Rapid Nexus Becomes the First Company to Receive FDA Clearance for its Advanced Wound-Healing Device Hemastyl

BREA, Calif., Nov. 13, 2025 /PRNewswire/ -- Rapid Nexus Nanotech Wound Solutions, Inc., a California-based med-tech company focused on advanced wound care, today announced it has received FDA 510(k) clearance for its Hemastyl gel device—marking a historic milestone as the first company to directly target the underlying reason chronic wounds fail to heal.

For decades, wound care has centered on managing surface symptoms—covering and cleaning wounds—without addressing the damaged tissue that determines whether healing can occur. Rapid Nexus’s newly cleared technology is the first to treat this critical tissue environment directly, restoring conditions for closure and helping patients avoid amputations.

“This FDA clearance validates years of research focused on one of medicine’s most persistent challenges—why chronic wounds don’t heal,” said Dr. Margaret Kalmeta , founder and CEO of Rapid Nexus. “By targeting the periwound tissue—the living edge that determines whether a wound closes or deteriorates—we’re giving clinicians a way to help patients who previously had no options.”

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