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Bechtel Medical, a Phoenixville, Pennsylvania, wound care device maker, has received FDA 510(k) clearance for Wound VOX, which the company describes as the first 510(k)-cleared system to combine negative pressure wound therapy (NPWT) and topical oxygen therapy (TOT). The system offers three modes: continuous NPWT, intermittent NPWT, and intermittent NPWT with adjunctive TOT.
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NPWT has been used for decades, and many clinicians regard it as a gold standard for complex wounds. TOT has been studied more widely over the last fifteen years but still faces reimbursement challenges. Bechtel Medical believes putting both in one platform may reduce the operational complexity of running separate technologies. Founder and CEO John Gvodas said the aim is “simplifying the delivery of advanced wound care.”
The company points to a 2025 systematic review and meta-analysis in Advances in Wound Care that covered 11 randomized controlled trials. It reported higher complete wound healing rates and lower bacterial positivity with combination treatment than with NPWT alone. Bechtel Medical notes those findings concern the treatment approaches studied and did not come from clinical studies of Wound VOX.
Bechtel Medical plans a limited commercial release in December 2026.
For the broader MedTech space, the clearance adds a combined device to a wound care field where the two therapies have so far been delivered separately.
