[Market Focus] NextBioMedical Hits Record High on Hopes for Entry into U.S. Medical Device Market

NextBioMedical continues to show strong performance in the afternoon trading session.

As of 1:40 p.m. on November 27, shares of NextBioMedical were trading at 83,800 won, up 9.26% (7,100 won) from the previous day. During the session, the stock surged to as high as 89,600 won, setting a new 52-week high.

Investor sentiment was boosted by news that the company has completed the pre-submission process with the U.S. Food and Drug Administration (FDA) for its self-developed vascular embolization medical device, Nexphere. Previously, Nexphere had already secured certification from the Ministry of Food and Drug Safety (MFDS) in Korea and the European CE mark. The recent pre-submission consultation with the FDA is considered a significant step toward entering the U.S. market.

According to the company, Nexphere is a vascular embolization medical device composed of a hydrophilic material containing gelatin. It is used to temporarily block blood flow to a targeted area by mixing it with a contrast agent and injecting it into the blood vessel through a catheter during embolization procedures.