Freespira’s third FDA clearance addresses surging adolescent anxiety and provider shortages with unique medication-free treatment combining capnometry-guided respiratory intervention (CGRI) with behavioral coaching
Freespira, Inc., developer of the first FDA-cleared at-home treatment for anxiety disorders, including panic disorder (PD), and post-traumatic stress disorder (PTSD), today announced FDA 510(k) clearance (K233337), extending its indications to adolescents aged 13–17. This milestone positions Freespira as the only prescription, medication-free treatment explicitly targeting physiological root causes of panic attacks and PTSD symptoms through real-time, software-driven respiratory guidance and 1:1 video coaching to correct the respiratory dysfunction commonly underlying these disorders.
Youth mental health has reached crisis levels, with 32% of U.S. adolescents meeting criteria for an anxiety disorder in 20251, and nearly 30% of K-12 students now chronically absent as a result of mental health challenges, up significantly since the pandemic. Recent data also indicates that 48% of surveyed students report depression, anxiety, or stress interfering with school performance2. Further compounding the issue, more than half of Americans reside in designated mental health provider shortage areas3, severely limiting access to the care they need.
Freespira’s FDA clearance is backed by clinical data demonstrating significant symptom relief for adolescents through its at-home, 28-day treatment:
- Panic Disorder Symptoms: Adolescents achieved a 54% mean reduction in symptom severity on the Panic Disorder Severity Scale for Adolescents (PDSS-A); 68% achieved clinically meaningful symptom improvement, with 45% reaching remission.
- PTSD Symptoms: Adolescents reported a 44% mean symptom reduction on the PTSD Checklist (PCL-5), with 75% no longer meeting the diagnostic threshold after treatment.
- Treatment Adherence and Safety: Adolescents showed an average 71% adherence to the twice-per-day, 28-day treatment, consistent with adult populations, with no serious adverse events reported.
Actual feedback from a teen patient (female, aged 16, New York) highlights the practical benefits and accessibility: “I tried therapists before, but it felt awkward and my parents said therapy was too expensive anyway. I didn't want meds because I knew they wouldn’t really fix the problem. Breathing slowly and controlling my anxiety wasn’t always easy, but now I’m calmer. I have reached my goal and I didn't have to go to therapy or get on medications.”
“Traditional mental health therapies for adolescents often require missing school and parental time off work, creating logistical and economic barriers,” said Malika Closson, MD, double-board-certified psychiatrist in adult, child and adolescent psychiatry, 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.”
Freespira’s adolescent indication leverages multiple studies over a decade and more than 6,000 patients treated, demonstrating sustained symptom relief and significant economic benefits.
“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 Bob Cuyler, Chief Clinical Officer, Freespira.
Unlike app-based digital approaches offering cognitive or mindfulness-based content, Freespira uniquely combines direct monitoring of both respiration rate and exhaled CO₂ via a nasal sampling sensor, guided respiratory training through software on a supplied tablet, and integrated behavioral coaching. This comprehensive approach provides payors and clinicians with a highly differentiated, evidence-based therapeutic adjunct to traditional mental health treatments.
With the new CMS reimbursement codes introduced in January 2025, specifically for FDA-cleared digital mental health treatments (DMHTs), Freespira anticipates new opportunities for broader reimbursement with payors, especially for adolescent care. This regulatory shift represents a significant opportunity to address the growing access and affordability issues, which disproportionately impact underserved communities and are especially present in adolescent mental healthcare.
"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. "Our partnership offers health plans a treatment option that provides consistent clinical outcomes, direct cost savings, positive patient satisfaction scores and a shared risk pricing model. 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."
Further supporting the broad applicability and inclusivity of the treatment, the Freespira protocol has shown efficacy across different demographic areas throughout the United States, addressing equity gaps in mental healthcare access with its at-home approach.
Freespira’s adolescent treatment is available now. Interested health plans can contact Freespira directly at HealthPlans@freespira.com. For additional information on Freespira for Teens, please visit freespira.com/teens.
About Freespira
Freespira, Inc. is an emerging growth company shifting the paradigm for behavioral healthcare solutions. As the developer of the leading at-home behavioral health treatment with FDA indications for panic disorder and PTSD symptoms, Freespira’s clinically validated solution combines a medical device with high-touch support to deliver rapid and lasting symptom relief in just 28 days. Over the past decade, Freespira has been dedicated to transforming the lives of those struggling with panic disorder and PTSD by offering personalized and accessible care through advanced technology. Recognized as one of the top 10 most innovative medical device companies by Fast Company, Freespira's at-home treatment empowers patients to visually identify and self-regulate their breathing patterns. The company is committed to breaking down barriers to mental health treatment, such as lack of providers, long wait times for appointments, and the stigma associated with seeking help. For more information, visit freespira.com.
1 https://www.nimh.nih.gov/health/statistics/any-anxiety-disorder
2 https://www.attendanceworks.org/the-impact-of-school-mental-health-services-on-reducing-chronic-absenteeism/
3 https://www.commonwealthfund.org/publications/explainer/2023/may/understanding-us-behavioral-health-workforce-shortage
View source version on businesswire.com: https://www.businesswire.com/news/home/20250513424670/en/
"This new FDA indication reinforces Freespira’s commitment to improving access to care for the high-risk adolescent population suffering from anxiety disorders."
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