Irvine, California, U.S., October 12, 2026
Spiro Medical has announced that it has treated the first patient in its PULSAR feasibility study, evaluating an investigational neuromodulation approach for people with severe, uncontrolled asthma. The study is being conducted under a U.S. Food and Drug Administration (FDA)-approved Investigational Device Exemption (IDE) and aims to assess whether targeted nerve stimulation can provide a new treatment option for patients whose asthma remains inadequately controlled despite optimized medication or biologic therapy. The first patient was enrolled through the Lillian S. Wells Department of Neurosurgery at the University of Florida and underwent implantation by Ajay Antony, M.D., at The Orthopedic Institute in Gainesville, Florida. The study plans to enroll up to 30 patients across multiple U.S. clinical centers. The milestone marks an important step in the clinical development of Spiro Medical’s implantable technology, which is designed to influence neurological pathways involved in respiratory function. The device remains investigational and is not approved for commercial use in the United States.
PULSAR Study Evaluates Neuromodulation for Severe Asthma
Severe, uncontrolled asthma can significantly affect daily life, causing persistent breathing difficulties, recurrent exacerbations and, in some cases, emergency department visits or hospitalizations despite intensive treatment. Current management commonly relies on inhaled medications, corticosteroids and biologic therapies selected according to individual disease characteristics. However, some patients continue to experience inadequate symptom control even when receiving optimized treatment. Spiro Medical’s PULSAR study—Pulmonary Stimulation for Asthma Relief—is investigating an alternative approach that focuses on the nervous system’s role in regulating airway function. The feasibility study is designed to evaluate the safety and potential effectiveness of pulmonary neuromodulation in people with moderate-to-severe uncontrolled asthma. Researchers will assess asthma control and health-related quality of life while monitoring participants for safety concerns. The study’s enrollment target of up to 30 patients will provide early clinical experience with the investigational system, helping investigators determine whether the approach warrants further evaluation in larger studies.
How the Implantable Technology Works
Spiro Medical is developing an implantable neuromodulation system that uses targeted spinal nerve stimulation to influence autonomic nervous system pathways associated with respiratory function. These pathways play a role in regulating bronchial tone and may also influence inflammatory responses in the airways. Asthma has traditionally been approached primarily as an inflammatory disease characterized by airway narrowing, hypersensitivity and excessive mucus production. Emerging research suggests that neurological mechanisms may also contribute to airway hyper-responsiveness in certain patients. By targeting these pathways, the company’s technology is designed to investigate whether modulation of nerve activity can complement existing asthma treatments. The scientific rationale is particularly relevant for patients who continue to experience symptoms despite receiving high-dose corticosteroids, biologic medicines or other appropriate therapies. Nevertheless, the proposed mechanism and potential clinical benefits must be evaluated through controlled clinical research. The first-patient milestone does not establish that the device reduces asthma attacks, improves lung function or eliminates the need for medication. Those questions will require systematic assessment during the PULSAR study and subsequent clinical development.
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Clinical Endpoints and Future Development
The PULSAR feasibility study is designed to examine both asthma symptom control and quality of life, alongside the safety of the implanted system. Investigators will use the Asthma Control Test (ACT) to assess disease control and the Asthma Quality of Life Questionnaire (AQLQ) to evaluate the impact of symptoms on patients’ everyday activities. The study design includes randomized treatment activation, with one group receiving active stimulation initially and another group receiving delayed activation. This approach is intended to help researchers evaluate outcomes while accounting for the effects of implantation and the timing of stimulation. The trial is expected to follow participants for six months, with assessments at multiple time points. Findings from this early study may inform decisions about patient selection, device programming, safety monitoring and the design of future clinical investigations. Demonstrating acceptable safety and meaningful improvements in asthma control will be essential before the technology can advance toward broader clinical use. Spiro Medical previously announced a $67 million Series A financing in January 2026 to support development of its neuromodulation platform. The PULSAR study represents a further milestone in the company’s efforts to develop device-based treatment options for chronic respiratory disease.
Source: Spiro Medical press release
