MedaSystems Reports Breakthrough Year of Global Growth, Clinical Trust, and Platform Expansion

MENLO PARK, Calif.--(BUSINESS WIRE)--Jan 12, 2026--

MedaSystems, the leading SaaS platform for Expanded Access, Post Trial Access, and Investigator Initiated Studies, today announced a milestone year defined by accelerated customer growth, strong clinical adoption, and significant advances in regulatory and AI readiness. The company continued to expand its role as a trusted partner to life sciences organizations and clinicians seeking treatment pathways for patients with urgent medical needs.

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MedaSystems continues to support a diverse and growing customer community. A sampling of current customers includes:

Global Reach Across High-Impact Therapies

MedaSystems supported a broad range of activities across various therapeutic areas during the year, including oncology, metabolic and genetic diseases, dermatology, infectious diseases, and neurology. The platform facilitated pre-approval access programs across many regions worldwide and supported the delivery of advanced therapies for both rare and high-need conditions. This global footprint highlights the increasing complexity of pre-approval access and the industry-wide shift toward modern, compliant digital infrastructure.

Widespread Clinical Trust Across Leading Institutions

Since its founding, clinicians at nearly three hundred institutions have used MedaSystems to coordinate pre-approval access requests. These institutions include many of the world’s leading academic medical centers, university hospitals, national referral centers, pediatric specialty hospitals, and top-ranked cancer programs. More than one-third of these organizations are high-prestige clinical or research institutions, underscoring the strong trust they have earned from the medical community.

Institutional adoption spans North America, Europe, Asia Pacific, Latin America, and the Middle East, making MedaSystems one of the most geographically diverse Expanded Access networks in the industry.

Advancing AI for Access Programs

MedaSystems continued to build on its early leadership in applied AI for regulated workflows. The company’s PHI Redaction Agent has processed thousands of document interactions across sponsor programs.

The agent performs deterministic, auditable actions within strict guardrails and routes each suggested change through a human approval step before finalization. These innovations reflect the company’s long-term vision to bring safe, transparent automation to the workflows that matter most in Expanded Access and related programs.

Executive Commentary

“ 2025 has been a milestone year for MedaSystems as we continue to redefine how life sciences organizations manage Expanded Access worldwide,” said Brian Irwin, CEO, MedaSystems. “The rapid growth of our customer base and the trust placed in us by global pharmaceutical leaders reflect the industry’s need for modern, compliant, and scalable solutions. We’re proud to support sponsors and healthcare professionals in bringing critical therapies to patients faster, and we’re excited to build on this momentum in the year ahead.”

Regulatory Momentum and the Evolving Role of Pre-Approval Access

In November, the FDA introduced the Plausible Mechanism Pathway, a major regulatory development that expands the role of pre-approval access programs. Under this approach, data generated through certain single-patient Expanded Access cases may contribute to the evidence supporting approval of individualized or genetically targeted therapies.

The introduction of this pathway is expected to increase demand for structured, high-fidelity real-world evidence produced within access programs. MedaSystems’ global case management, audit-ready documentation, and longitudinal follow-up capabilities will enable sponsors navigating this emerging regulatory era.

Looking Ahead

MedaSystems enters 2026 with strong momentum, supported by expanding partnerships, continued platform adoption, and rising recognition from clinical and regulatory communities. The company will continue investing in workflow intelligence, regulatory innovation, and modern infrastructure that supports timely patient access to investigational therapies worldwide.

About MedaSystems

MedaSystems is the leading developer of secure, GxP-compliant software for managing requests for experimental therapies—including Expanded Access, Post-Trial Access, and Investigator-Initiated Studies. By connecting physicians and pharmaceutical companies in a centralized, audit-ready environment, MedaSystems reduces administrative burden, improves data quality, and helps patients worldwide gain timely access to investigational treatments.

MedaSystems, the leading SaaS platform for Expanded Access, Post Trial Access, and Investigator Initiated Studies, today announced a milestone year defined by accelerated customer growth, strong clinical adoption, and significant advances in regulatory and AI readiness.

HAVANA (AP) — Cuban President Miguel Díaz-Canel said Monday that his administration is currently not in talks with the U.S. government, a day after President Donald Trump threatened the Caribbean island in the wake of the U.S. attack on Venezuela.

Díaz-Canel posted a flurry of brief statements on X after Trump suggested that Cuba “make a deal, BEFORE IT IS TOO LATE.” He did not say what kind of deal.

Díaz-Canel wrote that for “relations between the U.S. and Cuba to progress, they must be based on international law rather than hostility, threats, and economic coercion.”

He added: “We have always been willing to hold a serious and responsible dialogue with the various US governments, including the current one, on the basis of sovereign equality, mutual respect, principles of International Law, and mutual benefit without interference in internal affairs and with full respect for our independence."

His statements were reposted by Cuban Foreign Minister Bruno Rodríguez on X.

On Sunday, Trump wrote that Cuba would no longer live off oil and money from Venezuela, which the U.S. attacked on Jan. 3 in a stunning operation that killed 32 Cuban officers and led to the arrest of President Nicolás Maduro.

Cuba was receiving an estimated 35,000 barrels a day from Venezuela before the U.S. attacked, along with some 5,500 barrels daily from Mexico and roughly 7,500 from Russia, according to Jorge Piñón of the Energy Institute at the University of Texas at Austin, who tracks the shipments.

The situation between the U.S. and Cuba is “very sad and concerning,” said Andy S. Gómez, retired dean of the School of International Studies and senior fellow in Cuban Studies at the University of Miami.

He said he sees Díaz-Canel’s latest comments “as a way to try and buy a little bit of time for the inner circle to decide what steps it’s going to take.”

Gómez said he doesn’t visualize Cuba reaching out to U.S. officials right now.

“They had every opportunity when President (Barack) Obama opened up U.S. diplomatic relations, and yet they didn’t even bring Cuban coffee to the table,” Gómez said. “Of course, these are desperate times for Cuba.”

Michael Galant, senior research and outreach associate at the Center for Economic and Policy Research in Washington, D.C., said he believes Cuba might be willing to negotiate.

“Cuba has been interested in finding ways to ease sanctions,” he said. “It's not that Cuba is uncooperative.”

Galant said topics for discussion could include migration and security, adding that he believes Trump is not in a hurry.

“Trump is hoping to deepen the economic crisis on the island, and there are few costs to Trump to try and wait that out,” he said. “I don’t think it’s likely that there will be any dramatic action in the coming days because there is no rush to come to the table.”

Cuba's president stressed on X that “there are no talks with the U.S. government, except for technical contacts in the area of ​​migration.”

The island’s communist government has said U.S. sanctions cost the country more than $7.5 billion between March 2024 and February 2025.

Coto reported from San Juan, Puerto Rico.

The Cuban flag flies at half-mast at the Anti-Imperialist Tribune near the U.S. embassy in Havana, Cuba, Monday, Jan. 5, 2026, in memory of Cubans who died two days before in Caracas, Venezuela during the capture of Venezuelan President Nicolas Maduro by U.S. forces. (AP Photo/Ramon Espinosa)