“MEDEZE Group” Complies with Stem Cell Laws and Regulations of the Medical Council Confident in Internationally Standardized Storage System, Ensuring Customers Can Use Cells in Accordance with Ministry of Public Health Announcements and Medical Cell Service Standards of Healthcare Facilities

Medeze Group Public Company Limited (MEDEZE), a company listed on the Stock Exchange of Thailand, disclosed that following the "Educating Doctors on Stem Cell Usage Guidelines" seminar held in collaboration with the Ministry of Public Health, the Medical Council, the Department of Health Service Support, and the Food and Drug Administration (FDA), the Medical Council emphasized its concern and support for the broader use of stem cells. This must, however, adhere strictly to treatment conditions recognized by international standards. Otherwise, it risks misleading patients into receiving treatments that are not yet medically proven to be effective.

Currently, the use of stem cells is regulated by two main agencies: the Ministry of Public Health and the Medical Council. According to the Ministry of Public Health’s 2022 announcement on "Medical Cell Service Standards for Treatment Use in Healthcare Facilities," the guidelines extend beyond stem cells to include any type of cell used for medical purposes in humans.

At present, there are only two categories of diseases for which stem cell treatment is permitted: blood disorders and eye diseases. Any claims of using stem cells for other treatments, such as cosmetic procedures, liver diseases, kidney diseases, or heart diseases, are considered violations of the standards and the Ministry of Public Health’s regulations.

The company has consistently confirmed that it adheres to legal and regulatory standards in the study, development, and provision of stem cell services. MEDEZE functions solely as a provider of analysis, isolation, cultivation, and storage of stem cells, as well as immuno-cell potency testing (e.g., NK Cells). The company does not engage in the application or treatment processes involving stem cells.

MEDEZE operates a state-of-the-art cleanroom laboratory at Class 100 standards, equipped with advanced technology for stem cell banking. This includes a liquid nitrogen freezing system, an automated hematopoietic stem cell isolation device (Auto Xpress), and an automated mesenchymal stem cell expansion system (Quantum). These facilities meet the stringent international standards set by the Association for the Advancement of Blood and Biotherapies (AABB) in the United States, an organization that certifies stem cell banking operations to comply with global quality standards, including those of the U.S. Food and Drug Administration (U.S. FDA).

The standards encompass all activities related to umbilical cord blood, from long-term storage to global transportation for patient treatments. Additionally, since 2013, MEDEZE has maintained Clean Room Class 100 standards certified by the National Environmental Balancing Bureau (NEBB) from the United States, ensuring appropriate control of particles, pressure, and temperature within its laboratory environments.

“The company strictly provides services for the analysis, isolation, and cultivation of cells and is not a healthcare facility. For its stem cell storage services, the company conducts cell condition assessments, isolation, and cultivation according to medical standards, as well as the stem cell banking standards of Thailand. The use of stem cells for treatment is strictly limited to the individual who owns the stored cells with the company.

MEDEZE has always supported the lawful use of stem cells. However, the responsibility for the proper use of stem cells lies jointly with the customers and the healthcare facilities involved, which must be leading establishments operating under the oversight of relevant laws, regulations, and Ministry of Public Health announcements.

The company boasts a strong network of medical professionals in top-tier healthcare facilities across the country. This ensures that customers using MEDEZE’s services for the analysis, isolation, cultivation, and storage of stem cells, as well as the assessment of immune cell potential (e.g., NK Cells), receive services that comply with all applicable laws and regulations and meet international standards.

When customers utilize stem cells, the process is reviewed and executed in accordance with legal requirements and regulations, under the supervision of healthcare facilities.

The company places great importance on and is fully aware of the implications of advertising or publicizing any activities related to its business operations. To ensure compliance, the company has established advertising standards and policies governing the promotion of its services. These policies are aligned with the regulations outlined in the Healthcare Facility Act.

To manage this, the company has set up a risk management committee tasked with overseeing advertising and public relations efforts. This committee works closely with executives and employees and regularly reports to the company's Board of Directors. The objective is to prevent any violations of current laws and to ensure compliance with any future regulations that may be enacted and come into effect.

The company kindly requests shareholders, investors, and all relevant parties to place their trust and confidence in the company. We affirm our commitment to adhering strictly to all applicable laws, regulations, rules, and directives issued by relevant authorities, such as the Ministry of Public Health, the Medical Council, and the Food and Drug Administration (FDA). The company is dedicated to operating under principles of good governance, transparency, and accountability.”