Heartseed

Heartseed Inc. is a clinical-stage biotechnology firm established in November 2015, specializing in developing treatments for severe heart failure. The company was founded by Professor Keiichi Fukuda, a renowned cardiologist and a global leader in cardiac regeneration research since the 1990s. His journey began with a landmark achievement in 1999, where he was the first to differentiate cardiomyocytes from bone marrow stem cells. Realizing the challenges in efficiently producing pure, functional cardiomyocytes for large-scale application, he founded Heartseed to commercialize his research from Keio University.

The company's core focus is on addressing severe heart failure, a condition with limited treatment options beyond heart transplants, which are scarce. Heartseed's business model revolves around the development and commercialization of its proprietary cell therapies. A key component of its strategy includes a major collaboration with Novo Nordisk, which holds exclusive rights to develop, manufacture, and commercialize Heartseed's lead product, HS-001, globally, except in Japan. In Japan, Heartseed retains development rights, with a 50/50 profit and cost-sharing arrangement for co-commercialization with Novo Nordisk. This agreement structure provides Heartseed with significant milestone payments and royalties on international sales, funding further research and development.

Heartseed's lead product, HS-001, is a cell therapy composed of allogeneic induced pluripotent stem cell (iPSC)-derived ventricular cardiomyocyte spheroids. These are clusters of approximately 1,000 highly purified heart muscle cells designed for transplantation into a damaged heart. This "remuscularization" approach aims to have the transplanted cells electrically couple with the patient's own heart muscle, thereby improving its pumping function. A key technological advantage is the company's method for purifying cardiomyocytes to nearly 99% purity, which mitigates the risk of tumors. The spheroids are implanted into the myocardial layer using a specialized needle (SEEDPLANTER®) to ensure efficient and safe delivery, improving cell retention and viability. The company is conducting a Phase 1/2 clinical trial (LAPiS Study) in Japan for patients with advanced heart failure from ischemic heart disease, with the first patient dosed in late 2022.

Keywords: cardiac regeneration, iPSC-derived cardiomyocytes, heart failure therapy, cell therapy, remuscularization, Keiichi Fukuda, HS-001, cardiomyocyte spheroids, Novo Nordisk collaboration, allogeneic cell therapy, clinical-stage biotech, ventricular cardiomyocytes, SEEDPLANTER, LAPiS Study, Keio University, ischemic heart disease, myocardial regeneration, cardiovascular disease, stem cell treatment, Japan biotech