TOKYO, JAPAN, May 25, 2023 - Heartseed (Heartseed Inc.), a Tokyo-based biotechnology company developing iPSC-derived cardiomyocytes for heart failure (HF), today announced it has raised 2 billion JPY at Series D round, bringing its total financial backing to 10.2 billion JPY (approx. $74 million) since it was founded in 2015.

New investors are Japan Co-Invest IV Limited Partnership (GP: Sumitomo Mitsui Trust Investment), Arcus South East Asia, Atsushi Sakano (Partner of Aspex Management), Koei Tecmo Capital, Nikon-SBI Innovation Fund, etc. Among the existing investors, SMBC Venture Capital, Private Equity Co-Invest II Limited Partnership (GP: Sumitomo Mitsui Trust Investment), UTokyo Innovation Platform, Medical Incubator Japan, Keio Innovation Initiative (KII), etc. participated this round.

Heartseed plans to use the new funds to complete the Phase 1/2 clinical trial of our lead asset, HS-001 for HF in Japan, as well as to establish an organization for its launch. In addition, Heartseed will also examine a less invasive administration such as transendocardial injection using a catheter for global development by Novo Nordisk.

"Heartseed achieved the first human dosing of HS-001 in December 2022, and initial safety and early sings of efficacy are being confirmed." said Keiichi Fukuda, co-founder and CEO at Heartseed. "The commitment from both new and existing investors in this round is a strong validation of our technology and strategic vision. With their support, we look forward to accelerating our development to deliver potentially curative therapy for heart failure across the globe." 

About HS-001 and LAPiS Study

HS-001, is allogeneic iPSC-derived, highly purified ventricular cardiomyocyte spheroids. By forming micro-tissue-like spheroids, retention rate and viability of cell transplant are improved. The spheroids are transplanted using a special administration needle (SEEDPLANTER®) and guide adapter developed for safe and efficient administration of the spheroids into the myocardial layer of the heart.

The expected mechanism of action is that the transplanted cardiomyocytes electrically couple with the patient's myocardium to improve cardiac output by remuscularization, and secretion of angiogenic factors to form new blood vessels around the transplant site (neovascularization).

LAPiS Study a 52-week, phase 1/2, open-label, dose-escalation study in patients with advanced heart failure caused by ischaemic heart disease, conducted at various study sites in Japan. HS-001 will be transplanted into the diseased tissue of the heart during open-heart surgery in conjunction with a planned coronary artery bypass graft procedure. The study will enrol 10 patients in two dose cohorts of 50 million and 150 million cardiomyocytes. The primary endpoint of the study is safety at 26 weeks post-transplantation, and secondary efficacy endpoints include left ventricular ejection fraction and myocardial wall motion.

About Heartseed

Heartseed Inc. was founded in 2015 to develop and commercialize cardiac remuscularization therapy developed by Professor Keiichi Fukuda and his group at the Department of Cardiology, Keio University, Tokyo, Japan. Heartseed has proprietary technologies throughout the entire manufacturing process of the cardiomyocyte-cell product, including purification, cell delivery and iPSC production.

Heartseed announced the global collaboration and license agreement with Novo Nordisk A/S for HS-001 in June 2021. Heartseed received "Minister of Science and Technology Policy Award" at Japan Venture Awards 2021 and "Ministry of Education, Culture, Sports, Science and Technology Award" at Academic Startups 2021, and "Most Promising Pipelines Awards (iPSC)" at Asia Pacific Cell & Gene Therapy Excellence Awards 2022. For more information, visit heartseed.jp, LinkedIn and YouTube.

Company Name: Heartseed Inc.

Established:         November 30, 2015

Founder & CEO:  Keiichi Fukuda

Headquarter:        The Art Complex Center of Tokyo #302, Daikyo-cho 12-9, Shinjuku-ku, Tokyo, Japan

Contact:

Kikuo Yasui,

COO, Heartseed Inc.

Tel: +81-3-6380-1068

Email: kikuo.yasui@heartseed.jp