Collaboration Advances Local Regulatory Pathway for AI-Enabled ECG Diagnostics to Address the Growing Cardiovascular Disease Burden in Jamaica
TORONTO, ON / ACCESS Newswire / November 4, 2025 / AI/ML Innovations Inc. ("AIML" or the "Company") (CSE:AIML)(OTCQB:AIMLF)(FWB:42FB) is pleased to announce that its wholly owned subsidiary, NeuralCloud Solutions Inc. ("NeuralCloud"), has engaged with Lonacas Consultants Ltd. ("Lonacas"), a Kingston-based clinical research and regulatory consultancy, to lead the regulatory submission process for NeuralCloud's CardioYield software combined with a single-lead ECG wearable chest strap to the Jamaica Ministry of Health & Wellness - Standards and Regulation Division. The Company thanks Jamaican Canadian business leader and investor Wayne Isaacs for making this introduction to the medical, regulatory and academic stakeholders in Jamaica.
"The introduction of the CardioYield software, along with its companion ECG wearable device, will be an exciting development in the field of cardiology within Jamaica." Isaacs states. He further states that, "These digital health solutions could lead to lower costs and improved access to quality cardiac care for patients across the country. This marks a promising step forward for the Jamaican cardiac care landscape."
This initiative marks a significant step in NeuralCloud's Caribbean expansion strategy and represents the Company's commitment to delivering affordable, high-quality cardiac diagnostics through a locally regulated, end-to-end digital solution.
The collaboration with Lonacas will enable NeuralCloud to pursue local registration and regulatory validation of its CardioYield platform, an AI-powered ECG signal interpretation software designed to deliver faster, more accurate, and more accessible Holter diagnostics. Paired with a medical-grade wearable chest strap, the combined system will provide a foundation to allow healthcare providers across Jamaica to access high-standard cardiac reporting at scale.
The regulatory submission process will establish a framework for the safe, compliant, and scalable deployment of CardioYield across clinics, hospitals, and community health centers. This step is critical for bringing the technology into clinical use in Jamaica and ensuring that the solution meets the country's standards for data security, patient safety, and clinical efficacy.
Cardiovascular disease remains one of the leading causes of death and disability in Jamaica, accounting for a rising share of hospital admissions and outpatient visits[1] . Access to timely and accurate cardiac diagnostics remains limited, particularly outside urban centers.
Through this initiative, NeuralCloud aims to bridge this diagnostic gap-introducing a low-cost, AI-enhanced monitoring solution that empowers clinicians to detect abnormalities early, streamline workflow, and reduce dependence on legacy Holter systems.
Unlike traditional multi-lead adhesive or patch-based Holter monitors, the single-lead ECG wearable chest strap offers a more durable, patient-friendly solution for continuous monitoring-especially in tropical climates such as Jamaica's. In regions where high humidity and temperatures prevail year-round, sweat and skin moisture can easily loosen adhesive electrodes, disrupting signal quality, or causing leads to detach. The chest-strap design avoids these issues, ensuring consistent contact, stable signal acquisition, and greater patient comfort over extended wear periods. NeuralCloud believes that, when paired with CardioYield, a single lead is sufficient to achieve Holter-grade diagnostic accuracy, eliminating the need for complex multi-lead adhesives and significantly simplifying both clinical workflow and patient experience.
"Our collaboration with Lonacas represents an essential step in making important cardiac care more accessible to the Jamaican population," said Esmat Naikyar, President of NeuralCloud. "By formalizing the regulatory process for CardioYield, we're not only ensuring compliance but also building the infrastructure necessary to deliver affordable, reliable, and scalable cardiac diagnostics at the national level."
This initiative, led by Dr. Lorenzo Gordon, M.D., PhD, Vice Dean and Medical Director at the Caribbean School of Medical Science, Lonacas brings extensive experience in clinical, regulatory, and epidemiological research. The firm specializes in clinical trial management, site operations, and product registration, providing end-to-end regulatory support from documentation through submission to approval.
"We are proud to partner with NeuralCloud on this important initiative," said Dr. Lorenzo Gordon, Medical Director of Lonacas. "The integration of advanced cardiac technology with Jamaica's health infrastructure aligns perfectly with our mission to enhance the regulatory readiness and research capability of the Caribbean region. This project demonstrates how local expertise and global innovation can combine to meet real public health needs."
If granted approval, CardioYield-combined with NeuralCloud's wearable chest strap device-will represent a fully integrated diagnostic ecosystem designed for the realities of emerging healthcare markets. The system enables rapid ECG acquisition, automated interpretation, and report generation with near real-time precision, supporting local clinicians in delivering faster, more confident diagnoses.
"Establishing regulatory pathways in key international markets like Jamaica is part of AIML's broader commercialization roadmap," said Paul Duffy, Executive Chairman and CEO of AIML. "It's a foundational step toward demonstrating how our technologies can support health systems in regions facing growing cardiometabolic challenges-while meeting the highest clinical and regulatory standards."
Stock Option Grant
AIML also advises that the Company's Board of Directors has authorized, pursuant to its 2025 Stock Option Plan, the grant of an aggregate of 1,405,000 stock options (" Options ") to certain directors, employees and consultants of the Company, to purchase an aggregate of 1,405,000 Common Shares effective November 4, 2025 ("Grant Date"). The Options were awarded at an exercise price of $0.10 per Common Share and expire five years from the Grant Date. Of the Options granted, 375,000 Options vest on the Grant Date, 125,000 Options vest in February 2026, 250,000 Options vest quarterly over one year, with the balance of the Options vesting evenly over various performance-based milestones.
About Lonacas Consultants Ltd.
Lonacas (Kingston, Jamaica) is a full-service clinical research and regulatory consultancy offering end-to-end CRO and SMO services. The company provides strategic guidance and operational support for product registration, clinical trials, and post-market compliance across the Caribbean. Lonacas supports clients through every stage of research and regulatory engagement-from concept development to final approval. For more information, visit Lonacas Consultants. https://www.lonacas.com/
About AIML Innovations Inc.
https://www.aiml.health/
AIML Innovations Inc. is a global technology company pioneering the use of artificial intelligence and neural networks to transform digital health. Our 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.
AIML's shares trade on the Canadian Securities Exchange (CSE:AIML), the OTCQB Venture Market (AIMLF), and the Frankfurt Stock Exchange (42FB).
For detailed information please see AIML's website or the Company's filed documents at www.sedarplus.ca .
Contact:
Blake Fallis (778) 405-0882
On behalf of the Board of Directors:
Paul Duffy, Executive Chairman and CEO
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Forward Looking Statements - Certain information set forth in this news release may contain forward-looking statements that involve substantial known and unknown risks and uncertainties, including risks associated with the implementation of the Company's products and services. These forward-looking statements are subject to numerous risks and uncertainties, certain of which are beyond the control of the Company, including with respect to the nature and timing of future operations and the receipt of all applicable regulatory approvals. Readers are cautioned that the assumptions used in the preparation of such information, although considered reasonable at the time of preparation, may prove to be imprecise and, as such, undue reliance should not be placed on forward-looking statements.
[1]World Heart Federation. (n.d.). Heart health in Jamaica . World Heart Observatory. Retrieved November 3, 2025, from https://world-heart-federation.org/world-heart-observatory/countries/jamaica/
SOURCE: AI/ML Innovations, Inc.
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https://www.accessnewswire.com/newsroom/en/healthcare-and-pharmaceutical/aiml-subsidiary-neuralcloud-solutions-engages-lonacas-consultants-to-1096593