Spirair announces positive results from first clinical study of SeptAlign nasal implant

Spirair Inc., a medical device startup focused on minimally invasive ENT solutions, has announced positive 12-month outcomes from the first clinical study evaluating its SeptAlign bioabsorbable implant. The results, published this week, show the device significantly improved symptoms of nasal obstruction in patients with nasal septal deviation (NSD), a common condition that affects millions.

SeptAlign offers a cartilage-sparing alternative to traditional septoplasty, a surgical procedure that often requires the removal of cartilage to correct a deviated septum. The implant is designed to hold the septum in a corrected position and gradually dissolves over six months.

The Zephyr Study, a feasibility trial involving 14 patients, demonstrated a 71.8% median improvement in NOSE (Nasal Obstruction Symptom Evaluation) scores and a 60.3% improvement in SNOT-22 (Sinonasal Outcome Test) scores one year after the procedure. Most patients reported rapid improvement 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 Greg Davis, lead author of the study and an ENT specialist with Proliance Surgeons.

The study also highlighted the implant’s strong safety and tolerability profile. “This innovation could redefine how we approach treatment for nasal obstruction caused by septal deviation,” added Steven Davis of the Breathe Clear Institute, a co-principal investigator.

The study authors concluded that the results support further clinical use and larger, prospective studies of the SeptAlign system, which received FDA clearance in 2024 and is now commercially available in the United States.

Minimally invasive advances transform ENT treatment

The release of Spirair’s SeptAlign study results reflects a broader trend in otolaryngology: the shift toward less invasive, office-based procedures that preserve anatomy while offering faster recovery and improved outcomes.

In recent years, ENT specialists have increasingly adopted bioabsorbable implants, balloon-based dilation systems, and advanced imaging guidance to treat chronic sinusitis, nasal obstruction, and snoring. These technologies aim to reduce the need for general anesthesia and hospital-based surgery, making care more accessible and cost-effective.

One example is the expanded use of bioabsorbable steroid-eluting sinus implants, such as those used after functional endoscopic sinus surgery (FESS), to reduce inflammation and scarring. Similarly, balloon sinuplasty has become a mainstream option for chronic sinusitis, allowing patients to undergo treatment in the office with minimal downtime.

The SeptAlign implant represents a new frontier in the management of nasal septal deviation. Traditional septoplasty, while effective, can be invasive and structurally altering. SeptAlign’s cartilage-sparing design may appeal to a wider range of patients, especially those with anterior caudal deviations—a particularly challenging subtype to treat.

ENT practices that embrace these new technologies may find themselves better positioned to meet patient expectations and improve outcomes with fewer complications and faster recovery times.