Stem Cell Company Miracell Issues Correction Regarding False Claims About Salary Standards
[Medical Newspaper] July 23, 2018 /In the June 11th and 12th articles titled “Where Does the ‘Moral Hazard’ of Stem Cell Companies End?” and the June 18th article titled “Serious ‘Moral Hazard’ in Stem Cell Companies,” Miracell applied for a new medical technology assessment for “autologous bone marrow stem cell therapy for patients with cartilage defects.” However, the technology was determined to be research-level technology with unproven safety and efficacy. Therefore, it cannot be commercially used in clinical settings. Furthermore, despite the fact that the reimbursement standards remained unchanged, Miracell spread false information claiming that “the age restriction for stem cell therapy for cartilage defects had been lifted,” and raised concerns about “moral hazard.” But Miracell’s ‘Autologous bone marrow stem cell therapy for patients with cartilage defects’ was given a limited medical technology grade B in the new medical technology assessment. On May 29, 2018, it was confirmed that Miracell Co., Ltd. had been added to the list of technologies eligible for limited medical technology applications with confirmed safety. Therefore, it has been confirmed that Miracell Co., Ltd. did not spread false information, and we are correcting this. This report is subject to the mediation of the Press Arbitration Commission. Medical Newspaper medicalnews@bosa.co.kr
Miracell Obtains Medical Device Manufacturing and Sales Approval from the Ministry of Food and Drug Safety
[Medworld News] October 18, 2018 Miracell (CEO Shin Hyun-soon), a stem cell company that promotes “the world’s safest stem cell technology,” has received approval from the Ministry of Food and Drug Safety to manufacture and sell medical devices. CEO Shin Hyun-soon announced this in a recent letter to shareholders, “Miracell’s technology competes with the world’s best, with five registered technology patents and nine patent applications. We are currently conducting a cell count to obtain an equivalence assessment to verify the excellence of our medical devices.” Miracell holds five technology patents: a decanting kit for easy component separation and extraction, a centrifuge vessel for easy component separation and extraction, a swing rotor assembly for centrifuges, a centrifuge vessel, and a dual-wavelength laser device for skin treatment. Miracell holds eight domestic patents and has one international PCT patent pending, including: a centrifuge vessel for easy component separation and extraction; a centrifuge kit for easy sample collection and component separation; a bucket for centrifuges; a component separation plotter for centrifuges; a vending machine for customized cosmetics manufacturing using AI; and a centrifuge equipped with a charging device. Currently, Miracell’s stem cell therapy for diabetic lower extremity ischemia and knee arthritis has been designated as a limited new medical technology and has been selected for new support under the Health and Medical Technology Research and Development Project. Professor Chae Dong-sik (Orthopedic Surgery) at Catholic Kwandong University International St. Mary’s Hospital has demonstrated a cartilage regeneration rate of over 70% using autologous bone marrow stem cell transplantation using Miracell’s SmartPRep2 BMAC system, a new medical technology. Professor Eun-soo Park (Department of Plastic Surgery) at Soonchunhyang University Bucheon Hospital is also giving hope to patients who had previously undergone limb amputation through autologous bone marrow stem cell therapy for diabetic lower extremity ischemia using Miracell’s Smart Prep 2 Bio-Mechanical System. Reporter Myeong-in Park pmi0901@hanmail.net
Miracell: “We will dedicate ourselves to global research and development.”
