[Asia Economy Reporter Hyungsoo Park] Spinal implant company L&K Biomed announced on the 17th that its new product ‘PassLock-TM,’ approved by the U.S. Food and Drug Administration (FDA) in March this year, has embarked on its first export to the United States through its newly established U.S. subsidiary, L&K Spine.
L&K Biomed held a shipment ceremony at its factory in Yongin, Gyeonggi Province, attended by company executives including Son Woo-geun, Head of Production Technology Headquarters, and Kang Guk-nam, Head of Global Business Headquarters. A total of 515 units of the ‘PassLock-TM’ product were exported, worth approximately $770,000 (9.8 billion KRW).
A company official explained, "The newly established U.S. subsidiary, L&K Spine Inc., completed registration for medical device import and sales in the U.S. earlier this year," adding, "We have started registering with major hospitals in the U.S."
He continued, "We plan to complete registration with at least two or more hospitals within this month and sign additional contracts with several distributors to accelerate growth in the U.S. market this year."
PassLock-TM is a posterior and posterolateral insertion type product with the highest frequency of procedures. Like the expandable spinal implant cage, it allows height adjustment with various widths and angles up to 20 degrees. PassLock-TM minimizes the incision site during surgery, reducing risks such as excessive bleeding and infection. Its greatest feature is the high patient satisfaction by helping patients return to daily life in a short time after surgery.
L&K Biomed, established in 2008 for the development, manufacturing, and sales of spinal implants, is a global spinal medical specialist company. It has obtained product approvals from the U.S. Food and Drug Administration (FDA), the European Union’s CE certification, and the Ministry of Food and Drug Safety (MFDS) in Korea. The company mainly designs, develops, manufactures, and sells spinal fixation devices and surgical products needed in orthopedics and neurosurgery.
Last year, L&K Biomed completed its second factory in Yongin, Gyeonggi Province, establishing state-of-the-art facilities for each process and achieving production centralization. In line with increasing export volumes to the U.S., Australia, Europe, and Asia, it has already built a system capable of doubling existing production capacity.
Park Geun-joo, CEO of L&K Biomed, said, "Spinal implant surgeries, which were halted due to the recent COVID-19 pandemic, have resumed with the easing of quarantine measures," adding, "We will leverage our experience, know-how, and expert networks accumulated in the U.S. medical device market to expand our sales network worldwide, including not only the U.S. but also Australia, Europe, Asia, and Latin America."
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