Home Therapy Company

Pulmonary Neuromodulation
for Severe Asthma

An investigational implantable system designed to modulate respiratory function through targeted nerve stimulation.

Pulmonary Neuromodulation

The Spiro Medical device is designed to deliver Pulmonary Neuromodulation (PNM), targeting critical neural pathways that regulate bronchial tone and pulmonary function.

Through a proprietary algorithm, the device is intended to modulate the autonomic and central nervous system, potentially reducing bronchial hyperresponsiveness and inflammatory signaling.

The Clinical Burden of Severe Asthma

Many therapies, many limitations.

30M
people suffer from asthma in the US. 5-10% have severe, uncontrolled symptoms1
495K
people die from asthma every year in the world2
$82B
Estimated annual healthcare costs for severe asthma management in the US3

1 Adv Ther (2022) 39:5307–5326

2 GINA

3 J Manag Care Spec Pharm. 2019;25(5):510-14

Potential Advantages of PNM Therapy

A single procedure for long-term symptom control
Reversible therapy
Cost-effective solution
Complementary to existing biologics and corticosteroids
Non-pharmacological intervention reducing potential side effects

Clinical Evidence

First-In-Human Study

Completed
98%
Reduction in asthma medication
Patients reduced their daily medication use by 98% — with 73% of patients stopping all medication entirely, within days of treatment.
100%
Achieved asthma control
Every patient went from poorly controlled to fully controlled asthma — no wheezing, no chest tightness, zero asthma-related ER visits over 12 months.
+3.4 pts
Quality of life restored
All patients reported a dramatic quality of life improvement — jumping from "highly impaired" to "near normal" — with no adverse events from the therapy.

IDE Feasibility Study

Actively Recruiting
20
Moderate to Severe Asthma patients (up to)

Endpoints

ACT, ACQ, AQLQ, asthma symptoms, healthcare utilization

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Scientific Publications & Resources

First-in-Human Study of Pulmonary Neuromodulation
Pyles & Gehlsen et al.
Results from the first-in-human study evaluating the safety and efficacy of Pulmonary Neuromodulation in 11 moderate to severe asthma patients.
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