BOSTON--(BUSINESS WIRE)--Sep 9, 2026--
Emulate, Inc., the leading provider of next-generation Organ-on-a-Chip technology, today announced it has submitted its FDA Innovative Science and Technology Approaches for New Drugs (ISTAND) full qualification package (FQP) for its Human Liver-Chip, advancing the company's efforts to establish Organ-on-a-Chip technology as a qualified Drug Development Tool (DDT) for drug-induced liver injury (DILI) assessment.
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The submission includes data generated on both Emulate’s Zoë ® Culture Module and its next-generation AVA Emulation System, extending the qualification package across two Organ-Chip platforms designed to support different stages and scales of pharmaceutical research. If the FDA ultimately qualifies the Human Liver-Chip for DILI assessment, it would establish an important regulatory precedent for Organ-on-a-Chip technology and provide drug developers with a standardized, human-relevant approach for evaluating liver toxicity.
"Submitting this qualification package represents years of close collaboration with the FDA and reflects the maturity of Organ-on-a-Chip technology as a practical tool for drug development," said Jim Corbett, Chief Executive Officer of Emulate. "Our application has been strengthened and shaped by the FDA reviewers’ comments and questions throughout the Letter of Intent and Qualification Plan stages, helping us develop a robust evidence package to support qualification. As the industry continues shifting toward more human-relevant approaches, we're proud to help drive that progress with technology designed to inform clearer, more confident preclinical decision-making."
The qualification package includes data demonstrating:
While the initial round of qualification data was established on the Zoë platform, incorporating additional data from the AVA Emulation System in the final submission demonstrates that the same scientific performance can be achieved on Emulate's automated, higher-throughput system, enabling broader adoption across pharmaceutical discovery and development workflows. By including both platforms within the qualification package, researchers could move seamlessly from Zoë to AVA as their throughput needs grow.
This pioneering qualification package has been spearheaded by Emulate’s Chief Technology Officer,Daniel Levner, Ph.D., and Emulate’s Chief Scientific Officer,Lorna Ewart, Ph.D. "The strength of this submission is not simply that the Liver-Chip works, it's that it works consistently," said Dr. Ewart. "The data show reproducibility across laboratories, multiple cell donors, and studies conducted months apart, which are exactly the characteristics regulators and industry need to trust a new Drug Development Tool. Including AVA in the qualification package also extends that confidence to a platform designed for larger-scale studies, making it a realistic tool to incorporate in standard pharmaceutical workflows."
The submission builds on years of collaboration between Emulate and the FDA, including joint scientific publications that helped establish best practices and official guidelines for interpreting Liver-Chip data. Entering the final stage of the ISTAND’s qualification process reflects a momentous milestone in the FDA's broader efforts to accelerate the adoption of scientifically validated, human-relevant methods to improve drug development and reduce reliance on animal testing.
About Emulate, Inc.
Emulate, Inc. is the pioneer of Organ-on-a-Chip technology, enabling researchers to accurately replicate human tissue function and disease biology through next generation in vitro models. From target discovery to IND submission, Emulate aims to ignite a new era in human health research—one that reduces animal testing, cuts drug development costs, and accelerates the delivery of life-saving treatments. Emulate’s Organ-Chip platforms, consumables, and organ models help the world’s leading pharmaceutical, biotech, and academic teams generate human-relevant data that advance safer, more effective therapies.
Learn more at www.emulatebio.com or follow us on LinkedIn and Twitter.
The Emulate Liver-Chip S1 is a human Organ-Chip model designed to recreate key aspects of liver biology, providing researchers with a more human-relevant way to study liver function and drug response.
ATLANTA & RIYADH, Saudi Arabia--(BUSINESS WIRE)--Oct 31, 2026--
The United States of America has signed its Participation Contract for Expo 2030 Riyadh, marking a significant milestone in the World Expo’s preparations and further strengthening the momentum for international participation in the global event.
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The signing marks an important step in the United States’ journey towards Expo 2030 Riyadh, paving the way for the development of its pavilion, programming and visitor experience. It also reinforces the growing international commitment to Expo 2030 Riyadh, as countries move from confirming their participation to actively shaping the experiences, ideas and innovations they will bring to the Kingdom in 2030.
The Participation Contract was signed by His Highness Prince Faisal bin Farhan Al Saud, Minister of Foreign Affairs of the Kingdom of Saudi Arabia, and U.S. Secretary of State Marco Rubio, during a bilateral meeting held on the sidelines of the 2026 G20 Foreign Ministers’ Meeting in Atlanta, Georgia. The signing ceremony was attended by Her Royal Highness Princess Reema bint Bandar bin Sultan bin Abdulaziz Al-Saud, Ambassador of the Kingdom of Saudi Arabia to the United States, and Talal Al-Marri, CEO of Expo 2030 Riyadh.
Building on its longstanding tradition of participation in World Expos, the United States will develop its presence on a dedicated plot within Expo 2030 Riyadh’s Technology precinct. Its participation will offer an opportunity to showcase American innovation, creativity and technological leadership, while contributing to the Expo’s theme, “Foresight for Tomorrow.”
The United States joins a growing number of countries that have formalised their participation in Expo 2030 Riyadh, reflecting continued progress in international engagement. More than 185 Official Participants have confirmed participation, with preparations advancing across pavilion planning, content development and programming. Each new contract marks a further step in translating international commitments into a robust and compelling World Expo experience.
Meanwhile, work continues to progress across the Expo site in northern Riyadh, with infrastructure development and construction of key assets advancing. Together, these milestones demonstrate the progress being made on both fronts: building the physical foundations of Expo 2030 Riyadh and bringing together the international participants who will shape its content and visitor experience.
Held under the theme “Foresight for Tomorrow,” Expo 2030 Riyadh will take place from 1 October 2030 to 31 March 2031, bringing together countries and international organisations from around the world and welcoming more than 42 million visits over six months. Through its five thematic areas - Technology, Planet, Humanity, Culture and Collaboration - the Expo will provide a global platform for nations to share their achievements and ambitions, explore solutions to shared challenges and inspire new possibilities for the future.
About Expo 2030 Riyadh
Running from 1 October 2030 to 31 March 2031, Expo 2030 Riyadh will be among the most ambitious World Expos ever conceived with a 6 million square meter site that will bring together 197 Official Participants and is expected to welcome 42 million visits across 5 distinct districts.
Held under the theme “Foresight for Tomorrow,” and hosted in Riyadh - a city of action and ambition - Expo 2030 Riyadh will provide a platform for participants to exchange ideas, shape solutions, and build partnerships that drive real impact, address global challenges, and unlock new opportunities. The World Expo will feature immersive cultural zones, daily activations, and AI-powered interactions, blending traditional Saudi hospitality with cutting-edge technology. Following the six-month event, the Expo site will evolve into a vibrant destination, continuing to attract visitors and contribute to Riyadh’s dynamic urban landscape.
For more information, please visit: https://www.expo2030riyadh.sa/en/
Proposed site for Expo 2030 in Riyadh, Saudi Arabia.
His Highness Prince Faisal bin Farhan Al Saud, Minister of Foreign Affairs of the Kingdom of Saudi Arabia, signs the Participation Contract.
The Participation Contract was signed by His Highness Prince Faisal bin Farhan Al Saud, Minister of Foreign Affairs of the Kingdom of Saudi Arabia, and U.S. Secretary of State Marco Rubio, during a bilateral meeting held on the sidelines of the 2026 G20 Foreign Ministers’ Meeting in Atlanta, Georgia.
