#United States #Gainesville #Neuromodulation #Asthma Treatment #Spiro Medical

Spiro Medical's Groundbreaking Asthma Treatment

On October 12, 2026, Spiro Medical, Inc., a pioneering company in the realm of clinical-stage medical devices, made headlines by successfully treating its first patient suffering from severe asthma. This treatment is a significant part of the PULSAR feasibility study, which is being conducted under the aegis of the U.S. Food and Drug Administration (FDA) with an Investigational Device Exemption.

The patient was treated at the Lillian S. Wells Department of Neurosurgery at the University of Florida, with the procedure performed by Dr. Ajay Antony at The Orthopedic Institute in Gainesville. The study aims to reach a participant pool of up to 30 individuals across various centers in the United States. Specifically, those enrolled are expected to have severe asthma that remains uncontrolled despite receiving optimal pharmacologic or biologic therapies.

Dr. Daryl Fields, a neurosurgeon and principal investigator for the site, commented on the development, stating, "Neuromodulation continues to demonstrate that it can unlock entirely new therapeutic pathways when conventional treatments have exhausted their limits." His enthusiasm reflects the potential of this groundbreaking technology to address a condition that severely hampers quality of life.

Asthma is a chronic respiratory disorder affecting nearly 28 million Americans, with up to 10% – approximately 2.8 million individuals – grappling with its most severe manifestations. Many suffer through cycles of emergency room visits and hospitalizations without relief, even with the maximum allowed medical therapies. As of 2026, asthma places an estimated economic burden of $118 billion on the U.S. healthcare system, in addition to the deep personal toll it inflicts on patients and their families.

Dr. Natalia Moguillansky, a pulmonologist at UF Health, emphasized the limitations of traditional treatments, explaining that while severe asthma has typically been treated as an inflammatory and airway disease, there are instances when medications alone are inadequate. Dr. Moguillansky views this study as a pivotal shift in addressing chronic respiratory disorders that have not been amenable to pharmaceutical interventions alone.

The notion that neurological pathways may contribute to the hyper-responsiveness of the lungs is gaining traction. This emerging understanding suggests that a neuromodulation strategy—such as the one Spiro Medical is developing—could play a pivotal role in regulating respiratory function. Dr. Michael E. Wechsler, a professor of medicine and director of the asthma program at National Jewish Health, underscored the importance of this innovative outlook, stating, "What distinguishes this program is its disruptive perspective on the disease and the high caliber of the expert team leading it. I maintain a positive outlook on how a dedicated neuromodulation approach may enhance the quality of life for our patients."

About Spiro Medical

Spiro Medical is committed to advancing treatment options for those struggling with chronic respiratory diseases. They are developing a specialized implantable neuromodulation system intended to utilize targeted spinal nerve stimulation. By modulating respiratory functions, this therapy aims to regulate autonomic pathways that impact bronchial tone and inflammatory responses. This approach is particularly crucial for patients who still experience significant symptom burdens, despite optimized treatments, including biologics and high-dose corticosteroids. In early 2026, the company announced a $67 million Series A financing to further this development, led by Andera Partners based in Paris.

While Spiro Medical's technology is still investigational and not yet approved for commercial distribution in the U.S., the implications of these advancements herald a potential new era in the treatment of severe asthma. For further details, visit Spiro Medical's official website.