Traditional methods for evaluating therapeutic efficacy and cardiotoxicity often lead to high failure rates during clinical trials,resulting in significant development costs

Human-specific diseases cannot be accurately modeled by animals,leading to limited medical options or advancements

This new study leverages the capabilities of artificial intelligence (AI) and machine learning (ML) to address the challenge of achieving automated and comprehensive "smart" drug screening using Medera's mini-Heart technology platform

Innovative AI/ML-based model combines data from multiple human mini-Heart screening assays and takes advantage of the complementary strengths to achieve superior next-generation drug classification capabilities

The unique combination of AI/ML and human mini-Hearts can accelerate drug discovery,clinical translation and precision medicine by improving screening efficiency,reducing costs,enhancing safety and creating new opportunities for patient benefits

SUMMIT,N.J. and BOSTON,Mass.,Oct. 31,2024 --Medera Inc. ("Medera"),a clinical-stage biotechnology company focused on targeting difficult-to-treat cardiovascular diseases using a range of next-generation gene- and cell-based approaches,announced today the publicationof a new study in the peer-reviewed journal Pharmacological Research (volume 209). This study,entitled "Enhanced Drug Classification Using Machine Learning with Multiplexed Cardiac Contractility Assays," demonstrates how Novoheart,Medera's wholly-owned preclinical subsidiary focused on human cardiovascular disease modeling for drug discovery,is leveraging AI and ML to improve next-generation drug screening processes.

The present work aims to address a long-standing challenge in the pharmaceutical industry: accurately screening and classifying drug candidates for their effects on human heart function. By applying AI-driven automation,the objective is to enhance the success rates of future clinical trials and ultimately improve patient benefits by modernizing the drug development process.

Traditional methods for evaluating therapeutic efficacy and cardiotoxicity often lead to high failure rates (over 90%) during clinical trials,resulting in development costs that can exceed $2 billion per drug on average. Furthermore,human-specific diseases cannot be accurately modeled by animals,leading to limited medical options or advancements. Novoheart's present study demonstrates a novel approach utilizing AI/ML combined with comprehensive functional data from its various human mini-Heart assays,engineered from human pluripotent stem cell-derived cardiomyocytes,to create a more predictive and automated preclinical model of human cardiac responses. This innovative approach improves the accuracy of drug screening,promising to increase efficiency,reduce costs,and enhance safety of developing new drugs,thereby creating opportunities for drug developers and improving outcomes for patients.

By testing three distinct proprietary engineered human mini-Heart assays,including our flagship human-heart-in-a-jar,specialized for measuring different cardiac characteristics,with a library of known compounds spanning a range of drug classes,the Novoheart research team generated a robust dataset encompassing electrophysiology and contractility parameters. The resulting ensemble AI-based algorithm achieved an impressive 86.2% predictive accuracy in classifying the effects of unknown compounds,surpassing prior ML methods for drug classification. This study is an expansion of the Company's patent-pending,single-assay ML technology as previously published.

"By harnessing the power of machine learning in our suite of human-based mini-Heart assays,we are advancing the frontiers of preclinical drug development," stated Kevin Costa,Ph.D.,Novoheart's Chief Scientific Officer and co-founder. "This innovation simplifies and improves the cardiac screening process for both our internal teams,partners and clients utilizing Novoheart's technology."

"This innovative approach clearly outperforms traditional single-assay models and aligns with the objectives advocated in the FDA Modernization Act 2.0," stated Ronald Li,Medera's CEO and Founder. "The unique combination of AI/ML with human mini-Hearts can significantly accelerate drug discovery and screening,and improve precision by automating the analysis of very complex biological data. It can minimize the need for animal testing and enhance predictive toxicology,reducing the risk of late-stage failures,thereby increasing successes for drug developers and maximizing benefits for patients. Such a human-based AI approach also promotes precision medicine (by taking into consideration different genetic backgrounds or disease mutations) and optimization of formulations,leading to more effective and marketable therapies and improving patient safety throughout the drug development process."

This AI/ML-based automation will be made commercially available via Novoheart's software and hardware platforms. Please direct any inquiries to sales@novoheart.com.

On September 5,2024,Medera and Keen Vision Acquisition Corporation ("KVAC") (Nasdaq: KVAC,KVACW),announced they had entered into a definitive merger agreement.

About Medera

Medera (www.medera.bio)is a clinical-stage biopharmaceutical company focused on targeting difficult-to-treat or currently incurable diseases with significant unmet needs,utilizing next-generation gene and cell-based approaches in combination with bioengineered human-based technology (including the mini-Heart platform). Medera operates via the two preclinical and clinical business units,Novoheart and Sardocor,respectively.

Novoheart capitalizes on the world's first and award-winning "mini-Heart" Technology for revolutionary disease modelling and drug discovery,uniquely enabling the modelling of human-specific diseases and discovery of therapeutic candidates free from species-specific differences in accordance to the FDA Modernization Act 2.0. Novoheart's versatile technology platform provides a range of state-of-the-art automation hardware and software as well as screening services,for human-specific disease modelling,therapeutic target discovery and validation,drug toxicity and efficacy screening,and dosage optimization carried out in the context of healthy and/or diseased human heart chambers and tissues. Global pharmaceutical and academic leaders are using Novoheart's technology platform their drug discovery and development purposes. The Novoheart platform has facilitated and accelerated the development of Sardocor's lead therapeutic candidates that are currently in clinical trials.

Sardocor is dedicated to the clinical development of novel next-generation therapies for Medera. Leveraging Novoheart's human-based drug discovery and validation platforms,Sardocor aims to expedite drug development and regulatory timelines for its gene and cell therapy pipeline. Sardocor has received Investigational New Drug (IND) clearances from the FDA for three ongoing AAV-based cardiac gene therapy clinical trials targeting Heart Failure with Reduced Ejection Fraction (HFrEF),Heart Failure with Preserved Ejection Fraction (HFpEF) with the Fast Track Designation,and Duchenne Muscular Dystrophy-induced Cardiomyopathy (DMD-CM) with the Orphan Drug Designation. Additionally,Sardocor's pipeline includes four preclinical gene therapy and three preclinical small molecule candidates targeting various cardiac,pulmonary,and vascular diseases.

About Keen Vision Acquisition Corporation

Keen Vision Acquisition Corp ("KVAC"),listed on Nasdaq,is a blank check company incorporated for the purpose of effecting a merger,share exchange,asset acquisition,share purchase,reorganization or similar business combination with one or more businesses or entities. KVAC is focused on biotechnology,consumer goods or agriculture opportunities,which are also evaluated on their sustainability,environmental,social,and corporate governance ("ESG") imperatives. EF Hutton LLC and Brookline Capital Markets,a division of Arcadia Securities,LLC,are serving as Capital Markets Advisors for KVAC.

www.kv-ac.com

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