L&K Biomed, a spinal implant specialist, is ramping up its U.S. market strategy by broadening the clinical applications of its cervical height-expandable cage, BluEX-C.
The company announced on Wednesday that it successfully performed a three-level anterior cervical discectomy and fusion (ACDF) using BluEX-C at the Arizona Spine and Joint Hospital.
ACDF is a surgical procedure that involves making an incision in the front of the neck to remove a damaged disc and insert a cage to stabilize the vertebrae. BluEX-C is engineered to allow height adjustments after implantation.
L&K Biomed had previously conducted surgeries at levels 1, 2, and 4 using BluEX-C. With this latest three-level surgery, the company has now demonstrated clinical applications across all levels from 1 to 4 within just a month of the initial operation.
In May, BluEX-C received 510(k) clearance from the U.S. Food and Drug Administration (FDA). The agency classified it as a cervical interbody fusion device to be used in conjunction with bone graft materials.
The surgery was performed by Dr. Terence Crowder, a renowned U.S. spine specialist. After encountering BluEX-C during a visit to South Korea last month, Dr. Crowder completed the hospital registration and surgical application in a mere two weeks.
Dr. Crowder noted that the device’s ability to expand precisely in situ minimized the risk of endplate damage often associated with static cage insertion. It also proved beneficial in restoring and stabilizing the height of each vertebral segment.
The adoption of BluEX-C in U.S. hospitals is gaining momentum. The company reports that the device is currently registered in 13 hospitals nationwide, with 20 additional product registration and introduction processes underway.
An L&K Biomed spokesperson stated that the aim is to establish BluEX-C as a premium product recognized for its value in the global market. It’s committed to expanding the network with leading U.S. hospitals and medical professionals while strengthening the portfolio of high-value products.