The landscape of advanced medical diagnostics in Latin America presents a stark and challenging paradox. On one hand, the region has demonstrated a clear commitment to modernizing its clinical capabilities. Between 2014 and 2020, the number of gamma cameras, including advanced hybrid SPECT/CT systems, nearly doubled, increasing by a remarkable 93%.2 This investment signals a strong and growing demand for sophisticated diagnostic imaging. Yet, this progress is fundamentally undermined by a critical and persistent infrastructure deficit at the very source of modern nuclear medicine: the production of radiopharmaceuticals.
Latin America, a region of over 650 million people, is served by a mere 67 operational medical cyclotrons. This equates to just 0.1 units per million inhabitants, a figure that pales in comparison to the 0.38 units per million in the United States.1 This chasm between diagnostic capacity and isotope production capability creates a systemic bottleneck. Hospitals and imaging centers that have invested heavily in state-of-the-art scanners find themselves unable to fully leverage their technology due to chronic shortages, unpredictable supply chains, and logistical delays associated with imported isotopes. The result is underutilized capital equipment, compromised patient scheduling, delayed diagnoses, and missed opportunities to participate in cutting-edge clinical research. This is the infrastructure-capability paradox that Synapse Latam was created to solve.
Formed as a strategic joint venture between the regional clinical research experts at bioaccess® and the radiopharmaceutical pioneers at Nucleotron MIT, Synapse Latam introduces a new paradigm for nuclear medicine in the region.1 This is not the offering of a conventional equipment vendor. It is the deployment of a complete, proven U.S. operational model from the molecular imaging leader CIRA Health, built around the revolutionary IONETIX ION-12SC superconducting cyclotron—the first and only FDA-approved system in its class.1
The core thesis of this new model is simple yet transformative: to de-risk and democratize access to advanced radiopharmaceutical production. Synapse Latam’s comprehensive, turnkey solution manages every stage of establishing a modern radiopharmacy, from initial feasibility studies and complex regulatory navigation to facility construction, operational staffing, and long-term revenue generation. This integrated approach empowers healthcare institutions to break free from the constraints of the past and finally achieve clinical and economic self-sufficiency in the rapidly evolving world of theranostics and personalized medicine.
For decades, Latin American healthcare institutions have faced a set of interconnected and formidable obstacles that have kept local, reliable radiopharmaceutical production out of reach for all but a select few. Understanding these deep-seated pain points is essential to appreciating the transformative nature of a truly integrated solution.
The primary barrier has historically been the technology itself. Traditional medical cyclotrons are large, complex, and prohibitively expensive machines, often requiring the construction of purpose-built, heavily shielded concrete vaults. Their significant capital expenditure and massive physical footprint have made them non-starters for the vast majority of hospitals and research centers. Furthermore, most of the older, existing cyclotrons in the region are limited in their capabilities, primarily devoted to producing Fluorine-18 ($^{18}$F) and lacking the flexibility to synthesize the next generation of PET isotopes critical for advanced cardiology and theranostics.4
Despite these limitations, the demand for local production is undeniable. The Latin American medical cyclotron market, valued at a modest USD 14.6 million in 2023, is projected to grow at a compound annual growth rate (CAGR) of 11.6% through 2030.1 This forecast reflects a significant pent-up demand for more accessible, affordable, and versatile cyclotron technology—a demand that the legacy market has been unable to meet.
The reliance on a handful of centralized producers and imported isotopes has created a supply chain of extreme fragility. This vulnerability was laid bare in Brazil during a 2021 crisis when a funding shortfall at the federal Institute for Energy and Nuclear Research (IPEN)—the supplier for 85% of the country's demand—led to a complete shutdown of production.1 The immediate consequence was the potential cancellation of 9,000 essential medical procedures
each day, jeopardizing patient care across the nation.1
This event highlights a fundamental flaw in the centralized model. The short half-life of PET isotopes—the time in which their radioactivity decays by half—means that any disruption in production or transportation can render a batch useless. Delays at customs, flight cancellations, or production halts at a facility thousands of miles away directly translate into canceled patient appointments. This model is inherently unreliable. The failure of large-scale government projects, such as the Brazilian Multipurpose Reactor (RMB), which remains unbuilt after more than a decade of planning due to inconsistent funding, further demonstrates that a centralized, state-led approach is not a resilient solution for the region's needs.7 This history of systemic failure has created a clear and urgent strategic opening for a more robust, decentralized infrastructure model.
Even for institutions that can secure the capital for a cyclotron, the path to operation is fraught with regulatory complexity. Latin America lacks a harmonized regulatory framework for medical devices and radiopharmaceuticals. A project must navigate a patchwork of national agencies, each with its own distinct rules, timelines, and submission requirements.8 Key authorities include ANVISA in Brazil, COFEPRIS in Mexico, and INVIMA in Colombia.1
The approval process can be lengthy and unpredictable. In Brazil, for instance, securing authorization for a clinical trial can involve sequential reviews by both a national ethics committee (CONEP) and an institutional committee (CEP), a process that can take many months.10 In contrast, Colombia’s INVIMA operates on a more predictable 30-day meeting schedule, but still requires deep procedural knowledge to navigate effectively.10 For any organization lacking extensive, on-the-ground experience with these specific agencies, the regulatory landscape represents a significant project risk, capable of stalling initiatives indefinitely and causing massive budget overruns.