[Medical Newspaper] October 18, 2018 Shin Hyun-soon, CEO, revealed in a shareholder letter that he has “5 technology patents and 9 patent applications, on par with the world’s best.” Stem cell specialist Miracell (CEO Shin Hyun-soon) announced in a shareholder letter on the 18th that it will dedicate itself to continuous research and development toward becoming the world’s leading stem cell specialist. Miracell collaborates with domestic and international medical institutions on research and development to specialize in safe stem cell treatments. Miracell aims to lead the way in advanced medical technology, not only treating diseases but also emphasizing ethics and morality. Its goal is to contribute to the development of hospitals and the promotion of public health. CEO Shin Hyun-soon stated, “We are pleased to announce that the Ministry of Food and Drug Safety has approved the manufacture and sale of medical devices, a long-awaited project that has been in the works for a long time. With five registered technology patents and nine pending patents, our technology stands shoulder to shoulder with the world’s best.” He added, “We are currently conducting a cell count to verify the excellence of our medical devices. We will continue to strive to expand beyond the domestic market and into global export markets, thereby increasing sales and achieving further growth for Miracell.” Miracell currently holds five technology patents, including a decanting kit for easy ingredient-specific extraction, a centrifuge vessel for easy ingredient-specific extraction, a swing rotor assembly for centrifuges, a centrifuge vessel, and a dual-wavelength laser device for skin treatment. Furthermore, Miracell holds eight domestic patents and one international PCT patent application, including a centrifuge vessel for easy ingredient-specific extraction, a centrifuge kit for easy sample collection and ingredient separation, a bucket for centrifuges, a component separation plotter for centrifuges, a vending machine for personalized cosmetics manufacturing using AI, and a centrifuge equipped with a charging device. Meanwhile, Miracell’s stem cell therapy for diabetic lower extremity ischemia and stem cell therapy for knee arthritis were selected as limited new medical technologies and eligible for new support from the Health and Medical Technology Research and Development Project. Professor Chae Dong-sik (Orthopedic Surgery) at International St. Mary’s Hospital has demonstrated a cartilage regeneration rate of over 70% using autologous bone marrow stem cell transplantation using Miracell’s new medical technology, the “Smart Prep 2 Bi-Mac System.” Professor Park Eun-soo (Plastic Surgery) at Soonchunhyang University Bucheon Hospital is also providing hope to patients who previously had to undergo limb amputation through autologous bone marrow stem cell therapy for diabetic lower extremity ischemia. Reporter Oh In-gyu 529@bosa.co.kr
Chungbuk Biotech Promotion Center Leads KRW 240.2 Billion in Corporate Investment
[Chungcheong Ilbo] December 11, 2018 The Bio-industry Investment Promotion Team (PNP), directly under the Chungcheongbuk-do Bio-industry Bureau, signed investment agreements with 22 companies and attracted KRW 240.2 billion in investment in just six months since its launch. This represents 85% of the provincial Bio-industry Bureau’s total investment attraction performance for the year. According to North Chungcheong Province on the 11th, the PNP was established on June 4th to attract outstanding domestic bio companies, accelerate the establishment of Osong Bio Valley’s R&D capabilities, and serve as a foundation for the domestic and provincial bio-industry engine. Since then, the PNP has initiated investment attraction activities in Osong Bio Valley and has conducted comprehensive attraction and promotional activities for approximately 50 bio-related companies and public institutions. Furthermore, the PNP has also worked to revitalize the province’s bio-industry by improving various systems and developing policies. A prime example is the recognition that the Osong Advanced Medical Complex was excluded from the youth transportation subsidy program for small and medium-sized enterprises in industrial complexes. They persuaded relevant ministries and agencies to extend the benefits to 88 companies and approximately 200 employees. The attraction team also took the lead in improving the working environment and living conditions for workers in the Osong complex, including securing land for the “SME Joint Workplace Daycare Center” managed by the Korea Workers’ Compensation and Welfare Service. In particular, they focused on attracting promising biotech companies and institutions. With the global aging population, leading pharmaceutical companies are investing astronomical sums, yet tangible results remain elusive. The attraction of G2G Bio, which is developing an improved dementia treatment, to Osong is considered a model case. Miracell, which researches stem cell therapy, a cutting-edge biopharmaceutical, is expected to create approximately 120 employees and is expected to contribute to establishing Osong as a forward base for the development of cutting-edge biopharmaceuticals. Osong-based Osbio is a foreign-invested company established with overseas investment (from Japan). The company is expected to create high added value in the agricultural industry through research on natural products produced in agricultural production research complexes and smart farms (farms operated using information and communication technology). It is also expected to contribute to the development of the province’s agricultural and biotechnology industries by expanding into overseas markets. The attraction team plans to continue its active recruitment efforts next year, identifying biotechnology companies suitable for North Chungcheong Province and conducting on-site consultations, with the goal of attracting 3 trillion won during the 7th elected government. Kwon Seok-gyu, Director of the Provincial Biotechnology Industry Bureau, acknowledged, “The achievements in attracting investment from biotechnology companies and institutions in just six months since the formation of the attraction team are the fruit of the team’s tireless efforts.” He expressed his commitment, saying, “We will expand the biotechnology industry to all cities and counties in the province and further solidify North Chungcheong Province’s status as a biotechnology hub that will lead the biotechnology economy.” Reporter Kim Hong-min | hmkim2075@daum.net