HEALWELL’s DARWEN(TM) AI Platform Demonstrates One of the World’s First Examples of Using AI to Generate Regulatory-Grade Real-World Data (RWD) for Supporting Patient Access and Advancing the Pharmaceutical Industry

• HEALWELL, in collaboration with Takeda Pharmaceutical, presented new AI generated and regulatory-grade real-world data (RWD) on vedolizumab dose escalation in ulcerative colitis and Crohn’s disease at the prestigious United European Gastroenterology (UEG) Week in Berlin on October 6, 2025.
• HEALWELL’s DARWEN AI platform generated real-world data (RWD) demonstrating that vedolizumab dose escalation from every 8 weeks to every 4 weeks improved remission outcomes, supporting label advancement and access growth. This is one of the world’s first examples of using AI to generate this kind of regulatory-grade RWD for these types of applications.
• AI-driven real-world data (RWD) and real-world evidence (RWE) generation capability for these types of applications is globally unique to HEALWELL and is expected to be an important driver for both clinical and commercial value.
• HEALWELL continues to earn global recognition for its leadership in healthcare AI, being named a finalist in Newsweek’s inaugural AI Impact Awards 2025 for advancing validated, ethical AI that drives measurable clinical and commercial impact.

Toronto, Ontario–(Newsfile Corp. – October 21, 2025) – HEALWELL AI Inc. (TSX: AIDX) (OTCQX: HWAIF) (“HEALWELL” or the “Company“), a healthcare artificial intelligence company focused on preventative care, is pleased to announce that HEALWELL’s DARWEN AI Platform has demonstrated one of world’s first examples of using AI to generate real world data (RWD) for supporting greater patient access, product advancement & reimbursement growth for the pharmaceutical industry. AI-driven real-world data (RWD) and real-world evidence (RWE) generation capability for these types of applications is globally unique to HEALWELL and is expected to be an important driver for both clinical and commercial value.

On October 6^th 2025, HEALWELL in collaboration with Takeda Pharmaceutical (a top 20 global pharmaceutical company¹) presented new AI generated and regulatory-grade real-world data (RWD) and real-world evidence (RWE) on vedolizumab dose escalation in ulcerative colitis and Crohn’s disease at the prestigious United European Gastroenterology (UEG) Week in Berlin. HEALWELL’s DARWEN AI platform generated real-world data (RWD) demonstrating that vedolizumab dose escalation from every 8 weeks to every 4 weeks improved remission outcomes, supporting label advancement and access growth. Ultimately the real-world data generated provided evidence that demonstrated remission improvement outcomes; an important outcome to drive improved patient outcomes in a disease area that has significant population burden. Inflammatory bowel disease affects approximately 2.39 million people in the United States² and nearly 400,000 people in Canada³.

“Our collaboration with Takeda demonstrates how our DARWEN AI platform can unlock clinically meaningful insights from the wealth of data buried and not effectively used within electronic health records and documents,” said Dr. Christopher Pettengell, Chief Medical Officer. “By identifying patient factors that influence response, we are helping clinicians and life science partners advance more precise, effective, and patient-centered care. We can see a world in which the majority of RWE will be generated by novel AI systems such as DARWEN^TM AI. This will advance the speed and accuracy with which the global pharmaceutical community can advance to improve patient outcomes.”

HEALWELL’s DARWEN AI platform has been globally recognized and validated with over 40 peer-reviewed published manuscripts; as a leading platform in healthcare artificial intelligence with regards to its unique capabilities for clinical data abstraction and real-world data and evidence generation. HEALWELL continues to earn global recognition for its leadership in healthcare AI, being named a finalist in Newsweek’s inaugural AI Impact Awards 2025 for advancing validated, ethical AI that drives measurable clinical and commercial impact.

“AI is reshaping our world, and the organizations receiving this award are at the forefront of that transformation,” said Jennifer H. Cunningham, editor-in-chief of Newsweek. “We are proud to spotlight the companies whose technologies and practices are pushing the boundaries of what AI can achieve-responsibly and effectively.”

James Lee
Chief Executive Officer
HEALWELL AI Inc.

