Positive results from the first in-human study of the LATERA™ absorbable nasal implant from Spirox, Inc. have been published in the journal Facial Plastic Surgery. Data show that patients who received LATERA, designed to support lateral nasal cartilage to address nasal valve collapse (NVC), had a significant and sustained reduction in nasal obstruction symptoms through 12 months with no adverse change in appearance. NVC is a major contributor to nasal obstruction.
Conducted at three sites in Germany, the study included 30 adult patients with NVC. Patients had severe or extreme symptoms as established by the validated Nasal Obstruction Symptom Evaluation (NOSE) instrument. A total of 56 LATERA implants were placed in these 30 subjects, 26 of whom received implants on both sides of the nose. Patients were assessed at 1 week and 1, 3, 6 and 12 months post-procedure. Average NOSE score reduction of 48.4, 43.3 and 40.9 was seen at 3, 6 and 12 months, respectively. There was a statistically significant average NOSE score reduction at 3, 6 and 12 months (p < 0.001), with no adverse change in cosmetic appearance at 12 months post procedure.
"These results are very promising, as they demonstrate the safety and efficacy of the LATERA implant and provide an optimal approach for correcting a common cause of nasal obstruction," said Dr. Marion San Nicoló, MD, University Clinic of Munich, LMU and Principal Investigator in the study, in a statement. "I believe that the LATERA implant is an important advance that has the potential to transform the treatment of NVC."