#Japan #Tokyo #Japan Lifeline #Heartseed #HS-005

Heartseed and Japan Lifeline Collaborate on Groundbreaking Cardiac Therapy

Heartseed Inc., located in Minato, Tokyo, and Japan Lifeline Co., Ltd., based in Shinagawa, Tokyo, have announced significant progress in their partnership focusing on the clinical trials of Heartseed's advanced cardiac therapy, HS-005. This innovative treatment utilizes allogeneic iPS cell-derived cardiac muscle balls (cardiomyocytes) and is designed to enhance heart regeneration in patients suffering from severe cardiac conditions.

As part of their agreement, Japan Lifeline is providing a specialized catheter system for the delivery of HS-005 during the clinical trials. Registration of cases for the trials is on track, with the goal of submitting a clinical application by the end of 2025 remaining unchanged. The HS-005 program marks the next step following the successful completion of patient dosing in the prior LAPiS study with HS-001, which delivered iPS-derived cardiomyocytes through thoracotomy.

Overview of HS-005

The HS-005 therapy leverages advanced techniques to produce cardiac muscle cells from allogeneic iPS cells at a high purity level. These cells are aggregated into small tissue units termed cardiac muscle balls, enhancing their engraftment and viability compared to single-cell injections. In this next-generation therapy, unlike HS-001 which utilized a proprietary injection needle (SEEDPLANTER®) for external delivery, HS-005 employs a catheter to administer the cardiomyocytes from inside the heart. This method is expected to improve heart contraction capabilities and promote neovascularization, thereby fostering new blood vessel growth around the injection site due to the secretion of various angiogenic factors by the delivered muscle cells.

Japan Lifeline is recognized as a leading manufacturer in the electrophysiological diagnostic catheter market. The company boasts extensive experience in developing catheter systems used for cell delivery to the heart, marking it as the sole domestic entity with this expertise. Their catheter design incorporates sophisticated mechanisms that ensure precise cell delivery to targeted areas within the heart. Furthermore, the catheter supports 3D mapping of the heart, allowing physicians to visualize the cardiac imagery in real-time as they maneuver the catheter accurately to the desired location. A unique structural feature that includes an electrode at the tip lets clinicians verify the position of the cell delivery component within the myocardial layer by monitoring ECG changes (Protected by patent No. 7368599).

The Role of 3D Mapping Technology

3D mapping technology plays a crucial role in accurately visualizing the electrical signals and anatomical structures inside the heart. This capability has significantly improved treatment precision in arrhythmias by allowing practitioners to accurately locate the sources of atypical electrical signals and assess the shapes of cardiac chambers. By integrating this technology into cardiac regenerative medicine, the partners aim to enhance the precision of cell delivery to affected areas in the heart.

The collaboration has elicited enthusiastic responses from both companies. Heartseed's President, Eiichi Fukuda, remarked on the necessity of a system that can accurately target specific areas in the cardiac muscle, asserting that Japan Lifeline's advanced technology and robust track record in catheter development make them an ideal partner. He believes this collaboration represents significant progress toward the societal implementation of minimally invasive cardiac therapies.

Similarly, Keisuke Suzuki, President of Japan Lifeline, expressed excitement about their contribution to regenerative medicine, viewing the collaboration as an opportunity to utilize their high-functioning catheter systems to benefit Heartseed's innovative approaches to treatment. Both companies are committed to combining their strengths to deliver new hope to patients suffering from heart failure through this important collaboration.

Company Overview

Heartseed is a biotech venture dedicated to advancing cardiac regenerative medicine, having established its foundation with plans to go public on the Tokyo Stock Exchange's Growth Market in July 2024 (Stock Code 219A). The company has developed proprietary techniques for creating high-purity ventricular cardiac muscle cells from iPS cells, along with various other techniques crucial for the advancement of cardiac regenerative therapies. Notably, Heartseed entered a licensing agreement with Novo Nordisk, a major pharmaceutical company based in Denmark, for the development, manufacturing, and distribution of HS-001 in June 2021. The company has garnered multiple awards for its innovations, including the Japan Venture Awards 2021 and the Asia-Pacific Cell & Gene Therapy Excellence Awards.

Japan Lifeline, traded on the Tokyo Stock Exchange (Prime), specializes in medical devices relevant to the cardiac and circulatory field. The company handles a portfolio of electrophysiological catheters and artificial blood vessels, employing both importing and manufacturing capabilities to deliver the latest medical devices to healthcare professionals globally. With 48 domestic sales offices and a commitment to international outreach, Japan Lifeline aims to consistently provide cutting-edge medical equipment to healthcare institutions and patients.

This press release contains forward-looking statements regarding Heartseed and individuals involved in its clinical trials. These statements are based on information available as of the release date and contain inherent risks and uncertainties that could lead to actual results differing materially from those projected. Notably, Heartseed is not obliged to update this information routinely.

For further inquiries regarding this press release:

Heartseed Inc.
COO & Public Relations Manager, Kikuo Yasui
1-2-3 Shibaura, Minato, Tokyo 105-0023, Japan
TEL: +81-3-6380-1068
E-mail: [email protected]

Japan Lifeline Co., Ltd.
Director and Executive Vice President, Takayoshi Egawa
2-2-20 Higashi Shinagawa, Shinagawa, Tokyo 140-0002, Japan
TEL: +81-3-6711-5214
E-mail: [email protected]