Entellus Medical (ENTL) Says 18 and 24-Month Data Confirms Durable Relief of Nasal Obstruction Symptoms with Latera from Spirox
Entellus Medical, Inc. (NASDAQ: ENTL) today announced data from its first-in-human study of the Latera® absorbable nasal implant from Spirox®. The 18 and 24-month data demonstrate that patients who received Latera had significant improvement in nasal obstruction symptoms with no negative cosmetic changes. The results were selected for presentation at the 2017 Annual Conference of the European Academy of Facial Plastic Surgery (EAFPS) and the 2017 Annual Meeting of the American Academy of Facial Plastic and Reconstructive Surgery (AAFPRS).
“These newly released data from our study have met our pre-defined criteria for success including symptom relief without negatively affecting appearance,” stated Dr. Marion San Nicolo, M.D., University Clinic of Munich, LMU and lead enroller in the study stated. “In addition, patients who benefitted from Latera experienced continued symptom relief after the implant had absorbed.”
The study was conducted at three sites in Germany and included 30 adult patients with nasal valve collapse (NVC)—one of the most frequent causes of nasal obstruction, a condition that limits airflow and makes breathing through the nose more difficult. Patients had severe or extreme symptoms as established by the validated Nasal Obstruction Symptom Evaluation (NOSE) instrument and were treated with Latera alone. A total of 56 Latera implants were placed in 30 subjects, and patients were assessed at 1 week and 1, 3, 6, 12, 18 and 24 months post-procedure.
Key findings of the study include:
- Continuing, significant NOSE score reduction at all time points, averaging 63.4%, 56.2%, 52%, 52.5% and 57.7% at 3, 6, 12, 18 and 24 months, respectively (p<0.001)
- No adverse change in cosmetic appearance at 24 months post procedure
- Short learning curve for physicians adopting the technology
"We are pleased to see continued evidence reinforcing that Latera is a safe and effective treatment option for patients with NVC, with the potential to become standard of care,” said Robert White, President and Chief Executive Officer of Entellus Medical. “We look forward to increasing access to Latera for ENT physicians and plastic surgeons seeking a treatment option for their nasal obstruction patients.”