[Press Release] Healthcare Target ③ Successfully Localizes Stem Cell Extraction Device “Smart Mcell 2”

[Healthcare Target] ③ Successful Localization of Stem Cell Extraction Device “Smart Mcell 2” Miracell Wins the Ministry of Food and Drug Safety Commissioner’s Award (Innovative Medical Sector)Smart Mcell 2, World-Leading Cell Viability and Recovery RatesAlso Selected as a National Innovative Company By Kim Young-hwan [Edaily Reporter Kim Young-hwan] Stem cell specialist Miracell Co., Ltd. received the Minister of Food and Drug Safety Award (Innovative Medical Category) at the Edaily Global Healthcare Awards. This recognition recognizes the company’s technological achievements in researching and developing cell extraction systems to establish stem cell treatments in Korea. Miracell successfully developed and domestically produced the “Smart M-Cell 2” stem cell extraction equipment and kit, which boast world-leading cell viability and recovery rates. Smart M-Cell 2 is a cutting-edge “bone marrow and blood stem cell manufacturing” system that extracts hematopoietic stem cells (CD34+) from blood and mesenchymal stem cells from bone marrow using biological drug manufacturing technology. According to experimental results from Seoul National University Bundang Hospital, Smart M-Cell 2 demonstrated cell counts and viability rates comparable to or exceeding those of the world’s leading product, SmartPrep from the United States. Approximately 2.9 billion cells can be separated and extracted in one session, achieving a cell viability rate of 80-98%. Another notable feature is its closed system, which prevents air contact and prevents cell deformation. Smart Mcell 2 is currently used in major hospitals in Korea. In May, Miracell was selected as a “National Representative Innovative Company” by the government. The National Representative Innovative Company program evaluates promising companies possessing patents and core technologies in various fields and selects companies that will lead innovation-driven growth industries. In February, Miracell also received NET (No. 179) certification from the Ministry of Health and Welfare for its “Bone Marrow Blood Stem Cell Extraction Device Including a Centrifuge for Selective Separation.”

K-Healthcare Shines Amid COVID-19: “Hopefully This Will Be an Opportunity to Take It to the Next Level”

K-Healthcare Shines Amid COVID-19: “Hopefully This Will Be an Opportunity to Take It to the Next Level” The Edaily Global Healthcare Awards Ceremony was held on the 19th. Miracell Co., Ltd. and Rainbow & Nature Korea received the MFDS Minister of Food and Drug Safety Award. [Edaily Reporter Kim Young-hwan] “I hope this will contribute significantly to the development of Korea’s medical and healthcare industries.I also hope this will serve as an opportunity to elevate the level of our country’s medical industry.” Shin Hyun-soon, CEO of Miracell Co., Ltd. (left), poses for a commemorative photo after receiving the Minister of Food and Drug Safety Award in the Innovative Medical Device category at the 8th Edaily Global Healthcare Awards held at the KG Harmony Hall in the KG Tower in Jung-gu, Seoul on the afternoon of the 19th. (Photo = Reporter Lee Young-hoon) At the 8th Edaily Global Healthcare Awards ceremony held at the KG Harmony Hall on the first basement level of the KG Tower in Jung-gu, Seoul on the 19th, the chair of the judging panel, Seo Yoo-seong, Vice President of Medical Affairs and Director of Soonchunhyang University Medical Center, explained the significance of the awards ceremony. Ten medical institutions and related companies received awards at the event. The Edaily Global Healthcare Awards, held this year for the 8th time, aims to discover and foster outstanding medical institutions and related companies in the healthcare industry, enhance their global competitiveness, and provide consumers with sound standards for choosing healthcare services.Hosted by Edaily, the event was sponsored by the Ministry of Health and Welfare, the National Assembly Health and Welfare Committee, the Ministry of Food and Drug Safety, and the Korea Medical Devices Industry Association. Stem cell specialist Miracell Co., Ltd. received the Minister of Food and Drug Safety Award in the Innovative Medical Device category in recognition of its successful domestic development and localization of the “SMART M-CELL2” and kit. SMART M-CELL2 is a stem cell extraction device that offers world-class cell viability and recovery rates. In May, Miracell was also selected as a “National Representative Innovative Company” by the government.

