Latest Updates from HeartForce™

HeartForce is expanding its collaboration with healthcare providers through planned pre-market release studies. These studies will help gather real-world feedback from clinicians and patients and support the development of a strong network of medical experts who will contribute to clinical education and awareness of coronary artery disease screening. At the same time, HeartForce is mapping reimbursement pathways across North America and Europe to support future access, while continuing to build a broad omnichannel presence to educate, inform, and connect with healthcare professionals and patients.

To support future access to CardioClin™, HeartForce has upgraded its Vancouver assembly facility and invested in new sensor manufacturing components to meet quality, scalability, and design expectations for medical devices. The CardioClin™ application has also been enhanced with improved functionality and user experience and is now available through the Google Play Store, enabling simple updates and reliable use.

This November, the company initiated the U.S. FDA review process by submitting its pre-submission package, with a formal meeting set for January 2026. With all required documentation for both regions on track to be finalized early 2026, HeartForce expects to begin its European MDR and Canadian MDSAP submissions shortly thereafter.

We’ve successfully completed and tested the alpha version of the CardioClin™ mobile application and AWS-based backend.
The app now accurately calculates the EMCR Score™ directly within the mobile application, a major milestone in our product development journey.
Next steps include UI refinements and preparing for beta release to address final usability improvements.

Our paper, “Assessing Coronary Artery Disease Risk Using Seismocardiography in Patients with Chest Pain" was accepted and presented at EMBC 2025 in Copenhagen.

This study introduces the Electro-mechanical CAD Risk Score (EMCR Score™), an innovative AI‑driven model that merges non‑invasive seismocardiography (SCG) with clinical variables, like age, sex, symptoms, and risk factors, to estimate the pre‑test probability of obstructive coronary artery disease (CAD). Our multimodal approach empowers earlier and more accessible risk stratification, especially for patients who may be at high-risk or whose traditional assessments are inconclusive.

Key highlights:

• Presented during a poster session at the world’s largest biomedical engineering event
• Introduced our EMCR Score™, a novel AI-based risk prediction model for CAD
• Published in the IEEE Xplore digital library (available ~90 days post-conference)
• Submitted for JACC (Journal of American College Cardiology

The final CardioClin™ hardware design is complete and optimized for usability, aesthetics, and clinical reliability. The finalized design reflects extensive user feedback and engineering validation, and has been developed in alignment with our Quality Management System (QMS). We've now started injection molding and early-stage production, marking a key step toward broader clinical rollout.This marks the transition from iterative prototyping to our launch-ready hardware. A device that will set the foundation for clinical studies and broader market introduction.

Moniek Haan has joined HeartForce™ AG to lead global strategy and market positioning for CardioClin. She is driving brand evolution, go-to-market planning, and demand generation across the full spectrum of healthcare delivery, while also shaping commercialization models and strategic partnerships with patient associations, hospitals, and longevity clinics to support market access and future clinical opportunities. With over 20 years of international experience in life sciences and MedTech, including roles at Pfizer, Medtronic, and the European Respiratory Society, Moniek brings deep expertise in marketing, communications, and commercial execution.

HeartForce has been selected to present our latest research paper and lead a mini-symposium at the 47th Annual IEEE EMBC Conference. Our session, “From Signals to Insights,” highlights the future of cardiac electromechanical signal analysis in early CAD detection and places us at the forefront of discussions within our field.

Our Uzbekistan-based clinical study focused on monitoring patients after stent procedures with our CardioClin™ device. The results show strong evidence that seismocardiography vibration signals, when paired with our EMCR Score™, are a reliable indicator for:

• Predictive monitoring; establishing baseline cardiovascular function, allowing clinicians to effectively monitor changes afterward.
• Improved patient management; healthcare providers can identify patients at risk of deterioration, enabling them to prioritize those requiring further diagnostic evaluation or treatment.
• Early identification of complications; prompt detection of restenosis and other potential complications, leading to better patient outcomes.
• Customized follow-up care; post-stent treatment tailored to individual risk profiles, enhancing patient-centered care.
• Minimized unnecessary cardiac testing: avoidance of superfluous follow-up tests which leads to optimized healthcare resources.

Henk Meertens brings over 33 years of global MedTech leadership to HeartForce™ AG, including 33 years at Medtronic in senior regional and global roles across Europe, the US, and Asia. As CEO, he leads strategic growth, global expansion, and long-term value creation. His expertise spans business transformation, P&L oversight, and partnerships—having managed operations up to $7.5B and led the separation of a $2.2B business unit. He holds an MBA from Erasmus University Rotterdam.