Maxiocel advanced wound care dressing gets USFDA 510k clearance and HCPCS code

Maxiocel Advanced Woundcare dressing made of 100% chitosan

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.

MaxioCel is a soft, sterile, single-use absorbent gelling wound dressing. It is Advamedica’s next-generation chitosan based advanced care dressing built using proprietary BMG technology which is designed to support faster wound healing while managing bacteria, biofilm and exudates. Centers for Medicare and Medicaid Services (CMS) has assigned Healthcare Common Procedure Coding System (HCPCS) Level II codes, A6196,A6197, A6199 for MaxioCel Chitosan Wound Dressing

MaxioCel advanced wound care dressing range has been proven for effective management of chronic and acute wounds, including diabetic foot ulcers, venous leg ulcers, pressure ulcers, surgical wounds, traumatic injuries, burns, skin abrasions and lacerations. It is one of the few advanced wound care products that also has proven hemostatic properties.

MaxioCel dressings have already made significant inroads in both European and Asian markets, with an impressive deployment of over a million units. Their adoption in medical settings across these regions has yielded tangible clinical benefits, notably by accelerating the healing process for patients. Now with HCPCS codes, MaxioCel simplifies billing and claims processing for providers and these codes positions MaxioCel in wound clinic practice, particularly within Medicare and Medicaid populations in the United States.

Chronic wounds affect an estimated 6.5 million Americans annually, driven by diabetes, vascular disease, pressure injuries, and aging demographics. The U.S. wound-care market is projected to reach $11.4B by 2030 with advanced wound-care products outpacing traditional dressings.

Leo Mavely, Founder and President of Advamedica Inc. remarked “Obtaining USFDA 510(k) clearance for MaxioCel Chitosan Wound Dressing along with HCPCS codes is a significant achievement that reflects our unwavering commitment to improving patient outcomes. We are excited to introduce this innovative wound care technology to healthcare professionals across the United States, enhancing their capacity to provide exceptional care”.

About Advamedica
Advamedica Inc. is a leading medical technology company specializing in advanced wound care and bleeding control solutions. With innovations such as Axiostat and MaxioCel, Advamedica is transforming emergency, surgical, and chronic wound management across global markets. Backed by strong clinical evidence and global adoption, Advamedica is committed to delivering science-driven solutions that improve patient outcomes and redefine standards of care.

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Leo Mavely
Advamedica Inc.
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