Latest Updates from HeartForce™

HeartForce’s novel approach to non-invasive cardiac evaluation will be showcased at IMECE 2026 within the Biomedical & Biotechnology Engineering track. Dr. Parastoo Dehkordi will present the company’s foundational R&D on tri-axial seismocardiography, demonstrating how capturing chest-wall mechanical forces reveals early changes in myocardial performance.

This invitation highlights HeartForce’s scientific rigor in transforming complex cardiac mechanical signals into a standardized, AI-driven risk evaluation score, validating the CardioClin™ not just as a clinical tool, but as a breakthrough in medical sensor engineering.

HeartForce is bringing its flagship CardioClin™ platform to the Canadian Cardiovascular Congress (CCC) in Ottawa, Canada’s largest national gathering of cardiologists, clinical researchers, and healthcare leaders.

Beyond demonstrating 60-second point-of-care assessments at the HeartForce exhibition booth, the company will showcase new scientific evidence during the General Cardiology poster session. Dr. Parastoo Dehkordi, VP of Research & Development, will present study findings evaluating HeartForce’s electro-mechanical risk model against traditional clinical likelihood assessments (Board #244, Thursday, Oct 15). The study highlights how integrating non-invasive cardiac mechanical signals with clinical variables significantly improves diagnostic specificity while maintaining high sensitivity, offering Canadian clinicians a reliable, objective tool for triaging symptomatic patients prior to advanced imaging.

Presenting to an audience of international cardiologists and imaging specialists at the European Society of Cardiology (ESC) Congress in Munich, Dr. Richard Kobza (Cardiopuls Medical Centre, Luzern) shared new clinical validation data evaluating HeartForce’s CardioClin™ technology.

Speaking during a moderated session on AI and multimodal imaging chaired by prominent European cardiology faculty, Dr. Kobza detailed how combining non-invasive cardiac mechanical signals with machine learning establishes a powerful electro-mechanical model for early CAD evaluation. The presentation demonstrated how CardioClin™ provides reliable pre-test probability assessment across diverse patient symptom profiles, delivering point-of-care precision without relying on costly imaging or ionising radiation.

HeartForce has officially completed the commercial manufacturing design, optimized sensor molds, eco-friendly custom packaging, and user-facing mobile application for the flagship CardioClin™ platform. With the full product suite finalized and the mobile application awaiting launch on the Google Play Store, HeartForce has placed an initial production run of 500 commercial CardioClin™ sensors. This milestone establishes full commercial readiness as the company awaits final regulatory clearance to begin international market fulfillment.

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.

On December 31st, 2025, HFAG acquired HFM in a share for share offer. HFAG purchased all issued and outstanding HFM shares on the basis of 1 HFAG Share for 28 HFM Shares. The Offer Consideration is valued at a deemed price of $0.168 CAD per HFM Share.

Over 90% of HFM’s minority shareholders have supported the offer to fully integrate HFM into HFAG as a wholly owned subsidiary. The result is a normalized and simplified capital structure, which HFAG believes will provide improved access to capital, improve financial flexibility to pursue strategic initiatives, and enhance the market’s understanding of the business.

HFM minority shareholders held 20% of HFM’s shares and upon completion of the offer and compulsory acquisition, the minority shareholders will end up owning 13% of HFAG’s shares. This modest premium to HFAG’s existing shareholders reflects the risk of investment in HFM that they have borne over the last seven years.

We welcome the new shareholders of the Company and look forward to their continued support as we advance the Company’s mission in the medical device and life-science industry.

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.

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.