Cellusion

About Cellusion

Cellusion Inc. is a Japanese regenerative medicine startup founded in January 2015, spun out from the Department of Ophthalmology at Keio University School of Medicine. The company was established by Professor Kazuo Tsubota, Professor Shigeto Shimmura, and Dr. Shin Hatou, who now serves as the CEO. Dr. Hatou, a clinical ophthalmologist specializing in corneal transplants, was motivated by the significant global shortage of donor corneas, with an estimated 13 million patients waiting for a transplant. This first-hand experience in his clinical practice and doctoral research into corneal regenerative medicine using iPS cells led to the founding of Cellusion.

The company is focused on developing therapies for bullous keratopathy, a condition causing corneal swelling and vision loss due to a decline in corneal endothelial cells. This disease is a leading reason for corneal transplants. Cellusion's core product, CLS001, is a cell therapy that uses a proprietary method to create corneal endothelial substitute cells (CECSi) from induced pluripotent stem cells (iPSCs). This technology aims to overcome the three main bottlenecks of traditional corneal transplants: the reliance on donor corneas, the need for highly skilled surgeons, and the necessity of eye bank infrastructure. The treatment involves a simple injection of the cultured cells into the eye, a less invasive procedure that is easier for ophthalmologists to learn compared to complex transplant surgeries.

Cellusion's business model is centered on the mass production of its CLS001 cells. The company has developed a direct differentiation induction method that allows for the stable, large-scale production of CECSi cells from a single allogeneic iPSC stock in about a month. The final product can be cryopreserved, enabling off-the-shelf availability and global distribution, similar to conventional pharmaceuticals. The firm has entered into partnerships to advance its manufacturing and commercialization efforts, including a business alliance with Nikon CeLL innovation and a manufacturing agreement with Minaris Regenerative Medicine for the U.S. market. In September 2022, Cellusion signed an exclusive licensing agreement with Celregen, a subsidiary of Fosun Pharma, to develop, manufacture, and commercialize CLS001 in Greater China, a deal potentially worth over $100 million.

The company has progressed through several funding rounds, raising a total of $32.2 million as of June 2023, with its Series C round securing $21 million. These funds are allocated to advance company-sponsored clinical trials in Japan and prepare for global trials. The first-in-human clinical study of CLS001 began in 2022 at Keio University Hospital, and the first patient was transplanted in March 2023, showing promising early results in safety and efficacy. In December 2023, CLS001 received Orphan Drug Designation from the U.S. FDA for the treatment of bullous keratopathy.