Los Gatos, California – December 1, 2025 – Venova Medical, a privately held company developing a next generation technology for the creation of percutaneous arteriovenous fistulas (pAVF) for hemodialysis access, announced today the publication of first-in-human clinical data for the company’s Velocity® Percutaneous AVF System in the Journal of Endovascular Therapy. The VENOS-1 study was a prospective, single-arm, single-center, open-label, early feasibility study designed to evaluate the safety and feasibility of the Velocity pAVF System which enrolled subjects who were hemodialysis (HD) dependent with a central venous catheter and had anatomy suitable for a surgical brachial-cephalic AVF. The study demonstrated that an implant-based technique is effective and safely creates an AVF for HD. The results also confirmed that by directing arterial flow into the superficial venous system, the Velocity implant can create hemodynamic conditions that facilitate physiologic AVF maturation without the need for adjunctive procedures.
Subsequent to the above, Venova Medical has initiated two separate U.S. prospective multicenter Investigational Device Exemption (IDE) studies (VENOS-2 and VENOS-3) designed to provide further evidence of the safety and efficacy of the Velocity pAVF System
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