In July 2024, we reached a major milestone with the conditional and time-limited approval of AKUUGO® Suspension for Intracranial Implantation (“AKUUGO®”), a cell therapy medicine aimed at achieving the world’s first regeneration of brain tissue. In the fiscal year ended January 31, 2026, we fulfilled the conditions attached to this approval regarding product shipment, enabling commercial shipment to commence. We are now awaiting NHI drug price listing and product launch, and full-scale clinical application is finally within reach.
With the approval of AKUUGO®, we are now able to bring to society a cell therapy that promotes the regeneration of brain tissue. The current fiscal year marks a pivotal period for us as we transition toward real-world implementation of this product. After many years of research and development, we are deeply encouraged to have reached the stage where we can finally deliver AKUUGO® to patients. As we mark the milestone of our first commercial shipment in the current fiscal year, I would like to once again express my sincere gratitude to our shareholders for their longstanding support.
As we strive to become a global leader in regenerative medicine, we are strengthening our infrastructure to support the smooth adoption of AKUUGO® in Japan while accelerating initiatives for further growth. In the current fiscal year, we will steadily advance preparations for consultations with the Pharmaceuticals and Medical Devices Agency (PMDA) with the aim of expanding AKUUGO®’s indications to include ischemic stroke.
In the U.S., building on our approval in Japan, we will proceed with consultations with the U.S. Food and Drug Administration (FDA) toward initiating clinical trials. Through these efforts, we will take concrete steps to bring Japan-originated regenerative medicine to the global stage.
There are still many patients worldwide suffering from central nervous system disorders for which effective treatments remain limited. We will continue to address traumatic brain injury (TBI) while also expanding into additional indications, including ischemic stroke and hemorrhagic stroke. Through these efforts, we aim to achieve both sustainable enhancement of corporate value and the creation of social value.
Our mission is to transform the potential of regenerative medicine into real-world healthcare. We will continue to move steadily into the next stage of growth, and we sincerely ask for your continued support.
April 22, 2026
Keita Mori, CEO
