07 August 2014
Polyganics obtains FDA 510k clearance to market NASOPORE-FD®
Groningen, the Netherlands, 7 August 2014 – Today, Polyganics announces it has obtained FDA clearance for NASOPORE-FD®, a sinunasal dressing with a rapid clearance time. The approval comes after the CE regulatory approval of NASOPORE-FD® in April 2014 and marks a next step in the commercialization Polyganics’ front-running bioresorbable nasal dressing portfolio marketed under the NASOPORE® brand.
“This is another important milestone in the extension of our successful NASOPORE® product family”, says Rudy Mareel, CEO of Polyganics. “We believe the unique characteristics of NASOPORE-FD® offer a valuable new option to doctors and are very excited that it now becomes available on the US market.”
Polyganics is a medical technology company with multiple versatile polymer platforms. The Company develops, manufactures and commercializes innovative bioresorbable medical devices that facilitate tissue repair and regeneration.
The existing portfolio includes products developed in-house and in collaboration with leading medical technology companies and academic centers of excellence. Surgical applications include peripheral nerve repair, neuro-, general, as well as ear, nose & throat surgery.
Polyganics is profitable, privately held, and based in Groningen, The Netherlands, a center of biomedical engineering excellence. The Company’s polymer platform technologies are protected by a broad portfolio of patents.
For more information, please visit www.polyganics.com