A successful radiopharmacy requires more than just equipment; it demands a highly specialized team of nuclear physicists, radiochemists, and trained technicians. This human capital is critically scarce across Latin America. According to data from the Regional Cooperation Agreement for the Promotion of Nuclear Science and Technology in Latin America and the Caribbean (ARCAL), only 12 of its 21 member states report having a dedicated workforce of nuclear-medicine physicists.1
This shortage is compounded by a lack of standardized, accredited training and certification programs in many countries. Institutions are often left with the daunting task of recruiting from a tiny talent pool or attempting to train staff without access to established curricula or expert guidance. This not only creates severe operational bottlenecks but also raises potential concerns about quality control and safety, acting as a powerful deterrent to launching an in-house program.
The final barrier is financial uncertainty. The conventional business model for cyclotron vendors ends at installation and commissioning. They sell a piece of hardware and then depart, leaving the institution to grapple with the immense and unfamiliar challenges of clinical validation, navigating reimbursement, establishing commercial dose-sales contracts, and integrating the facility into research programs.1
This fragmented approach places the full weight of operational and commercial risk on the buyer. Without a clear, data-driven model for generating revenue and controlling costs, the path to achieving a positive return on a multi-million-dollar investment is opaque at best. This high-capital, high-risk proposition has understandably made many hospital administrators and investors hesitant to commit, perpetuating the cycle of import dependency and infrastructure scarcity.
Synapse Latam was engineered from the ground up to systematically dismantle each of the five critical barriers to radiopharmaceutical self-sufficiency. The solution is not a single product but a fully integrated ecosystem of technology, expertise, and operational support that provides partners with a single, accountable entity to ensure success. Synapse Latam is a specialized joint venture between bioaccess® and Nucleotron MIT, both in Miami, FL. Synapse Latam offers a comprehensive, turnkey solution to bring this vision to life: To facilitate the complete technology and knowledge transfer of a proven U.S. operational model from CIRA Health, centered around the state-of-the-art ION-12SC superconducting cyclotron.
Countering the fragmented vendor model, Synapse Latam delivers a comprehensive, end-to-end program management solution. The partnership begins long before any equipment is ordered, with detailed feasibility studies, site-specific financial modeling, and demand analysis. The team then manages every subsequent phase: vault engineering and construction, cyclotron installation, system validation, development of Standard Operating Procedures (SOPs), and even eventual decommissioning.1 By acting as the single point of accountability from concept to first patient dose, this model eliminates the coordination friction and blame-shifting that can plague complex projects involving multiple vendors, ensuring a streamlined and efficient path to operation.
At the core of the technical solution is the IONETIX ION-12SC, a revolutionary superconducting cyclotron that redefines the possibilities for on-site isotope production. Synapse Latam is the exclusive distributor of this technology in Latin America, offering partners several game-changing advantages 1:
Synapse Latam transforms the regulatory process from a major project risk into a predictable and manageable timeline. This is achieved by leveraging the deep, localized expertise of the bioaccess® team, which has over 15 years of experience successfully managing clinical research and regulatory submissions across Latin America.1 This proven expertise translates into a powerful, quantifiable advantage: Synapse Latam has demonstrated the ability to secure regulatory approvals
40% faster than traditional pathways.1 This acceleration is the direct result of established relationships with key personnel at INVIMA, ANVISA, and COFEPRIS, and a granular understanding of the specific documentation and procedural requirements of each agency.
The ultimate benefit of the Synapse Latam model is true supply chain independence. On-site production with the ION-12SC ends the reliance on distant nuclear reactors and fragile logistics networks.1 For partner institutions, this means an end to patient scans being canceled due to shipping delays, customs holds, or production shutdowns hundreds or thousands of miles away. It provides absolute control over the clinical workflow, improves scheduling efficiency, enhances patient care, and ensures that life-saving diagnostic agents are available when they are needed, without exception. This decentralized model builds the regional resilience that the centralized approach has failed to deliver.
Directly addressing the critical challenge of ROI, Synapse Latam provides a clear, multi-pronged business model to ensure the financial sustainability and profitability of the radiopharmacy. The revenue generation program is built on three pillars:
This model is not theoretical. Synapse Latam provides data-driven financial projections showing that a single ION-12SC site can achieve breakeven in under three years.1 Furthermore, the partnership provides a direct gateway to advanced clinical research opportunities. Leveraging bioaccess's proven trial management capabilities, partners can achieve
50% faster patient enrollment than the industry average, making their sites highly attractive to international sponsors and positioning them as leaders in medical innovation.1
To solve the human capital crisis, Synapse Latam has developed a comprehensive program for talent development and operational support. The solution includes extensive, bilingual training curricula for the entire radiopharmacy team—physicists, radiochemists, and technicians—that are fully aligned with International Atomic Energy Agency (IAEA) competency frameworks.1 This is followed by annual recertification audits to ensure skills remain sharp. Beyond initial training, Synapse Latam provides ongoing 24/7 remote monitoring and expert support to guarantee greater than 99% system uptime, ensuring the long-term success and safety of the operation.1
The Synapse Latam model is defined not just by its comprehensive promises but by its demonstrated results. The value proposition is validated by hard data, quantifiable performance metrics, and the success of its strategic partnerships, which de-risk the investment for future partners.
