Heartseed Inc. announced that Takehiko Kaneko, M.D., Board Director and Chief Medical Officer (CMO), will speak at the Global CVCT Forum (Global CardioVascular Clinical Trialists Forum), to be held in Washington D.C., USA, from December 8 to 10, 2025.

The Global CVCT Forum is a prestigious international conference that brings together principal investigators, statisticians, pharmaceutical executives, and regulators from major agencies such as the FDA and EMA. The forum serves as a platform to discuss the latest findings, trial designs, and regulatory challenges in cardiovascular clinical trials. With over 45 scientific sessions, the event fosters high-level discussions on clinical research trends and provides valuable networking opportunities.

Dr. Kaneko's invitation to speak at this forum highlights the growing global attention surrounding Heartseed's clinical development of HS-001 and HS-005 (LAPiS study, EMERALD study) within the context of cardiovascular therapeutic advancement.

Dr. Kaneko will participate in a key session titled "CELL THERAPY HEART FAILURE TRIALS," co-chaired by renowned experts Dr. Philippe Menasché (France) and Dr. Emerson Perin (USA). This session will address strategies regarding cell delivery methods and cell types (e.g., MSC vs. iPSC).

Specifically, Dr. Kaneko will join the "Industry Viewpoints" panel discussion alongside representatives from leading biotech companies in the US and China. The panel will debate critical issues regarding "Clinical trial design, and safety and efficacy endpoints."

Establishing trial designs that build consensus with regulatory authorities and investigators is crucial for the global development of regenerative medicine products. Through this forum, Heartseed aims to deepen strategic discussions to further optimize the ongoing studies and future global clinical trials.

■ Presentation Overview

• Conference: Global CVCT Forum (Global CardioVascular Clinical Trialists Forum)
• Session: CELL THERAPY HEART FAILURE TRIALS: CELLS, DELIVERY, AND DISEASE-SPECIFIC STRATEGIES
• Chairpersons: Philippe Menasché, MD, PhD (Paris, FRA) & Emerson Perin, MD, PhD (Houston, USA)
• Panel Topic: Design, and Safety and Efficacy Endpoints Related Issues - Industry Viewpoints
• Website: https://www.globalcvctforum.com/scientific-program-2025