ShockWave Medical, Inc. (NASDAQ: SWAV) climbed early Wednesday, on news of developments with one of major products.
CEO Doug Godshall said, "We are pleased by the encouraging performance in the first quarter and, in particular, with the excellent reception of our newly-launched C 2 Coronary IVL product in the United States.
"I commend our team on their extraordinary preparation and execution of the launch of C 2 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."
The C 2 System was approved by the U.S. Food and Drug Administration in February 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 C 2 in the United States through March 29.
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.
C 2 clinical performance in the U.S. has been consistent with Shockwave’s experience with C 2 in international markets.
Over 120 U.S. customers have purchased the C 2 Launch Kit, with initial launch orders averaging approximately six C 2 units.
Nearly 50% of U.S. accounts that have initiated launch have completed the launch activities and are able to use IVL independently.
SWAV shares climbed $3.98, or 3.2%, to $126.87.
