Financing Will Support Clinical Development and Commercialization of Shockwave Medical's Lithoplasty Technology
October 10, 2017—Shockwave Medical, Inc. announced new financing that will be used to expand commercialization and advance clinical development of the company’s peripheral and coronary Lithoplasty systems in the United States and Europe and to advance development of a program evaluating the technology as a potential treatment for aortic valve stenosis. The $35 million in funds is an extension of the company’s previously announced $45 million Series C financing.
According to the company, this funding enables Shockwave Medical to move forward with multiple preclinical, clinical, and commercial initiatives, including the global launch of the company's below-the-knee device and the launch of its coronary platform outside of the United States next year. The company will also begin a chronic human feasibility study of its transcatheter aortic valve lithotripsy system in the first half of 2018.
Shockwave Medical's peripheral Lithoplasty system is commercially available in both the United States and Europe and is intended for lithotripsy-enhanced balloon dilatation of lesions, including calcified lesions, in the peripheral vasculature, including the iliac, femoral, iliofemoral, popliteal, infrapopliteal, and renal arteries. It is not for use in the coronary or cerebral vasculature.
The coronary Lithoplasty system received CE Mark approval earlier this year. In the European Union, the Shockwave Medical coronary Rx Lithoplasty system is indicated for lithotripsy-enhanced, low-pressure balloon dilatation of calcified, stenotic, de novo coronary arteries before stenting.
Shockwave Medical's coronary Lithoplasty system and transcatheter aortic valve lithotripsy system are investigational devices in the United States and are not available for sale.