Spirox today released 1-year data from the 1st-in-human study of its Latera absorbable nasal implant designed to support nasal cartilage and prevent nasal valve collapse, which can contribute to nasal obstruction.
Results from the study were published in the April issue of the journal Facial Plastic Surgery.
Data from the study indicated that patients treated with Latera had significant and sustained reduction in nasal obstruction through 12 months, the Menlo Park, Calif.-based company said.
The 30 patient study explored the use of the device in patients with severe or extreme symptoms, and utilized a total of 56 latera implants, with 26 patients receiving implants on both sides of the nose. Data indicated an average Nasal Obstruction Symptom Evaluation score reduction of 48.4, 43.3 and 40.9 at 3, 6 and 12 months respectively, with no adverse changes in cosmetic appearance reported.
“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. I believe that the Latera implant is an important advance that has the potential to transform the treatment of NVC,” principal study investigator Dr. Marion San Nicoló of the University Clinic of Munich said in a prepared statement.
“Spirox was founded to address the significant need for more accessible and effective treatments for the millions of people who have diminished quality of life due to nasal obstruction. The results of this study support the Latera implant as an important treatment option for patients who want nasal obstruction symptom relief,” Spirox chief medical officer Dr. Don Gonzales said in a press release.
Last September, Spirox released results from a multi-center study of its Latera absorbable nasal implant. Results from the previous study were presented at the 2016 Annual Meeting of the American Academy of Otolaryngology-Head and Neck Surgery.