Information
16-25 Dongbaekjungang-ro 16beon-gil, Giheung-gu, Yongin-si, Gyeonggi-do, South Korea
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Overview
- Summary
- A global medical specialized company in spinal implants for treating spinal disorders and pectus excavatum implants. Providing solutions for all spinal conditions including cervical, thoracic, and lumbar spine, based on height-adjustable expandable spinal implant technology. Contributing to human health improvement through innovative product development and global market expansion. Since its establishment in 2008, the company has accumulated unique technological expertise in the spinal implant sector. As a global total healthcare enterprise, it strives to develop original medical devices to overcome diseases.A global medical specialized company in spinal implants for treating spinal disorders and pectus excavatum implants. Providing solutions for all spinal conditions including cervical, thoracic, and lumbar spine, based on height-adjustable expandable spinal implant technology. Contributing to human health improvement through innovative product development and global market expansion. Since its establishment in 2008, the company has accumulated unique technological expertise in the spinal implant sector. As a global total healthcare enterprise, it strives to develop original medical devices to overcome diseases.
- Key Products/Technologies
- The company's spinal implant product line includes various solutions applicable to all spinal regions, such as cervical, thoracic, and lumbar spine. Height-adjustable expandable interbody fusion devices represent a key product group with concentrated core technologies.The company's spinal implant product line includes various solutions applicable to all spinal regions, such as cervical, thoracic, and lumbar spine. Height-adjustable expandable interbody fusion devices represent a key product group with concentrated core technologies.
- PathLoc-TM is a posterior and postero-lateral insertion product, offering precise adjustment capabilities for insertion angle (up to 20 degrees), length (up to 25mm), and height (up to 4mm) according to the patient's spinal environment. This product has demonstrated high stability through over 4,000 successful surgeries in the U.S. market.PathLoc-TM is a posterior and postero-lateral insertion product, offering precise adjustment capabilities for insertion angle (up to 20 degrees), length (up to 25mm), and height (up to 4mm) according to the patient's spinal environment. This product has demonstrated high stability through over 4,000 successful surgeries in the U.S. market.
- BluEx-TM is the next-generation version of PathLoc-TM, featuring a specialized surface treatment process. The BluEx series includes 6 new product developments, expanding the range of product choices.BluEx-TM is the next-generation version of PathLoc-TM, featuring a specialized surface treatment process. The BluEx series includes 6 new product developments, expanding the range of product choices.
- ExcelFix is the world's first height-adjustable cage with a curved design, suitable for both lumbar lateral interbody fusion and oblique lateral interbody fusion. ExcelFix-XT is a posterior insertion type for minimally invasive surgery, while ExcelFix-XTP holds the world's first patent for its curved shape and technology in lateral cages.ExcelFix is the world's first height-adjustable cage with a curved design, suitable for both lumbar lateral interbody fusion and oblique lateral interbody fusion. ExcelFix-XT is a posterior insertion type for minimally invasive surgery, while ExcelFix-XTP holds the world's first patent for its curved shape and technology in lateral cages.
- For cervical products, BluEX-C and Castleloc P 2.0 are currently undergoing U.S. FDA approval processes, and Castleloc, the first domestic height-adjustable cervical cage, is also a key product. The new spinal implant, PathLoc Lumbar Plate System, has received U.S. FDA marketing approval, expanding its product range in North America.For cervical products, BluEX-C and Castleloc P 2.0 are currently undergoing U.S. FDA approval processes, and Castleloc, the first domestic height-adjustable cervical cage, is also a key product. The new spinal implant, PathLoc Lumbar Plate System, has received U.S. FDA marketing approval, expanding its product range in North America.
- Pectus, an implant for pectus excavatum, provides specialized solutions for the treatment of this condition. This product has obtained U.S. FDA and Thailand FDA approvals, accelerating its global market entry.Pectus, an implant for pectus excavatum, provides specialized solutions for the treatment of this condition. This product has obtained U.S. FDA and Thailand FDA approvals, accelerating its global market entry.
- The company holds patents for various spinal fixation implants, including anterior cervical plates and lumbar plates. Efforts are underway to accelerate the XTP-project for the development of proprietary surgical instruments.The company holds patents for various spinal fixation implants, including anterior cervical plates and lumbar plates. Efforts are underway to accelerate the XTP-project for the development of proprietary surgical instruments.
- Core Advantages
- Possession of original patented technology in height-adjustable spinal implants is a core competitive advantage. This includes innovative technological capabilities such as the development of the world's first height-adjustable ATP curved cage.Possession of original patented technology in height-adjustable spinal implants is a core competitive advantage. This includes innovative technological capabilities such as the development of the world's first height-adjustable ATP curved cage.
- Technological superiority in establishing the second full lineup of height-adjustable cage products globally, following the world's leading company. Completion of a diverse product portfolio applicable to various surgical methods.Technological superiority in establishing the second full lineup of height-adjustable cage products globally, following the world's leading company. Completion of a diverse product portfolio applicable to various surgical methods.
