Funding Will Support Clinical Studies of the VelocityTM pAVF System in Patients with Chronic Kidney and End-Stage Renal Disease

 (Los Gatos, California) – Venova Medical, Inc. (Venova Medical), a privately held company developing a next generation technology for the creation of percutaneous arteriovenous fistulas (pAVF) for hemodialysis access today announced the initial closing of a $30M Series B funding round. Catalyst Health Ventures and a leading medical device company co-led the financing, with participation from ShangBay Capital, Mirae Asset Capital, KOFA Healthcare, Cadence Healthcare Ventures, Aphelion Capital and other new and existing investors. The funding will be used to further develop the company’s technology and conduct clinical studies in the U.S. to support FDA regulatory approval. Venova Medical also announced the appointment of Darshana Zaveri, Managing Partner at Catalyst Health Ventures, to the company’s Board of Directors.

Venova Medical’s VelocityTM pAVF System, is an innovative medical technology being developed to use a minimally invasive technique to create an arterio-venous fistula (AVF) for hemodialysis vascular access. The Velocity pAVF System is designed to provide optimal and durable fistula flow to support maturation and clinical use for hemodialysis. The percutaneous procedure is designed to be performed in an office, surgery center or outpatient hospital setting.

“Providing a safe, effective and long-lasting method for vascular access is a significant challenge in hemodialysis treatment for patients with kidney failure,” said Darshana Zaveri. “Conventional methods such as surgical arteriovenous fistulas (AVF), arteriovenous grafts, or central venous catheters have not adequately met this need. Venova Medical’s technology aims to overcome the limitations of these traditional approaches, offering a transformative solution for patients dependent on hemodialysis”.

“Despite decades of tremendous efforts from healthcare providers, the vast majority of patients starting dialysis do so with a central venous catheter, subjecting them to increased risk of morbidity and mortality and cost to the U.S. healthcare system as compared to the safer AVF procedure,” stated Erik van der Burg, CEO of Venova Medical. “We believe that the Velocity pAVF System will become the new standard of care and reduce the barriers preventing a majority of patients from starting dialysis with an AVF.”

About Venova Medical

Venova Medical, Inc., headquartered in Los Gatos, California, is a privately held clinical stage company addressing the challenges associated with providing optimal vascular access for patients needing hemodialysis. Venova Medical developed the Velocity pAVF System, a next generation percutaneous AVF technology designed to reduce the need for reinterventions to achieve fistula maturation, maintain functionality and improve vascular access outcomes while reducing costs. Venova Medical has completed enrollment in a prospective, single center VENOS-1 clinical trial (NCT05757726) to evaluate the safety and feasibility of Velocity pAVF System in patients on hemodialysis who are candidates for AVF. VENOS-1 results will be presented at the Controversies in Dialysis Access Conference (CiDA) on October 5, 2024.

Forward-Looking Statements

This release contains forward-looking statements, which represent estimates and assumptions with respect to certain future events, which are subject to significant risks and uncertainties. Products discussed in this release are in the investigational stage and have not yet been approved, nor are they available, for sale in the U.S. or any other country.