1
High-Need Use Cases
Focus on uncontrolled or difficult-to-manage hypertension and CKM populations where needs are greatest.
Phase 1
Focused Use Case
A Staged U.S. Development Pathway
A practical, partner-aligned approach to bring BPmap™ to U.S. care.
2
U.S. Bridging & Calibration
Calibrate and validate performance in U.S. populations and conduct retrospective and prospective bridging studies.
Phase 2
U.S. Bridging & Calibration
3
Partner-Aligned Regulatory Strategy
Develop a tailored regulatory pathway with partners—efficient, data-driven, and aligned with intended use.
Phase 3
Partner-Aligned Regulatory Strategy
4
Workflow & Evidence Generation
Integrate into clinical workflows, generate real-world evidence, and demonstrate clinical utility.
Phase 4
Workflow & Evidence Generation
Strategic Principle: First step: focused, practical, partner-informed.
We will start with clinic-based pilots, integrate with connected BP monitoring, and validate workflow and clinical utility with clinicians and care teams.