post treatment. More impressively, Freespira also had an enduring impact with a majority of patients maintaining clinical response through 12-months. In a clinical trial focused on PTSD, 89% of patients reported a significant decrease in symptoms based on CAPS-5 Score and 50% of patients were in remission at 6 months.

Freespira also has published health economic outcome (HEOR) data that provided significant reductions across key costs, including: medical costs by 35%, emergency department by 65%, and pharmacy costs by 68%.


Sources: Kaplan, et al., 2020; Ostacher, et al., 2021


Product Overview

Medical conditions:

Freespira has two FDA indications: Post-traumatic stress disorder (PTSD) and Panic Disorder (which includes panic or anxiety attacks)

Target patient population:

Patients over 18 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


Note: for more information, please visit https://freespira.com/for-individuals/.

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


In real world data, clinical outcomes seen confirmed those achieved in clinical studies:

For PTSD patients, at 6-months post-treatment:

For health plan costs, one prospective study showed:

Sources: Kaplan, et al., 2020 and Ostacher, et al., 2021


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:

Freespira corrects dysfunctional breathing associated with CO2 hypersensitivity. When people with CO2 hypersensitivity are exposed to everyday anxiety, it can trigger panic attacks. People with PTSD share this CO2 hypersensitivity and dysfunctional breathing, which sets the stage for post-traumatic flashbacks and other symptoms. By teaching patients who suffer from panic attacks and PTSD to normalize breathing using Freespira, everyday anxiety no longer triggers a catastrophic bodily response.

The Freespira treatment includes:

The at-home Freespira system includes:

Prescription status:

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

Patient access:

Health plans, self-insured employers and the Veterans Administration provide Freespira’s drug-free solution to improve quality of life, reduce medical expenditures and support the appropriate use of valuable healthcare resources.

Patients have two pathways for enrollment into the Freespira program: self-referral through the website, or referral from a healthcare provider. Once referred, patients will engage with a Freespira advisor to verify benefits and validate the patient meets clinical criteria for enrollment. This advisor will also explain the onboarding process to begin treatment.

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 (see Highmark medical policy here), 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

The provided set of evidence represents a sample of conducted studies. For a comprehensive collection contact manufacturers directly.

Note: for more research, please visit https://freespira.com/resources/.

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