Wara Samar
22nd May 2025
Freespira Wins FDA Clearance to Treat Adolescents with Anxiety and PTSD at Home
Freespira, the developer of the first FDA-cleared at-home treatment for panic disorder (PD) and post-traumatic stress disorder (PTSD), has announced a major expansion of its therapeutic reach. With FDA 510(k) clearance (K233337), Freespira is now indicated for use in adolescents aged 13 to 17, marking a milestone in digital mental health solutions for younger populations.
This newly approved adolescent indication makes Freespira the only prescription, medication-free treatment that directly addresses the physiological root causes of panic attacks and PTSD symptoms. The treatment delivers real-time, software-driven respiratory guidance combined with 1:1 behavioral coaching, aiming to correct dysfunctional breathing patterns commonly associated with anxiety disorders.
An Urgent Response to a Growing Adolescent Mental Health Crisis
The clearance comes at a time when youth mental health challenges have reached crisis levels. In 2025, an estimated 32% of U.S. adolescents meet the criteria for an anxiety disorder, and nearly 30% of K-12 students are chronically absent, largely due to mental health struggles. Nearly half of surveyed students report that depression, anxiety, or stress interfere with their academic performance. These issues are compounded by widespread provider shortages, with more than half of Americans living in areas lacking adequate mental health services.
“The positive outcome and safety data reviewed by the FDA in this application have now culminated in the expansion of indications to adolescents ages 13 to 17, a group that has been challenged by rising rates of anxiety as well as significant problems with access to mental health providers,” said Robert Cuyler, Chief Clinical Officer at Freespira, in a statement.
Clinical Results Show Strong Symptom Reduction and Adherence
Backed by robust clinical evidence, Freespira’s 28-day, at-home treatment has shown measurable impact on adolescent populations:
- Panic Disorder: A 54% average reduction in symptoms was recorded using the Panic Disorder Severity Scale for Adolescents (PDSS-A), with 68% of teens experiencing meaningful improvement and 45% reaching remission.
- PTSD: Participants saw a 44% mean reduction in PTSD symptoms, with 75% no longer meeting diagnostic criteria post-treatment.
- Adherence and Safety: Adolescents maintained a 71% average adherence to the twice-daily treatment schedule, comparable to adult usage, and no serious adverse events were reported.
“Traditional mental health therapies for adolescents often require missing school and parental time off work, creating logistical and economic barriers,” noted Dr. Malika Closson, a double-board-certified psychiatrist and and consulting clinician to Freespira. “Freespira’s at-home, 28-day protocol uniquely addresses these barriers by enabling teens to complete the clinically validated treatment in the convenience and privacy of their own home without disrupting their school schedule or family routines.”
A Distinctive, Data-Driven Approach to Digital Mental Health
Freespira distinguishes itself from other app-based mental health tools by combining direct physiological monitoring with guided respiratory training and behavioral coaching. Its nasal sensor tracks both respiration rate and exhaled CO₂, providing feedback that is used to retrain disordered breathing patterns commonly seen in anxiety and PTSD.
With the introduction of new CMS reimbursement codes in January 2025 for FDA-cleared digital mental health treatments (DMHTs), Freespira is positioned to expand access and affordability for adolescent care. This regulatory update could significantly improve coverage, particularly in underserved communities.
A Scalable Solution for Health Plans and Providers
“This new FDA indication reinforces Freespira’s commitment to improving access to care for the high-risk adolescent population suffering from anxiety disorders,” said Joseph Perekupka, CEO of Freespira. “Our objective is to reduce the risk associated with introducing a new solution for a health plan, in an effort to improve access to care for all those in need of treatment for these debilitating anxiety disorders.”
The Freespira protocol, tested across over 6,000 patients and multiple demographic settings, continues to demonstrate sustained symptom relief and broad applicability. By removing many of the barriers associated with traditional in-person therapy, Freespira offers a new path forward for adolescent mental healthcare—one that is accessible, evidence-based, and effective.
Also Read: Sheba Medical Center-Backed Mentaily Secures $3M to Scale AI-Powered Mental Health Platform
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