Pluri Adds ISO 9001 and ISO 13485 Certifications to Support PluriCDMO Commercial Expansion

Supporting expanded manufacturing services and new commercial opportunities across the regulated life sciences industry

HAIFA, Israel, Nov. 09, 2026 (GLOBE NEWSWIRE) -- Pluri Inc. (Nasdaq, TASE: PLUR) ("Pluri" or the "Company"), a biotechnology company advancing cell-based solutions for health and longevity, today announced that its PluriCDMO™ business has obtained ISO 9001:2015 certification for its quality management system supporting research and development of cell-based products and their derivatives, and ISO 13485:2016 certification, which was obtained in August 2026. These certifications support PluriCDMO's efforts to engage additional customers.

ISO 9001 is an internationally recognized quality management standard used across industries, while ISO 13485 addresses medical device quality systems. For prospective customers, the certifications provide independently assessed quality frameworks to consider when evaluating a development or manufacturing partner. Pluri's ISO 13485:2016 certification covers contract manufacturing services for medical device companies.

PluriCDMO, launched in 2024, has entered into commercial agreements with a number of customers for development and manufacturing services. The added certifications build on that operating base and support the business in pursuing projects with a broader range of life sciences companies.

"We have spent more than two decades building manufacturing capabilities, and our goal is to turn them into more customer programs and revenue," said Yaky Yanay, Chief Executive Officer and President of Pluri. "Quality systems matter when customers select manufacturing partners. The ISO certifications complement our extensive cGMP-based cell therapy manufacturing experience and enable us to offer PluriCDMO's services to customers whose qualification requirements specifically include ISO 9001 or ISO 13485."

PluriCDMO provides process development and manufacturing services supported by Pluri's extensive cell manufacturing experience, analytical capabilities and dedicated infrastructure. It serves cell-based product developers and is pursuing medical device contract manufacturing opportunities within the scope of its certified systems. For more information, visit www.pluri-biotech.com/cdmo.

About Pluri

Pluri™ is a biotechnology company advancing cell-based solutions for health and longevity. Powered by its proprietary 3D cell expansion platform, Pluri develops and manufactures innovative cell-based products designed to address significant unmet medical needs and support healthier, longer lives. With decades of expertise in cell science, clinical development and scalable manufacturing, Pluri is building a portfolio of regenerative and longevity-focused solutions while leveraging its technology and manufacturing capabilities through strategic partnerships and CDMO services. To learn more, visit www.pluri-biotech.com or follow Pluri on LinkedIn and X.

Safe Harbor Statement

This press release contains express or implied forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other U.S. federal securities laws. For example, Pluri is using forward-looking statements when it discusses the potential for its ISO 9001 and ISO 13485 certifications to support PluriCDMO’s commercial expansion and enable PluriCDMO to engage additional customers, the ability of PluriCDMO to pursue projects with a broader range of life sciences companies, the potential for the certifications to enable PluriCDMO to offer its services to customers whose qualification requirements include such certifications, the pursuit of medical device contract manufacturing opportunities, and the potential for PluriCDMO to generate additional customer programs and revenue. These forward-looking statements and their implications are based on the current expectations of the management of Pluri only and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements.

The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: the possibility that the anticipated commercial benefits of the ISO certifications are not realized; the possibility that the certifications do not result in additional customers, projects or revenue; the Company's ability to successfully execute its commercialization and strategic initiatives; changes in economic, business, market or regulatory conditions; inability to retain or attract key employees; increased competition, loss of market share or pricing pressure; inability to timely develop and introduce new technologies, products and applications; and other risks and uncertainties that may affect the Company's business. Except as otherwise required by law, Pluri undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.

For a more detailed description of the risks and uncertainties affecting Pluri, reference is made to Pluri's reports filed from time to time with the Securities and Exchange Commission.

Contact

investor.relations@pluri-biotech.com