HAIFA, Israel – December 20, 2024 –Pluri Inc., a leader in cell-based technologies and an innovator in the development of mesenchymal stromal cell (“MSC”) products for various indications, congratulates Mesoblast Ltd. (“Mesoblast”) and its Chief Executive Officer, Silviu Itescu, on the U.S. Food and Drug Administration (the “FDA”) approval of the first MSC-based therapy for steroid-refractory acute graft-versus-host disease (“SR-aGVHD”). This landmark achievement marks a pivotal moment in the advancement of regenerative medicine and highlights the growing clinical and regulatory recognition of MSC therapies’ transformative potential.

“This milestone is not just a triumph for Mesoblast, but for the entire field of cellular medicine,” said Yaky Yanay, Chief Executive Officer and President of Pluri. “Silviu and the team at Mesoblast have opened a new chapter in harnessing MSC therapies to treat devastating conditions like SR-aGVHD. This approval validates the immense therapeutic promise of MSCs and inspires all of us working in this space to redouble our efforts to bring innovative solutions to patients in need.”

The FDA approval also underscores the critical role of regenerative medicine in transforming healthcare systems globally. “Regenerative medicine has the potential to shift the paradigm from managing chronic conditions to enabling true healing and regeneration,” Mr. Yanay added. “By addressing the root causes of diseases rather than just their symptoms, regenerative therapies can potentially improve patient outcomes while creating more sustainable and efficient healthcare systems.”

Pluri has long championed the potential of MSCs through its proprietary platform, harnessing its unique 3D cell-expansion technology to develop robust and scalable cell-based therapies. The Company’s innovative approach positions it at the forefront of cell therapy development, enabling the creation of next-generation solutions that address critical unmet medical needs.

“At Pluri, we share a vision of a future where cell-based technologies transform lives across a spectrum of diseases,” Mr. Yanay said. “We believe that the FDA’s decision underscores the urgency and opportunity to accelerate the development of MSC-based therapies globally.”

Pluri remains steadfast in its mission to expand the therapeutic boundaries of MSCs, leveraging its expertise to pioneer new treatments that meet the highest standards of efficacy, safety, and accessibility. Pluri’s PLacental eXpanded cells are placenta-derived, mesenchymal-like adherent stromal cells which are being studied for the treatment of hematopoietic indications such as Acute Radiation Syndrome as well as orthopedic indications such as Knee Osteoarthritis. For more information about Pluri and its advanced cell therapy product candidates, visit https://pluri-biotech.com/solutions-pluri-health/