The SeptAlign system uses the company’s bioabsorbable implant to straighten minor cartilaginous septal deviation. The implant won FDA clearance in August 2023.
Nasal septal devition is one of the most common causes of nasal airway obstruction, making breathing difficult through the nose. Typical treatment options have been limited to over-the-counter medication to alleviate symptoms or invasive surgical techniques like septoplasty to address structural issues.
“Demand for minimally invasive treatment options has been steadily rising across healthcare in recent years, but there have been few such options for people suffering from symptomatic NSD,” CEO Benjamin Bishop said in a news release. “SeptAlign is a minimally invasive treatment that can be safely and conveniently performed under local anesthesia and enables ENTs to expand their treatment options for more patients.”
Spirair said SeptAlign has been clinically demonstrated to straighten minor cartilaginous septal deviation. It can be performed in any site of service as part of standard septoplasty techniques.
The bioabsorbable implant is inserted in the cartilage near the front of the nose and holds the straightened septum under tension, then dissolves within six months. No cartilage is removed using the implant, allowing ENTs to expand their therapeutic offerings for more patients without limited future treatment options, according to the company.
“Septal deviation is one of the primary contributors to nasal airway obstruction. Physicians can’t move septal cartilage with medicines so mechanical correction through surgery has been the best choice for many patients. Until SeptAlign, there has been little to no change in how we perform septoplasty,” Dr. David Yen, chief of otorhinolaryngology at St. Luke’s University Health Network in Bethlehem, Pennsylvania, said in a news release. “SeptAlign is uniquely suited to treat cartilaginous septal deviations at the nasal valve, the narrowest cross-sectional area, with less recovery for the patient.”
SeptAir is being investigated as part of two IRB-approved nonsignificant risk (NSR) U.S. clinical trials. The company plans to begin a Series B fundraising round and commercialize the device following the FDA clearance.
