Designation by MuseCell Innovations®, the sole global licensor of Professor Mari Dezawa’s pluripotent stem cell technology developed at Tohoku University, extends authorized access to Dezawa MuseCells® across the company’s Mexican clinic network

R3 Stem Cell International today announced that it has been designated an Authorized Provider of Dezawa MuseCells® by MuseCell Innovations® (MCI), effective May 2026. Under the terms of the license agreement, all of R3 Stem Cell International’s clinics located in Mexico are authorized to deliver protocols incorporating these MCI-licensed cell products under the applicable Mexican regulatory framework.

MuseCell Innovations® is the sole global licensor of the Dezawa MuseCell® and Dezawa MuseExosome® intellectual property developed by Professor Mari Dezawa and the Department of Stem Cell Biology and Histology at Tohoku University Graduate School of Medicine, Japan. Multilineage-differentiating Stress-Enduring (Muse) cells are a subpopulation of pluripotent-like stem cells first reported in 2010, characterized by SSEA-3 surface expression and described in the published literature as non-tumorigenic, immune-tolerant, and capable of multilineage differentiation.

Strategic Context

“The MuseCell Innovations® designation extends our network’s authorized access to a clinically distinct cell and extracellular vesicle technology and complements our existing standardized protocol portfolio,” said CEO Dr. David Greene, MD, PhD, MBA, R3 Stem Cell International. “We selected MCI as a long-term licensing partner because of the underlying scientific provenance — Professor Dezawa’s peer-reviewed work at Tohoku University — and because MCI’s authorized provider framework defines clear sourcing, training, and quality standards across the network.”

Dr. David Greene, R3 Stem Cell Founder/CEO added: “Operating across [eight] countries, we maintain a disciplined approach to which biological products are deployed in our clinics and under what licensing and regulatory authority. Joining the Dezawa MuseCells® authorized network is part of that approach.”

Scope of the Authorization

Under the agreement with MuseCell Innovations®, R3 Stem Cell International is authorized to:

• Access Dezawa MuseCells® and Dezawa MuseExosomes® products at all of its clinic locations in Mexico, in accordance with MCI sourcing and quality standards.
• Use the Dezawa MuseCells® and Dezawa MuseExosomes® registered marks in accordance with the marketing and trademark-use guidelines provided by MCI.
• Participate in MCI’s authorized-provider clinician training and quality assurance programs.
• Contribute, on a voluntary and de-identified basis, to multi-center clinical outcomes data collection initiatives where established by MCI and consistent with each operating country’s ethical and regulatory requirements.

Regulatory Status

Dezawa MuseCells® and Dezawa MuseExosomes® products are administered by R3 Stem Cell International only at clinics located in jurisdictions where the products are authorized under the applicable national regulatory framework. In Mexico, cell-based and extracellular vesicle products are regulated under COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios) and applicable provisions of the General Health Law and its Regulations on Health Research.

These products are not approved by the U.S. Food and Drug Administration for any clinical indication. R3 Stem Cell International does not manufacture, distribute, or administer Dezawa MuseCells® or Dezawa MuseExosomes® within the United States. Information in this release is provided to medical, scientific, and trade audiences for purposes of corporate and licensing reporting and is not a solicitation of patients or an offer of treatment to consumers in any jurisdiction.

About Muse Cells and the Underlying Science

Multilineage-differentiating Stress-Enduring (Muse) cells were first reported by Professor Mari Dezawa and colleagues in the Proceedings of the National Academy of Sciences in 2010. The cells are isolated by SSEA-3 selection and have been characterized in the peer-reviewed literature for properties including multilineage differentiation potential, stress tolerance, and a non-tumorigenic profile in pre-clinical models. A separate Japanese clinical development program for an investigational Muse cell-based product (CL2020) has been conducted by Life Science Institute, Inc., a Mitsubishi Chemical Group company, in indications including stroke, acute myocardial infarction, spinal cord injury, ALS, and dystrophic epidermolysis bullosa. The MuseCell Innovations® program licensed by R3 Stem Cell International is a separate commercial program that licenses Professor Dezawa’s underlying intellectual property internationally.

R3 Stem Cell International notes that, as with all developing cell-based therapies, the existing clinical evidence is preliminary in many indications and that controlled prospective studies are required to establish efficacy for any specific clinical use.

Real-World Evidence Initiatives

R3 Stem Cell International confirmed that prospective observational registry protocols on selected indications are in development for review by CONBIOÉTICA-registered Comités de Ética en Investigación in Mexico, with planned ClinicalTrials.gov registration prior to enrollment. Where consistent with the MCI authorized-provider framework, outcomes from patients treated with Dezawa MuseCells® or Dezawa MuseExosomes® may be included in those registries on a voluntary, informed-consent basis with independent oversight, pre-specified endpoints, and a commitment to publish results regardless of direction. Specific registry designs and indications will be the subject of separate announcements following IRB approval.

About R3 Stem Cell International

R3 Stem Cell International is a multinational regenerative medicine network operating approximately 80 affiliated clinics in 8 countries including South Africa, Mexico, Pakistan, a India, USA, Turkey, UAE, Philippines.. The company’s clinics deliver cell-based and biologic protocols under the management of locally licensed clinicians and under the regulatory authorities applicable in each country of operation. Additional information is available at https://r3stemcell.com

About MuseCell Innovations®

MuseCell Innovations® (MCI) is the sole global licensor of Professor Mari Dezawa’s Muse cell intellectual property developed at Tohoku University, Japan. MCI licenses Dezawa MuseCells® and Dezawa MuseExosomes® to authorized providers internationally under defined sourcing, training, and quality frameworks.

Forward-Looking Statements and Regulatory Disclaimer

This announcement contains forward-looking statements regarding the company’s licensing arrangements, planned research initiatives, and clinical operations. Actual outcomes may differ materially from those described. Statements in this release have not been evaluated by the U.S. Food and Drug Administration. Dezawa MuseCells® and Dezawa MuseExosomes® are not approved by the U.S. Food and Drug Administration and are not intended to diagnose, treat, cure, or prevent any disease in the United States. Dezawa MuseCells® and Dezawa MuseExosomes® are registered trademarks of MuseCell Innovations® and are used with permission. This release is provided to medical, scientific, and trade audiences for purposes of corporate and licensing reporting and is not a solicitation of patients or an offer of treatment to consumers in any jurisdiction.