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 laboratory tests with more than 10 healthy volunteers in a laboratory, 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.
Current Validation KPIs
90+
Individuals tested.
9000+
Complete cardiac cycles measured.
Zero
Faulty measurements were observed during the tests.
Cohort
Bologna studio and laboratory.
Product Validation
Phase 1 - AUTHORIZED
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. The study has been authorized by the Italian Ministry of Health.
Enrollment will start in September 2026.
Preliminary findings from this study are intended to be submitted to leading international peer-reviewed cardiology journals at the end of the study in April 2027.
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.
