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NewsBrightonix Imaging Obtains Medical Device Manufacturing Certification for Korea's First Developed Clinical PET System

Brightonix Imaging Obtains Medical Device Manufacturing Certification for Korea's First Developed Clinical PET System▲ PHAROS     'PHAROS', the first clinical positron emission tomography (PET) system developed by deep-tech startup Brightonix Imaging (Jae Sung Lee, CEO) in Korea, received a medical device manufacturing certificate from the Korea's National Institute of Medical Device Safety Information on February 13th.'PHAROS' is a versatile and multifunctional digital PET system that allows brain imaging in the sitting or supine position and breast imaging in the prone position. It can be installed and operated in a smaller space compared to conventional whole-body PET/CT. Brain PET scans are expected to play a major role in the early detection and treatment of brain diseases, especially as the incidence of degenerative brain diseases is increasing due to the aging population, and the U.S. FDA's accelerated approval of Biogen's Leqembi and Eli Lilly's successful Phase III clinical trial of Donanemab. 'PHAROS' has been developed with close support from Korea Medical Device Development Fund, where streamlined the entire process from product development to regulatory approval. Recognized for its forward-looking feaures and high potential for future advancements in the medical device field, it has garnered significant attention from both the market and the industry, earning recognition as one of the top 10 representative achievements by the KMDF team.  Brightonix Imaging's CEO, Jae Sung Lee, expressed significant meaning in obtaining the medical device manufacturing certification for the 'PHAROS' system. He emphasized that this achievement, marking the first domestically produced clinical PET system to receive medical device manufacturing certification, is the result of the dedicated efforts of many researchers working towards the localization of PET systems, along with continuous support from the government. Lee stated, "This milestone holds great significance, as it signifies the culmination of valuable efforts. Moving forward, we aim not only to penetrate the domestic market but also to showcase the excellence of domestically produced medical devices on the global stage through FDA/CE certifications." In addition, Dr. Guen Bae Ko, CTO of Brightonix Imaging explained, "'PHAROS' has achieved a revolutionary improvement in the spatial resolution uniformity of PET images by precisely measuring gamma-ray reaction depth information within the scintillation crystal, a feature not provided by conventional whole-body PET/CT systems. With a specialized design for local organs such as the brain, it will minimize patient radiation exposure, enabling more efficient and accurate diagnoses."<저작권자 ⓒ 약품신문 무단전재 및 재배포 금지>출처: 브라이토닉스이미징, 국내 최초 개발 임상용 PET 시스템 의료기기 제조인증 획득:약품신문 - https://www.yakpum.co.kr/12853

PaperCerenkov luminescence imaging of interscapular brown adipose tissue using a TSPO-targeting PET probe in the UCP1 ThermoMouse

Rationale: [18F]fluorodeoxyglucose-positron emission tomography ([18F]FDG-PET) has been widely used as an imaging technique to measure interscapular brown adipose tissue (iBAT) activity. However, it is challenging to obtain iBAT-specific images using [18F]FDG-PET because increased uptake of [18F]FDG is observed in tumors, muscle, and inflamed tissues. Uncoupling protein 1 (UCP1) in the mitochondrial membrane, a well-known molecular marker of BAT, has been proposed as a useful BAT imaging marker. Recently, the UCP1 ThermoMouse was developed as a reporter mouse for monitoring UCP1 expression and investigating BAT activation. In addition, Translocator protein-18 kDa (TSPO) located in the outer mitochondrial membrane is also overexpressed in BAT, suggesting that TSPO-targeting PET has potential for iBAT imaging. However, there are no studies monitoring BAT using TSPO-targeting PET probes in the UCP1 ThermoMouse. Moreover, the non-invasive Cerenkov luminescence imaging (CLI) using Cerenkov radiation from the PET probe has been proposed as an alternative option for PET as it is less expensive and user-friendly. Therefore, we selected [18F]fm-PBR28-d2 as a TSPO-targeting PET probe for iBAT imaging to evaluate the usefulness of CLI in the UCP1 ThermoMouse.Methods: UCP1 ThermoMouse was used to monitor UCP1 expression. Western blotting and immunohistochemistry were performed to measure the level of protein expression. [18F]fm-PBR28-d2 and [18F]FDG were used as radioactive probes for iBAT imaging. PET images were acquired with SimPET, and optical images were acquired with IVIS 100.Results: UCP1 ThermoMouse showed that UCP1 and TSPO expressions were correlated in iBAT. In both PET and CLI, the TSPO-targeting probe [18F]fm-PBR28-d2 was superior to [18F]FDG for acquiring iBAT images. The high molar activity of the probe was essential for CLI and PET imaging. We tested the feasibility of TSPO-targeting probe under cold exposure by imaging with TSPO-PET/CLI. Both signals of iBAT were clearly increased after cold stimulation. Under prolonged isoflurane anesthesia, TSPO-targeting images showed higher signals from iBAT in the short-term than in long-term groups.Conclusion: We demonstrated that TSPO-PET/CLI reflected UCP1 expression in iBAT imaging better than [18F]FDG-PET/CLI under the various conditions. Considering convenience and cost, TSPO-CLI could be used as an alternative TSPO-PET technique for iBAT imaging.Keywords: Interscapular brown adipose tissue, UCP1, TSPO, PET, Cerenkov luminescence imagingLink: Cerenkov luminescence imaging of interscapular brown adipose tissue using a TSPO-targeting PET probe in the UCP1 ThermoMouse - PMC (nih.gov)

