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Regenerative Medical Technology Group Inc.

For the period ended Dec 31, 2024. Filed Apr 15, 2025.

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FY2024 · Filed Apr 15, 2025

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Contents

Item 1. BUSINESS

ITEM 1.BUSINESS

Business Overview

Since the acquisition of Global Stem Cell Group (GSCG) in August of 2021, our focus has been mainly dedicated to its operations serving the markets in the regenerative medicine industry. We believe stem cell therapy is becoming an increasingly effective clinical solution for treating conditions that traditional or conventional medicine only offers within palliative care and pain management. Patients around the world are seeking a natural regenerative alternative without the potential risks and side effects sometimes associated with traditional surgeries and /or conventional pharmaceuticals.

We work with doctors and their staff to provide products, solutions, equipment, services, and training to help them be successful in the application of Stem Cell Therapies. We also engage in patient procedures from treatments that GSCG is offering at its Cancun, Mexico clinic, and its clinic in a joint venture with an investor that is scheduled to open in 2025, extended from a prior launch date of November 23, 2024, located at the Hyatt Hotel in Jumeirah, a coastal residential area of Dubai UAE.

Our team combines solutions from extensive clinical research with the manufacturing and commercialization of viable cell therapy and immune support related products that we believe will change the course of traditional medicine around the world forever. Our strategy allows us the ability to create immediate revenue streams through treatments, product sales, distribution, and clinical applications, driven by our extensive education platform. Our revenue comes directly from treating patients, our training and seminars, from the resale of kits, products, equipment, services, and from the reoccurring application of our process using the kits and solutions we provide.

Global Stem Cells Group is a leader in the Stem Cell and Regenerative Medicine fields, covering clinical research, patient applications, along with physician training through our state-of-the-art global network of companies. Its mission is to enable physicians to make the benefits of stem cell medicine a reality for patients around the world. GSCG has been educating doctors on the science and application of cell-based therapeutics for the past 10 years. Our professional trademarked association “ISCCA” INTERNATIONAL SOCIETY FOR STEM CELL APPLICATION is a global network of medical professionals that leverages these multinational relationships to build best practices and further our mission.

Review of Fiscal Year 2024

2024 marked a pivotal year for Regenerative Medical Technology Group (RMTG) and Global Stem Cells Group (GSCG ) as we expanded our international footprint, launched strategic business divisions, and strengthened our proprietary operations in regenerative medicine. Our growth trajectory was supported by our three core business pillars: physician training through the International Society for Stem Cell Application (ISSCA), strategic partnerships with medical institutions, and enhanced manufacturing capabilities.

International Growth and Market Penetration

Throughout 2024, RMTG/GSCG achieved remarkable international expansion that has further solidified our position as a global leader in regenerative medicine.

The International Society for Stem Cell Application (ISSCA), our educational arm, substantially expanded its global physician training programs in 2024. This expansion included hosting comprehensive conferences and immersive workshops in numerous locations across the globe, including Argentina, Peru, Indonesia, Belgium, Mexico (specifically Cancún), the United States, and several other strategic locations. These educational initiatives were designed to disseminate cutting-edge knowledge and practical skills in regenerative medicine to medical professionals worldwide.

Our physician education programs successfully trained medical professionals in over 20 countries during 2024, providing them with advanced knowledge and practical skills in cellular therapy, exosome technology, and peptide applications. This extensive educational outreach has not only elevated the standard of regenerative medicine practice globally but has also established GSCG as the preeminent authority in the field, building a global network of skilled practitioners aligned with our methodologies and standards.

Southeast Asia Expansion

Our strategic market entry efforts yielded particularly strong results in Southeast Asia, where we successfully launched five new clinics under our network. These facilities now serve as regional hubs for advanced regenerative treatments and physician training.

South American Growth

We established stronger distribution channels throughout South America, with particular focus on development in key markets. Our analysis has identified potential office locations in Los Cabos (Mexico), Puerto Rico, and Chile to better serve the growing demand in these regions.