Stem Cell Innovation System, SMART M-CELL2

Stem Cell Innovation System, SMART M-CELL2 SMART M-CELL2 is an automatic isolation and extraction system, developed based on scientific patent technology to maximum cell viability and recovery rate. https://youtu.be/Ko7kHvO6ID8 List

Military Personnel Also Receive Stem Cell Therapy

Military personnel also receive stem cell treatment. Miracell’s Stem Cell ExtractorSelected as a “Public Innovation Product” by the Public Procurement ServicePromoting Supply to Military Hospitals and Other Public Healthcare Services The door is now open for ROK military personnel to receive cutting-edge stem cell treatments developed by a domestic company. Stem cell specialist Miracell announced on the 17th that its “Bone Marrow and Blood Stem Cell Extractor” was selected as a candidate for the Public Sector Evaluation of Innovative Products by the Public Procurement Service on the 18th of last month. To improve the quality of public services, the government operates an innovative product designation system that contracts innovative products at the national level and supports them with public institutions. With this designation, Miracell can now supply stem cell extraction devices through private contracts with public institutions. Miracell CEO Shin Hyun-soon (pictured)“This means we can now supply products certified as new health technologies to public hospitals,” he said. “We are currently coordinating with the Armed Forces Hospital under the Armed Forces Medical Command regarding their adoption.” If Miracell’s stem cell extraction device is approved for delivery to military hospitals, soldiers who suffered trauma during training or suffered chronic pain are expected to benefit. CEO Shin emphasized, “Providing stem cell treatment opportunities to soldiers who have unfortunately retired due to lack of treatment benefits or those who have been hospitalized for long periods of time will contribute to national defense and reduce treatment time and costs.” Miracell plans to gradually expand its services beyond military hospitals to public medical institutions in Korea. Consequently, not only military personnel but also police officers and firefighters will be able to benefit from stem cell treatment. Miracell’s “Smart Mcell 2,” a bone marrow and blood stem cell extraction device, is considered a domestically produced alternative to the “Smart Prep” developed by the Harvard University Immunology Institute. This device extracts bone marrow and blood, concentrates them through centrifugation, and automatically separates stem cells to extract large quantities. It is already in use at major hospitals in Korea, including Soonchunhyang University Hospital. Miracell was recently selected as a “National Representative Innovative Company” by nine ministries, including the Ministry of Trade, Industry and Energy. CEO Shin is using this designation as a springboard for aggressive overseas expansion. He plans to establish a production system by installing automated facilities and expanding factories with government financial support. Miracell has already signed Non-Disclosure Agreements (NDAs) with 13 countries and is currently negotiating the details of these agreements. These include countries within the European Union (EU), the Middle East, and Southeast Asia. CEO Shin stated, “Our long-term goal is to export to 40 countries worldwide. We will actively pursue exports, taking advantage of our product’s superior performance and price competitiveness compared to existing US products.” [Reporter Park Yoon-gyun]

[Dong-A Ilbo] Miracell Selected as National Representative for Health and Diagnostic Innovation

Miracell Selected as National Representative for Health and Diagnostic Innovation Independently Developed Stem Cell ExtractorSuccessfully Localized US-Production AlternativeOpening New Paths to Treating Incurable Diseases Stem cell specialist Miracell has been selected as a “National Representative Innovative Company” by the government. Miracell announced on the 8th that it was selected as a National Representative Innovative Company by the Financial Services Commission, based on evaluations by nine government ministries, including the Ministry of Trade, Industry and Energy and the Ministry of Health and Welfare. The National Representative Innovative Company is a system in which nine ministries, including the Ministry of Trade, Industry and Energy, the Ministry of SMEs and Startups, the Ministry of Science and ICT, the Ministry of Health and Welfare, and the Ministry of Oceans and Fisheries, select representative innovative companies from each industry and provide various support programs to foster them as future core companies. This corporate support system was decided on at the 12th meeting of the Central Economic Response Headquarters on July 30, 2020. Miracell was selected as one of the “Health and Diagnostic Innovative Companies” in the fields of new health technologies, medical devices, and innovative pharmaceuticals, based on selection criteria established by the Ministry of Health and Welfare. Miracell is a stem cell company launched in 2009, adopting Harvard University’s cell extraction technology.In 2017, it successfully developed a “minimally manipulated stem cell isolation and amplification source technology.” The Ministry of SMEs and Startups selected this technology as a small and medium-sized enterprise (SME) commercialization technology development project. Based on this technology, Miracell successfully developed and domestically produced the SMART M-CELL2 kit, a replacement for the SmartPReP2 kit developed by the Harvard Medical School Immunology Research Institute in 2018 and exported globally. Tests at Seoul National University Bundang Hospital showed that its performance was comparable to or even superior to that of the SmartPReP2 kit. The SMART M-CELL2 extracts large quantities of stem cells by concentrating bone marrow blood extracted from the body through centrifugation. It is currently used in major hospitals both domestically and internationally. Miracell CEO Shin Hyun-soon stated, “Being selected as a National Representative Innovative Company is very significant. It opens up a new avenue for scientifically treating rare and intractable diseases, as well as Parkinson’s disease and intractable chronic renal failure, using stem cells.” Shin explained, “Stem cell therapy involves extracting bone marrow blood from the patient’s own body, concentrating it through centrifugation, extracting a large number of stem cells, and then reinjecting them into the body.” “Because old cells are regenerated into healthy ones, the effect of improving the body’s functions is remarkable.” Smart Mcell 2, recognized as an innovative technology, is a biopharmaceutical manufacturing technology. It is a cutting-edge system for “bone marrow and blood stem cell manufacturing,” extracting hematopoietic stem cells (CD34+) from blood and mesenchymal stem cells from bone marrow. Approximately 2.9 billion cells can be separated and extracted in one session, and the cell survival rate is as high as 80-98%. It features an automated system that prevents cell mutation.The Smart Mcell 2 is equipped with a special light-emitting diode (LED) to enhance cell activity, transitioning from the existing analog method to a digital one. It is also equipped with voice support, earning it recognition as a cutting-edge bio-healthcare medical device. Miracell, which began its medical business in 1986, has been dedicated to research and development as a stem cell specialist since 2007. In particular, its biological drug manufacturing technology has been certified by the Ministry of Health and Welfare as a new medical technology that helps treat conditions such as acute myocardial infarction, critical limb ischemia, and cartilage defects. Furthermore, it has secured various core technologies, including GMP, ISO13485, ISO9001, and CE European Union certifications, and 22 patent applications for cell extraction technology. Lee Jin-han, Medical Reporter

