Spiro Medical begins neuromodulation study for severe asthma
Spiro Medical has treated its first patient with severe asthma in the PULSAR feasibility study. The study is investigating neuromodulation-based therapies for chronic respiratory diseases.
Irvine, Calif. – Spiro Medical, Inc. has initiated a new neuromodulation-based therapy for severe, uncontrolled asthma, treating its first patient in the PULSAR feasibility study. This study is being conducted under an Investigational Device Exemption approved by the U.S. Food and Drug Administration (FDA).
The first patient was enrolled and treated at the University of Florida. The study aims to enroll up to 30 patients across multiple centers in the United States. The therapy is targeted at individuals with severe asthma that remains uncontrolled despite optimal medical or biologic treatments.
Daryl Fields, M.D., Ph.D., neurosurgeon and principal investigator at the University of Florida, highlighted the potential of neuromodulation to offer new treatment avenues when conventional therapies are insufficient. Severe asthma is a debilitating chronic respiratory condition in the U.S., imposing significant healthcare costs and impacting patients' quality of life.
The study seeks to determine if Spiro Medical's neuromodulation platform can provide an alternative approach for patients who do not achieve adequate symptom control with existing medications. The system is designed to target neurological pathways that influence bronchial tone and inflammatory responses in the lungs.