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May. 13, 2025Press Release

Sysmex and Gaudi Clinical Agree on a Business Collaboration and Capital Alliance

- Aiming to Provide Safer, Higher Quality Treatments in the Field of Regenerative Cellular Medicine -

Sysmex Corporation
Gaudi Clinical Inc.

Sysmex Corporation (HQ: Kobe, Japan; President: Kaoru Asano) and Gaudi Clinical Inc. (HQ: Bunkyo-ku, Tokyo; CEO: Morikuni Tobita; "Gaudi Clinical") announced that they signed a basic agreement regarding a business collaboration and capital alliance with the aim of jointly supporting medical institutions providing regenerative cellular medicine from the perspective of quality control of cell manufacturing in order to provide safer and higher quality treatments to patients.

Expectations are high for the practical application of regenerative cellular medicine, as it has the potential to treat diseases for which no effective treatments are known to date. On the other hand, because regenerative cellular medicine is new medical technology, safety and ethical aspects should be fully considered. For this reason, it is important for academia and companies to conduct research and development appropriately and commercialize regenerative medicine products under the Pharmaceuticals and Medical Devices Act (PMD Act).¹

In addition to treating diseases that affect vital prognosis, regenerative cellular medicine is also attracting attention as a form of medical treatment that aims to improve patients' quality of life. For example, research into tissue repair and functional improvement for periodontal diseases, joint diseases, and other conditions using platelet-rich plasma is actively conducted at universities and research institutions. These areas of regenerative cellular medicine have a large number of target patients and are beginning to be implemented in society under the Act on the Safety of Regenerative Medicine¹ at local medical institutions, such as clinics, that are closer to patients. However, issues preventing widespread use include extremely complicated processes in transporting raw cells, preparing the cells before administration, and collecting and organizing treatment data, as well as the difficulty in training the personnel required to carry out these tasks.

To address these issues, Gaudi Clinical uses its ability to manufacture and deliver cells whose safety and validity for use in Japanese patients are assured at strictly controlled cell processing center (CPC). In addition, by placing stationary clean booths (kiosk-type cell preparation laboratories) next to the clinics and having dedicated regenerative cell therapy coordinators provide full support to each medical institution, we will prepare an environment where patients can receive regenerative cellular medicine at their primary care clinics while also reducing the workload of medical institutions.

Sysmex, leveraging the technology and know-how it has cultivated for more than 50 years in the field of in vitro diagnostics, works to create new businesses in the field of regenerative cellular medicine. In 2024, the company launched research reagents for measuring proteins for regenerative cellular medicine using the Automated Immunoassay System HISCL™-5000/HISCL™-800.² In addition, in collaboration with academia and companies, it has been suggested that Sysmex's testing instruments and reagents could be used for quality control testing for regenerative cellular medicine, which is expected to contribute to the evaluation of cell functions and quality that are essential in verifying the effectiveness of treatment scientifically.

Kiosk-Type Cell Preparation Laboratories (Gaudi Clinical)

Automated Immunoassay System HISCL™-5000 and Reagents (Sysmex)

Gaudi Clinical, which provides cell manufacturing contract services to medical institutions using kiosk-type cell preparation laboratories, and Sysmex, which provides testing instruments and reagents in the in vitro diagnostics field, have entered into a business collaboration and capital alliance agreement in April 2025 with the aim of providing safer and higher quality regenerative and cellular medicine.

By combining the strengths of both companies, Gaudi Clinical and Sysmex aim to create safe and secure treatment opportunities for patients from the perspective of quality control in cell manufacturing so that medical institutions practicing regenerative cellular medicine can provide scientifically appropriate treatments.

Terminology

	1	The Pharmaceuticals and Medical Devices Act (PMD Act) and the Act on the Safety of Regenerative Medicine:
		In Japan, there are two important acts that serve as a legal system to promote regenerative and cellular medicine. One is the Pharmaceuticals and Medical Devices Act (PMD Act), which relates to the approval, manufacturing, and sale of pharmaceuticals, medical devices, regenerative medicine, and other products. The other is the Act on the Safety of Regenerative Medicine, which doctors and dentists must comply with when providing regenerative cellular medicine in clinical research (excluding clinical trials) or as a treatment.

Product name	Medical device marketing notification number
Automated Immunoassay System HISCL™-5000	28B1X10014000011
Automated Immunoassay System HISCL™-800	28B1X10014000012

About Sysmex Corporation

Sysmex Corporation, headquartered in Kobe, Japan, is a global leader in in vitro diagnostics. Since its foundation in 1968, Sysmex has focused on diagnostics as the core of its business, and today, it supports the health of people in over 190 countries and regions worldwide. Sysmex continues to innovate in diagnostics, and to collaboratively create unique values in the areas of personalized medicine and novel treatments, under its long-term vision of "Together for a better healthcare journey." Through its unique technology, solutions, and co-creation with various partners, Sysmex delivers new value and addresses the universal desire of people to live longer and healthier lives. For more information about Sysmex, please visit www.sysmex.co.jp/en/.
* "Healthcare journey" is a trademark of Sysmex Corporation, registered in Japan.

About Gaudi Clinical, Inc.

With its mission of "providing solutions to the last mile of regenerative and cellular medicine," Gaudi Clinical aims to play a role in connecting academia, local medical institutions, and patients, thereby providing safe and secure regenerative and cellular medicine technologies to as many people as possible while providing comprehensive support services for regenerative and cellular medicine to medical institutions. Specifically, the company transfers regenerative and cellular medicine technology verified by academia and, based on the Act on the Safety of Regenerative Medicine, including use of cells, provides services that comprehensively support the regenerative and cellular medicine operations of local medical institutions, such as undertaking cell culture and processing in such fields as dentistry and orthopedics, supporting regulatory compliance, providing education and training on regenerative and cellular medicine to medical professionals, and collecting treatment data in accordance with relevant laws.

The purpose of this news release is to communicate our business activities to our stakeholders. It may or may not include information about Sysmex's products or their research and development, but this is not intended for promotion, advertising or medical advice. The information contained in this news release is current as of the date of the announcement but may be subject to change without prior notice.

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