Johnson & Johnson (J&J) MedTech announced on 6 February that it has entered into an exclusive distribution and promotion agreement for SigiBio-SigiMedTech’s Novocis. Under the agreement, J&J MedTech will be the exclusive distributor of NovoSys in South Korea, Taiwan, Thailand, India, Hong Kong and Macau SAR. In South Korea, J&J MedTech will only distribute NovoSys Trauma for the treatment of traumatic fractures. As a bone substitute, NovoSys is mainly used for acute traumatic upper and lower extremity fractures and spinal fusion surgery with implants. It is a recombinant bone morphogenetic protein (rhBMP-2) product combined with hydroxyapatite ceramic. The hydroxyapatite ceramic acts as a scaffold to promote bone formation and allows the ceramic carrier to be released gradually. Novocis has been used as a bone graft material in more than 100,000 surgeries worldwide.
The Ministry of Food and Drug Safety announced that it will hold a meeting of the international standardization working group for 'Medical Devices and Catheter Delivery Systems' (ISO/TC 84) at the Atrium Hotel in Seoul from the 10th to 14th of this month. This meeting is being conducted by the Korea Medical Devices Safety Information Center in its capacity as the domestic standard development cooperation agency for ISO/TC 84, aimed at accelerating the registration of domestic development standards into international standards for medical device standards development and revision by the International Organization for Standardization (ISO). Experts from 15 countries, including the United States, Denmark, and Germany, will participate in the meeting, which will discuss three standard revision topics, including disposable sterile urethral catheters, aseptic drainage catheter auxiliary devices, and stainless steel needles for medical device manufacturing.
CAREGEN announced on the 6th that its self-developed synthetic peptide raw material 'Myoki' has received new dietary ingredient (NDI) approval from the U.S. Food and Drug Administration (FDA). Myoki is the first peptide in the world to demonstrate functionality for the prevention and treatment of muscle wasting. It works by inhibiting the function of myostatin, a muscle growth inhibitor, promoting muscle production and delaying muscle degeneration. CAREGEN proved the efficacy and safety of Myoki in a clinical trial involving 80 patients with muscle wasting in 2024. The company reported that participants who took Myoki for 12 weeks experienced a 2.52% increase in muscle mass in their arms and legs and a 2.56% increase in lean body mass.
Xcell Therapeutics announced on the 6th that it has simultaneously obtained both 'ISO 9001' and 'ISO 13485' certifications from the International Organization for Standardization (ISO), the world's largest standards organization. The company explained that it received official recognition for its global GMP-level capabilities in the development and production of cell culture media, becoming the first in South Korea to obtain ISO certification for serum-free chemical composition culture media. ISO 9001 is an international standard concerning quality management systems established by the ISO. ISO 13485 meets rigorous international regulatory requirements applicable to medical devices and related services and guarantees quality. The company noted that this certification recognizes the quality management system for the development, manufacturing, and quality management of its cell culture media 'CellCor.'
Genolution announced on the 6th that it has participated in 'Medlab Middle East 2025 (MEDLAB 2025)' in Dubai, United Arab Emirates. MEDLAB 2025 is the world's largest exhibition for diagnostics and medical devices, with more than 800 corporations participating. At this event, Genolution showcased an innovative automation solution for NGS (Next Generation Sequencing) testing in collaboration with NGeneBio. Genolution plans to introduce the Geno-N, a library preparation automation device optimized for NGeneBio's NGS panel, to global markets including the Middle East.
The Patient-Centered Medical Technology Optimization Research Project at the Korea Health and Medical Research Institute announced on the 6th that it established the 'Patient-Centered Medical Technology Optimization Research Project Clinical Research Data Repository (PACEN)' in January and has begun public disclosure and distribution of clinical research data. PACEN is a nationally supported public clinical research project aimed at providing scientific evidence for the clinical efficacy and safety of medical technologies and supporting policy decisions. The clinical research data includes information collected over five years targeting common representative diseases among Koreans, with follow-up data on approximately 1,135 patients collected from an average of 17.2 medical institutions per project.