Miracell Selected as National Innovator in the Health and Diagnostics Sector

Miracell Selected as National Representative Innovative Company in Health and Diagnostics [Medical Newspaper/Daily Newspaper=Reporter Kim Won-jun] Stem cell specialist Miracell has been selected as a “National Representative Innovative Company” by the government. Miracell (CEO Shin Hyun-soon) announced on the 1st that it was selected as a National Representative Innovative Company by the Financial Services Commission, based on evaluations by nine government ministries, including the Ministry of Trade, Industry and Energy and the Ministry of Health and Welfare. Miracell was selected as one of the “Health and Diagnostic Innovative Companies” in the health technology, medical device, and innovative pharmaceutical sectors, based on selection criteria established by the Ministry of Health and Welfare. Miracell, a stem cell specialist company launched in 2009 with the introduction of Harvard University’s cell extraction technology, successfully developed a “minimally manipulated stem cell isolation and amplification source technology” in 2017. The Ministry of SMEs and Startups selected this technology as a technology development project for commercialization by small and medium-sized enterprises. In particular, based on this technology, Miracell successfully developed and domestically produced SMART M-CELL2, a replacement for the SmartPReP2 kit developed by the Harvard Medical School Immunology Research Institute in 2018 and exported worldwide. CEO Shin Hyun-soon stated, “Being selected as a national innovative company is very significant. This opens up a new avenue for scientifically treating rare and intractable diseases, including Parkinson’s disease and intractable chronic renal failure, using stem cells.” Meanwhile, Miracell, which began its medical business in 1986, has been dedicated to research and development as a stem cell specialist since 2007. In particular, its biological drug manufacturing technology has been certified by the Ministry of Health and Welfare as a new medical technology for treating conditions such as acute myocardial infarction, critical limb ischemia, and cartilage defects. In addition, the company has secured core technologies through GMP, ISO13485, ISO9001, and CE certifications, as well as 22 patent applications for cell extraction technology. Source: Medical Newspaper (http://www.bosa.co.kr)

Stem cell company Miracell selected as a “National Innovative Company.”

Stem cell company Miracell selected as a “National Innovative Company Representative” ▲ Stem cell company Miracell announced on the 1st that it has been selected as one of the companies in the government’s “1,000 National Innovative Companies Representative” project. This project aims to foster innovative and technologically advanced small and medium-sized enterprises and venture companies, and the government will select a total of 1,000 companies and provide financial support. Miracell is a stem cell-based biologic product research and development (R&D) company. (Seoul = Yonhap News)

Miracell selected as one of the nation’s top 1000 innovative companies in the health and diagnostics sectors.

