Maxiocel, Advamedica’s chitosan-based wound care dressing, gets USFDA 510(k) clearance & HCPCS codes, boosting US access for chronic & acute wound treatment.

CAMBRIDGE, MA, UNITED STATES, September 26, 2025 / EINPresswire.com/ — Advamedica Inc., an innovative medtech company specialized in novel biomaterials, today announced US Food and Drug Administration (FDA) 510(k) clearance and HCPCS code approval for Maxiocel – advanced wound care range based on 100% chitosan. Maxiocel had already received CE clearance and has been in use in Europe and in several countries for over 5 years.

This press release can be viewed online at: https://www.einpresswire.com/article/852697553

US FDA granted 510(k) clearance to Axiostat Gauze, which is intended for use as a temporary external dressing to control moderate to severe bleeding and manage external abrasions, lacerations.

Also as an over-the-counter product for the local management of bleeding wounds such as minor cuts, lacerations, and abrasions.

Ax-Surgi is the first FDA-cleared chitosan-based surgical hemostat intended for the temporary control of internal organ space bleeding in patients displaying class III or IV bleeding. In the US, the product will be marketed by Advamedica Inc, headquartered in Boston.

Meet us at LSI USA Emerging Medtech Summit 2023, at Dana Point, California from 20th March to 23rd March. LSI USA 2023 is one of the largest medtech partnering event which sees participation of leading medtech startup CEOs, innovators, investors, and industry leaders.