Participated · Series B · Nov 2019

Heartseed develops HS-001, an allogeneic iPSC-derived, highly purified ventricular cardiomyocyte spheroid therapy intended to remuscularize the myocardium and promote neovascularization. The company completed first human dosing of HS-001 in December 2022 and reports initial safety and early signs of efficacy. Heartseed plans to use new funds to complete its Phase 1/2 LAPiS study in Japan and to build an organization for product launch. It is also examining less invasive delivery, such as transendocardial catheter injection, for global development by Novo Nordisk. Since its founding in 2015, Heartseed has raised a total of 10.2 billion JPY (approx. $74 million). The LAPiS study is a 52-week, open-label, dose-escalation Phase 1/2 trial in patients with advanced ischemic heart failure with primary safety assessment at 26 weeks and secondary endpoints including LVEF and myocardial wall motion. Heartseed raised 4 billion yen (approx. $37M) in a Series C financing. The company will use the funds to accelerate initiation of a global clinical trial of HS-001 for heart failure, confirm proof of concept in the Phase 1/2 LAPiS study in Japan, and examine less invasive administration such as transendocardial injection via catheter. HS-001 is an allogeneic iPSC-derived, highly purified ventricular cardiomyocyte spheroid designed to improve retention rate and viability by forming micro-tissue-like spheroids. The spheroids are transplanted using a special administration needle (SEEDPLANTER®) and guide adapter developed for safe and efficient delivery into the myocardial layer. The round brought Heartseed’s total financial backing to 8.2 billion yen (approx. $75M) since its foundation in 2015. The company is led by co-founder and CEO Professor Keiichi Fukuda and is based in Tokyo, Japan. Heartseed is a Tokyo-based biotechnology company originating from Keio University that is developing HS-001, an allogeneic iPSC-derived cardiomyocyte spheroid therapy for severe heart failure. The company is preparing to initiate clinical trials for HS-001 and is arranging clinical-trial supply logistics. In advance of the trial, Heartseed will outsource manufacturing to Nikon CeLL innovation Co., Ltd. and is discussing transport of the cardiomyocyte spheroids with MEDIPAL. MEDIPAL and its wholly owned subsidiary SPLine will collaborate with Heartseed on logistics and will begin research on transport solutions for the therapy. MEDIPAL will also acquire an equity stake in Heartseed as part of the capital and business alliance. MEDIPAL brings a distribution system compliant with Japanese GDP guidelines and an ultra-low temperature transport system used for regenerative medicine products. Heartseed develops iPSC-derived ventricular-specific cardiomyocytes as a regenerative medicine approach for heart failure. Its lead program, HS-001, is intended to engraft in patients' hearts long-term and is positioned as a potential curative therapy for severe HFrEF. The company says it has solved key technical challenges including ventricular-specific cardiomyocyte differentiation, purification, large-scale manufacturing and efficient cell delivery. Heartseed planned to initiate a Phase 1/2 clinical trial for HS-001 in late 2020 and is supporting an investigator-initiated trial for dilated cardiomyopathy expected in the first half of 2020. Financially, Heartseed announced a ¥2.8 billion (approx. $26M) Series B and reports total financial backing of ¥3.8 billion (approx. $35M).