Healios K.K. is developing a treatment for patients with pneumonia induced ARDS using HLCM051, a somatic stem cell regenerative medicine. As announced on March 2, 2023, have disclosed the outline of the trial necessary for data augmentation required to advance the product to approval in Japan. In addition, the company announced that in preparation for the start of this study, have also conducted a regenerative medicine product quality consultation with the Pharmaceuticals and Medical Devices Agency (PMDA) to receive advice on the investigational product to be used in this study, and have reached an agreement to use investigational product manufactured by 3D bioreactor-based method.

The use of a 3D bioreactor- based method enables efficient and stable mass production of cells, and therefore allows for the supply of product in large quantities in a stable manner for commercial production after the launch of the product, as compared to the conventional 2D method utilized in prior studies. Importantly, the 3D method also promises cost efficiencies and anticipated superior economics.