Global Reach Enhancement

By systematically addressing regional market needs with tailored approaches, we've been able to significantly expand our global footprint while maintaining consistent service quality and treatment protocols across diverse regulatory environments.

Manufacturing & Regulatory Strengthening

A cornerstone of our 2024 strategy and a major milestone for our continued growth in 2025 is the expansion of our proprietary manufacturing facilities. We believe this strategic initiative will significantly enhance our capabilities to increase product offerings and serve a broader patient base with consistent, high-quality regenerative medicine products.

Our state-of-the-art manufacturing facility in Cancún, Mexico represents a significant achievement in our vertical integration strategy. This facility has received full accreditation from Cofepris (the Mexican FDA equivalent), validating our commitment to maintaining the highest regulatory standards in our manufacturing processes. The facility is designed to produce advanced mesenchymal stem cells (MSCs), exosomes, and peptide-based products under stringent quality control protocols. This manufacturing center will serve as the foundation for our global product distribution network and provide standardized treatment products for patient care across our clinical network.

Cancún Manufacturing Capabilities

■Full Cofepris accreditation (Mexican FDA)
■Production of mesenchymal stem cells (MSCs)
■Advanced exosome isolation and purification
■Peptide-based product development
■Quality control laboratories with state-of-the-art equipment
■Sterile processing environments for biological materials

Dubai Facility Development

While our planned Dubai, UAE facility encountered unexpected regulatory and construction delays in 2024, we remain firmly committed to launching this strategic facility in 2025. The Dubai location will serve as a critical hub for our presence in the Middle East and Asia, complementing our existing operations and providing regional access to our advanced treatments and technologies.

Potential for United States Manufacturing

As U.S. regulations on regenerative medicine continue to evolve, we are actively evaluating market entry strategies that would allow us to expand our clinic network and manufacturing capabilities in North America. Our regulatory affairs team is closely monitoring developments at the FDA and working with industry associations to position RMTG/GSCG advantageously as the regulatory landscape clarifies. This proactive approach will ensure we are prepared to capitalize on opportunities in the U.S. market when conditions are favorable.

Product Expansion & Market Innovation

In 2024, RMTG significantly broadened its market reach through strategic product expansion and innovative business models that position us for sustained growth in the regenerative medicine sector. Our diversification efforts have created multiple revenue streams while maintaining our focus on scientific excellence and therapeutic effectiveness.

Celgenic, our product development and distribution division, achieved remarkable growth by expanding beyond our traditional cellular therapies portfolio. The introduction of peptide-based treatments has been particularly successful, addressing complementary therapeutic needs and creating synergies with our existing stem cell applications. This product diversification has been accompanied by enhanced global distribution capabilities, allowing us to reach more practitioners and patients worldwide with our comprehensive regenerative medicine solutions.

Strategic Shift to Establish Our Own Network

In a pivotal strategic repositioning, we transitioned from external clinical alliances to establishing our own Global Stem Cells Group clinic network. This vertical integration ensures standardized patient care protocols, consistent quality control, and optimized revenue streams across all treatment locations.

Network Implementation

The implementation of our proprietary clinic network model has already demonstrated significant benefits in terms of treatment consistency, patient outcomes, and operational efficiency. By maintaining direct oversight of clinical operations, we can rapidly deploy innovations and ensure adherence to our rigorous standards.

Clinical Innovation

Our licensed Global Stem Cells Group network Centers worldwide continue to push the boundaries of stem cell applications through clinical studies and advanced treatment protocol development. These centers serve as innovation hubs where new therapeutic approaches are refined before broader implementation.

The expansion of our proprietary clinic network has created valuable opportunities for vertical integration between our manufacturing facilities, product development initiatives, and treatment delivery systems. This integrated approach not only improves operational efficiency but also enhances our ability to gather clinical data, refine protocols, and accelerate the development of next-generation regenerative therapies.

