Study Data Reveal Positive Outcomes for Spirair’s SeptAlign Implant

The first clinical study evaluating Spirair Inc.’s SeptAlign implant show the bioabsorbable device is both safe and effective to use in treating nasal septal deviation (NSD).

NSD is a leading cause of nasal airway obstruction, impacting breathing and quality of life for millions. Unlike standard septoplasty, which often requires cartilage removal, SeptAlign supports a tissue-preserving technique that can be used to address cartilaginous septal deviations, including difficult-to-treat anterior deviations.

“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,” said Steven Davis, M.D., of the Breathe Clear Institute and study co-principal investigator.

In the prospective Zephyr Study of 14 patients with mobile cartilaginous NSD, the SeptAlign implant was inserted alongside inferior turbinate reduction. Results at 12 months post-procedure demonstrated:

• A 71.8% median improvement in NOSE (Nasal Obstruction Symptom Evaluation) scores (from 58 to 15; p=0.001)
• A 60.3% median improvement in SNOT-22 (Sinonasal Outcome Test) scores (from 37 to 8; p=0.004)
• Rapid improvement, with 92.9% of patients showing NOSE score response and 78.6% 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 Greg Davis, M.D., MPH of Proliance Surgeons and lead study author.

The study authors conclude that early findings support the safety, tolerability, and efficacy of the SeptAlign implant. These results support larger, prospective, open-label studies and continued clinical use.

SeptAlign is a proprietary bioabsorbable implant developed to correct cartilaginous nasal septal deviations. The implant is inserted in the cartilage near the front of the nose and holds the straightened septum under tension, dissolving within six months. Its design allows ENT specialists to realign and support the nasal septum, including challenging anterior caudal deviations, while preserving cartilage. SeptAlign can be used in any site of service as part of standard septoplasty techniques, including the office, the operating room (OR), and the ambulatory surgery center (ASC). The SeptAlign System received U.S. Food and Drug Administration clearance last year and is commercially available in the United States.

Spirair Inc. is an early-stage company pioneering minimally invasive solutions that help ENTs advance care. Spirair is developing new therapies that can easily integrate in any ENT’s treatment algorithms so they can help more of their patients breathe better. The company originated from the Stanford Biodesign Innovation Fellowship and Fogarty Innovation—renowned medtech incubators that train innovators to identify unmet healthcare needs, develop novel solutions, and bring them to clinical use.