[Special Stock] L&K Bio Demonstrates Excellence with 5x Price and FDA Approval for Spinal Implant Product in the US

Overhang Resolution... Expecting Increased Sales of Expandable Cages in the US
Expanding Market Share in the 3 Trillion Won Market with Patented Technology for Cervical Expandable Cages

[Asia Economy Reporter Hyungsoo Park] L&K Bio is showing strong performance day after day. The overhang issue disappeared as KTB Asset Management, a major shareholder, sold all its holdings after trading resumed, and it appears to reflect expectations that sales of the core spinal implant product, the 'Expandable Cage,' will increase.

As of 11:07 AM on the 2nd, L&K Bio is trading at 6,940 KRW, up 15.09% from the previous day.

The stock price has surged for four consecutive days. Despite the recent sharp rise, the stock price has not yet reached the initial public offering price of 15,000 KRW at the time of listing before November 2016.

According to the Financial Supervisory Service's electronic disclosure system, KTB Asset Management sold all of its 11.86% stake in L&K Bio on the market between the 4th and 13th of last month. Trading of L&K Bio shares was suspended for 14 months due to issues with the internal accounting control system review opinion. After trading resumed, it appears that KTB Asset Management sold all its holdings.

L&K Bio rebuilt its internal accounting control system in consultation with an accounting firm. Regarding the 2019 financial statements, it received an 'appropriate' opinion on the internal accounting control system, was removed from the investment caution list, and stock trading resumed.

During the trading suspension period in September last year, L&K Bio received approval from the U.S. Food and Drug Administration (FDA) to sell the AccelFix-XT, the first domestically developed expandable cage. The expandable cage is a product designed to allow the cage, a core component inserted between vertebrae during spinal implant surgery, to be adjusted according to the patient's spinal condition. Unlike existing products that require sequential expansion of the intervertebral space before cage insertion, L&K Biomed explains that surgery can be performed without additional procedures.

At the time of approval, a company official stated, "The expandable cage demonstrated safety and efficacy in FDA inspections and received approval as a medical device import item. The expandable cage is the most sought-after product in the U.S. spinal implant market, priced at over five times higher (5,000 USD) than existing products, which proves its excellence."

He added, "With the FDA approval process completed, sales in overseas markets are expected to increase sharply starting from the fourth quarter of this year, when the expandable cage will be fully launched in the U.S. market."

L&K Bio has completed patent registration for the 'Expandable Cage.' It plans to proceed with international applications under the Patent Cooperation Treaty (PCT) applicable to major countries including the U.S. L&K Bio submitted an FDA approval application on March 30 for a cervical expandable cage reflecting this technology. The company plans to obtain approval and launch the product within this year.

An L&K Bio official said, "The expandable cage products have proven performance comparable to those of Globus Medical, which is considered top-tier among products released in the U.S. market through various tests and clinical trials. If FDA approval for this new product is granted, we expect to increase our market share in the cervical implant market, which is currently worth about 3 trillion KRW."

This content was produced with the assistance of AI translation services.