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Re: rosemountbomber post# 54

Wednesday, 04/21/2021 12:50:11 PM

Wednesday, April 21, 2021 12:50:11 PM

Post# of 270
Rose ...new high today , Q1 earnings on May 10th .
Be interesting to see the order flow since the coronary application FDA approval .


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




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