IRVINE, Calif., Oct. 12, 2026 /PRNewswire/ -- Spiro Medical, Inc., a clinical-stage medical device company pioneering neuromodulation-based therapies for chronic respiratory diseases, today announced that it has treated its first patient suffering from severe, uncontrolled asthma as part of the PULSAR feasibility study.
The study is being conducted under an Investigational Device Exemption approved by the U.S. Food and Drug Administration.
The first patient was enrolled at the Lillian S. Wells Department of Neurosurgery at the University of Florida and implanted by Ajay Antony, M.D., at The Orthopedic Institute in Gainesville. The study is designed to enroll up to 30 patients in multiple centers across the United States. Targeted patients include people with severe asthma that are uncontrolled despite optimal pharmacology or biologic therapy.
"Neuromodulation continues to demonstrate that it can open entirely new treatment avenues where conventional therapies have reached their limits," said Daryl Fields, M.D., Ph.D., neurosurgeon and site principal investigator at the Lillian S. Wells Department of Neurosurgery at the University of Florida. "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."
Severe, uncontrolled asthma remains one of the most debilitating chronic respiratory conditions in the United States. Nearly 28 million Americans live with asthma, and up to 10 percent of them – as many as 2.8 million people – suffer from its severe form, often cycling through emergency room visits and hospitalizations despite maximal medical therapy. Asthma carries an estimated economic burden of $118 billion in 2026, in addition to a substantial toll on patients' quality of life.
"Severe asthma has long been treated primarily as an inflammatory and airway disease, but for many patients, medication alone is not enough. This study offers a long-awaited new angle on chronic respiratory disorders – one that drugs cannot tackle on their own," said Natalia Moguillansky, M.D., pulmonologist at UF Health.
To date, severe asthma has been treated primarily as an inflammatory disease. Emerging research, however, indicates that neurological pathways may also be involved in regulating the hyper-responsiveness of the lungs in patients suffering from chronic respiratory disease – a mechanism that Spiro Medical's neuromodulation platform is designed to directly address.
"I have been involved in numerous asthma studies over the years, spanning biologics, bronchial thermoplasty and beyond," said Michael E. Wechsler, M.D., MMSc, Professor of Medicine and Director of the Asthma Program at National Jewish Health, and Principal Investigator of the study. "What sets this program apart is its disruptive view of the disease and the caliber 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."
About Spiro Medical
Spiro Medical is a clinical-stage medical device company developing a purpose-built, implantable neuromodulation system that uses targeted spinal nerve stimulation to modulate respiratory function. The Company's therapy is designed to target autonomic nervous system pathways that influence bronchial tone and inflammatory responses, offering a promising complementary treatment approach for patients with severe, uncontrolled asthma who continue to experience significant symptom burden despite optimized pharmacological treatment, including biologics and high-dose corticosteroids. In January 2026, Spiro Medical announced a $67 million Series A financing, led by Paris-based Andera Partners .
Spiro Medical's technology is investigational and is not yet approved for commercial use in the United States. For more information, visit www.spiromedical.com.
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SOURCE Spiro Medical
