[Market Focus] Astherasis Surges on Coolfase FDA 510K Clearance

Astherasis, a company specializing in aesthetic medical devices, saw its stock surge in early trading on October 20. Investor sentiment appears to have improved following news that its flagship product, Coolfase, received 510K clearance from the United States Food and Drug Administration (FDA).

As of 9:11 a.m. on the same day, Astherasis shares on the KOSDAQ market were trading at 16,150 won, up 9.12% from the previous trading day. The stock opened at 16,850 won and at one point during the session climbed as high as 17,480 won.

On this day, Astherasis announced that on October 14, Coolfase, its aesthetic medical device, was granted FDA 510K clearance. Coolfase is a radiofrequency lifting device that received manufacturing approval from the Ministry of Food and Drug Safety in April last year and was launched in Korea. It subsequently obtained regulatory approvals in Brazil in September of the same year, and in Taiwan, Indonesia, and Thailand this year, accelerating its entry into the global market.

With FDA approval, the product's safety and efficacy have been validated. As Coolfase utilizes proprietary cooling technology (DCC) to enhance treatment satisfaction in the global market, it is now evaluated as being well-positioned to become a market leader in the United States.

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