First Clinical Study of SeptAlign™ Implant Demonstrates Safety and Efficacy in Treating Nasal Septal Deviation While Preserving Cartilage

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Spirair, Inc., an early-stage company developing minimally invasive solutions to help ENTs improve patient care, today announced the publication of the first clinical study evaluating its SeptAlign™ implant. The positive 12-month outcomes demonstrate the safety and efficacy of this novel bioabsorbable device, which offers a cartilage-sparing approach to traditional septoplasty for the treatment of 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.

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

• 71.8% median improvement in NOSE (Nasal Obstruction Symptom Evaluation) scores (from 58 to 15; p=0.001)
• 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 author of the study.

“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 co-principal investigator of the study.

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.

About SeptAlign™

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 innovative 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 FDA clearance in 2024 and is commercially available in the United States. Visit septalign.com for more information.

About Spirair®

Spirair, Inc. is an early-stage company pioneering minimally invasive solutions that help ENTs advance care for their patients by providing strong outcomes and a better patient experience. Spirair is committed to 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. Visit spirair.com for more information.