The flagship site for the Synapse Latam network is the Hospital Internacional de Colombia (HIC) in Bucaramanga, one of Latin America's top-ranked medical institutions.1 In a landmark achievement that validates the entire Synapse Latam ecosystem, HIC recently became the first hospital in Colombia—and the first in all of South America—to be accepted into the prestigious Mayo Clinic Care Network.12
This partnership is far more than a ceremonial affiliation. Acceptance into the network is granted only after Mayo Clinic conducts a rigorous, in-depth evaluation of an institution's clinical and business practices, quality standards, and patient safety protocols.12 HIC's success in this vetting process serves as the ultimate independent, third-party validation of the world-class operational standards that the Synapse Latam model helps to establish. This alliance provides HIC's physicians with direct access to Mayo Clinic's knowledge base and expertise, including collaborative efforts to further enhance HIC's programs in oncology and cardiology—the very service lines that are powered by advanced radiopharmaceutical imaging.12
This achievement creates a powerful "halo effect." It signals to the global medical community that institutions within the Synapse Latam network operate at an international standard of excellence. This level of prestige acts as a magnet, attracting further collaborations, top-tier clinical trials, and leading medical talent, transforming a partner hospital from a local provider into a regional center of excellence.
The strategic value of the Synapse Latam partnership is reflected in a suite of clear and compelling performance metrics that differentiate it from any other approach:
Innovative Frameworks: The partnership brings access to cutting-edge clinical trial methodologies, such as the proprietary ADEPT framework, which has been shown to reduce the costs of Phase 1 trials by 40%. It also includes expertise in navigating accelerated FDA pathways like the Exploratory IND, further enhancing a site's research capabilities.1
The choice facing healthcare leaders is no longer about simply buying a piece of equipment. It is a strategic decision between a fragmented, high-risk conventional path and an integrated, de-risked partnership model. The table below summarizes the fundamental differences.
Latin America stands on the cusp of a radiopharmaceutical renaissance. For too long, however, this potential has been constrained by systemic barriers—inaccessible technology, fragile supply chains, labyrinthine regulations, and a scarcity of specialized talent. These obstacles have kept life-saving and life-changing diagnostic and therapeutic isotopes out of reach for millions of patients.
Synapse Latam offers the definitive solution to these long-standing challenges. It resolves these pain points not with a single product, but with an unmatched synthesis of compact, state-of-the-art cyclotron technology, deep regulatory and operational mastery, and a proven, data-driven model for achieving financial sustainability and clinical excellence. The partnership provides more than just equipment; it delivers a complete, turnkey pathway to regional leadership in nuclear medicine.
The vision extends beyond individual institutions. The roadmap begins with the flagship HIC site in Colombia and expands to a target of seven sites across the region by 2027.1 This will create a distributed, resilient, and collaborative isotope manufacturing grid that can underpin cross-border clinical trials and ensure rapid, reliable access to radiopharmaceuticals for the entire continent.
An investment in a partnership with Synapse Latam is a strategic decision to build a more innovative and self-sufficient future. It is a commitment to securing clinical leadership, establishing sustainable new revenue, and earning a prominent place in the global advancement of medical research.
Q1. How long does a typical Synapse Latam project take from contract to first patient?
A: Most sites can expect to achieve GMP-ready production within 12–15 months. The exact timeline depends on the complexity of the required civil works and local permitting processes.1
Q2. What are the space and power requirements for the ION-12SC cyclotron?
A: The ION-12SC is designed for installation in existing facilities. It requires a shielded room measuring approximately 4 meters × 4 meters with a ceiling height of 3.2 meters. The system operates on standard 208V three-phase power, plus standard HVAC for climate control.1
Q3. Can the cyclotron produce therapeutic isotopes such as Lutetium-177 ($^{177}$Lu)?
A: The ION-12SC platform is optimized for producing PET isotopes. However, its design is forward-looking and supports the future addition of solid-target modules, which can expand its production capabilities into therapeutic beta- and alpha-emitting isotopes.1
Q4. How are staff trained and certified to operate the facility?
A: Synapse Latam provides a comprehensive training solution that includes bilingual classroom instruction, e-learning modules, and intensive on-site, hands-on training. All curricula are aligned with IAEA competency frameworks. This is followed by annual recertification audits to ensure continued excellence and safety.1
Q5. What financing options are available for acquiring the system?
A: Recognizing the significant capital investment, Synapse Latam works with partners to facilitate a variety of financing structures. These can include equipment leasing programs, vendor-direct financing, and assistance in applying for funding from multilateral development banks, with options tailored to both public and private ownership models.1