NewsDr. Jae Sung Lee, CEO of Brightonix Imaging delivers a Plenary Talk at IEEE NSS/MIC/RTSD

Dr. Jae Sung Lee, CEO of Brightonix Imaging delivers a Plenary Talk at IEEE NSS/MIC/RTSDAdvancements in digital PET and artificial intelligence and promising technologies for the futureBrightonix Imaging, a medical imaging company, announced that Dr. Jae Sung Lee, CEO of Brightonix Imaging and Professor of Nuclear Medicine at Seoul National University, delivered a plenary talk at the Institute of Electrical and Electronics Engineers' Nuclear Science, Medical Imaging, and Room Temperature Semiconductor Detector Conference (IEEE NSS/MIC/RTSD) in Vancouver, Canada last week. At the plenary session held on the 6th of this month, Lee delivered a lecture on the development history and recent trends of digital positron emission tomography (PET) and artificial intelligence technologies that have revolutionised the field of nuclear medicine molecular imaging, highlighting the significant impact of technological innovation on the development of medical imaging and introducing promising technologies for the future.After receiving the Medical Imaging Technical Achievement Award from the IEEE's Nuclear and Plasma Society (NPSS) last year, which recognises a researcher who has made innovative contributions to the field of medical imaging technology based on their cumulative research achievements and leadership, Lee was invited to deliver the keynote lecture at this year's conference, the largest conference organised by the NPSS. Lee was also invited to speak at the 'Ultra-Low Dose PET Workshop' on the 11th, the last day of the conference, where he introduced the latest artificial intelligence technology for ultra-low dose PET and the core technology of the Pharos system, a high-resolution, multi-purpose PET developed with the support of the Korea Medical Device Development Fund, and is planning a clinical evaluation at Seoul National University Hospital.<Copyright ⓒ 약품신문 무단전재 및 재배포 금지>출처: 브라이토닉스이미징 이재성 대표, 국제전기전자공학회‘기조연설-약품신문 - http://www.yakpum.co.kr/10294

NewsBrightonix Imaging receives Excellence Award on Pitching & Connect Day held by Seoul Start-up Hub Scale-up Center

Brightonix Imaging receives Excellence Award on Pitching & Connect Day held by Seoul Start-up Hub Scale-up Center Brightonix Imaging Inc. (led by Jae Sung Lee, CEO), a deep-tech medical imaging specialist, was awarded the Excellence Award at the Seoul Startup Hub Scale-up Pitching & Connect Day event organized by the Seoul Business Agency (SBA) and Hana Ventures.  The event took place on July 6th at the eoul Startup Hub Scale-up Center, located in the Korea Science and Technology Center in Gangnam-gu, Seoul. Among the 140 companies that Hana Ventures has invested in over the past five years, eight outstanding portfolio companies were pre-selected through screening to participate in the IR pitching session. Among them, four outstanding companies were selected and awarded.  Brightonix Imaging was recognized for commercializing positron emission tomography (PET) for the first time in Korea, starting with the supply to the U.S. National Institutes of Health (NIH) and generating overseas exports, and for the excellent performance of the Pharos PET system, which is being developed to respond to the demand for PET testing for Alzheimer's disease, which is expected to increase rapidly in the future.In addition, BTXBrain, an artificial intelligence (AI)-based brain PET/SPECT image analysis software that secured an unparalleled sales advantage within six months of domestic medical device approval, was also recognized for supplying it to leading medical institutions such as Seoul National University Hospital and Seoul St. Mary's Hospital in collaboration with GE and Siemens. "By next year, we will complete the licensing of the Pharos PET system and BTXBrain medical devices in Korea, the U.S., and Europe," said Jae Sung Lee, CEO of Brightonix Imaging. "Brightonix Imaging will show that Korea's advanced medical device technology can work in the ultra-high-end medical imaging market." <저작권자 ⓒ 약품신문 무단전재 및 재배포 금지>출처: 브라이토닉스이미징, 서울창업허브 스케일업 피칭&커넥트데이 우수상 수상-약품신문 - http://www.yakpum.co.kr/6703

NewsAdvanced brain imaging technology of Brightonix Imaging gains a focus at SNMMI 2023 meeting

