Seoul National University Hospital

SEOUL, South Korea, Sept. 18, 2023 /PRNewswire/ -- VUNO Inc., South Korean medical AI company announced that its AI-based cardiac arrest risk management system, VUNO Med®-DeepCARS™, has proven its clinical validity for the first time through a prospective study utilizing Real World Data(RWD). VUNO announced that the multicenter clinical study paper, which confirms the clinical validity of VUNO Med®-DeepCARS™ through its initial prospective research, has been published in "Critical Care," a leading international journal in intensive care medicine. Continue Reading VUNO Med®-DeepCARS™ is a medical AI device that analyzes four vital signs: respiratory rate, body temperature, blood pressure, and heart rate to predict cardiac arrest within 24 hours in general ward patients. It's Korea's first cardiac arrest prediction AI medical device and is recognized as a breakthrough device by the Korean Ministry of Food and Drug Safety(MFDS). In the study published in Critical Care, the VUNO research team conducted a multicenter study using patient data from general wards at four tertiary medical institutions: Seoul National University Hospital, Bundang Seoul National University Hospital, Inha University Hospital, and Dong-A University Hospital, each with varying sizes, locations, and medical environments. A total of 55,083 patients admitted to general wards in all participating institutions over three months, comparing the in-hospital cardiac arrest (IHCA) prediction accuracy, unexpected intensive care unit transfer (UIT) prediction accuracy, and false alarm rate of VUNO Med®-DeepCARS™ with existing high-risk patient prediction systems like NEWS (National Early Warning Score). The study found that the predictive performance of VUNO Med®-DeepCARS™ had an AUROC score of 0.869, outperforming traditional methods (NEWS 0.767, MEWS 0.756). The number of alarms per 1,000 beds was more than halved compared to the same sensitivity level, proving higher trustworthiness in the alarms leading to actual medical interventions. Furthermore, its effectiveness was apparent across varying patient ages, genders, and times of occurrence. In this study, VUNO Med®-DeepCARS™ displayed exceptional predictive abilities and adaptability in identifying high-risk patients, even in its first prospective research. It consistently performed at the same level as in previous retrospective studies published in renowned international journals. Yeha Lee, CEO of VUNO said, "The significance of this research lies in its successful execution of the first multicenter prospective study with many variables and challenges, thereby reaffirming the consistent predictive performance and versatility of VUNO Med®-DeepCARS™" and he said, adding "We will continue to enhance the product's credibility in clinical settings by conducting additional prospective research. We are committed to introducing it to more medical settings as essential care to ensure patient safety." SOURCE VUNO Inc.

SEOUL, South Korea, Aug. 14, 2023 /PRNewswire/ -- ROKIT HEALTHCARE, a pioneering biotech firm specializing in advanced organ regeneration, proudly announces a significant milestone. In July 2023, the company obtained the coveted certification under the European Medical Device Regulation (CEMDR) for its revolutionary "Dr. Invivo AI Regen Platform." This certification underscores ROKIT's commitment to advancing medical technology and patient care. Continue Reading ROKIT_HEALTHCARE_Inc_Photos_attached_to_press_releases_20230809 The "Dr. Invivo AI Regen Platform" marks a leap in organ regeneration and medical device innovation, fusing artificial intelligence (AI) with bioprinting. This groundbreaking approach delivers exceptional outcomes without immune responses in a short timeframe, revolutionizing organ regeneration. Central to the platform is cutting-edge AI technology identifying affected areas, translating data into bioprinting code files. Using the patient's own fat tissues, the kit generates a specialized regeneration-patch for transplantation. This treatment targets chronic wounds like diabetic foot ulcers (DFU), redefining skin regeneration. Dedication to diabetes foot treatment led to trials across nations, backed by recognized SCI-level journal publications. With approvals from global medical authorities, including the U.S. FDA and the South Korean Ministry of Food and Drug Safety (MFDS), the "Dr. Invivo AI Regen Platform" gained worldwide recognition. Exported to 10 countries, including the U.S., recent CEMDR certification paves the way for ROKIT HEALTHCARE's expansion into advanced markets. CEMDR's significance lies in stringent standards for medical device sales in Europe, replacing the European Medical Device Directive (MDDCE). Certified devices can be marketed in 31 countries, including the European Economic Community (EEA) and European Union (EU). Europe leads regenerative medicine with 10% annual growth. SeokHwan You, CEO of ROKIT HEALTHCARE, states, "This certification propels us globally, extending advanced medical solutions." A regenerative medicine leader, the company advances AI-driven regenerative medicine and bioprinting. Established in 2012, ROKIT HEALTHCARE, a Born2Global Centre member, pioneers AI and bioprinting-based regenerative medicine. Collaborating with Seoul National University Hospital (SNUH) and Asan Hospital, it addresses chronic renal failure. Photo - SOURCE ROKIT Healthcare

