Volcano to Acquire AtheroMed

May 27, 2014—Volcano Corporation announced that it has signed an agreement to acquire AtheroMed, Inc., a privately held company that has developed the Phoenix atherectomy system, which is used in the treatment of peripheral artery disease (PAD). The system enables physicians to treat PAD with a low-profile peripheral atherectomy catheter that continuously removes diseased material as it is debulked. 

In January 2014, the Phoenix system received 510(k) clearance from the US Food and Drug Administration (FDA). The device has also received European CE Mark approval, as well as reimbursement in the United States and select countries in Europe.

The Phoenix peripheral atherectomy system has been designed to provide physicians with a safe, versatile, easy-to-use primary therapy for treating PAD to restore blood flow to the ankle and foot. The over-the-wire system uses a rotating, front-cutting element located at the distal tip of the catheter to shave material directly into the catheter. The debulked material is then continuously captured and removed by an internal Archimedes screw running the length of the catheter. The device is available in multiple sizes to treat diseased vessels both above and below the knee.

Volcano noted that data from the pivotal EASE (Endovascular Atherectomy Safety and Effectiveness) trial, which supported FDA clearance, demonstrated a high level of safety and effectiveness, with 95.1% of the lesions treated achieving technical success and 94.3% of patients free from major adverse events at 30 days. 

Volcano plans to initiate a limited market release of the Phoenix by the end of 2014 and a full market release in early 2015. The company plans to initiate manufacturing at AtheroMed’s facility in Menlo Park, California, but will transition manufacturing activities to Volcano’s manufacturing facility in Costa Rica in late 2015.

Under terms of the agreement, Volcano will pay $115 million in cash at closing, which is expected to occur in the current quarter. In addition, Volcano will make a $15 million milestone payment if the current Phoenix device receives FDA clearance by November 15, 2014. This application covers design for manufacturing improvements to the currently approved device. In addition, the agreement calls for potential future revenue-based milestone payments by Volcano to AtheroMed.