L&K Biomed Performs First Surgery with Korean Spinal Implant at U.S. Veterans Hospital

L&K Biomed, a company specializing in spinal implants, announced on August 12 that it has successfully completed its first spinal implant surgery at a VA hospital (Veterans Affairs Hospital), one of the leading public medical institutions in the United States. The company stated that this marks a significant turning point in its entry into the highly regulated U.S. public healthcare market.

L&K Biomed has been working on registration procedures to enter U.S. veterans hospitals since 2014. In 2021, it signed a vendor contract with a procurement agency. To register new medical devices, companies must undergo multiple evaluation steps in addition to U.S. Food and Drug Administration (FDA) approval, including separate registration in the federal procurement system, as well as rigorous clinical and safety verifications.

A representative from L&K Biomed explained, "After years of continuous effort to register our products with the highly demanding U.S. veterans hospitals, we have finally completed the registration process following a stringent review." The representative added, "Through this first surgery, we have gained a comprehensive understanding of the operational procedures and systems at veterans hospitals." They further stated, "Building on this achievement, we plan to secure references at public hospitals across North America and actively expand spinal surgeries at veterans hospitals throughout the United States."

The surgery was performed at a veterans hospital in Miami, Florida. U.S. veterans hospitals are federal government medical institutions under the Veterans Affairs administration, with more than 170 hospitals and approximately 1,400 affiliated outpatient clinics nationwide, forming a large-scale healthcare system. The number of eligible registered users who can access veterans hospitals exceeds 40 million. The Miami VA Hospital, located in southern Florida, serves as a regional hub, providing care to about 63,000 veteran patients.

Dr. Timur M. Urakov, who performed the surgery, is actively practicing at the internationally renowned Jackson Memorial Hospital and Miami VA Hospital in the fields of neurosurgery and spinal surgery. He has also served as a clinical professor at the University of Miami School of Medicine. Regarding the surgery, he stated, "The procedure using L&K Biomed's spinal implant product line was completed with both precision and safety," adding, "L&K Biomed's products will significantly help reduce the surgical burden on patients and shorten recovery times."

A representative from L&K Biomed emphasized, "This is the first case where a spinal implant product developed with domestic technology has been applied at a U.S. veterans hospital," highlighting, "It is a symbolic first step in our global expansion strategy."

L&K Biomed plans to begin actively collecting clinical data from veterans hospitals starting with this surgery. The company aims to deepen its understanding of operational procedures and systems at each hospital and, in the long term, expand its supply network to veterans hospitals across the United States.

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