SeptAlign
- Six-month Vayu Study results published in Laryngoscope Investigative Otolaryngology
- 63 percent reduction in NOSE scores
- One-day median return to work
- 97 percent of patients would recommend the procedure to friends or family members
- No serious adverse events
MOUNTAIN VIEW, Calif., Oct. 08, 2026 (GLOBE NEWSWIRE) -- Spirair, Inc., a medical technology company advancing next-generation solutions for ear, nose, and throat care, today announced publication of six-month results from the Vayu Study of SeptAlign®, the company’s FDA-cleared bioresorbable implant for minimally invasive correction of cartilaginous nasal septal deviation. The manuscript, “Safety and Effectiveness of a Bioabsorbable Septal Implant for Cartilaginous Nasal Septal Deviation,” appears in Laryngoscope Investigative Otolaryngology.
In the prospective, multicenter study, 80 patients with nasal airway obstruction caused primarily by cartilaginous septal deviation underwent a SeptAlign procedure, either alone or with inferior turbinate reduction, in either the operating room or a physician office. Of these patients, 92.5% had moderate-to-severe deviation at baseline. The 75 patients with successful implants were followed for outcomes.
At six months, mean Nasal Obstruction Symptom Evaluation (NOSE) scores fell 63.2%, from 67.5 to 23.6 (p < 0.0001), and 22-item Sino-Nasal Outcome Test (SNOT-22) scores fell from 43.7 to 14.5 (p < 0.001). Outcomes were similar with and without turbinate reduction: 91.4% of patients treated with SeptAlign alone and 88.2% treated with SeptAlign plus turbinate reduction were NOSE responders.
“These findings highlight SeptAlign’s ability to significantly relieve nasal obstruction while preserving the patient’s natural septal cartilage,” said Thomas S. Higgins, MD, MSPH, MBA, lead author of the study. “What is most encouraging is the lasting impact. Patients continue to experience relief at six months, even after the implant has safely dissolved, demonstrating that the corrected septum now maintains its own structural integrity.”
In the study, 46.3% of procedures were performed in the office under local anesthesia. Among patients who took time off work, the median return to work was one day. At three months, 97.2% said they would recommend the procedure to a friend or family member.
No serious adverse events occurred; there were no cases of epistaxis, cerebrospinal fluid leak, septal hematoma, or septal perforation. Procedure- or device-related adverse events occurred in 7.5% of patients and were mild or moderate, such as fever, adenopathy, lightheadedness, and other reactions typically associated with nasal surgery.
“The publication of the Vayu Study is an important milestone for Spirair and provides strong clinical support for a cartilage-preserving approach to septoplasty,” said James Kintzing, PhD, co-founder and CTO of Spirair. “We developed SeptAlign to give physicians a less-invasive way to correct septal deviation, including challenging anterior deviations, while preserving native anatomy and supporting an easier recovery.”
The results are a six-month interim analysis of an ongoing 24-month study at nine U.S. otolaryngology clinics. As an observational study without a control group, it was not designed for direct comparison with conventional septoplasty. Longer-term follow-up is underway.
The manuscript is available at https://onlinelibrary.wiley.com/doi/10.1002/lio2.70579.
About SeptAlign
SeptAlign is an FDA-cleared bioresorbable implant for the minimally invasive correction of cartilaginous nasal septal deviation. It applies mechanical traction to straighten and stabilize the septum without cartilage resection, and is gradually resorbed, leaving no permanent implant behind.
About Spirair
Spirair is shaping the future of ENT through next-generation solutions optimized for physicians and grounded in the highest standards of patient care. Founded in 2020 by two Stanford Biodesign Innovation Fellows, Spirair takes a needs-driven approach to identifying clinical challenges and developing technologies that meaningfully improve outcomes for physicians and their patients. For more information, visit www.spirair.com.
A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/48286263-70e4-4576-8928-557fd3217e18
CONTACT: Media Contact Naomi Pritikin VP, Marketing npritikin@spirair.com
