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 (OTCQX: HWAIF) reported that its DARWEN™ AI platform generated regulatory-grade real-world data (RWD) supporting vedolizumab dose escalation from every 8 weeks to every 4 weeks, with improved remission outcomes for ulcerative colitis and Crohn's disease.
HEALWELL presented these AI-generated RWD findings with Takeda on October 6, 2025 at UEG Week in Berlin. The company says DARWEN has 40+ peer-reviewed publications and was named a finalist in Newsweek's AI Impact Awards 2025.
HEALWELL (OTCQX: HWAIF) ha comunicato che la sua piattaforma DARWEN™ AI ha generato dati real-world di livello regolatorio (RWD) a supporto dell'aumento della dose di vedolizumab da ogni 8 settimane a ogni 4 settimane, con migliori risultati di remissione per la colite ulcerosa e la malattia di Crohn.
HEALWELL ha presentato questi risultati RWD generati dall'AI insieme a Takeda il 6 ottobre 2025 durante l'UEG Week a Berlino. L'azienda afferma che DARWEN vanta oltre 40 pubblicazioni peer-reviewed ed è stata nominata finalista nei AI Impact Awards 2025 di Newsweek.
HEALWELL (OTCQX: HWAIF) informó que su plataforma DARWEN™ AI generó datos del mundo real de calidad regulatoria (RWD) que respaldan la escalada de dosis de vedolizumab de cada 8 semanas a cada 4 semanas, con mejoras en los resultados de remisión para la colitis ulcerosa y la enfermedad de Crohn.
HEALWELL presentó estos hallazgos de RWD generados por IA junto a Takeda el 6 de octubre de 2025 en UEG Week en Berlín. La empresa afirma que DARWEN cuenta con más de 40 publicaciones revisadas por pares y fue nombrada finalista en los Premios AI Impact de Newsweek 2025.
HEALWELL (OTCQX: HWAIF) 은 DARWEN™ AI 플랫폼이 규제 등급의 실제 세계 데이터(RWD)를 생성하여 vedolizumab의 용량을 매 8주에서 매 4주로 증가시키는 것을 뒷받침했고, 궤양성 대장염과 크론병에서의 완화 결과가 개선되었다고 밝혔습니다.
HEALWELL은 이 AI로 생성된 RWD 발견을 Takeda와 함께 2025년 10월 6일에 베를린에서 열린 UEG Week에서 발표했습니다. 회사는 DARWEN이 40편이 넘는 동료심사 논문을 보유하고 있으며 Newsweek의 AI Impact Awards 2025의 파이널리스트로 선정되었다고 합니다.
HEALWELL (OTCQX: HWAIF) a annoncé que sa plateforme DARWEN™ AI a généré des données du monde réel de niveau réglementaire (RWD) soutenant l’augmentation de la dose de vedolizumab de toutes les 8 semaines à toutes les 4 semaines, avec des résultats de rémission améliorés pour la colite ulcéreuse et la maladie de Crohn.
HEALWELL a présenté ces résultats RWD générés par l’IA avec Takeda le 6 octobre 2025 lors de l’UEG Week à Berlin. L’entreprise affirme que DARWEN compte plus de 40 publications évaluées par des pairs et a été nommée finaliste dans les Newsweek AI Impact Awards 2025.
HEALWELL (OTCQX: HWAIF) meldete, dass seine Plattform DARWEN™ AI regulatorisch zugelassene Real-World-Daten (RWD) generiert hat, die eine Erhöhung der Vedolizumab-Dosis von alle 8 Wochen auf alle 4 Wochen unterstützen, mit verbesserten Remissionsraten bei Colitis ulcerosa und Morbus Crohn.
HEALWELL präsentierte diese KI-generierten RWD-Ergebnisse zusammen mit Takeda am 6. Oktober 2025 während der UEG Week in Berlin. Das Unternehmen sagt, dass DARWEN mehr als 40 begutachtete Publikationen hat und als Finalist in den Newsweek AI Impact Awards 2025 genannt wurde.
HEALWELL (OTCQX: HWAIF) ذكرت أن منصتها DARWEN™ AI أنتجت بيانات واقعية من العالم الحقيقي بجودة تنظيمية (RWD) تدعم رفع جرعة فيدوليزوماب من كل 8 أسابيع إلى كل 4 أسابيع، مع تحسن في نتائج الإرتقاء/الشفاء لالتهاب القولون التقرحي ومرض كرون.
قدمت HEALWELL هذه النتائج المستندة إلى RWD التي ولّدتها الذكاء الاصطناعي مع Takeda في 6 أكتوبر 2025 خلال UEG Week في برلين. وتقول الشركة أن DARWEN لديها أكثر من 40 منشوراً مُحكماً من الأقران، كما تم اختيارها كمرشحة في جوائز Newsweek AI Impact 2025.
HEALWELL (OTCQX: HWAIF) 报告称其 DARWEN™ AI 平台生成的符合监管级别的真实世界数据（RWD）支持将 vedolizumab 的剂量从每8周一次提高到每4周一次，并在溃疡性结肠炎和克罗恩病的缓解结果方面有所改善。
HEALWELL 在 2025年10月6日 于柏林的 UEG Week 与 Takeda 一同展示了这些由 AI 生成的 RWD 发现。公司表示 DARWEN 拥有 40 多篇同行评审出版物，并被 Newsweek 的 2025 年 AI Impact Awards 评为决赛入围者。
- Presentation date: October 6, 2025
- Takeda collaboration presented AI-generated RWD
- 40+ peer-reviewed publications validating DARWEN
- Finalist in Newsweek AI Impact Awards 2025
- No regulatory approval or label change announced
- No numerical remission rates or statistical metrics disclosed
- 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 6th 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 DARWENTM 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.
- https://www.fiercepharma.com/special-reports/top-20-pharma-companies-2024-revenue
- https://www.gastroenterologyadvisor.com/factsheets/ibd-statistics/
- 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.
For more information:
Pardeep S. Sangha
Investor Relations, HEALWELL AI Inc.
Phone: 604-572-6392
ir@healwell.ai
To view the source version of this press release, please visit https://www.newsfilecorp.com/release/271257
FAQ
What did HEALWELL (HWAIF) announce about vedolizumab at UEG Week on October 6, 2025?
How does HEALWELL's DARWEN AI support Takeda's vedolizumab data in 2025?
Did HEALWELL report clinical metrics or statistical remission rates for vedolizumab dose escalation?
Will HEALWELL's DARWEN AI data trigger an immediate label change for vedolizumab?
What independent validation does HEALWELL cite for DARWEN AI as of October 2025?
