PuriCore's Vashe Wound Cleaning System gets FDA approval

By Lisa Kerner

Charlotte, N.C., July 7 - The Food and Drug Administration granted 510(k) approval to PuriCore plc, allowing the company to market its proprietary Vashe Wound Cleansing System as a medical device.

The device produces hypochlorous acid from the electrolysis of saline solution, which is used in wound cleansing, irrigating, moistening and debriding acute and chronic dermal lesions.

PuriCore said the device is indicated in the treatment of stage 1-4 pressure ulcers, stasis ulcers, diabetic ulcers, post surgical wounds, first and second degree burns, abrasions and minor skin irritations.

"This is a significant step in the company's execution of its wound care business plan and builds on the clinical work already conducted that supports the Vashe solution benefits," chief executive officer Greg Bosch said in a company news release.

"With this approval, we look forward to initiating discussions with potential commercial partners."

Results from a multi-year study showed observable improvement in healing rates, pain reduction, effective wound debridement and cleansing action, according to PuriCore.

Based in Malvern, Pa., PuriCore markets a portfolio of branded systems that produce hypochlorous acid solutions on-site at a customer's location from water, electricity and common salt.

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