Bechtel Medical Receives FDA Clearance for Wound VOX™, the First 510(k)-Cleared Combined Negative Pressure and Topical Oxygen System
PR Newswire
PHOENIXVILLE, Pa., Nov. 10, 2026
PHOENIXVILLE, Pa., Nov. 10, 2026 /PRNewswire/ -- Bechtel Medical designs, engineers and manufactures wound care devices and dressings in the Advanced Wound Care sector with an emphasis on improving patient outcomes and supporting clinical best practices. Today, Bechtel Medical is proud to announce that its flagship product, Wound VOX™, has received 510(k) clearance from the U.S. Food and Drug Administration (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.
Clinicians and potential durable medical equipment (DME) distribution partners can learn more and request information at woundvox.com.
About Bechtel Medical
Bechtel Medical, Inc., a medical device company based in Phoenixville, Pennsylvania, designs, develops, and manufactures wound care technologies grounded in engineering excellence, clinical insight, and a commitment to patient safety. Its product portfolio reflects a focus on responsible innovation, addressing unmet clinical needs while maintaining rigorous standards of quality and compliance. Learn more at bechtelmedical.com.
Media Contact
Andy DeGuilio
VP, Marketing & Strategy
Bechtel Medical, Inc.
AndyD@bechtelmedical.com
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SOURCE Bechtel Medical, Inc
