Aegis Spine Receives US FDA Approval... "Will Grow into a Comprehensive Medical Device Company for Spine and Joints"

[Asia Economy Reporter Hyungsoo Park] Aegis Spine, the US subsidiary of spinal implant developer L&K Biomed, announced on the 15th that it has received FDA approval in the US for a height-expandable interbody fusion device (height-expandable cage) under the brand name 'XYPAN'.

L&K Biomed is the largest shareholder, holding approximately 74.3% of the shares of Aegis Spine, a US-based spinal specialty distributor. Aegis Spine acts as the exclusive distributor for L&K Biomed in the US, importing L&K Biomed products into the US and handling direct sales to hospitals or indirect sales through dealerships.

Aegis Spine plans to become a comprehensive medical device company with distribution capabilities across all spinal and joint product lines. Based on this, it has set a plan to be listed on the NASDAQ market in the US. Last year, Aegis Spine signed a technology licensing agreement with L&K Biomed.

This year, Aegis Spine aims to obtain all product approvals for the licensed products and acquire cGMP (Current Good Manufacturing Practice), the US pharmaceutical quality management standard. As a manufacturer of FDA-approved products, production is carried out through OEM by L&K Biomed. Spinal implant products are supplied and distributed from L&K Biomed.

Aegis Spine has signed a supply contract with Rootlock, a Korean joint specialty company, to sell knee joint implants used in Total Knee Arthroplasty. Preparations are underway for sales in the US. It is also discovering Korean companies with excellent quality for artificial hip joints and trauma devices.

For the bone graft material DBM (Demineralized Bone Matrix) necessary for spinal implant surgery, Aegis Spine is sourcing from Hans Biomed in Korea. It is also in discussions with CG Bio to import bone marrow separation kits that separate and concentrate autologous bone marrow to promote bone fusion during spinal surgery.

A company official stated, "Aegis Spine will complete its portfolio not only with spinal implants, artificial knee joints, and artificial hip joints related to all spine and joint implants but also with bio products necessary for surgical operations," and added, "The day will come when L&K Biomed and Aegis Spine stand tall together in the global market."

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