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Heartseed Inc. announced the successful administration of HS-005 to the first patient in its domestic Phase I/II clinical trial, the EMERALD Study. The therapy targets patients with severe heart failure with reduced ejection fraction (HFrEF) due to ischemic heart disease or dilated cardiomyopathy. HS-005 consists of clusters of purified heart muscle cells derived from induced pluripotent stem cells (iPSCs), designed to restore heart function by integrating into damaged tissue.

Nikon CeLL innovation Co., Ltd. (NCLi), a Nikon subsidiary, manufactured the cardiomyocyte spheroids for HS-005 under contract to Heartseed. The collaboration between NCLi and Heartseed will continue to support future commercial supply in Japan, leveraging their combined expertise in regenerative medicine. The goal is to advance practical applications of cell therapy to improve patient quality of life.

Heartseed, listed on the Tokyo Stock Exchange Growth Market since July 2024, holds proprietary technologies across the entire manufacturing process of its cardiomyocyte cell product. These include purification, cell delivery, and iPSC production, with multiple domestic and international awards recognizing its innovations in cardiac remuscularization therapy.

HS-005 uses a catheter system for endocardial delivery, unlike HS-001, which employs a proprietary needle for epicardial delivery. The administered cardiomyocyte spheroids are expected to engraft into the myocardium, promoting remuscularization and improving cardiac contractility while secreting angiogenic factors to stimulate new blood vessel formation around the treatment sites.