TOKYO - Nikon CeLL innovation Co., Ltd. (NCLi), a subsidiary of Nikon Corporation (Nikon), manufactures iPSC-derived purified cardiomyocyte spheroids of HS-005, under contract to Heartseed Inc.(Heartseed).

Heartseed today announced that the successful dosing of the first patient in its domestic phase I/II clinical trial (EMERALD Study) of HS-005 which utilizes a catheter system for endocardial delivery to administer cardiomyocyte spheroids for patients with severe heart failure with reduced ejection fraction (HFrEF) with underlying ischemic heart disease as well as dilated cardiomyopathy.
HS-005 is an investigational cell therapy consisting of clusters of purified heart muscle cells (cardiomyocyte spheroids) derived from induced pluripotent stem cells (iPSCs) that are designed to restore heart muscle and function in patients with severe heart failure.

Cardiomyocyte spheroids of HS-005 have been manufactured by NCLi following HS-001^* under contract to Heartseed. NCLi and Heartseed will continue to collaborate for future supply of this treatment in the commercial phase of Japanese market by leveraging the know-how and technology of both companies.

Nikon and NCLi will contribute to this effort towards the practical use of regenerative medicine in Japan and to the improvement of QOL (Quality of Life).

Heartseed Inc. was founded with the aim of realizing cardiac remuscularization therapy, and it was listed on the Tokyo Stock Exchange Growth Market in July 2024 (Stock Code: 219A). Heartseed has proprietary technologies throughout the entire manufacturing process of the cardiomyocyte cell product, including purification, cell delivery and iPSC production. To date, the Company has received numerous awards in Japan and internationally, including the Japan Venture Awards 2021 (Minister of Science and Technology Policy Award), the University Venture Awards 2021 (Minister of Education, Culture, Sports, Science and Technology Award), the Asia-Pacific Cell & Gene Therapy Excellence Awards (Most Promising Pipelines Award), the IP BASE AWARD (Startup Category Grand Prize) presented by the Japan Patent Office, the 7th Japan Medical Research and Development Award – Startup Award (January 2025), and the Intellectual Property Achievement Award – Minister of Economy, Trade and Industry Award (April 2025).

The cell utilized by Heartseed in cardiac remuscularization therapy is an allogeneic iPSC-derived, highly purified ventricular cardiomyocyte product formulated in spheroids. The non-clinical studies confirmed that forming micro-tissue-like spheroids enhances the cell retention rate and viability compared to single cells in their administration.
When administering cardiomyocyte spheroids into the myocardial layer of the heart, HS-001 uses a proprietary delivery needle (SEEDPLANTER®) and guide adapter developed by Heartseed for epicardial delivery. In contrast, HS-005 utilizes a catheter system for endocardial delivery. The administered cardiomyocytes are expected to be engrafted into the patient's myocardium, promoting “remuscularization” and improving cardiac contractility. Additionally, they are anticipated to secrete various angiogenic factors, promoting neovascularization (formation of new blood vessels) around the administration sites.