San Juan Capistrano, United States
Avenu Medical is a well-established medical device company dedicated to creating a paradigm shift in vascular access for hemodialysis patients. Their focus is on pursuing unmet clinical needs by developing a minimally invasive, cost-effective, and efficient approach to vascular access.
Founded in 2010 and headquartered in Orange County, California, the company has developed the Ellipsys® Vascular Access System, an innovative, image-guided, single catheter system used to percutaneously create an arteriovenous (AV) fistula for hemodialysis access. Over the past three years, the Ellipsys System has been used in clinical trials outside the United States. In December 2014, they received approval from the Food and Drug Administration (FDA) to begin a pivotal Phase III clinical trial in the United States through an Investigational Device Exemption (IDE). Patient enrollment for the trial was completed in June 2016.
The Ellipsys System has received FDA approval and European CE Mark approval for the creation of an arteriovenous fistula in patients with chronic kidney disease requiring hemodialysis. The company's last investment was a $12.00M Venture Round investment at 31 October 2018.
