Kreate Medical has received two FDA 510(k) clearances for its innovative wound matrix products, including Antibacterial Absorbable Synthetic Matrix and Absorbable Synthetic Matrix. These dual clearances mark their entry into the US market and the debut of a versatile portfolio designed to address unmet clinical needs in wound management.
ALPHARETTA, Ga., May 18, 2026 /PRNewswire-PRWeb/ -- Kreate Medical, a developer of advanced wound care technologies, today announced that it has received two 510(k) clearances from the US Food and Drug Administration (FDA) for its Antibacterial Absorbable Synthetic Matrix and Absorbable Synthetic Matrix product lines, marking the company's official entry into the US market.
These dual clearances underscore Kreate Medical's commitment to addressing unmet clinical needs in wound management. By launching a comprehensive portfolio that includes both antibacterial and standard matrices, Kreate Medical provides physicians with advanced, tested and versatile options tailored to specific patient needs.
"Receiving these FDA clearances is a foundational step in our journey to push the boundaries of what's possible in soft tissue repair and wound healing," Sean Chen, the CEO of Kreate Medical, said. "Our goal has always been to empower every wound to heal and every patient to thrive. With the introduction of these products, we are proud to begin supporting clinicians in both hospital and physician office settings across the continuum of care with reliable, clinically supported technologies."
The inaugural product family includes:
- SurCura™ AB / Redermax® Antibacterial Absorbable Wound Matrix
- SurCura™ / Redermo® Absorbable Wound Matrix
This regulatory achievement validates Kreate Medical's rigorous focus on technology excellence and paves the way for the company's initial commercial rollout in the US. The company remains dedicated to providing healthcare providers with more clinical evidence and tools to improve patient outcomes and lower the wound care burden.
For more information about Kreate Medical's technology and product family, please visit www.kreatemed.com.
About Kreate Medical
Based in Alpharetta, GA, Kreate Medical is a medical device company focused on the design and commercialization of advanced soft tissue repair and wound healing solutions. Driven by a mission "empowering every wound to heal, every patient to thrive", the company combines innovative biomaterials design and engineering expertise with premium clinical utility, providing advanced, evidence-based, and accessible solutions for physicians and patients worldwide.
Media Contact
Calvin Zhang, Kreate Medical Inc., 1 8664325425, [email protected], www.kreatemed.com
SOURCE Kreate Medical Inc.
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