SEOUL, South Korea--(BUSINESS WIRE)-- Lemonex Inc., a biotechnology company developing innovative messenger RNA (mRNA) and siRNA therapeutics based on a novel nanoparticle drug delivery system announced on the 9th of August that an Investigational New Drug (IND) application has been approved by the Ministry of Food and Drug Safety (MFDS) for mRNA vaccine LEM-mR203 with its nano-drug delivery technology, DegradaBALL® on 21st of July. This press release features multimedia. View the full release here: Figure 1. "100 days mission for next pandermic" using DegradaBALL DDS platform technology. DegradaBALL can be stored for more than 2 years at room temperature, and drug products can be prepared by simple mixing with APIs right before administration. It is possible to quickly respond to the next pandemic through pre-production, stock storage, and priority supply of DegradaBALL. (Provided by Lemonex) LEM-mR203 is the first mRNA vaccine candidate to which Lemonex's proprietary drug delivery platform technology, DegradaBALL (DegradaBALL-mRNA system), is applied. This clinical trial is for Covid-19, and safety and immunogenicity will be evaluated in healthy adults at Seoul National University Hospital, Korea. In terms of timely and effective pandemic response, mRNA vaccines have an advantage over antigen protein vaccines because they can be developed more rapidly. However, effective delivery of mRNA in the body requires drug delivery technology. The LNP that is currently applied to existing mRNA vaccines has shown limitations, such as safety concerns including anaphylaxis, myocarditis, and pericarditis, as well as the need for an ultra-low-temperature cold chain. Therefore, there is a need for next-generation drug delivery technology. The drug delivery technology of DegradaBALL developed by Lemonex may address these issues, suggesting a more advanced DDS technology for mRNA vaccines and therapeutics. An official from Lemonex said, “LEM-mR203 is an advanced mRNA vaccine candidate harnessing DegradaBALL technology that can complement the limitations of LNP.” “We confirmed the safety and tolerability of DegradaBALL in healthy adults by successfully finishing the phase 1 clinical trial of LEM-S401 (siRNA therapy with DegradaBALL, DegradaBALL-siRNA system). IND approval of LEM-mR203 phase I clinical trial once again proved the value of the DegradaBALL technology for mRNA vaccine that improved and supplemented the limitations of LNP.” Another official from the company said, “mRNA vaccines and therapies will be playing an increasingly important role. However, current mRNA vaccines employing LNP pose challenges when it comes to storage, packaging, and transportation due to their formulation instability. In addition, the complicated mRNA encapsulation process should be performed immediately after mRNA synthesis in a dedicated facility, which requires further improvement for better encapsulation efficiency.” “However, unlike LNP, DegradaBALL can be pre-produced even before mRNA synthesis and stored in stock at room temperature. DegradaBALL can stabilize mRNA formulation, extend the shelf-life of the final formulation, reduce the risk of mRNA damage, and eliminate the necessity of ultra-cold chain for mRNA vaccine supply. Currently, Lemonex is developing various competitive new drug candidates based on the DegradaBALL drug delivery platform. siRNA gene therapy LEM-S401: Successfully completed the phase 1 clinical trial in healthy human, Dual-acting RNA immuno-oncology drug LEM-S403: Production of clinical samples for clinical entry after completion of the GLP-tox studies, cytokine IL-2 therapy BALLkine-2: Completed preclinical PoC. In addition, Lemonex is strengthening its global network by signing MOUs with the International Vaccine Institute (IVI) and the mRNA vaccine technology transfer hub, the initiative supported by WHO. In addition, Lemonex presented its DegradaBALL platform technology at the 2018 mRNA Health Conference and received an invitation to the Global Vaccine Immune Research Forum (GVIRF) hosted by the WHO, NIH, and the Bill Melinda Gates Foundation this year. Currently, the company is preparing for an IPO to list on the KOSDAQ market and seeking pre-IPO fundraising.