Advanced brain imaging technology of Brightonix Imaging gains a focus at SNMMI 2023 meetingBrightonix Imaging (led by Jae Sung Lee, CEO) showcased advanced brain imaging technology and its related products at the Society of Nuclear Medicine and Molecular Imaging (SNMMI) conference held at McCormick Place in Chicago, USA, from June 24th for four days. This SNMMI conference, the first to be held in the US since the onset of the COVID-19 pandemic, had approximately 8,000 oneline and offline attendees who are nuclear medicine and molecular imaging experts and industry professionals. With the support of the Korea Medical Device Development Fund, the Pharos PET system, which is currently under clearance of domestic and international medical device approvals, and BTXBrain, which gained domestic medical device approval at the end of last year and has established a dominant market position in the field of AI-based brain PET image analysis software, drew significant attention from SNMMI participants from various countries. This can be interpreted as a response to the recent FDA approval of Biogen's Leqanemab (Leqambi), a novel anti-amyloid therapy for Alzheimer's disease, and the successful outcome of Eli Lilly's phase III clinical trial of Donanemab, leading to a significant expansion of amyloid brain PET tests. It is also related to the increasing demand for PET exams due to the rise in radiotherapy for prostate cancer and neuroendocrine tumors, leading to an increase in waiting times for the exams. Furthermore, Guen Bae Ko, Director of Brightonix Imaging's Research Institute, presented the evaluation results of the PHAROS PET system's performance at oral presentations. This presentation once again drew attention as an innovative technology, highlighted by Professor LJ Meng of the University of Illinois during the summary session in the fields of physics, equipment, and data science. Brightonix Imaging's PHAROS PET system, which won the 2022 Innovation Start-up Award granted by the Ministry of Science and ICT, was also selected as one of the top 10 representative achievements of the Korea Medical Device Development Fund Projects in May.Brightonix Imaging will continue its promotion by having exhibit booths at the Alzheimer's Association International Conference (AAIC 2023) in Amsterdam, Netherlands, from July 16th, and at the European Association of Nuclear Medicine (EANM 2023) in Vienna, Austria, from September 9th. Copyrightⓒ사이언스엠디뉴스 무단 전재 및 재배포 금지

NewsTop 10 promosing technologies leading the medical device industry: Patient-specific dental model, Brain PET, Peripheral microvascular disgnostic d...

Top 10 promosing technologies leading the medical device industry: Patient-specific dental model, Brain PET, Peripheral microvascular disgnostic device... Leading South Korea to a stronghold of medical devicesThe government has announced the top 10 key technologies aimed at propelling South Korea to become the 5th largest exporter of medical devices, with an estimated medical device export value of approximately 21 trillion won by 2027. The selection includes groundbreaking medical devices that are expected to be developed for the first time globally, as well as initiatives focused on domesticating imported medical devices, addressing public health and social issues. The government plans to continuously foster future growth opportunities by unveiling 10 representative projects each year.On the 23rd, the Medical Device Research and Development Project Group held the "2023 Performance Report Conference" at The Westin Chosun Seoul hotel, where they announced the top 10 representative projects. This performance report conference, which was jointly sponsored by the Ministry of Science and ICT, the Ministry of Trade, Industry and Energy, the Ministry of Health and Welfare, and the Ministry of Food and Drug Safety, marked its first occurrence since the establishment of the task force.Kim Beob-min, the head of the task force, explained, "Since its establishment, we have built a support system as a platform to enhance the success rate of medical device research and development (R&D) and generate excellent results by providing support for various research projects. We will actively communicate with researchers and promote the commercialization of medical devices." He added, "The leading projects selected each year may involve technologies that have been previously selected, as well as new technologies."The selected representative projects are expected to play a pivotal role in achieving the government's goal of becoming the 5th largest exporter of medical devices, which was set by Yoon Seok Yeol government. In February of this year, the government announced plans to expand the medical device export value from approximately 8.6 billion dollars in 2021 to 16 billion dollars by 2027, positioning South Korea as a leading exporter in the field.The 10 projects announced include promising fields such as medical imaging diagnosis, in vitro diagnostics, dental technology, and digital health. Among them, three projects are anticipated to win the world's first title. Director Kim stated, "We selected these projects based on evaluations considering the appropriateness of research and development execution, technological and medical aspects, as well as the socio-economic ripple effects, out of a total of 869 achievements submitted by 90 organizations."The followings are the top 10 medical device projects, the institutions involved, and their development status that have been underway since 2020. [omitted]Development of Brain PET System and Integrated Molecular Imaging Platform to Overcome Neurodegenerative Brain DiseasesBrightonix Imaging aims to domestically produce medical device by developing brain PET system targeting neurodegenerative diseases such as dementia and Parkinson's disease. Currently, for the diagnosis of neurodegenerative diseases in the elderly, the combination of computed tomograhy (CT) or magnetic resonance imaging (MRI) is essential. However, this technology visualizes functional changes in the brain using PET only for disease diagnosis. Brightonix Imaging received the Korean Innovation Sartup Award by the Minister of Science and ICT. The project runs from September 1, 2020, to December 31, 2025, with government funding of 11.66 billion won. [Omitted] <Copyright holder ⓒ Prohibition of unauthorized reproduction and redistribution of Chosun Biz Newspapers>Source: 환자 맞춤형 치과모델·뇌전용PET·말초 미세혈관 진단기기...의료기기 강국 이끌 10대 유망 기술 - 조선비즈 (chosun.com)