L&K Biomed Receives US FDA Approval for Next-Generation Height-Expandable Spinal Implant

[Asia Economy Reporter Hyungsoo Park] L&K Bio, a developer of spinal implants, announced on the 14th that it has received FDA approval in the United States for its next-generation height-expandable spinal implant product, 'PathLoc-TM,' used for treating spinal diseases.

PathLoc-TM is a next-generation spinal implant product used in the posterior and posterolateral approaches, which are the most frequently performed procedures. It is inserted into the body at a minimal height, allowing for the minimization of the incision area. It enables minimally invasive surgery, which is expected to result in high patient satisfaction after surgery.

PathLoc-TM has an 'H' shape, allowing it to hold more bone graft material than existing products. It improves bone fusion capability. It is designed to increase the spinal insertion angle (up to 20 degrees), length (up to 25mm), and height (up to 4mm) according to the patient's various spinal conditions.

A company official stated, "PathLoc-TM is a product that consolidates L&K BioMed's unique advanced technology," adding, "With the recent increase in spinal degenerative diseases due to the aging population and obesity, it is a next-generation technology-intensive product poised to capture the global spinal implant market, which has grown to a scale of 9 trillion won."

The official also emphasized, "PathLoc-TM, which is at the pinnacle of the spinal implant field, is a product that competing companies have found difficult to develop due to its technical complexity," and added, "Establishing a direct sales system through the U.S. branch to be set up in the first half of this year will contribute to increased sales and enhanced brand image."

Spinal implant products are classified into five types based on the surgical approach: posterior, posterolateral, lateral, anterolateral, and anterior approaches. PathLoc-TM is a product for the posterior and posterolateral approaches, which account for about 70% of all procedures due to their high frequency of use.

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