Shockwave Medical has reeled in $35 million in new financing, expanding upon the $45 million it raised in a series C round last fall. The proceeds will support commercialization of Shockwave’s ultrasound balloon treatment for peripheral and coronary artery disease, as well as R&D in some new indications.
The Fremont, California-based company markets a treatment for calcified cardiovascular disease that combines traditional angioplasty with lithotripsy, or ultrasound shock waves that are used to break up kidney or bladder stones. Dubbed lithoplasty, Shockwave Medical’s treatment uses ultrasound to break up calcified plaques and an angioplasty balloon to restore blood flow.
Its lithoplasty system for the treatment of peripheral artery disease earned a CE mark in 2015, followed by FDA approval the following year. The new financing will support a commercial expansion for this device—at the moment, Shockwave only has sales operations in Germany, said CEO Doug Godshall.
The company is looking to boost its commercial operations nationally and to “expand substantially geographically, he said.
In May this year, the lithoplasty device snagged a CE mark for the treatment of coronary artery disease. Shockwave plans to launch it on a limited basis and to follow up with a more substantial rollout, Godshall said.
Shockwave is also developing a smaller-profile version of the lithotripsy system to treat peripheral artery disease in the smaller blood vessels below the knee. The device was shown to be safe and effective in a study of 20 patients with arterial blockage below the knee. The company anticipates an ex-U.S. launch in 2018, according to a statement.
The financing—which included participation from existing backer T. Rowe Price Associates and new investor Fidelity Management & Research Company—will also support R&D efforts for a lithotripsy system to treat aortic valve stenosis.
“We feel extremely fortunate to have received this investment particularly coming from these two funds,” Godshall said in the statement. “This infusion enables us to move multiple preclinical, clinical and commercial initiatives forward with greater certainty.”