2025 Strategic Outlook

Our operational strategy for 2025 centers on translating our market position and technological advantages into sustainable revenue growth and expanded market share. We anticipate accelerated growth as we execute on our operational plans for clinic network expansion, manufacturing scale-up, and market penetration in key regions including Southeast Asia, Latin America, and potentially North America. We believe our diversified revenue streams from training, product sales, and clinical services provide a solid foundation for sustainable long-term growth and shareholder value creation.

Key performance indicators for 2025 are expected to include operational efficiency metrics, market penetration rates in target regions, production capacity utilization at our manufacturing facilities, and financial performance measures including revenue growth, profit margins, and return on invested capital. Our management team has implemented robust tracking and reporting systems to monitor these metrics and make data-driven adjustments to our execution strategy as needed throughout the year.

Expansion of Clinical Network

A cornerstone of our 2025 growth strategy is the continued expansion of the GSCG Network Clinics, representing our transition from a primarily educational and product-focused organization to a comprehensive regenerative medicine enterprise with direct patient care capabilities. This strategic evolution allows us to capture additional value in the treatment delivery phase while ensuring consistent application of our proprietary protocols.

For 2025, we have confirmed plans for the official launch of a minimum of four new clinic locations. These include strategically selected sites in Indonesia, Puerto Rico, Santiago (Chile), and Lisbon (Portugal). Each location has been chosen based on comprehensive market analysis, regulatory considerations, local healthcare ecosystem dynamics, and potential patient demographics. These new clinics will implement our standardized operational model while incorporating necessary adaptations for local market conditions and regulatory requirements.

Beyond these confirmed locations, our development pipeline includes additional planned clinics in Mexico, the United States, and other key international markets identified through our ongoing market analysis process. These locations are currently in various stages of development, from initial feasibility studies to advanced site selection and regulatory approval processes. Our network expansion follows a disciplined approach that balances growth opportunities with operational sustainability and quality control considerations.

2025 Anticipated Clinic Launches

■Indonesia: Serving the rapidly growing Southeast Asian market
■Puerto Rico: Strategic gateway between North and South American markets
■Santiago, Chile: Expanding our Latin American presence
■Lisbon, Portugal: Strengthening our European operations

Network Clinic Standardization

Each RMTG/GSCG Network Clinic operates under our proprietary standards for facility design, equipment specifications, staff qualifications, treatment protocols, and patient management systems. This standardization ensures consistent quality of care while allowing for efficient scaling of operations across diverse geographic locations. Our clinic expansion model includes comprehensive support systems for practitioner training, operational management, quality assurance, and marketing development.

Manufacturing Scale-Up

A critical element of our 2025 strategic plan is the completion and full operational scaling of our manufacturing infrastructure. These facilities represent significant capital investments that will strengthen our vertical integration strategy, enhance product consistency, and improve operational margins across our business units. Our manufacturing capabilities directly support our ability to serve global markets with standardized, high-quality regenerative medicine products.

The Cancún facility, which achieved regulatory approval in 2024, will transition to full-scale production in 2025. This advanced manufacturing center is designed to support product demand across Latin America and beyond, with robust capacity for mesenchymal stem cell production, exosome isolation, and peptide synthesis. The facility incorporates state- of-the-art quality control systems, including real-time monitoring of production parameters, comprehensive batch testing protocols, and advanced storage capabilities for biological materials.

In parallel with optimizing our existing manufacturing operations, we are actively evaluating opportunities for additional manufacturing locations to further enhance production efficiency and geographic distribution capabilities. These evaluations include considerations such as proximity to key markets, local regulatory environments, availability of skilled workforce, and capital investment requirements. Any expansion of our manufacturing footprint will follow our established model of phased development with careful attention to regulatory compliance and operational excellence.

Production Capacity Expansion

Implementing phased scale-up of production volumes to match growing demand while maintaining strict quality parameters and operational efficiency.

