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.
DUBAI, United Arab Emirates (AP) — Iran’s Supreme Leader Ayatollah Mojtaba Khamenei said Thursday that the leverage of closing the Strait of Hormuz should be used and that Iran’s attacks on Gulf Arab neighbors will continue.
His first statement since his appointment was read on state television by a news anchor. Khamenei did not appear on camera, and an Israeli assessment indicates he was wounded in the war’s opening salvo.
Iran's unrelenting attacks on shipping traffic and energy infrastructure in the Persian Gulf pushed oil back above $100 a barrel on Thursday, as American and Israeli strikes pounded the Islamic Republic with no sign of an end to the war in sight.
Iran is trying to inflict enough global economic pain to pressure the United States and Israel to halt their bombardment, which started the war on Feb. 28. Iran's president said its attacks would continue until Iran gets security guarantees against another assault, indicating that even a ceasefire or U.S. declaration of victory might not halt the conflict.
U.S. President Donald Trump has meanwhile promised to “finish the job,” even though he claimed Iran is “virtually destroyed.”
Iran-backed Hezbollah militants meanwhile launched some 200 rockets from Lebanon at northern Israel while sirens rang out and loud booms from the interception of Iranian missiles could be heard in other areas. Israel launched another wave of attacks on Tehran and in Lebanon, where 11 people were killed.
The U.N. refugee agency said up to 3.2 million people in Iran have been displaced by the ongoing war. It said most have fled from Tehran and other major cities toward the north of the country or rural areas. It says at least 759,000 people have been internally displaced in Lebanon.
Iranian President Masoud Pezeshkian suggested online Thursday that for the war to end, the world would need to recognize Iran’s “legitimate rights,” pay reparations and offer guarantees against future attacks.
In addition to attacking energy infrastructure around the region, Iran has a stranglehold on the Strait of Hormuz, the waterway leading from the Persian Gulf toward the Indian Ocean through which a fifth of the world's oil is transported.
Amid speculation that the U.S. might target Kharg Island in the Persian Gulf, Iran’s main oil terminal, Iran's parliamentary speaker Mohammad Bagher Qalibaf threatened in a social media post that any attempt to take Iranian islands would “make the Persian Gulf run with the blood of invaders.”
With traffic in the strait effectively stopped, the price of Brent crude oil, the international standard, rose another 9% to more than $100 a barrel, up some 38% over what it cost when the war started. Prices have swung back and forth in recent days, at one point surging to around $120 a barrel.
It was a sleepless night for many Israelis as Hezbollah launched some 200 rockets at the country’s north and deeper into Israel, according to the Israeli military.
“The noise was extraordinary, it was really scary,” said Naama Porat, a resident of the rural community of Klil, some 15 kilometers (9 miles) from the Lebanese border. As the sound of explosions and interceptions rang out, she dashed with her son to a shelter and spent the night there.
No serious injuries were reported, but the extent of the fire shook residents of the north, who have repeatedly been told by their leaders that Hezbollah was dealt a devastating blow in 2024 during its last war with Israel.
“They have stocks of weapons and it just doesn’t end. We don’t know how much and what to expect,” Porat said.
Israeli Defense Minister Israel Katz warned Lebanon that if its government does not prevent Hezbollah from attacking, Israel “will take the territory and do it ourselves.”
Israel, meantime, hit a car in a seaside area of Lebanon's capital where dozens of displaced people have been sheltering, killing eight and wounding 31, the Lebanese Health Ministry said. The Israeli military said it was “not aware” of a strike at that location.
The Israeli military said it struck a nuclear facility in Iran in recent days. Israel had destroyed the “Taleghan 2” site in an airstrike in October 2024. Earlier this year satellite photos raised concerns that Iran was working to restore the facility.
The U.S. and Israel say that destroying whatever remains of Iran's nuclear program is one of the central aims of the war. They have long suspected Iran seeks nuclear weapons, while the Islamic Republic says its nuclear program is peaceful.
In Tehran, security force checkpoints came under attack for the first time on Wednesday night, the semiofficial Fars news agency reported. At least 10 people were killed in the suspected drone assaults.
Israel and the U.S. military did not immediately respond to requests for comment over whether they were behind the attacks.
Iran’s latest attacks on its Gulf neighbors flouted a U.N. Security Council resolution approved Wednesday.
Early Thursday, a container ship was hit with a projectile off the coast of Dubai, sparking a small fire, according to British military’s United Kingdom Maritime Trade Operations Center. It said the crew were safe.
An Iranian attack sparked a major fire on Muharraq Island, home to Bahrain's international airport. Kuwait authorities said an Iranian drone smashed into a residential building, wounding two people, and that a drone attack on Kuwait International Airport had caused damage but no casualties.
The UAE said it had activated air defenses twice to protect the futuristic city of Dubai from attacks, and firefighters extinguished a blaze at a tower after a drone hit.
Saudi Arabia, meanwhile, said it shot down a drone targeting the diplomatic quarter in its capital, Riyadh, and other drones in the east, including at least one trying to target its Shaybah oil field.
Following an attack on Iraq's Basra port Wednesday that killed at least one person, officials said Thursday that operations were halted at all the country's oil terminals.
In the UAE, Citibank said it would close all but one of its branches due to an Iranian threat — not yet realized — to target financial institutions in the region.
Melzer reported from Mitzpe Hila, Israel and Rising from Bangkok. Associated Press writer Sally Abou AlJoud in Beirut contributed to this report.
A woman gathers belongings from her family's home after it was damaged by a projectile launched from Lebanon, in Haniel, central Israel, Thursday, March 12, 2026. (AP Photo/Baz Ratner)
People inspect homes damaged by a projectile launched from Lebanon, in Haniel central Israel, Thursday, March 12, 2026. (AP Photo/Baz Ratner)
Workers inspect damage caused by a drone strike overnight at the Address Creek Harbour hotel in Dubai, United Arab Emirates, March 12, 2026. (AP Photo/Fatima Shbair)
An oil tanker burns after being hit by an Iranian strike in the ship-to-ship transfer zone at Khor al-Zubair port near Basra, Iraq, late Wednesday, March 11, 2026. (AP Photo)
A woman sits on rubble across from a residential building damaged last Monday during the U.S.-Israeli air campaign in Tehran, Iran, Thursday, March 12, 2026. (AP Photo/Vahid Salemi)
Israeli authorities inspect homes damaged by a projectile launched from Lebanon, in Haniel central Israel, Thursday, March 12, 2026. (AP Photo/Baz Ratner)
Israel Ambassador to the United Nations Danny Danon speaks during a meeting of the Security Council at U.N. headquarters, Wednesday, March 11, 2026. (AP Photo/Seth Wenig)
A family enjoys the sunset with the view of the city skyline and Burj Khalifa, at Dubai Creek Harbour in Dubai, United Arab Emirates, Wednesday, March 11, 2026. (AP Photo/Fatima Shbair)
Oil tankers and cargo ships line up in the Strait of Hormuz as seen from Khor Fakkan, United Arab Emirates, Wednesday, March 11, 2026. (AP Photo/Altaf Qadri)
Smoke rises after an explosion at the airport in Irbil, Iraq, late Wednesday, March 11, 2026. (AP Photo/Leo Correa)
A man inspects a car damaged in an Israeli airstrike at the Ramlet al-Baida public beach in Beirut, Lebanon, early Thursday, March 12, 2026. (AP Photo/Bilal Hussein)
