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Medera announced the publication of a study in Pharmacological Research demonstrating how its subsidiary Novoheart is using AI and machine learning to enhance drug screening with human mini-Heart technology. The study achieved an 86.2% predictive accuracy in classifying drug effects, addressing the challenge of high failure rates (over 90%) in clinical trials that result in development costs exceeding $2 billion per drug. The innovative approach combines AI/ML with multiple human mini-Heart screening assays to improve drug classification capabilities, potentially reducing costs and enhancing safety in drug development.
Medera announced completion of Cohort A and initiation of Cohort B dosing in its MUSIC-HFpEF Phase 1/2a clinical trial, evaluating SRD-002, a first-in-human gene therapy for Heart Failure with Preserved Ejection Fraction (HFpEF). The trial shows promising efficacy results at six months in Cohort A (low-dose 3x10^13 vg), with no unexpected events or toxicities. Following DSMB recommendation, Cohort B (high-dose 4.5x10^13 vg) enrollment has begun. The company expects to complete Cohort B enrollment in Q1 2025, with interim data expected in H1 2025. HFpEF affects nearly half of 64.3 million heart failure cases worldwide, with treatment options available.
Medera Inc., a clinical-stage biotechnology company, is set to be listed on NASDAQ through a merger with Keen Vision Acquisition (KVAC). The combined entity will have an initial enterprise value of approximately $622.6 million. Medera focuses on developing next-generation gene- and cell-based therapies for difficult-to-treat cardiovascular diseases. The transaction proceeds will accelerate Medera's three most advanced clinical programs for AAV-based gene therapy candidates.
Key highlights include:
- Medera's founders and key shareholders have committed $22.6 million
- All existing Medera shareholders are rolling 100% of their equity
- A closing condition requires Medera to have at least $40 million in available liquidity
- The merger is expected to close in Q4 2024
This NASDAQ listing aims to advance Medera's clinical and preclinical programs, potentially expediting the development of novel therapeutic solutions for patients with unmet needs.
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