- Precise implant design technology allowing for optimal adjustment of height, angle, and length tailored to each patient's spinal environment. High stability and clinical reliability, with no reported malfunctions or complications in over 4,000 PathLoc-TM surgeries in the U.S.Precise implant design technology allowing for optimal adjustment of height, angle, and length tailored to each patient's spinal environment. High stability and clinical reliability, with no reported malfunctions or complications in over 4,000 PathLoc-TM surgeries in the U.S.
- Capability to obtain and process stringent regulatory approvals from major developed and emerging markets, including U.S. FDA, Brazilian ANVISA, and Thailand FDA. This serves as a strong foundation for global market expansion.Capability to obtain and process stringent regulatory approvals from major developed and emerging markets, including U.S. FDA, Brazilian ANVISA, and Thailand FDA. This serves as a strong foundation for global market expansion.
- Efforts to secure a stable global supply chain through partnerships with major global medical device companies and the establishment of dedicated production lines. Aiming to achieve a production capacity of 200 billion KRW annually, doubling the existing capacity.Efforts to secure a stable global supply chain through partnerships with major global medical device companies and the establishment of dedicated production lines. Aiming to achieve a production capacity of 200 billion KRW annually, doubling the existing capacity.
- Plans to maximize the efficiency of medical professional training, sales, and marketing activities through the establishment of an AI-based digital platform. This contributes to strengthening market responsiveness and expanding customer engagement.Plans to maximize the efficiency of medical professional training, sales, and marketing activities through the establishment of an AI-based digital platform. This contributes to strengthening market responsiveness and expanding customer engagement.
- Aggressive market entry strategies into key global markets, including the U.S., Asia (Vietnam, Indonesia, Thailand, Taiwan, Hong Kong, Japan), Latin America (Brazil, Mexico, Chile), and Europe (UK).Aggressive market entry strategies into key global markets, including the U.S., Asia (Vietnam, Indonesia, Thailand, Taiwan, Hong Kong, Japan), Latin America (Brazil, Mexico, Chile), and Europe (UK).
- Target Industries
- Spinal disorder treatment in orthopedicsSpinal disorder treatment in orthopedics
- Spinal surgery in neurosurgerySpinal surgery in neurosurgery
- Pectus excavatum correction surgery in thoracic surgeryPectus excavatum correction surgery in thoracic surgery
- General medical device manufacturing and sales industryGeneral medical device manufacturing and sales industry
- Major Markets
- Vietnam, Indonesia, Thailand, Taiwan, Hong Kong, JapanVietnam, Indonesia, Thailand, Taiwan, Hong Kong, Japan
- United KingdomUnited Kingdom
- United StatesUnited States
- Brazil, Mexico, ChileBrazil, Mexico, Chile
- Certifications/Patents
- Acquisition of original patent for height-adjustable interbody fusion devicesAcquisition of original patent for height-adjustable interbody fusion devices
- Acquisition of cervical cage design patent (XCI product) and domestic patent for height-adjustable spinal fusion cagesAcquisition of cervical cage design patent (XCI product) and domestic patent for height-adjustable spinal fusion cages
- Possession of U.S. patent for anterior cervical plates and lumbar plate patentsPossession of U.S. patent for anterior cervical plates and lumbar plate patents
- Possession of the world's first curved shape and technology patent for ExcelFix-XTP productPossession of the world's first curved shape and technology patent for ExcelFix-XTP product
- Obtained marketing approval from the U.S. Food and Drug Administration (FDA) for products such as PathLoc-TM, BluEx-TM, Pectus, and PathLoc Lumbar Plate SystemObtained marketing approval from the U.S. Food and Drug Administration (FDA) for products such as PathLoc-TM, BluEx-TM, Pectus, and PathLoc Lumbar Plate System
- Completion of on-site inspection for Medical Device Good Manufacturing Practice (GMP) facilities by the Brazilian Health Regulatory Agency (ANVISA)Completion of on-site inspection for Medical Device Good Manufacturing Practice (GMP) facilities by the Brazilian Health Regulatory Agency (ANVISA)
- Obtained product approval for Pectus (pectus excavatum implant) from the Thailand Food and Drug Administration (FDA)Obtained product approval for Pectus (pectus excavatum implant) from the Thailand Food and Drug Administration (FDA)
- Acquisition of Venture Company Certification (valid from December 2025 to December 2028)Acquisition of Venture Company Certification (valid from December 2025 to December 2028)
- Chairman Kang Guk-jin awarded the Science and Technology Grand Prize in 2022Chairman Kang Guk-jin awarded the Science and Technology Grand Prize in 2022
- Received a plaque of appreciation as the Best Partner for Technology Commercialization from Seoul National University Bundang Hospital in 2024Received a plaque of appreciation as the Best Partner for Technology Commercialization from Seoul National University Bundang Hospital in 2024
- Awarded the Medical Sector Corporate Award at the 2021 Korea Global Crown Awards and the 2020 Korea Global Brand AwardsAwarded the Medical Sector Corporate Award at the 2021 Korea Global Crown Awards and the 2020 Korea Global Brand Awards
Introduction
Location
16-25 Dongbaekjungang-ro 16beon-gil, Giheung-gu, Yongin-si, Gyeonggi-do, South Korea
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