KVAC 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.

Clinical Trial Results: Medera Inc. announced positive interim results from its MUSIC-HFpEF Phase 1/2a clinical trial for SRD-002, a gene therapy aimed at treating heart failure with preserved ejection fraction (HFpEF), showing a favorable safety profile and early clinical benefits in patients.

Significance of HFpEF: HFpEF affects approximately half of all heart failure patients globally, representing a significant unmet medical need, and the promising results from SRD-002 may provide a transformative approach to address the underlying pathophysiology of this condition.

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.

Class Action Firm Recognition: Monteverde & Associates PC, a leading class action firm based in New York, has been recognized as a Top 50 Firm for recovering millions for shareholders and is currently investigating several proposed mergers involving companies like Playa Hotels & Resorts and Liberty TripAdvisor Holdings.

Investor Actions Required: Shareholders of the mentioned companies are urged to act promptly regarding upcoming tender offers and shareholder votes, with deadlines approaching between April 24 and April 29, 2025, and can seek further information at no cost.

Clinical Trial Progress: Medera Inc. has received a recommendation from the independent Data and Safety Monitoring Board to proceed with the Phase 2 portion of its MUSIC-HFrEF clinical trial, which evaluates the gene therapy candidate SRD-001 for treating heart failure with reduced ejection fraction (HFrEF).

Company Overview: Medera is focused on developing next-generation therapeutics for cardiovascular diseases and has entered into a merger agreement with Keen Vision Acquisition Corporation to enhance its clinical development efforts.