1. https://www.fiercepharma.com/special-reports/top-20-pharma-companies-2024-revenue
2. https://www.gastroenterologyadvisor.com/factsheets/ibd-statistics/
3. https://crohnsandcolitis.ca/About-Us/Resources-Publications/Impact-of-IBD-Report

About HEALWELL AI

HEALWELL is a healthcare artificial intelligence company focused on preventative care. Its mission is to improve healthcare and save lives through early identification and detection of disease. Using its own proprietary technology, the Company is developing and commercializing advanced clinical decision support systems that can help healthcare providers detect rare and chronic diseases, improve efficiency of their practice and ultimately help improve patient health outcomes. HEALWELL is executing a strategy centered around developing and acquiring technology and clinical sciences capabilities that complement the Company’s road map. HEALWELL is publicly traded on the Toronto Stock Exchange under the symbol “AIDX” and on the OTC Exchange under the symbol “HWAIF”. To learn more about HEALWELL, please visit https://healwell.ai/.

Forward-Looking Statements

Certain statements in this press release, constitute “forward-looking information” and “forward-looking statements” (collectively, “forward-looking statements”) within the meaning of applicable Canadian securities laws, including statements about the potential benefits of using generative AI to support patient access, product advancement & reimbursement growth for the pharmaceutical industry; and the expected impact of HEALWELL’s DARWEN AI Platform;, and are based on assumptions, expectations, estimates and projections as of the date of this press release. Forward-looking statements are often, but not always, identified by words or phrases such as “expected”, “supporting”, “advancing” or variations of such words and phrases or statements that certain future conditions, actions, events or results “will”, “may”, “could”, “would”, “should”, “might” or “can” be taken, occur or be achieved, or the negative of any of these terms . Forward-looking statements are necessarily based upon management’s perceptions of historical trends, current conditions and expected future developments, as well as a number of specific factors and assumptions that, while considered reasonable by HEALWELL as of the date of such statements, are outside of HEALWELL’s control and are inherently subject to significant business, economic and competitive uncertainties and contingencies which could result in the forward-looking statements ultimately being entirely or partially incorrect or untrue. Forward-looking statements contained in this press release are based on various assumptions, including, but not limited to, the following: the continued adoption of the software, tools and solutions created by HEALWELL and its subsidiaries; the stability of general economic and market conditions; sufficiency of working capital and access to financing; HEALWELL’s ability to comply with applicable laws and regulations; HEALWELL’s continued compliance with third party intellectual property rights; the effects of competition in the industry; the requirement for increasingly innovative product solutions and service offerings; technologies working as intended or at all; trends in customer growth and the adoption of new technologies in the industry; and that the risk factors noted below, collectively, do not have a material impact on HEALWELL’s business, operations, revenues and/or results. By their nature, forward-looking statements are subject to inherent risks and uncertainties that may be general or specific and which give rise to the possibility that expectations, forecasts, predictions, projections, or conclusions will not prove to be accurate, that assumptions may not be correct, and that objectives, strategic goals and priorities will not be achieved.

Known and unknown risk factors, many of which are beyond the control of HEALWELL, could cause the actual results of HEALWELL to differ materially from the results, performance, achievements, or developments expressed or implied by such forward-looking statements. Such risk factors include but are not limited to those factors which are discussed under the section entitled “Risk Factors” in HEALWELL’s most recent annual information form dated April 1, 2024, which is available under HEALWELL’s SEDAR+ profile at www.sedarplus.ca. The risk factors are not intended to represent a complete list of the factors that could affect HEALWELL and the reader is cautioned to consider these and other factors, uncertainties and potential events carefully and not to put undue reliance on forward-looking statements. There can be no assurance that forward-looking statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Forward-looking statements are provided for the purpose of providing information about management’s expectations and plans relating to the future. HEALWELL disclaims any intention or obligation to update or revise any forward-looking statements whether as a result of new information, future events or otherwise, or to explain any material difference between subsequent actual events and such forward-looking statements, except to the extent required by applicable law. All of the forward-looking statements contained in this press release are qualified by these cautionary statements.

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