ShockWave Updates on U.S. Launch of Coronary IVL System

 Shockwave Medical, Inc. (NASDAQ: SWAV), a pioneer in the development of Intravascular Lithotripsy (IVL) to treat severely calcified cardiovascular disease, today announced a preliminary forecast revenue range for the first quarter 2021, ahead of its participation in the Wells Fargo MedTech R&D Spotlight Call Series to be held at 1:00 p.m. Eastern Time on March 30, 2021.

“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 Doug Godshall, President and Chief Executive Officer of Shockwave Medical. “I commend our team on their extraordinary preparation and execution of the launch of C2 and am so grateful for the collaborative partnership we have with our customers. The entire Shockwave Medical organization remains focused on our mission to deliver life changing products to patients suffering from calcified arterial disease.”

Coronary Launch

The C2 System was approved by the U.S. Food and Drug Administration on February 12, 2021 for use in calcified de-novo coronary arteries prior to implanting a stent. Subsequent to FDA approval, the company has achieved the following results with C2 in the United States through March 29, 2021:

• 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 $31.0 million to $32.0 million, which would represent an increase of 104% to 111% over the first quarter of 2020. The first quarter 2021 revenue range included in this release is preliminary and prior to the completion of review procedures by Shockwave Medical’s external auditors and is therefore subject to adjustment.

Shockwave to Participate in Wells Fargo R&D Spotlight Call

Shockwave will participate in the Wells Fargo MedTech R&D Spotlight Call Series on Tuesday, March 30, 2021 at 1:00 pm Eastern Time. A live and archived webcast of the event will be available at https://ir.shockwavemedical.com/.

https://finance.yahoo.com/news/shockwave-provides-u-launch-coronary-123000417.html