The 18 and 24-month data reinforces clinical benefits without cosmetic downside.
PLYMOUTH, Minn., Oct. 30, 2017 (GLOBE NEWSWIRE) --Entellus Medical (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.”
About Entellus Medical, Inc.
Entellus is a medical technology company focused on delivering superior patient and physician experiences through products designed for less invasive treatments. Spirox Inc is a wholly-owned subsidiary of Entellus. Entellus products are used for the treatment of adult and pediatric patients with chronic and recurrent sinusitis, patients with nasal airway obstruction, as well as adult patients with persistent Eustachian tube dysfunction. The Entellus platform of products provides safe, effective and easy-to-use solutions intended to enable treatment of patients in more cost-effective sites of care. Entellus’s product lines including the XprESS™ ENT Dilation System, Latera™ Absorbable Nasal Implant, MiniFESS™ Surgical Instruments, XeroGel Nasal Dressing and FocESS™ Imaging & Navigation combine to enable ENT physicians to conveniently and comfortably perform a broad range of procedures in the most cost effective and efficient site of care. Entellus is committed to broadening its product portfolio with high-quality and purposeful innovations for the global ENT market.
About Latera
Latera® is an absorbable nasal implant, designed by ENT physicians. Latera supports the nasal cartilage to address nasal valve collapse (NVC), which reduces nasal obstruction symptoms and help patients breathe better. Patients who received the implant reported satisfaction with their breathing (86%) and appearance (93%) results.i
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i Data on file (TR-21076 Spirox NVC Experience). Individual patient results may vary and may include other procedures. Patient satisfaction results may be attributed to LATERA with other procedures.
Lynn Pieper Lewis
415-937-5402
ir@entellusmedical.com
