Hemastyl Gets FDA Clearance as a Topical Device for Chronic Wound Management

Rapid Nexus has received FDA 510(k) clearance for Hemastyl, a topical gel device developed to support healing in chronic wounds by acting directly on the damaged tissue that surrounds the wound. The decision marks the first FDA-cleared technology designed specifically to treat the periwound region. This is an area that determines whether stalled wounds can progress toward closure.

Hemastyl is a gel-based medical device intended for topical use. According to the company, the formulation provides a local environment that supports the biological processes required for tissue repair. Its design centers on the periwound zone rather than the wound bed itself.

Hemastyl may address an unmet clinical need in patients with chronic wounds and neuropathy who have few effective options.

Chronic wounds are a growing public health issue, affecting an estimated one in six Medicare beneficiaries in the US and costing Medicare about $22.5 billion annually, with global wound care spending approaching $150 billion.

Chronic wounds, including diabetic ulcers and wounds caused by trauma or vascular disease, often persist for months because the surrounding tissue loses nerve function, blood flow and the biological signals needed for repair. Diabetic foot ulcers, which affect an estimated 6.5 million people in the US each year and up to one-third of people with diabetes over their lifetime, remain a major driver of infection, hospitalization and amputation.

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Current wound care approaches generally focus on managing the surface of the wound through dressings, cleaning and infection control. However, the underlying tissue continues to deteriorate in many patients, increasing the risk of infection and, in severe cases, amputation.

The technology behind Hemastyl is designed to intervene before tissue breakdown leads to infection and irreversible damage.

Rapid Nexus stated that Hemastyl is the first technology cleared by the FDA that acts directly on the tissue surrounding chronic wounds. The company described this new treatment focus as critical for re-establishing the conditions necessary for closure.

The gel is expected to be used in clinical settings where chronic wounds have not responded to standard wound care. No companion device is required for use, though Rapid Nexus noted that a related system, the Periwound NerveStim device, is in the final stages of FDA review. That device is designed to work alongside Hemastyl to help restore nerve function and improve tissue activity in and around chronic wounds.

The company shared that in a small 2018 feasibility effort involving patients scheduled for amputation due to severe chronic wounds, those individuals did not undergo amputation after receiving the company’s technology. The company also reported observed improvements in local blood flow and nerve activity in these early cases.

These observations were part of early exploratory work and were not included in the evidence used for the FDA’s 510(k) decision.

Rapid Nexus is preparing a submission for FDA Breakthrough Device designation within the next 30 to 45 days.

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