L&K Bio-Med Receives FDA Approval for "Pactus"... "Foothold to Become Global No. 1 Product"

L&K Bio-Med, a spinal implant company, announced on April 28 that its newly developed pectus excavatum implant, "Pactus," has received approval from the U.S. Food and Drug Administration (FDA). This establishes a foundation for the company to expand into the pectus excavatum implant market.

L&K Bio-Med succeeded in developing Pactus based on 16 years of experience, accumulated expertise, and collaboration with medical professionals. The company completed its FDA application earlier this year and received final approval on April 25 (U.S. local time). A company representative stated, "This certification is significant as it validates the safety of our product through a reputable U.S. institution," and added, "This achievement is the result of thorough research, development, and review, demonstrating a significant upgrade in our R&D capabilities."

Pactus, which has obtained FDA approval, is a minimally invasive surgical product designed to improve the commonly used Nuss procedure for pectus excavatum correction. It was developed by combining clinical advice from leading thoracic deformity surgeons in countries such as the United States and China with L&K Bio-Med's expertise in spinal implant development.

Last month, L&K Bio-Med signed a memorandum of understanding (MOU) with Dr. Wang Wenlin, head of the Department of Cardiothoracic Surgery at the Second People's Hospital in China and a leading authority on thoracic deformity surgery in the country, to facilitate the entry of Pactus into the Chinese market. The company aims to enter the Chinese market by supporting local regulatory procedures and establishing a core training center for its products.

L&K Bio-Med also signed an MOU with Dr. Masahiko Noguchi, a renowned pectus excavatum surgeon at Nagano Prefectural Children's Hospital in Japan, to facilitate the entry of Pactus into the Japanese market. Through this partnership, the company plans to accelerate market expansion in Japan by operating clinical collaboration and training programs.

Starting with its entry into the United States, L&K Bio-Med aims to establish networks in overseas markets such as China and Japan, and to secure continuous growth engines for its global business, thereby seeking to gain a leading position in the Pactus market.

A company representative stated, "The development of the Pactus product is part of our efforts to discover a new cash cow beyond spinal implants, and to strengthen our competitiveness in new business areas within the medical device market alongside the company's growth." The representative added, "With FDA approval, we expect Pactus to establish a strong presence in the U.S., the world's largest medical device market, and believe we have secured a foothold to become the global No. 1 product in overseas markets as well."