Mr. Paul Duffy reports

AI/ML INNOVATIONS SUBSIDIARY NEURALCLOUD APPOINTS FORMER FDA REVIEWER DR. MEHMET KOSOGLU AS THE HEAD OF REGULATORY AFFAIRS

AI-ML Innovations Inc.'s wholly owned subsidiary, NeuralCloud Solutions Inc., has appointed Dr. Mehmet A. Kosoglu, PhD, as head of regulatory.

Dr. Kosoglu is a former U.S. Food and Drug Administration (FDA) lead reviewer and scientist with more than 15 years of experience spanning medical device development, biotechnology, FDA regulations, software-as-a-medical-device (SaMD), digital health, diagnostics, drug-device combination products and regulatory strategy. In his new role, Dr. Kosoglu will support NeuralCloud as the company advances its regulatory strategy for its artificial-intelligence-powered cardiac technologies, including MaxYield and CardioYield.

Dr. Kosoglu's appointment strengthens NeuralCloud's regulatory leadership at an important stage in the company's development, as NeuralCloud continues progressing its ECG signal-processing technologies through validation, regulatory engagement and preparation for commercial deployment.

The appointment of Dr. Kosoglu follows the company's last regulatory milestone for the company; the achievement of ISO 13485:2016 Medical Device Single Audit Program (MDSAP) certification, establishing the quality management system foundation supporting NeuralCloud's regulated medical device development and commercialization activities.

Paul Duffy, executive chairman and chief executive officer of AI-ML, commented: "Dr. Kosoglu brings exactly the type of regulatory depth and FDA experience that AI-ML needs as we continue building NeuralCloud as a medical device software company. His background as a former FDA lead reviewer, combined with his direct experience guiding SaMD and digital health products through regulatory pathways, will be invaluable as we advance MaxYield, CardioYield and our broader cardiac technology portfolio."

Dr. Kosoglu previously served at the FDA's Center for Devices and Radiological Health (CDRH) as a lead reviewer in the Office of Product Evaluation and Quality (formerly known as the Office of Device Evaluation), where he led review teams for premarket submissions including 510(k)s, De Novo applications, investigational device exemptions (IDEs), presubmissions and PMA supplements. He also contributed to FDA guidance documents and helped establish regulatory policy and special controls for novel device categories.

In addition to his CDRH experience, Dr. Kosoglu served at the FDA's Center for Drug Evaluation and Research (CDER) in the Office of New Drugs, Biomarker Qualification Program, where he worked on clinical trials, assay development, biomarkers, end points and scientific policy. His combined device, drug, biomarker and combination-product experience provides NeuralCloud with broad regulatory expertise across multiple areas relevant to AI-enabled health care technologies.

Dr. Kosoglu has also held senior regulatory and development roles in industry, where he led regulatory planning, FDA interactions, verification and validation planning, preclinical and clinical study design, quality-system development, and market authorization efforts. He has successfully introduced multiple FDA-regulated medical devices into the U.S. market, including software-as-a-medical-device products, and has secured an FDA clearance for a digital health SaMD application.

Dr. Mehmet Kosoglu, head of regulatory at NeuralCloud, commented: "AI-ML and NeuralCloud are developing technologies at the intersection of artificial intelligence, cardiac signal processing and regulated medical software. This is an area where strong regulatory strategy, disciplined validation and clear quality-system execution are essential. I look forward to working with the AI-ML and NeuralCloud teams to support a rigorous regulatory pathway for technologies that have the potential to improve ECG analysis and cardiac care."

Dr. Kosoglu holds a PhD in mechanical engineering from Virginia Tech, an MS in mechanical engineering from Lehigh University and a BS in mechanical engineering from Istanbul Technical University. He is also an award-winning researcher, primary inventor on multiple patents, and has authored or contributed to peer-reviewed publications in medical device and biomedical engineering fields.

Esmat Naikyar, president of NeuralCloud Solutions and chief product officer of AI-ML, added: "Regulatory strategy is not separate from product development; it shapes how we build, validate, document and deploy medical software. Dr. Kosoglu's experience across FDA review, SaMD, quality systems, clinical study design and product development will help ensure our technologies are advanced with the discipline required for regulated health care environments."

The company believes Dr. Kosoglu's appointment further supports NeuralCloud's continuing efforts to build the regulatory, clinical, and operational infrastructure required to develop and commercialize AI-powered medical device software.

About Dr. Mehmet Kosoglu

Dr. Kosoglu, PhD, is a senior regulatory affairs executive and former FDA lead reviewer with more than 15 years of experience in medical devices, biotechnology, FDA regulations, SaMD, digital health, diagnostics and combination products. During his FDA tenure, he worked within CDRH and CDER, conducting and leading reviews across 510(k), De Novo, IDE, presubmission, biomarker, and scientific policy matters.

Dr. Kosoglu has led regulatory strategy and FDA submissions for multiple medical device and digital health companies, including SaMD products. He has successfully secured FDA clearance for a digital health SaMD application, and has supported the development, registration and regulatory planning of multiple FDA-regulated technologies. He holds PhD, MS and BS degrees in mechanical engineering, and is an inventor on multiple patents.

About NeuralCloud Solutions Inc.

NeuralCloud Solutions, a wholly owned subsidiary of AI-ML Innovations, develops artificial intelligence and neural-network-based technologies for ECG signal analysis and cardiac software applications. Its platforms are designed to enhance ECG signal quality, support advanced waveform interpretation, enable arrhythmia analytics and improve clinical workflow efficiency across regulated health care environments.

About AI-ML Innovations Inc.

AI-ML Innovations is a global technology company pioneering the use of artificial intelligence and neural networks to transform digital health. The company's proprietary platforms leverage advanced signal processing and deep learning to convert complex biometric data into actionable clinical insights -- supporting earlier diagnosis, personalized treatment and more effective care.

AI-ML's shares trade on the Canadian Securities Exchange (CSE: AIML), the OTCQB Venture Market (AIMLF) and the Frankfurt Stock Exchange (42FB).

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