Bechtel Medical’s Wound VOX, a system that integrates negative pressure wound therapy and topical oxygen therapy has secured clearance from the US Food and Drug Administration (FDA).
The FDA clearance makes Wound Vox the first combined negative pressure and topical oxygen system cleared via the agency’s 510(k) pathway. Bechtel Medical now intends to initiate a limited commercial rollout of the system in December 2026.
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The company engineered Wound Vox to run in three operational modes: continuous NPWT, intermittent NPWT, and intermittent NPWT combined with adjunctive topical oxygen therapy (TOT).
Integrating both therapeutic modalities into one unit is intended to lessen the operational complications linked to managing independent wound care systems.
Bechtel’s founder and CEO, John Gvodas, said: “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.
“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.”
NPWT has been examined and deployed for decades across the medical sector, where it is frequently designated a gold standard for managing complex wounds.
Meanwhile, TOT has also gained clinical interest and research attention over the past 15 years for similar wounds, though it continues to confront reimbursement obstacles.
Independent clinical research has investigated the clinical impact of pairing both modalities.
Based in Pennsylvania, Bechtel Medical develops, engineers, and manufactures dressings and devices within the advanced wound care field, focusing on patient outcomes.
