Funding Will Support Clinical Trials of InterVene's BlueLeaf System for Deep Vein Reflux
June 25, 2019—InterVene, Inc. announced that it has raised $15 million in a Series B financing round, which will support the development of the company’s BlueLeaf endovenous valve formation system, which is a catheter-based solution for deep vein reflux (DVR).
According to the company, the BlueLeaf system is designed to correct one of the underlying causes of chronic venous insufficiency (CVI) by forming new vein valves out of a patient’s own vein wall tissue without the need for an implant. The resulting autogenous valves aim to reduce retrograde blood flow and alleviate the symptoms associated with elevated venous pressures.
The BlueLeaf technique is predicated on the Maleti Neovalve open surgical procedure but enables patients to avoid the trauma of open surgery, allows for multiple valves to be formed in a single procedure, and mechanizes certain aspects of the technically difficult open surgical procedure for ease of use and repeatability, stated InterVene.
InterVene advised that the funds will be utilized to expand its clinical research program abroad and to initiate trials in the United States via an investigational device exemption study. The studies are expected to further demonstrate the BlueLeaf system's safety and clinical effectiveness while the device and procedure are optimized in preparation for a subsequent pivotal study.
In the company's announcement, William Marston, MD, commented, “The BlueLeaf technology has the potential to offer a solution for patients with DVR, a current major gap in our treatment portfolio. The reports of the initial patients treated with the procedure are promising, and if confirmed in larger studies with longer follow-up, can provide a novel, important treatment option for this underserved patient group.”
Mikel Sadek, MD, added, “Treatment options for patients with DVR have been limited. This innovative technology may offer an alternative for patients needing procedural intervention to treat their disease.”
Dr. Marston is the George Johnson Jr. Distinguished Professor of Vascular Surgery at the University of North Carolina School of Medicine in Chapel Hill, North Carolina. Dr. Sade is a vascular surgeon and Assistant Professor of Surgery at NYU Langone Health in New York, New York.
The funding round was led by new investor 3x5 Partners and joined by previous investors RiverVest Venture Partners, Boston Scientific Corporation, Correlation Ventures, and others. InterVene is based in South San Francisco, California. It is a product of the Stanford Biodesign Fellowship program of the Byers Center for BioDesign at Stanford University in Stanford, California. InterVene is a former company-in-residence at the Fogarty Institute for Innovation in Mountain View, California.