KOSDAQ-listed ASTERASYS shares were strong early on the 20th. Buying appears to have gathered on news that the company's aesthetic medical device was approved by the U.S. Food and Drug Administration (FDA).
As of 9:09 a.m., ASTERASYS was trading at 16,450 won, up 1,650 won (11.15%) from the previous trading day. It rose to as high as 17,480 won intraday, hitting a 1-year high.
On Oct. 17, aesthetic medical device specialist ASTERASYS said that "Coolfase" was approved by the U.S. FDA with an FDA 510K classification.
Coolfase, a monopolar radio frequency (RF) aesthetic medical device, received medical device manufacturing approval from the Ministry of Food and Drug Safety in April last year and was launched in Korea. On that news, ASTERASYS shares once surged nearly 18% the same day.
ASTERASYS plans to begin full-scale U.S. sales of Coolfase starting next year after signing with a U.S. aesthetic medical device distributor.
A company official said, "As global procedure demand for differentiated RF devices expands, FDA approval for Coolfase signals the start of full-fledged competition in the world's largest market."