[팍스넷뉴스 전경진 기자] After L&K Bio fostered its U.S. subsidiary Aegis Spine as a comprehensive medical device company, it decided to promote the listing on NASDAQ. With the approval for sales of affiliates’ products from the US Food and Drug Administration (FDA), the company plans to pursue manufacturing and sales business in earnest, as well as signing supply contracts with excellent domestic medical device companies to continue expanding the business.
On the 15th, L&K Bio announced that Aegis Spine, a US subsidiary, received approval from the US Food and Drug Administration (FDA) under the brand’XYPAN’ for a height-extended intervertebral body height information type (height-expandable cage) on January 29. Revealed. L&K Bio owns a 74.3% stake in Aegis Spine, an American spinal medical device distributor.
Aegis Spine is a U.S. subsidiary of its parent company, L&K Bio, as well as the sole distributor of L&K’s US sales. Until now, L&K Biomed’s products have been imported into the United States and sold directly to hospitals or indirect sales through agencies.
Aegis Spine is transforming into a comprehensive medical device company with production and distribution capabilities for all products related to spine and joints this year. As part of this, Aegis Spine last year signed a technology licensing agreement with L&K Biomed. Based on this, it is planning to challenge the NASDAQ of the US in the near future.
Aegis Spine plans to expand its business area to manufacturing by ending all product licenses for technology-licensed products this year and acquiring cGMP (Current Good Manufacturing Practice), the US pharmaceutical quality control standard. As a manufacturer of FDA-approved products, L&K Biomed will be in charge of OEM production, and other spinal implant products will be supplied and distributed from L&K Biomed as they are now.
Aegis Spine signed a supply contract with Rootlock, a joint specialist in Korea, to sell a knee joint implant used in Total Knee Arthroplasty, and is currently preparing to sell it in the United States. In addition, for artificial hip joints and trauma devices, we are step by step to discover companies with excellent quality in Korea.
DBM (Demineralized Bone Matrix), which is a bone filling material used during spinal implant surgery, is supplied by Hans Biomed in Korea, and is designed to import a bone marrow separation kit that separates and concentrates autogenous bone marrow to promote bone union during spinal surgery. We are also discussing with Bio.
A company official said, “Easy’s Spine will be able to complete a portfolio this year that includes not only implants related to spine and joints, such as spinal implants, artificial knee joints, and artificial hip joints, but also bio products used for spinal and joint surgery.” .
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