[Featured Stock] L&K Bio Receives US FDA Approval for 6 Types of Height-Expandable Cages

Spine implant company L&K Biomed is showing strong performance. The news that six new products in the height-expandable cage line, the ‘BlueX Series,’ have received approval from the U.S. Food and Drug Administration (FDA) appears to be influencing the stock price.

As of 2:18 PM on the 24th, L&K Biomed is trading at 8,570 KRW, up 29.85% from the previous day.

L&K Biomed completed its FDA approval application last month and received final approval on the 23rd (U.S. local time). A representative from L&K Biomed stated, “It is an unusual achievement that the approval was completed within just 30 days from the FDA application,” adding, “Especially the fact that six items were approved in a short period is a result based on accumulated data through sufficient research, development, and review, reflecting an upgraded R&D capability.”

The six FDA-approved ‘BlueX Series’ products are height-expandable cages for lumbar (lower back) use, including ▲BlueX-T (height-expandable cage for posterior thoracic surgery) ▲BlueX-TC (height-expandable cage for posterior thoracic endoscopic surgery) ▲BlueX-L, BlueX-LT (height-expandable cages for lateral surgery) ▲BlueX-ATP (height-expandable cage for lateral/anterolateral use) ▲BlueX-A (height-expandable cage for anterior abdominal use), offering a full lineup that covers all surgical approaches.

The lineup has been further segmented and diversified by upgrading four existing height-expandable cage products and adding two new types. The surface is roughened to promote faster and stronger bone fusion between the titanium height-expandable cage and the human spine. This differentiation from existing height-expandable cage products has further strengthened competitiveness.

A representative from L&K Biomed emphasized, “The FDA approval of the six BlueX Series products is a global recognition of L&K Biomed’s R&D capabilities and global competitiveness.” They added, “We expect the ‘BlueX Series 6 products’ to successfully establish themselves in the U.S., the world’s largest medical device market,” and “We aim to expand the U.S. market with strengthened sales power through a diverse product lineup alongside existing products.”

L&K Biomed has previously obtained FDA approval for many products, including height-expandable cages such as PassLock-TM, ExcelFix-XTP, and PassLock-TA. Building on this expertise, the company plans to pursue FDA approval for more than eight new products, including the chest wall deformity (pectus excavatum) implant ‘CastleLoc Pectus Bar System,’ height-expandable products for the cervical spine (neck) with navigation programs applied, products for the sacroiliac joint (the joint formed by the sacrum and ilium bones), and projects for Ambulatory Surgery Centers (ASC) focused on providing same-day surgical treatment.