SAN DIEGO, Dec. 3, 2012 /PRNewswire/ -- Volcano Corporation (Nasdaq: VOLC), a leading developer and manufacturer of precision guided therapy tools designed to enhance the diagnosis and treatment of coronary and peripheral vascular disease, said today it has signed an agreement to acquire Crux Biomedical, a privately-held company that has developed a highly differentiated inferior vena cava (IVC) filter—the Crux VCF System—to treat pulmonary embolisms (PE's). Founded in 2004 and based in Menlo Park, California, Crux has received a CE Mark and 510(k) clearance for its Crux VCF System, an innovative IVC filter designed to facilitate bi-directional retrieval through either the femoral or jugular veins.
Under terms of the agreement, Volcano will pay $36.0 million in cash at closing, which is expected to occur within the next week, subject to a working capital adjustment and customary closing conditions. Volcano will also 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 $3.0 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, California, facility. The company also plans to seek regulatory approval to market the Crux VCF System in combination with its IVUS (Intravascular Imaging) technology.
Pulmonary Embolism, which is caused by a migration of a large blood clot from the deep veins of the legs, affects 600,000 patients in the U.S. every year and results in an estimated 200,000 deaths annually. IVC filters, particularly those which can be retrieved, are an important tool in reducing PE risk for patients in whom anticoagulation is contraindicated or ineffective. The IVC filter market in the U.S. is estimated at approximately $300 million.
The Crux VCF System received CE Mark in December 2011 and 510(k) clearance in July 2012. The device has a unique helical design that self-centers and allows bi-directional retrieval through either the jugular or femoral vein. In the RETRIEVE 2, 3 and 4 pivotal clinical trials, which enrolled 125 patients at high risk for PE across 22 global sites, the Crux VCF System demonstrated both deployment and retrieval success at 98 percent with zero percent embolization, migration and fracture."We are delighted to be adding the novel Crux VCF System, as well as Crux's other pipeline devices, to our innovative product portfolio. Our ability to provide this type of cutting-edge therapy furthers our leadership in the delivery of precision guided therapy and symbolizes our continued evolution from an intravascular imaging company to one that provides a wide variety of diagnostic and therapeutic solutions," said Scott Huennekens, president and chief executive officer of Volcano. "A key element of our growth strategy is to diversify beyond coronary applications and increase penetration of the peripheral market with our imaging technology. As we increase our focus on this market, the ability to offer a unique IVC filter and, through further regulatory approvals, use IVUS to facilitate its placement at the bedside, represents compelling clinical and economic value for patients, clinicians and the healthcare system," he added.