Product Line Diversification

Expanding manufacturing capabilities to support new product development initiatives, including advanced exosome formulations and specialized peptide combinations.

Quality System Enhancement

Continuous improvement of quality management systems to exceed regulatory requirements and support potential future certifications in additional markets.

Distribution Network Integration

Optimizing logistics and supply chain operations to ensure efficient distribution of manufactured products to our clinic network and external customers.

Educational Program Enhancement

The International Society for Stem Cell Application (ISSCA) continues to be a cornerstone of our business model and a primary driver of our industry leadership position. As the educational and professional development arm of Global Stem Cells Group, ISSCA plays a crucial role in establishing practice standards, disseminating knowledge, and creating a global community of trained regenerative medicine practitioners. In 2025, we will further strengthen ISSCA's position and expand its reach through strategic initiatives.

A key focus for 2025 will be significantly increasing the number and geographical distribution of our training events and physician certifications. Building on our successful 2024 programs conducted across more than 20 countries, we will expand both our foundational certification courses and our advanced specialization programs. These educational offerings will continue to evolve to incorporate the latest scientific advances, clinical best practices, and regulatory considerations relevant to regenerative medicine applications.

Q1 2025

Launch enhanced certification curriculum incorporating latest advances in exosome technology and peptide applications, with programs scheduled in Mexico, United States, and Indonesia.

Q2 2025

Introduce advanced specialization tracks for orthopedic, aesthetic, and chronic disease applications of regenerative therapies, with dedicated symposia planned for European and South American markets.

Q3 2025

Deploy comprehensive online learning platform to complement in-person training, providing ongoing education resources and community engagement for certified practitioners.

Q4 2025

Host major international congress bringing together leading researchers, practitioners, and regulatory experts to address emerging trends and future directions in regenerative medicine.

In addition to expanding our educational programming, we will strengthen our partnerships with global medical institutions in 2025. These collaborations will include joint research initiatives, faculty exchange programs, and shared curriculum development with respected academic and clinical organizations. By aligning with established medical institutions, we enhance the credibility of our educational offerings while creating pathways for institutional adoption of regenerative medicine protocols. These partnerships also provide valuable opportunities for clinical validation of emerging treatments and technologies developed within our research network.

Market Development

We intend to strategically enter new geographic markets, particularly in North America, as regulatory environments evolve favorably for regenerative medicine applications.

The United States represents a significant opportunity for Global Stem Cells Group, both in terms of market size and potential for scientific collaboration. Our 2025 strategy includes focused initiatives to expand our clinical presence in the U.S. as regulatory frameworks evolve to accommodate advances in regenerative medicine. This strategic market entry requires careful navigation of complex regulatory considerations while positioning RMTG/GSCG as a leader in North American regenerative medicine.

Our approach to the U.S. market is characterized by strategic patience combined with proactive preparation. While regulatory pathways for certain regenerative medicine applications remain under development at the FDA, we are actively monitoring policy developments and engaging with industry associations to contribute to the evolving regulatory dialogue. This engagement allows us to align our product development and clinical protocols with emerging standards while advocating for science-based regulatory frameworks that protect patients while enabling innovation.

Regulatory Navigation Strategy

We have established a dedicated U.S. regulatory affairs team to monitor FDA developments, prepare appropriate submissions, and develop compliant protocols for the U.S. market. This team works in close collaboration with legal advisors specializing in FDA regulations and regenerative medicine policy to ensure our market entry strategy adheres to all applicable requirements.

Clinical Partnership Development

In preparation for expanded U.S. operations, we are cultivating relationships with established U.S. medical institutions, research universities, and clinical practices interested in regenerative medicine applications. These partnerships are expected to facilitate knowledge exchange, protocol development, and potential collaborative research initiatives that align with U.S. regulatory expectations.

