KVACW Overview

Mini-Heart Models Development: A collaboration between Medera, Novoheart, and leading medical institutions aims to create the first human mini-heart models from stem cells of hypoplastic left heart syndrome (HLHS) patients, enhancing understanding and treatment personalization for this severe congenital heart condition.

Focus on Personalized Treatment: The initiative seeks to improve survival rates and quality of life for pediatric HLHS patients by identifying which individuals may benefit most from various treatments, leveraging advanced 3D bioengineered cardiac tissues that better replicate human heart function compared to traditional models.

Presentation Highlights: Medera Inc. showcased seven presentations at the ISSCR 2025, including a significant oral presentation on their first-in-human gene therapy for heart failure, utilizing their innovative human mini-Heart technology, which supports clinical trials and regulatory approvals.

Regulatory Advances: The FDA has recognized Medera's human-based screening platform as an animal-free alternative in drug development, emphasizing its potential to enhance drug classification, patient-specific disease modeling, and accelerate clinical translation while aligning with new federal policies.

Medera Inc. Clinical Trial Announcement: Medera Inc. will present data from its MUSIC-HFpEF clinical trial on the gene therapy candidate SRD-002 for heart failure with preserved ejection fraction (HFpEF) at the Heart Failure 2025 Congress in Belgrade, Serbia, highlighting the need for new therapeutic interventions in this area.

Company Background and Merger Plans: Medera, a biopharmaceutical company focused on developing next-generation therapeutics, is in the process of merging with Keen Vision Acquisition Corporation (KVAC), aiming to enhance its capabilities in targeting difficult-to-treat diseases.

Cutting-Edge Cardiac Research: Novoheart's CTScreen™ system has been installed at UMC Utrecht, enhancing capabilities for human cardiac disease modeling and therapeutic screening, which will facilitate advancements in drug development and gene editing approaches.

Driving Innovation: This collaboration between Novoheart and UMC Utrecht is expected to lead to breakthroughs in cardiovascular research and strengthen their partnership in exploring innovative cardiac regenerative technologies.

Medera's Upcoming Investor Conferences: Medera, a clinical-stage biotechnology company, will present at the Oppenheimer 35th Annual Healthcare Life Sciences Conference on February 11 and will also be available for meetings at the BIO CEO & Investor Conference on February 10 and 11.

Merger Agreement with Keen Vision Acquisition Corp: Medera has entered into a definitive merger agreement with Keen Vision Acquisition Corp, focusing on developing next-generation therapies for difficult-to-treat diseases, leveraging their innovative mini-Heart technology for drug discovery and validation.

Innovative Partnership: Medera's Novoheart has partnered with Curi Bio to integrate their human "Heart-in-a-Jar" technology with Curi Bio’s Pulse™ analytics, enhancing cardiac drug screening and aligning with the FDA Modernization Act 2.0 for ethical preclinical models.

Accelerated Drug Development: The collaboration aims to significantly improve efficiency in drug development processes, reducing time and costs while increasing predictivity, ultimately leading to safer and more effective therapies for patients.