Bechtel Medical Inc. has received 510(k) clearance from the U.S. Food & Drug Administration for its Wound VOX system that combines negative pressure wound therapy (NPWT) and topical oxygen therapy in one device.
The Phoenixville, Pennsylvania-based medical device company made the announcement in a Nov. 10 news release.
“NPWT has been widely studied and used in the marketplace for decades,” the announcement said. “Many refer to NPWT as a ‘gold standard’ therapy for a variety of complex wounds. Over the last 15 years, topical oxygen therapy (TOT) has also become more widely studied and used in the treatment of complex wounds, but continues to face reimbursement challenges.
“Wound VOX incorporates three modes of operation: continuous NPWT, intermittent NPWT, and intermittent NPWT with adjunctive TOT. Bechtel Medical believes that integrating these two therapeutic capabilities into a single platform may reduce the operational complexity associated with deploying separate wound care technologies.”
Bechtel Medical said the Wound VOX system improves patient outcomes via faster wound closure, reduced infection risks, and improved tissue quality. Adjustable settings can provide individualized therapy designed for each patient’s needs.
“Treating hard-to-heal wounds with both negative pressure and concentrated oxygen has historically required clinicians to manage separate systems, adding complexity to an already challenging clinical problem,” said John Gvodas, Bechtel Medical’s founder and CEO. “We designed Wound VOX to integrate these two therapeutic technologies into a single platform, with the goal of simplifying the delivery of advanced wound care while addressing some of the operational and economic barriers that have historically limited access to these therapies.”
The company is planning a limited commercial release in December 2026.
Image courtesy Wound VOX.
