Volcano, a developer and manufacturer of precision guided therapy tools for treatment of coronary and peripheral vascular disease, 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).

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. Volcano will also pay up to approximately $3.1 million in Crux transaction expenses.

"We are delighted to be adding the novel Crux VCF System, as well as Crux's other pipeline devices, to our innovative product portfolio,” said Scott Huennekens, president and CEO 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.”

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 IVUS (intravascular imaging) technology.

"The Crux VCF System's bi-directional retrievability makes it a highly valued solution in today's environment of increased clinical focus on removing IVC filters when the risk of PE is reduced. This novel device, which is self-centering and naturally adjusts to the shape of the vessel wall, is a strong and synergistic addition that advances our presence in venous applications,” said Neil Hattangadi, vice president and general manager of Volcano's peripheral vascular unit.

Thomas Fogarty, M.D., founder of Crux, added, "The Crux VCF represents the first major design innovation for IVC filters in nearly four decades and incorporates important product attributes that provide improved patient outcomes. This transaction pairs two companies that have led innovation and I believe the future addition of IVUS guidance to the Crux technology will represent a seminal change in the practice of vascular medicine.”