FDA 510(k) clearance for its Hemastyl gel device marks the first technology that has treated the tissue surrounding chronic wounds and prevented numerous amputations.
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.”
The Hemastyl gel is an FDA-cleared topical formulation designed to support wound closure by improving the local environment needed for tissue repair. The Periwound NerveStim device, currently in its final stages of FDA approval, works in conjunction with Hemastyl to help restore tissue function in and around chronic wounds—the area most responsible for stalled recovery. Together, they represent the first wound-healing technology that focuses specifically on the periwound region, a key factor in whether chronic wounds close successfully or progress toward infection and amputation.
Rapid Nexus is now finalizing its submission for FDA Breakthrough Device Designation, anticipated within 30–45 days. The designation will expand indications for use and accelerate pathways for reimbursement, enabling broader access for patients living with chronic wounds and neuropathy.
About Rapid Nexus Nanotech Wound Solutions, Inc.
Rapid Nexus Nanotech Wound Solutions, Inc.
is a California-based medical-device company developing advanced wound-healing technologies that address the core causes of non-healing wounds. Its patented Hemastyl gel and Periwound NerveStim devices are designed to treat the tissue surrounding chronic wounds and help prevent amputations in patients with diabetes, trauma, and vascular disease. The company received a TechConnect Defense Innovation Award for its potential to advance both civilian and military medicine.
Media Contact:
Sarah Kalmeta
[email protected]
(949) 572-9709
https://rapidnexus.com
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SOURCE Rapid Nexus
