Pulmonary neuromodulation for severe asthma: first-in-human off-label feasibility in 11 patients — complete medication cessation in asthma-only cohort
Summary
The clinical observation that motivated the founding of Spiro Medical: physician co-founder Dr. Aaron Pyles treated 11 patients with severe asthma or asthma+COPD using an existing, off-label peripheral nerve neurostimulator targeting airway nerves. Results from the small uncontrolled study revealed that patients with asthma alone could completely stop taking their medication without adverse effects — a remarkable finding that attracted world-class venture investors to fund a purpose-built Pulmonary Neuromodulation System (PNS) for asthma. Two COPD+asthma patients also showed improvement but did not achieve complete medication cessation.
Why it matters
Complete medication cessation in 9 of 9 asthma-only patients from an off-label peripheral nerve stimulator is the most striking airway neuromodulation result ever reported. Off-label observational data with this magnitude of effect is precisely what motivated Spiro Medical's $67M Series A — investors recognized that if a non-purpose-built stimulator could achieve this, a purpose-built PNS optimized for airway nerve targeting could be even more effective and controllable.
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