Educational Market Positioning

While developing our clinical strategy, we are enhancing our U.S. educational presence through ISSCA programs specifically designed for U.S. practitioners. These educational initiatives establish RMTG/GSCG as a thought leader in the U.S. market while building a community of trained physicians prepared to implement our protocols when regulatory pathways are established.

Our U.S. market entry strategy also includes evaluation of potential clinical locations in states with favorable regulatory environments for regenerative medicine. This location analysis considers factors such as existing medical infrastructure, patient demographics, physician density, and regulatory climate. By identifying optimal locations for initial U.S. clinical operations, we can better ensure efficient resource allocation and maximize the impact of our market entry efforts when regulatory conditions permit implementation.

Revenue Stream Diversification

A cornerstone of our financial strategy for 2025 is the continued diversification of our revenue streams, creating a balanced business model that reduces dependency on any single market segment while maximizing our ability to capture value across the regenerative medicine ecosystem. This diversified approach enhances our financial stability and provides multiple pathways for growth even as individual market segments experience fluctuations.

Central to our revenue diversification strategy is the strengthening of the Celgenic product line with new offerings in peptides, exosome therapies, and biologics. We believe these product categories represent significant growth opportunities as they address complementary therapeutic needs and can be used independently or in conjunction with our stem cell applications. Our 2025 product development roadmap includes the commercialization of several new formulations that have shown promising results in preliminary clinical applications.

In parallel with product development, we are enhancing our global distribution infrastructure to drive sales growth across all territories. This distribution strategy includes both direct sales to our network clinics and expanded relationships with qualified external partners who can effectively represent our products in their respective markets. Our distribution enhancements include improvements in logistics, inventory management, technical support, and sales training to ensure our products are effectively represented and properly utilized in clinical applications worldwide.

The continued expansion of our clinic network also represents a significant revenue diversification initiative, as it transitions more of our business model toward direct patient care services. These clinical operations generate recurring revenue streams from patient treatments while also creating demand for our manufactured products. The integration between our product development, manufacturing, and clinical service delivery creates valuable synergies that enhance overall profitability and market responsiveness.

Operational Efficiency Initiatives

As Global Stem Cells Group transitions from a growth phase characterized by rapid expansion into a period of operational consolidation, we are implementing comprehensive efficiency initiatives designed to optimize our processes, reduce costs, and enhance productivity across all business units. These operational improvements will be a key focus area for 2025, supporting our ability to deliver consistent profitability while maintaining our commitment to quality and innovation.

Our operational efficiency strategy encompasses several interconnected dimensions: process standardization, technology integration, workforce development, and continuous improvement methodologies. By addressing these elements systematically, we hope to create a foundation for sustainable operational excellence that supports our long-term growth objectives while enhancing near-term financial performance.

Process Standardization

Implementation of standardized operating procedures across all locations to ensure consistency, quality, and efficiency. This includes uniform protocols for manufacturing, clinical practices, training delivery, and administrative functions, allowing for better resource allocation and performance benchmarking.

Technology Integration

Deployment of integrated information systems to connect our global operations, enhance data accessibility, and improve decision-making capabilities. Future key initiatives on our longer roadmap may include implementation of enterprise resource planning (ERP) systems, laboratory information management systems, and customer relationship management platforms.

Workforce Development

Strategic investment in employee training and development programs to enhance skills, improve productivity, and reduce turnover. Our talent development initiatives focus on technical capabilities, leadership development, and cross- functional understanding to build a versatile workforce aligned with our strategic objectives.

Continuous Improvement

Additional future roadmap includes designs for the adoption of structured methodologies such as Lean and Six Sigma to identify and eliminate inefficiencies, reduce variation, and optimize resource utilization. These approaches are being integrated into our operational culture through training, incentive alignment, and visible management support.

The operational efficiency initiatives will be supported by enhanced performance metrics and accountability structures designed to track progress and identify areas requiring additional attention. Our management team has established specific efficiency targets for each business unit, with regular review processes to assess performance and adjust implementation strategies as needed. These metrics are directly tied to our financial objectives and will be a key component of management performance evaluation in 2025.

