PELNAC® Bilayer Wound Matrix Receives U.S. Food and Drug Administration (FDA) Clearance

April 29, 2020

Gunze is proud to announce that on April 29th, 2020, the U.S. Food and Drug Administration (FDA) granted 510(k) clearance for PELNAC® Bilayer Wound Matrix.
With this clearance, we will address assisting users in the U.S. and their wound care needs and also promote marketing activities.


PELNAC® is a collagen-based wound dressing that consists of two layers: a porcine tendon-derived atelocollagen sponge layer and a silicone film layer. It contains a non-adhesive gauze to reinforce the silicone film. The meshed type has slits to aid in the drainage of exudate. The biodegradable collagen matrix provides a scaffold for cellular invasion and capillary growth. PELNAC® has been adopted by more than 60% of teaching hospitals in Japan, and has contributed to improving and saving the lives of patients since its launch.

Overseas, PELNAC® is used in Europe, the Middle East, South Africa, China, South Korea, and Brazil.