TLDR: HEALWELL AI’s DARWEN™ platform has demonstrated a pioneering use of AI to generate regulatory-grade Real-World Data (RWD), specifically supporting vedolizumab dose escalation for ulcerative colitis and Crohn’s disease. This achievement, presented in collaboration with Takeda Pharmaceutical at UEG Week 2025, is a significant step towards enhancing patient access and advancing the pharmaceutical industry through AI-driven insights.
Toronto, Ontario – October 21, 2025 – HEALWELL AI Inc. (TSX: AIDX) (OTCQX: HWAIF), a leading healthcare artificial intelligence company dedicated to preventative care, today announced a groundbreaking milestone: its DARWEN™ AI Platform has successfully generated regulatory-grade Real-World Data (RWD), marking one of the world’s first examples of such an application in the pharmaceutical industry. This innovation is poised to significantly enhance patient access, accelerate product advancement, and drive reimbursement growth.
In a collaborative effort with Takeda Pharmaceutical, a top 20 global pharmaceutical company, HEALWELL presented these novel AI-generated and regulatory-grade RWD and Real-World Evidence (RWE) findings at the prestigious United European Gastroenterology (UEG) Week in Berlin on October 6, 2025. The data specifically focused on vedolizumab dose escalation in patients suffering from ulcerative colitis and Crohn’s disease.
The DARWEN™ AI platform’s analysis demonstrated that increasing vedolizumab dosage from every 8 weeks to every 4 weeks resulted in improved remission outcomes. This evidence is crucial for supporting label advancement and expanding patient access to more effective treatment regimens. The successful generation of regulatory-grade RWD for these applications is considered globally unique to HEALWELL, positioning it as a key driver for both clinical and commercial value within the healthcare sector.
Dr. Christopher Pettengell, Chief Medical Officer at HEALWELL, emphasized the platform’s transformative potential: “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. 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™ AI. This will advance the speed and accuracy with which the global pharmaceutical community can improve patient outcomes.”
Inflammatory bowel disease (IBD), encompassing ulcerative colitis and Crohn’s disease, represents a significant global health burden, affecting approximately 2.39 million people in the United States and nearly 400,000 individuals in Canada. The ability to generate robust RWD and RWE through AI offers a promising pathway to better manage these conditions and improve patient lives.
HEALWELL’s leadership in healthcare AI continues to garner international recognition. The DARWEN™ AI platform boasts over 40 peer-reviewed published manuscripts, validating its capabilities in clinical data abstraction and real-world data/evidence generation. Furthermore, HEALWELL was named a finalist in Newsweek’s inaugural AI Impact Awards 2025, acknowledging its commitment to advancing validated, ethical AI that delivers measurable clinical and commercial impact.
Jennifer H. Cunningham, editor-in-chief of Newsweek, commented on the significance of such accolades: “AI is reshaping our world, and the organizations receiving this award are at the forefront of that transformation. We are proud to spotlight the companies whose technologies and practices are pushing the boundaries of what AI can achieve—responsibly and effectively.”
Also Read:
- BostonGene Secures Five 2025 Stevie® Awards for Pioneering AI in Oncology Technology
- League Introduces AI-Powered Agent Teams for Continuous, Personalized Healthcare Experiences
HEALWELL AI Inc. is publicly traded on the Toronto Stock Exchange (TSX: AIDX) and the OTC Exchange (OTCQX: HWAIF), reinforcing its position as an innovator in the preventative care segment of the healthcare technology market.
