Tokyo Women's Medical University Educational Association

TOKYO--(BUSINESS WIRE)-- Heartseed (Heartseed Inc.), a Tokyo-based biotechnology company developing iPSC-derived cardiomyocytes for heart failure, today announced that the case reports of two patients in the Phase 1/2 clinical trial (LAPiS Study) of HS-001 in combination with coronary artery bypass grafting surgery for advanced heart failure, was presented by the investigator at the 71st Annual Meeting of the Japanese College of Cardiology (JCC) on September 9, 2023. Dr. Yuki Ichihara, Department of Cardiovascular Surgery, Tokyo Women's Medical University, presented his experience of two patients in the LAPiS study and according to the presentation, the cell transplantation went smoothly, and the immunosuppressants management proceeded without major complications, and improvement in cardiac function was observed. Dr. Ichihara stated, “Among ischaemic heart failure patients with reduced left ventricular ejection fraction (LVEF), we have experienced that LVEF does not improve after coronary artery bypass surgery, especially in severe cases with little remaining myocardium. In this clinical trial, the initial results suggest that the transplanted cardiomyocytes have engrafted, and I believe that this can be a new treatment method that aims to improve cardiac function by transplanting and replacing cardiomyocytes mainly in areas where there is little viable myocardium.” The efficacy results of the two cases presented at the congress (pre-transplant baseline and 26-week post-transplant) is shown in the table below. First Patient Second Patient LVEF (%) Echo 26 → 28 17 → 38 MRI 15 → 19 10.8 → 18.0 LVEDV (mL) Echo 345 → 252 (-27%) 196 → 164 (-16%) MRI 431 → 389 (-10%) 265 → 197 (-26%) Cardiothoracic ratio (%) 63.1 → 60.0 61.6 → 48.3 NT-proBNP (pg/mL) 11,471 → 5,733 (-50%) 5,225 → 817 (-84%) NYHA functional classification III → II III → I Both patients initially had severe heart failure, as indicated by their low LVEF and enlarged heart size. Both patients showed reverse remodeling, improvements in heart function, NYHA functional classification and biomarker at 26-week. Currently, four patients were dosed in the LAPiS trial. Regarding safety, there have been no events that would be problematic for the continuation of the clinical trial. Heartseed continues patient enrollment in the LAPiS trial. For details: View source version on businesswire.com: Contacts Kikuo Yasui, COO, Heartseed Inc. Tel: +81-3-6380-1068 Email: kikuo.yasui@heartseed.jp Source: Heartseed Inc. View this news release online at:

TOKYO--(BUSINESS WIRE)-- Japan Association for Cellular Agriculture (JACA), a Japan-based non-profit research institute hosted the inaugural meeting in Tokyo, in response to Japanese Prime Minister Fumio Kishida’s announcement in February 2023 of the intention to develop the domestic cultivated food industry. This press release features multimedia. View the full release here: Introduction of JACA by Megumi Avigail Yoshitomi, the Representative Director of JACA (Photo: Business Wire) JACA convened around 150 stakeholders from the Japanese Parliament, government officials from Japan and abroad, industry associations, member companies, academia, and media representatives to build a consensus of necessary measures on food safety requirements for cultivated food; treatment to protect Japanese farmers’ rights on branded-animal cells such as “Wagyu”; proper usage of “Wagyu” term in the cellular agriculture field; food labeling requirements including the definition of “Made in Japan” cultivated products; guidelines for transparent consumer communications; and more. Congratulatory speeches and a panel discussion The event included an introduction of JACA and congratulatory speeches from Norihiro Nakayama, The Executive Director of Japan’s Parliamentary Group for Cellular Agriculture; the representatives from the Ministry of Agriculture, Forestry and Fisheries and the Ministry of Economy, Trade and Industry; and Japanese food majors such as NH Foods Ltd. and Ajinomoto Co., Inc. A panel discussion including seafood major Maruha Nichiro Corporation followed. Megumi Avigail Yoshitomi, Representative Director of JACA, stressed that “Japan should leverage its global presence in food and regenerative medicine area to show its presence in cellular agriculture field”. On "Mock BBQ" of cultivated meat JACA demonstrated "Mock BBQ" for the guests to experience the aroma of grilled cultivated meats such as 3D bio-printed cultivated marbled beef from Consortium for Future Innovation by Cultured Meat; cultivated chicken from Diverse Farm; cultivated beef from Tokyo Women's Medical University-Waseda University Joint Institution for Advanced Biomedical Sciences. JACA avoided providing tasting opportunities during the event due to the lack of clear rules in Japan as well as to show consumers that safety consideration is of utmost concern for the industry. For a more detailed explanation, please see the official article and download material from the link here. About Japan Association for Cellular Agriculture (JACA) JACA aims to form policy recommendations about cultivated food, to contribute to key issues in Japan such as food security and sustainability. View source version on businesswire.com: Contacts Press Contact Japan Association for Cellular Agriculture Ginza Ohtake Bijidensu 2nd floor, 1-22-11, Ginza, Chuo-ku, Tokyo, Japan admin@jaca.jp Source: Japan Association for Cellular Agriculture Smart Multimedia Gallery Photo Introduction of JACA by Megumi Avigail Yoshitomi, the Representative Director of JACA (Photo: Business Wire) Photo Mock BBQ scene of Made-in-Japan cultivated meat (Photo: Business Wire) Photo Japanese cultivated meat “Barbequed” or displayed at the inaugural meeting of JACA (Graphic: Business Wire)) Logo View this news release and multimedia online at:

TOKYO, Feb. 2, 2023 /PRNewswire/ -- SONIRE Therapeutics Inc. (hereinafter referred to as "SONIRE"), based in Tokyo, announces that it has commenced a randomized phase 2 study for the treatment of unresectable pancreatic cancer with SONIRE's next-generation High-Intensity Focused Ultrasound (HIFU) therapy system (development code: Suizenji). Logo: The 5-year survival rate of pancreatic cancer is very low at 8.5%, and the number of deaths from it in Japan was estimated to be 37,677 patients in 2020, ranking fourth after lung cancer, colorectal cancer, and stomach cancer, and is increasing every year (*). In addition, treatment options for pancreatic cancer are limited, and there is a strong need for innovative treatment modalities. In this clinical trial, the efficacy of Suizenji in combination with second-line chemotherapy will be evaluated in patients with unresectable pancreatic cancer who are refractory or intolerant to first-line chemotherapy, with overall survival as the primary endpoint (expected enrollment: 90 participants). (*) Data from "Pancreatic, Statistical Information by Cancer Type," National Cancer Center's Cancer Information Service (updated on October 5, 2022) Image: Details of the study can be found on the following websites: - Japan Registry of Clinical Trials: - U.S. National Library of Medicine's ClinicalTrials.gov: SONIRE was established in February 2020 to develop a next-generation ultrasound-guided HIFU therapy system by utilizing the technology and clinical know-how established by Tokyo Women's Medical University, Tohoku University and Tokyo Medical University over the past years. HIFU therapy is expected to become a new treatment modality for cancer because it is minimally invasive, less burdensome to the body, and can be performed repeatedly without radiation exposure. SONIRE is developing the HIFU therapy system as a new treatment modality for pancreatic cancer, which is one of the most difficult-to-treat cancers. SOURCE SONIRE Therapeutics Inc.