Shockwave locks down $45M to develop, launch ultrasound PAD balloon

Calcified plaque--Courtesy of Shockwave Medical

Shockwave Medical picked up $45 million in a Series C round, which will propel the development and commercialization of its ultrasound balloon device for the treatment of peripheral artery disease.

The Fremont, CA-based company earned an FDA nod for the Medical Lithoplasty System in September. The device combines traditional angioplasty with lithotripsy, the use of ultrasound waves typically used to break up kidney stones. It treats calcified arteries in patients with PAD by delivering intermittent shock wave pulses while also restoring blood flow.

It will use the financing to drive the development of its lithoplasty balloon technology into other indications, as well as to ramp up its commercialization efforts in the U.S. and EU, the company said in a statement. At the time of approval, the company said it would conduct a limited launch of the device in the U.S. next year. Shockwave also plans to study its ultrasound balloon alongside drug-coated balloons in a randomized study involving more than 300 patients, according to the statement.

Sectoral Asset Management led the round, with participation from existing backers, Sofinnova Partners, Venrock, RA Capital, Deerfield and Ally Bridge Group, among others.

“When you consider the treatment challenges created by calcified lesions, it is clear there is a large market opportunity for Lithoplasty,” said Sectoral Asset Management Chief Investment Officer Michael Sjöström, in the statement. “The strong clinical results generated using a device built on a balloon-based platform offer a unique and compelling alternative to currently available therapies.”

Peripheral artery disease, characterized by narrowed blood vessels that restrict blood flow to the limbs and commonly cause pain in the legs, affects as many as 9 million Americans. And while arterial calcification--the hardening of plaques in the vessels--is on the rise in PAD patients, current therapies have “significant shortcomings” in how they can treat these patients.

“Lithoplasty is a unique approach that allows us to successfully treat these diseased vessels using a device built on a familiar balloon catheter platform, while minimizing the risk of vessel injury, including dissections that require stenting or other additional interventions,” said Dr. Kenneth Rosenfield, section head for Vascular Medicine and Intervention at Massachusetts General Hospital at the time.