Spiro Medical has treated the first patient in its PULSAR feasibility study evaluating neuromodulation for severe, uncontrolled asthma.
The clinical-stage medical device company is conducting the clinical investigation under an investigational device exemption approved by the US Food and Drug Administration (FDA).
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The initial procedure was carried out by Ajay Antony at The Orthopedic Institute in Gainesville, following patient enrolment at the University of Florida Lillian S. Wells Department of Neurosurgery.
The feasibility study is planned to enrol up to 30 patients across multiple centres in the US.
University of Florida Lillian S. Wells neurosurgery department and site principal investigator Daryl Fields said: “Neuromodulation continues to demonstrate that it can open entirely new treatment avenues where conventional therapies have reached their limits.
“To see this technology now applied to a disease as burdensome as severe asthma is a meaningful step forward for our field, and for the patients we treat.”
The investigational device is a purpose-built, implantable neuromodulation system that applies targeted spinal nerve stimulation to modulate respiratory function.
National Jewish Health Asthma Program director, medicine professor, and study principal investigator Michael Wechsler said: “I have been involved in numerous asthma studies over the years, spanning biologics, bronchial thermoplasty and beyond.
“What sets this programme apart is its disruptive view of the disease and the calibre of the highly experienced team behind it.
“I’m optimistic about what a purpose-built neuromodulation approach could mean for patients who are seeking a better quality of life.”
Spiro Medical designed the therapeutic approach to influence autonomic nervous system pathways that govern both bronchial tone and inflammatory responses.
The device is being assessed as an adjunct treatment for patients who still experience substantial symptoms despite taking optimised pharmacological therapy, such as biologics and high-dose corticosteroids.
Spiro Medical focuses on developing neuromodulation therapies for chronic respiratory conditions.
The procedure follows the company’s January 2026 announcement of a $67m Series A funding round, led by Paris-based Andera Partners.
