Rapid Nexus wins FDA Clearance for first device targeting root causes of chronic wounds

Rapid Nexus Nanotech Wound Solutions Inc. has secured FDA 510(k) clearance for its Hemastyl gel device, a topical formulation designed to restore the damaged tissue environment that prevents chronic wounds from healing. The California-based med-tech company says the clearance marks a pivotal shift in wound-care strategy, moving beyond surface-level treatment to directly address the periwound tissue—an area long recognized as central to whether a wound closes or worsens.

“This FDA clearance validates years of research focused on one of medicine’s most persistent challenges—why chronic wounds don’t heal,” said 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 cleared as a topical device intended to improve local tissue conditions needed for repair. It is designed to be used alongside the company’s Periwound NerveStim device, which remains in the final stages of FDA review. Together, the technologies aim to restore tissue function and help patients avoid infections and amputations, particularly in cases where wound healing has stalled.

The company expects to submit an application for FDA Breakthrough Device Designation within the next 30 to 45 days, which could pave the way for expanded indications and support faster reimbursement pathways.

Recent advances in chronic wound care

The wound-care sector has seen a wave of innovation in recent years as clinicians and researchers push beyond traditional bandages, dressings and debridement to focus on the biological and structural factors driving healing. One major trend is the shift toward treatments that modify the chronic wound microenvironment—addressing inflammation, promoting oxygenation, and supporting the cellular activity required to rebuild tissue. Tools that assess wound perfusion and tissue viability are also becoming more sophisticated, giving clinicians a clearer picture of what is preventing closure.

Another area of advancement involves neurosensory restoration and improved management of neuropathy, particularly for patients with diabetes. Emerging technologies aim to stimulate or support damaged nerves around chronic wounds, helping to reestablish sensory feedback and tissue function. This approach reflects a growing understanding that nerve impairment can significantly hinder healing by reducing protective sensation and altering the biological cues that guide tissue repair.

Biologically active therapies have also expanded rapidly. These include topical agents and graft materials that mimic or encourage natural healing processes, aiming to increase cellular proliferation, support extracellular matrix formation, or reduce bacterial burden. Some recent developments incorporate bioactive peptides, growth-factor-modulating compounds or specialized scaffolds that help guide new tissue formation.

Digital and remote-monitoring platforms are further reshaping the field, allowing clinicians to track wound progression more precisely and intervene earlier when healing stalls. These technologies can capture data on wound size, temperature changes and tissue health, helping stratify risk and personalize treatment.

Collectively, these advances reflect a broader movement toward comprehensive, biology-driven wound care—one that looks beyond surface management to the deeper physiological processes determining whether a wound heals or progresses toward infection or amputation.