SOUTH SAN FRANCISCO, Calif.– Spirair, Inc., a medical device company focused on minimally invasive solutions for ear, nose, and throat specialists, has announced promising results from the first clinical study of its SeptAlign™ implant. The 12-month data demonstrate the device’s safety and effectiveness in treating nasal septal deviation (NSD) while preserving nasal cartilage—marking a potential shift in how ENT specialists approach this common condition.
Nasal septal deviation is one of the most frequent causes of nasal airway obstruction, often requiring septoplasty surgery that can involve removing cartilage to realign the septum. The SeptAlign implant offers a cartilage-sparing alternative. It is a bioabsorbable device designed to correct cartilaginous deviations, including challenging anterior cases, without removing nasal tissue.
The Zephyr Study, a prospective feasibility trial, evaluated 14 patients diagnosed with mobile cartilaginous NSD who underwent treatment with the SeptAlign implant alongside inferior turbinate reduction. The results, published this week, highlight significant and lasting symptom improvement over the course of a year.
Patients experienced a 71.8% median improvement in NOSE (Nasal Obstruction Symptom Evaluation) scores, dropping from 58 to 15, and a 60.3% median improvement in SNOT-22 (Sinonasal Outcome Test) scores, decreasing from 37 to 8. Notably, most patients saw rapid symptom relief, with over 90% demonstrating NOSE score improvement and nearly 80% showing SNOT-22 response within the first month.
“These results show great promise for a minimally invasive, bioabsorbable implant to offer lasting symptom relief while preserving the structural integrity of the nasal cartilage,” said Dr. Greg Davis, MPH, of Proliance Surgeons and lead author of the study.
Dr. Steven Davis of the Breathe Clear Institute, a co-principal investigator, praised the device’s tolerability. “I was pleased to see the excellent safety and tolerability profile of the SeptAlign implant. This innovation could redefine how we approach treatment for nasal obstruction caused by septal deviation,” he said.
Study authors concluded that the implant demonstrates favorable safety and efficacy, supporting its continued clinical use and further investigation through larger, open-label trials. For ENT specialists and patients alike, the SeptAlign implant may soon offer a viable, less invasive alternative to traditional septoplasty.
