Volcano, a developer and manufacturer of tools for the diagnosis and treatment of coronary and peripheral vascular disease, has signed an agreement to acquire Crux Biomedical, a privately held company that has developed an inferior vena cava (IVC) filter—the Crux VCF System—to treat pulmonary embolisms (PEs).
Founded in 2004 and based in Menlo Park, Calif., Crux has received a CE Mark and 510(k) clearance for its Crux VCF System, an IVC filter designed to facilitate bi-directional retrieval through either the femoral or jugular veins.
Under terms of the agreement, Volcano will pay $36 million in cash at closing, which is expected to occur within the next week, subject to a working capital adjustment and customary closing conditions. San Diego-based Volcano also will pay up to approximately $3.1 million in Crux transaction expenses.
The merger agreement also provides for a potential post-closing cash milestone payment of $3 million upon FDA clearance of a 510(k) application submitted by Volcano on or before June 30, 2013, for a retrieval device currently being developed by Crux. In addition, Volcano may make additional cash payments for up to four years, based on sales of Crux products following their commercial launch. Volcano expects to initiate commercial sales of Crux products at the end of 2013 once full-scale manufacturing is implemented at its Rancho Cordova, Calif., facility. The company also plans to seek regulatory approval to market the Crux VCF System in combination with its intravascular imaging technology.
The Crux VCF System received CE Mark in December 2011, and 510(k) clearance in July. The device has a helical design that allows bi-directional retrieval through either the jugular or femoral vein. The RETRIEVE 2, 3 and 4 pivotal clinical trials enrolled 125 patients at high risk for PE across 22 global sites.