Shockwave Medical develops Lithoplasty® systems that integrate lithotripsy (sonic pressure waves) with angioplasty balloon catheters to preferentially disrupt calcified plaque in vessel walls. The Peripheral Lithoplasty System is commercially available in the United States and Europe, and the Coronary Lithoplasty System received a CE mark earlier in the year while remaining investigational in the U.S. The company is also developing a transcatheter aortic valve lithotripsy system and presented a first‑in‑human feasibility study at the PCR London Valves meeting; further studies and a transfemoral design are under development. Management said proceeds from the financing will expand commercialization and advance clinical development of the Peripheral and Coronary systems in the U.S. and Europe and advance the aortic valve program. Planned commercial efforts include preparing for a global launch of a below‑the‑knee device and launching the coronary platform outside the U.S. next year, and clinical plans include commencing a chronic human feasibility study of the transcatheter aortic valve lithotripsy system in the first half of the year. Shockwave Medical develops the Lithoplasty System, a balloon catheter platform that uses lithotripsy sound waves to selectively disrupt calcified plaques followed by low-pressure balloon inflation to restore blood flow. The Peripheral Lithoplasty System is commercially available in the United States and the European Union. The company recently received FDA clearance for lithotripsy-enhanced balloon dilation of lesions in the peripheral vasculature. Shockwave reported positive results from the first study of Lithoplasty in calcified coronary artery disease. Near-term plans include expanding commercialization for peripheral vascular disease, advancing the platform into new therapeutic areas, and conducting the DISRUPT PAD III randomized controlled study of 300+ patients. Financially, the company raised $45 million in a Series C to support these development and commercialization efforts. Shockwave Medical develops the Lithoplasty® system, a balloon catheter platform that integrates lithotripsy pulses to disrupt superficial and deep vascular calcium and enable low‑pressure dilatation. Early clinical work, including the 35‑patient DISRUPT PAD trial, showed safe and effective dilatation of calcified SFA and popliteal lesions with no acute failures, no major device‑related adverse events, no need for stent placement, and six‑month duplex ultrasound patency of 83%. The company has received CE Mark for use in peripheral vascular disease and plans to begin clinical work in aortic valves within the coming year; Lithoplasty is not available for sale in the United States. Shockwave positions Lithoplasty as naturally gentle to soft tissue while remaining effective on all types of calcium, including deep deposits that limit vessel expansion. Proceeds from the announced financing will be used to develop Lithoplasty balloon catheters for peripheral, coronary, and aortic valve applications. The company is led by CEO and co‑founder Daniel Hawkins and is based in Fremont, Calif. Shockwave Medical develops intravascular devices to treat advanced peripheral and coronary artery disease, centered on its Lithoplasty™ system. The Lithoplasty system combines traditional balloon angioplasty catheters with lithotripsy and has been in development since 2010. It was first used in patients with calcified peripheral artery disease in New Zealand in 2012. The company is preparing enrollment in a CE Mark study for PAD in Europe and New Zealand. Shockwave was founded by CEO Daniel Hawkins, John Adams and Dr. Todd Brinton. The recent financing will support continued device development and clinical studies.

Total raised

$133M

Funding rounds

4

Latest round

Series C

Latest activity

Oct 2017