23 October 2014
Polyganics obtains FDA 510k clearance to market HEMOPORE®
Groningen, the Netherlands, 23 October 2014 – Today, Polyganics announces it has obtained FDA clearance for HEMOPORE®. HEMOPORE® offers two forms of post-op hemostatic control in one bioresorbable sinunasal dressing. The clearance comes after the CE regulatory approval of NASOPORE FD® in April 2014 and FDA 510k approval of NASOPORE FD® in October 2014.
“This a significant step in the extension of our successful NASOPORE® product family”, says Rudy Mareel, CEO of Polyganics. “We believe the unique characteristics of HEMOPORE® offer a valuable new treatment option to doctors.”
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