Brightonix Imaging, which succeeded in commercializing a domestically made PET scanner dedicated to the brain, will develop next-generation whole-body digital PET (positron emission tomography) and PET-CT with government support.
Following the successful commercialization of the brain-dedicated PET scanner and AI imaging analysis software, the company is expanding into diagnosis of cancer, cardiovascular disease and neurological disorders. Rather than simply competing on performance with overseas corporations that dominate the global medical imaging market, the company's strategy is to combine artificial intelligence (AI) and next-generation imaging technology to secure both diagnostic performance and price competitiveness.
Lee Jae-sung, CEO of Brightonix Imaging and a professor in the Department of Nuclear Medicine at Seoul National University Hospital, said, "It is difficult for a latecomer to secure competitiveness by simply following the existing market," and noted, "We are approaching this in a way that provides new technology and the values demanded by the medical field."
Brightonix Imaging Inc. was founded in 2016 as a medical imaging specialist with support from the Seoul National University Holdings. It develops PET scanners and AI-based imaging analysis software in-house, and has commercialized the brain-dedicated PET scanner "PHAROS" and the PET imaging AI analysis software "BTX Brain." During the PHAROS development process, it also accumulated experience with U.S. Food and Drug Administration (FDA) approval.
The company was recently selected as the lead institution for a flagship project under the pan-ministerial advanced medical device research and development program jointly promoted by the Ministry of Science and ICT, the Ministry of Trade, Industry and Energy, the Ministry of Health and Welfare and the Ministery of Food and Drug Safety. Accordingly, over the next seven years it will develop next-generation whole-body digital PET and PET-CT systems with government support.
Lee said, "Being chosen for this flagship project is a great honor for Brightonix Imaging and also a heavy responsibility," adding, "It is significant in that our PET scanner and imaging analysis technologies, which we have built up over time, have been recognized in a program to foster national strategic technologies."
He added, "Beyond the achievements of a single company, we place great meaning on gaining the opportunity to enhance Korea's competitiveness in medical imaging technology and provide patients with a better diagnostic environment."
PET is a core medical imaging modality that uses radiopharmaceuticals to diagnose cancer, dementia, Parkinson's disease and cardiovascular disease. But the global market is currently led by a handful of multinational corporations, including GE HealthCare, Siemens Healthineers and Philips. Although the latest digital PET scanners deliver excellent performance, they are considered a heavy burden for medical institutions to adopt due to their high prices.
Through this project, Brightonix Imaging plans to develop a next-generation PET platform that combines Cherenkov time of flight (TOF) technology with AI-based image processing. Cherenkov TOF is a technology that improves resolution by enhancing the precision of time measurements in PET imaging. The company aims to achieve image performance on par with high-priced premium systems while lowering system expense to secure price competitiveness.
Lee explained, "The goal of this project is to develop next-generation whole-body digital PET and PET-CT systems that have both high diagnostic performance and price competitiveness," adding, "By leveraging Cherenkov TOF technology and AI-based image processing, we intend to secure performance that can compete with premium systems while reducing system expense."
As a strength compared with global competitors, the company cited its experience developing hardware and software together.
Lee said, "There are leading corporations in the global market with long-standing experience and technological prowess," adding, "Rather than competing at the same scale as these players, Brightonix Imaging intends to leverage the strengths of a research and development-centered company that can respond more quickly to new technologies and clinical needs."
He added, "Based on our experience developing both hardware and software, we expect to provide solutions that reflect the real needs of the medical field."
AI is also a core pillar of this development. The company has already developed BTX Brain, PET imaging quantitative analysis software, and supplies it to domestic medical institutions.
Lee said, "In next-generation PET, AI is not an optional technology but a key element for improving image quality, advancing quantitative analysis and enhancing data processing and analysis workflows," adding, "We plan to design and develop AI not as a simple add-on, but so it can be safely integrated across the entire medical device system."
He predicted that once next-generation digital PET is commercialized, changes will appear for patients and in the medical field.
Lee said, "The foundation to evaluate diseases earlier and more accurately will be strengthened," adding, "If improvements in digital PET performance are accompanied by better exam efficiency and expense structures, access to high-performance PET exams will expand, allowing patients to have more opportunities for testing and to reduce their burdens."
Seoul National University Hospital, Sogang University and KAIST will participate in this research and development as joint research institutions. Seoul National University Hospital will contribute to deriving clinical requirements, verifying system performance and developing AI technology, while Sogang University and KAIST will be responsible for detector and signal processing technology development.
Lee explained, "A PET system is a complex medical device that must combine detectors, electronic circuits, software and clinical validation," adding, "Rather than having a specific institution take sole charge of individual technologies, we plan to build an organic cooperative structure in which industry, academia and hospitals think through and solve the complex technical challenges that arise during development together."
The company is also fleshing out its commercialization and global expansion strategy.
Lee said, "Because we gained experience with U.S. FDA approval during the PHAROS development process, we plan to pursue this project by considering quality control and global regulatory requirements from the research and development stage," adding, "We will first prove the product's value in the domestic market, then proceed step by step into major markets such as the United States and Europe." He added, "We are also actively seeking opportunities to collaborate with overseas corporations and medical institutions."
Using this project as a springboard, Brightonix Imaging also laid out a blueprint to leap from a PET equipment company to a molecular imaging platform company.
Lee said, "We aim to grow into a company that makes a practical contribution to patient diagnosis and treatment through molecular imaging technology," adding, "We plan to strengthen our research and development capabilities not only in whole-body digital PET, but also in AI-based image analysis, quantitative imaging and theranostics." He emphasized, "We will continue to take on challenges so that technology developed domestically can be used in the global medical field."