Prototype Validation
Phase 0 - Completed
After developing prototype v2.0, we first conducted laboratory tests on more than 80 volunteers, recording over 8,000 cardiac cycles. Test cohort included individuals with various cardiac conditions, including heart failure.
We then performed a scientific study with more than 10 healthy volunteers at the University of Modena, evaluating five conditions including pre- and post-exercise. The results indicated the device’s ability to consistently capture high-quality cardiac signals even through heavy clothing, supporting the analysis of more than 750 cardiac cycles.
These activities were conducted in collaboration with Prof. Giuseppe Boriani, a globally recognized authority in implantable devices, heart failure, and health economics.
Current Validation KPIs
90+
Individuals tested.
8000+
Complete cardiac cycles measured.
Zero
Faulty measurements were observed during the tests.
Cohort
Bologna apartment and Modena University Hospital.
Product Validation
Phase 1 - Planned
A first Clinical Validation Study will be conducted at the Cardiology Department of the University of Modena, under the direction of Prof. Giuseppe Boriani as Principal Investigator.
The study aims to enroll 120 patients over a 12-month period in 2026. Prof. Boriani is a globally recognized authority in implantable devices, heart failure, and health economics.
Preliminary findings from this study are intended to be submitted to leading international peer-reviewed cardiology journals by June 2026 (e.g., Europace).
Phase 2 - Under Planning
A subsequent multi-centre international study is being planned to further evaluate the device’s performance and its potential role in supporting early heart failure risk assessment.
This phase will contribute to the clinical evidence required for MDR and FDA regulatory submissions, supporting the pathway toward global market authorization.
