Support from Blue-Chip Financial and Strategic Investors Will Advance Product and Clinical Development

FREMONT, Calif.–(BUSINESS WIRE)–Shockwave Medical, a pioneer in the treatment of peripheral and coronary vascular disease, today announced $40 million in funding, co-led by returning investor Sofinnova Partners and new investor Venrock, with the participation of RA Capital, Deerfield, Sectoral Asset Management, Ally Bridge Group, and two undisclosed large-cap strategic investors.

Proceeds from the financing will be used for development of the company’s Lithoplasty® balloon catheters in peripheral, coronary and aortic valve applications.

The company recently reported six-month follow-up results from the DISRUPT PAD trial, a 35-patient study of patients with calcified vascular stenosis of the superficial femoral artery (SFA) and popliteal artery treated with the Lithoplasty system. Data reported at the 37th Annual Charing Cross 2015 Symposium in London demonstrate safe and effective dilatation of calcified stenosis with no acute failures, favorable residual stenosis, no major device-related adverse events and no need for stent placement. Six-month durability was excellent with no need for re-treatment and patency by duplex ultrasound of 83%.

“We are very pleased to work with such a high quality group of investors to continue advancing the development of Lithoplasty,” said Shockwave Medical CEO and co-founder Daniel Hawkins. “We believe the Lithoplasty system is uniquely suited to address substantial unmet needs in the treatment of patients with peripheral, coronary and aortic valve disease using a balloon-based approach that is inherently familiar to physicians. Our returning and new investors provide us the depth of resources and breadth of support needed to achieve our goal of changing the paradigm in the treatment of advanced cardiovascular disease.”

“We were very impressed with the level of interest and the quality of the investor group that Shockwave was able to bring into this new funding round, with blue-chip financial investors as well as two major corporate investors,” said Antoine Papiernik, managing partner of Sofinnova Partners. ”This is a tribute to the strength of the Lithoplasty technology as well as to the work that management has done to develop it to this stage.”

“Shockwave has the potential to significantly improve the treatment of advanced cardiovascular disease with products based on an intuitive, simple platform technology. We are encouraged by the success to date and look forward to helping the management team build a world-class company,” said Colin Cahill, vice president at Venrock.

In advanced vascular disease, atherosclerosis becomes calcified deep inside the vessel walls, limiting blood flow. These deposits are difficult to treat because they limit the effectiveness of current endovascular devices, making today’s interventions challenging and prone to both procedural and long-term failure. Lithoplasty is a novel balloon-based technology that utilizes integrated lithotripsy, a pulsatile mechanical energy commonly used to break up kidney stones, to disrupt both superficial and deep calcium and normalize vessel wall compliance prior to low-pressure balloon dilatation. Lithoplasty is designed to be naturally gentle to soft tissue (non-diseased portions of the vessel) while remaining hard on calcium, the tissue that limits vessel expansion and the effectiveness of current technologies.

About Shockwave’s Lithoplasty® System

Delivered on a standard balloon catheter platform, Lithoplasty combines the calcium disrupting power of lithotripsy with the familiarity and simplicity of a balloon in a single enabling device. Lithoplasty applies a brief series of powerful mechanical pulses designed to safely travel through soft tissue and disrupt calcium. The integrated balloon is then dilated at low pressures to expand the lesion evenly, potentially minimizing acute soft tissue injury that could lead to the need for additional interventional treatments or long-term restenosis (re-blockage). Unlike current devices that treat only superficial calcium, Shockwave’s Lithoplasty system is designed to be effective on all types of calcium, including deep – the type known to limit vessel expansion.

Early clinical results demonstrate safety, tolerability, deliverability, and effectiveness for Lithoplasty as a treatment for patients with peripheral artery disease and as a pre-treatment of calcified coronary lesions prior to stenting. Clinical work will begin in aortic valves within the coming year. Shockwave has received CE Mark for use of Lithoplasty in the treatment of peripheral vascular disease. Lithoplasty is not available for sale in the United States.

To view an animation of Lithoplasty visit http://shockwavemedical.com/technology.

About Shockwave Medical

Shockwave Medical, based in Fremont, Calif., is pioneering Lithoplasty® technology, a promising breakthrough for the treatment of peripheral and coronary vascular disease and aortic stenosis. Delivered on a standard balloon catheter platform, Lithoplasty combines the calcium disrupting power of lithotripsy with the familiarity and simplicity of a balloon in a single enabling device. For more information visit www.shockwavemedical.com.

Contacts

Shockwave Medical
Nicole Osmer, 650-454-0504
nicole@nicoleosmer.com