News Release Details
Shockwave Provides Update on U.S. Launch of Coronary IVL System
“We are pleased by the encouraging performance in the first quarter and, in particular, with the excellent reception of our newly-launched C2 Coronary IVL product in the United States,” said
The C2 System was approved by the
- Shockwave territory managers have launched an average of just over 1.5
U.S.accounts per month, consistent with the company’s stated strategy of executing the launch in a disciplined and sustainable fashion.
- C2 clinical performance in the
U.S.has been consistent with Shockwave’s experience with C2 in international markets.
- Over 120 U.S. customers have purchased the C2 Launch Kit, with initial launch orders averaging approximately six C2 units.
- Nearly 50% of
U.S.accounts that have initiated launch have completed the launch activities and are able to use IVL independently.
- Five live cases utilizing C2 in
U.S.centers have been performed in conjunction with the recent Cardiovascular Research Technologies (CRT) and Scottsdale Interventional Forum(SIF) Conferences.
- Peripheral revenue in the
U.S.has continued to grow month-over-month throughout the quarter.
First Quarter 2021 Results
Preliminary first quarter 2021 revenue is expected to be in the range of
Shockwave to Participate in Wells Fargo R&D Spotlight Call
Shockwave will participate in the Wells Fargo MedTech R&D Spotlight Call Series on
Shockwave is focused on developing and commercializing products intended to transform the way calcified cardiovascular disease is treated. Shockwave aims to establish a new standard of care for the interventional treatment of atherosclerotic cardiovascular disease through differentiated and proprietary local delivery of sonic pressure waves for the treatment of calcified plaque, which the company refers to as Intravascular Lithotripsy (IVL). IVL is a minimally invasive, easy-to-use and safe way to significantly improve patient outcomes. To view an animation of the IVL procedure and for more information, visit www.shockwavemedical.com.
This press release contains statements relating to our expectations, projections, beliefs, and prospects, which are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. In some cases, you can identify these statements by forward-looking words such as “may,” “might,” “will,” “should,” “expects,” “plans,” “anticipates,” “believes,” “estimates,” “predicts,” “potential” or “continue,” and similar expressions, and the negative of these terms. You are cautioned not to place undue reliance on these forward-looking statements. Forward-looking statements are only predictions based on our current expectations, estimates, and assumptions, valid only as of the date they are made, and subject to risks and uncertainties, some of which we are not currently aware.
Important factors that could cause our actual results and financial condition to differ materially from those indicated in the forward-looking statements include, among others: the impact of the COVID-19 pandemic on our operations, financial results, and liquidity and capital resources, including the impact on our sales, expenses, supply chain, manufacturing, research and development activities, clinical trials, and employees; our ability to develop, manufacture, obtain and maintain regulatory approvals for, market and sell, our products; our expected future growth, including the size and growth potential of the markets for our products; our ability to obtain coverage and reimbursement for procedures performed using our products; our ability to scale our organizational culture; the impact of the development, regulatory approval, efficacy and commercialization of competing products; the loss of key scientific or management personnel; our ability to develop and maintain our corporate infrastructure, including our internal controls; the completion and review by our auditors of our financial results for the three months ended
Source: Shockwave Medical, Inc.