Research and Development Pipeline

Continued investment in research and development remains a strategic priority for Global Stem Cells Group as we work to expand our therapeutic capabilities, enhance treatment efficacy, and maintain our position at the forefront of regenerative medicine innovation. Our R&D activities span basic science investigation, translational research, and clinical application development, creating a comprehensive innovation pipeline that supports both near-term product enhancements and longer-term technological breakthroughs.

Our 2025 R&D strategy focuses on several key areas that represent significant opportunities for advancement in regenerative medicine. These focus areas have been selected based on emerging scientific evidence, unmet clinical needs, and alignment with our existing capabilities and infrastructure. By concentrating our research efforts on these strategic priorities, we optimize our resource allocation while maximizing potential impact on patient outcomes and market growth.

1.Exosome Characterization and Optimization:

Advanced analysis of exosome content and function to enhance therapeutic applications

2.Combination Therapy Protocols:

Development of synergistic treatment approaches combining stem cells, exosomes, and peptides

3.Tissue-Specific Regeneration Techniques:

Specialized protocols for targeted regeneration of specific tissue types and organs

4.Biomarker Identification and Validation:

Discovery of predictive indicators for treatment response and outcome measurement

5.Delivery System Innovations:

Novel approaches to enhance cellular therapy delivery, targeting, and persistence

Our R&D activities are supported by a network of collaborations with academic institutions, research organizations, and clinical partners that provide access to specialized expertise, advanced technologies, and diverse patient populations. These collaborative relationships accelerate our innovation cycle while ensuring our research directions remain aligned with evolving scientific understanding and clinical practice. In 2025, we plan to expand these collaborative networks with particular emphasis on partnerships that can support our U.S. market entry strategy and enhance our credibility in key international markets.

The integration between our R&D activities and our clinical network creates a powerful feedback loop that informs research priorities based on real-world clinical observations while facilitating the rapid translation of research findings into clinical applications. This translational approach differentiates GSCG from purely academic research organizations and enables us to quickly adapt our product offerings and treatment protocols to incorporate emerging scientific insights and technological capabilities.

Financial Outlook and Investment Strategy

Global Stem Cells Group enters 2025 with a robust financial foundation and a clear strategy for balancing continued growth investments with improving profitability metrics. Our financial management approach emphasizes disciplined capital allocation, operational cost control, and strategic investments in high-potential growth opportunities. This balanced approach is designed to deliver sustainable long-term value for our stakeholders while maintaining the financial flexibility needed to respond to evolving market conditions.

Our 2025 financial projections reflect the impact of our operational efficiency initiatives, continued revenue diversification, and the maturation of investments made in previous years. We anticipate accelerating revenue growth as our manufacturing facilities reach optimal production capacity and our expanded clinic network generates increasing patient volumes. These revenue improvements, combined with operational efficiencies, are expected to drive margin expansion and enhance overall profitability metrics throughout the year.

Our capital investment strategy for 2025 prioritizes high-impact projects that directly support our core strategic objectives. Major investment categories include clinic network expansion, manufacturing capacity optimization, technology infrastructure enhancements, and targeted R&D initiatives. Each investment proposal undergoes rigorous evaluation using standardized criteria including expected return on investment, strategic alignment, risk assessment, and implementation timeline. This disciplined approach ensures our capital resources are allocated to opportunities with the greatest potential for value creation.

In parallel with our operational investments, we continue to evaluate strategic acquisition opportunities that could accelerate our growth in key markets or enhance our technological capabilities. Our acquisition strategy focuses on targets that offer clear synergies with our existing operations, have compatible corporate cultures, and can be integrated efficiently into our operational structure. While we maintain an active acquisition pipeline, we approach each opportunity with disciplined valuation parameters and clear integration planning to ensure successful outcomes.

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