KIRKLAND, Wash. — Freespira, Inc., the developer of the first FDA-cleared at-home treatment for anxiety and post-traumatic stress disorder (PTSD), has received FDA clearance to expand its solution to adolescents ages 13 to 17. This clearance marks a significant step in addressing the escalating youth mental health crisis with a non-invasive, medication-free therapy.
The newly approved indication allows Freespira to offer its capnometry-guided respiratory intervention (CGRI) system to teens struggling with panic disorder and PTSD. The treatment combines real-time, software-driven respiratory training with one-on-one video coaching, targeting the physiological root causes of anxiety-related conditions by regulating breathing patterns and exhaled CO₂ levels.
The clearance is supported by clinical data demonstrating notable outcomes in adolescent populations. Participants with panic disorder experienced a 54% reduction in symptom severity, with nearly half achieving remission. For PTSD, symptoms dropped by 44%, and 75% of adolescents no longer met the diagnostic criteria following the treatment. The therapy also showed a strong adherence rate of 71% over its 28-day, twice-daily protocol, with no serious adverse events reported.
Freespira’s expansion comes amid alarming trends in youth mental health. According to recent data, nearly one-third of U.S. adolescents now meet the criteria for an anxiety disorder, and close to 30% of K–12 students are chronically absent from school, often due to mental health challenges. At the same time, more than half of Americans live in designated mental health provider shortage areas, limiting access to care—particularly for teens.
“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. “We aim to offer health plans a reliable, clinically proven solution that not only improves outcomes but also reduces costs and eliminates many of the logistical and economic barriers tied to traditional treatment.”
Unlike app-based mental health tools focused on cognitive or mindfulness-based therapies, Freespira’s system uses hardware—specifically a nasal sensor and a tablet-based program—to measure and retrain breathing patterns. The approach enables teens to complete their treatment privately and without missing school or requiring transportation to clinics or therapist appointments.
Clinicians working with Freespira emphasize the program’s ability to meet adolescents where they are. “Freespira’s at-home protocol eliminates common barriers to care, such as time off work for parents or school disruptions for teens,” said Dr. Malika Closson, a double-board-certified psychiatrist and clinical consultant to the company. “This makes treatment both accessible and sustainable.”
Freespira’s new indication builds on over a decade of research and use across more than 6,000 patients. With new CMS reimbursement codes for FDA-cleared digital mental health treatments taking effect in January 2025, the company expects broader insurance coverage, particularly benefiting underserved populations where access to mental health services remains limited.
The company’s Chief Clinical Officer, Dr. Bob Cuyler, said the clearance reflects growing recognition of Freespira’s value as an effective, scalable tool. “This expansion offers a critical new option for adolescents at a time when access to quality mental health care is more important—and more strained—than ever,” he said.
With its evidence-based, medication-free approach, Freespira is positioning itself as a vital player in addressing the youth mental health crisis, offering providers and payors a practical, at-home solution backed by clinical science.
