Healios KK

HEALIOS K.K. is a Japan-based company mainly engaged in research and development of pharmaceutical products. The Company has compound pharmaceutical products line and induced pluripotent stem cell (iPSC) regenerative medicine product line. The compound pharmaceutical product line contains HLM0021, HLM0022 and HLM0023. The products are ophthalmological surgery adjuvants, mainly contain brilliant blue G-250 (BBG250) which help capsule temporarily safely stained to protect the inner limiting membranes and lens during surgery of vitreous and cataract. The iPSC regenerative medicine product line contains HLCR011 and HLCR012. The products are in the preclinical testing and preparation for trial in Japan, which are candidate of regenerative medicine products. The products are iPS cell derived retinal pigment epithelium (RPE) cell suspension and sheet developed in Japan, United States and Europe.

Healios began developing somatic stem cell regenerative medicine after entering into a license agreement with Athersys, Inc. (NASDAQ: ATHX, “Athersys”) in 2016. Athersys’ stem cell product MultiStem® (HLCM051) is a cell therapy product derived from human bone marrow of consenting adult donors. The clinical grade product is produced by first creating a master cell bank, then a working cell bank, and subsequently producing clinical doses for patients. Athersys holds the patent and licensing rights to this important technology, and has conducted multiple studies demonstrating that it exhibits a consistent safety profile and therapeutic potential. HLCM051 can be stored for long periods of time using cryopreservation, does not require immunosuppressants, and dissipates rather than accumulating within the body when administered by intravenous injection (drip). The cells are believed to promote healing and recovery through several important mechanisms.