Venova Medical

Venova Medical, Inc. is a privately held, clinical-stage medical device company founded in 2018 by CEO Erik van der Burg and CMO Dr. Shant Vartanian. The company is focused on addressing the challenges associated with providing optimal and timely vascular access for patients with chronic kidney and end-stage renal diseases who require hemodialysis. Emerging from a residence in Los Gatos, California during the COVID-19 pandemic, the firm has grown to over 10 employees. The business model centers on the development and eventual sale of its proprietary medical device, pending regulatory approvals.

The company's core product is the Velocity™ pAVF System, a technology designed for the percutaneous (through the skin) creation of arteriovenous fistulas (pAVF). A fistula for dialysis is a connection created between an artery and a vein, which is necessary to ensure high blood flow for effective hemodialysis treatment. Traditionally, this requires open surgery. The Velocity™ system offers a minimally invasive alternative, using a needle stick to create the fistula, a procedure that can be performed in an outpatient setting, surgery center, or office. This approach aims to reduce the barriers preventing patients from starting dialysis with the safer AVF procedure, as many currently begin treatment with higher-risk central venous catheters. The system is engineered to provide durable fistula flow, reduce the need for subsequent interventions to help the fistula mature, and ultimately lower healthcare costs.

Venova Medical is actively pursuing regulatory clearance to bring its product to market. The company is conducting clinical trials, including the VENOS-1 and the now fully enrolled VENOS-2 early feasibility study, under an Investigational Device Exemption (IDE) from the U.S. Food and Drug Administration (FDA). A significant milestone was achieved in September 2024 with the closing of a $30 million Series B financing round. This funding, co-led by Catalyst Health Ventures and a major medical device company, is allocated to further technology development and support the clinical studies required for FDA approval. The company plans to submit an IDE application for a pivotal U.S. trial in the second quarter of 2025.

Keywords: vascular access, hemodialysis, medical device, chronic kidney disease, end-stage renal disease, arteriovenous fistula, percutaneous AVF, pAVF, Velocity System, minimally invasive surgery, renal care, medtech, clinical trials, FDA approval, venture capital, Series B, Catalyst Health Ventures, ShangBay Capital, interventional radiology, nephrology