FDA Clears First Combined Negative Pressure and Topical Oxygen System

The company plans a limited commercial release in December 2026.

Wound Vox negative pressure wound therapy device with digital display, purple reservoir, and clear tubing
Bechtel Medical

Bechtel Medical announced that its flagship product, Wound VOX, has received 510(k) clearance from the FDA.

Negative Pressure Wound Therapy (NPWT) has been widely studied and used in the marketplace for decades. Many refer to NPWT as a "Gold Standard" therapy for a variety of complex wounds. Over the last fifteen 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.

Independent clinical research has examined the potential benefits of combining NPWT and topical oxygen therapy. In a 2025 systematic review and meta-analysis published in Advances in Wound Care, Su et al. evaluated 11 randomized controlled trials and reported significantly higher complete wound healing rates and lower rates of bacterial positivity with combination treatment compared with NPWT alone. These findings concern the treatment approaches studied and were not generated from clinical studies of Wound VOX™.

"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, Founder and CEO of Bechtel Medical. "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."

Bechtel Medical plans a limited commercial release in December 2026.

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