Miracell selected as one of the nation’s top 1000 innovative companies in the health and diagnostics sectors. Smart Mcell 2 Successfully Localizes Advanced Bone Marrow and Blood Stem Cell SystemsMiracell, a stem cell specialist, has been selected by the government as one of the “National 1000 Innovative Companies.” Miracell (CEO Shin Hyun-soon) announced on the 1st that it was selected for the third round of the “National 1,000 Innovative Companies,” a program announced by the Financial Services Commission based on evaluations by nine government ministries, including the Ministry of Trade, Industry and Energy and the Ministry of Health and Welfare. The “National 1,000 Innovative Companies” program, launched on July 30, 2020, was approved at the 12th meeting of the Central Emergency Economic Response Headquarters. The program, which involved nine ministries, including the Ministry of Trade, Industry and Energy, the Ministry of SMEs and Startups, the Ministry of Science and ICT, the Ministry of Health and Welfare, and the Ministry of Oceans and Fisheries, selects representative innovative companies by industry and provides them with exceptional financial support to foster them as future core companies. ⓒKorea Medical Association NewspaperStarting with 32 companies in the first round, 247 were selected in the second round, and 321 companies were selected this time. The Financial Services Commission plans to select a total of 1,000 representative innovative companies by industry by 2022. Miracell was selected as one of the “Health and Diagnostic Innovation Companies” in the health technology, medical device, and innovative pharmaceutical categories, based on selection criteria established by the Ministry of Health and Welfare. Launched in 2009 with the introduction of Harvard University’s cell extraction technology, Miracell successfully developed a “Minimally Manipulated Stem Cell Isolation and Amplification Source Technology” in 2017, and the Ministry of SMEs and Startups selected this technology for a small and medium-sized enterprise commercialization technology development project. Based on this technology, Miracell successfully domestically developed and produced SMART M-CELL2, a replacement for the SmartPReP2 kit developed by the Harvard Medical School’s Immunology Research Institute in 2018 and exported globally. Test results at Seoul National University Bundang Hospital showed that its performance was comparable to or even superior to that of SMART M-CELL2. SMART M-CELL2 is a device that extracts large quantities of automatically separated stem cells by centrifuging bone marrow blood extracted from the body. It is currently used in major hospitals both domestically and internationally. Recognized as an innovative technology, SmartMcell2 is a cutting-edge system for “bone marrow and blood stem cell manufacturing,” using biological pharmaceutical manufacturing technology to extract hematopoietic stem cells (CD34+) from blood and mesenchymal stem cells from bone marrow. Approximately 2.9 billion cells can be isolated and extracted in less than an hour, with a cell viability rate of 80-98%. Its automated system, which eliminates air contact and prevents cell mutation, is characterized by its closed, air-tight system. Equipped with special LEDs to enhance cell activity, SmartMcell2 has transitioned from analog to digital. It also features voice support, making it a perfect fit for cutting-edge bio-healthcare medical devices. CEO Shin explained, “Stem cell treatment involves extracting bone marrow blood from the patient’s body, concentrating it through centrifugation, extracting a large quantity of stem cells, and then reinjecting them into the body. This process effectively improves bodily functions, as old cells regenerate into healthy ones.” Source: Korean Medical Association Newspaper (http://www.doctorsnews.co.kr)

[Kyunghyang Shinmun] Miracell Selected as Innovative Company in Health and Diagnostics

Miracell Selected as an Innovative Company in the Health and Diagnostics Sector Stem cell specialist Miracell (CEO Shin Hyun-soon) announced on the 1st that it has been selected as one of the government’s “1,000 Innovative Companies.” The “1,000 Innovative Companies” program, organized by nine ministries including the Ministry of Trade, Industry and Energy, the Ministry of SMEs and Startups, the Ministry of Science and ICT, the Ministry of Health and Welfare, and the Ministry of Oceans and Fisheries, selects leading innovative companies by industry.This program aims to foster these companies as future core businesses through innovative financial support. Starting with 32 companies selected in the first round, 247 companies were selected in the second round, and 321 companies were selected in the third round. Miracell Selected as an Innovative Company in the Health and Diagnostics SectorMiracell was selected as one of the “Innovative Companies in the Health and Diagnostics Sector” in the fields of new health technologies, medical devices, and innovative pharmaceuticals, based on selection criteria established by the Ministry of Health and Welfare. This company, a stem cell specialist launched in 2009 by adopting Harvard University’s cell extraction technology,succeeded in developing the “Minimum Manipulation Stem Cell Isolation and Amplification Source Technology” in 2017, and the Ministry of SMEs and Startups selected this technology as a small business commercialization technology development project. Based on this technology, the company independently developed and successfully domestically produced the Smart Mcell 2. The Smart Mcell 2 extracts bone marrow blood, concentrates it through centrifugation, and automatically separates a large quantity of stem cells. It is currently used in major hospitals both domestically and internationally.Its unique feature is its automated, closed system, which prevents air contact and prevents cell deformation. The Smart Mcell 2 is equipped with a special LED to enhance cell activity, converting the existing analog method to digital. It also features voice support,making it a highly regarded, cutting-edge bio-healthcare medical device.