The Problem: Central venous access devices (CVADs) are essential for delivering life-saving therapies to high-risk and complex patients, from fragile newborns to critically ill children and adults. Yet placing and maintaining these lines safely is difficult. Misplacement or migration can occur, often detected only after complications arise, relying on repeated X-rays that expose vulnerable patients like newborns and children to radiation, as well as increases costs, and delay treatment.
Our Solution Navi has developed Neonav®, a world-first medical platform that uses the heart’s ECG signals not only to guide safe line placement in real time, but also to provide ongoing surveillance of line position throughout therapy. This dual capability transforms vascular access — helping clinicians get placement right the first time and detect possibly dangerous migrations before they cause harm.
Why We Are Unique
World-first ECG surveillance: Extends beyond placement to continuously monitor catheter safety, addressing a long-standing unmet need particularly in newborns and children.
Broadest indications for use of any device on the market: Applicable across all catheter sizes and patient groups: Designed for high-risk and complex patients of all ages — neonatal, pediatric, and adult.
Catheter-agnostic: Compatible with existing catheters from multiple suppliers, enabling faster adoption and broader impact.
Regulatory recognition: U.S. FDA 510(k) clearance and Breakthrough Device Designation highlight both safety and market potential.
Scalable platform: Establishes a foundation for broader applications in vascular access and critical care.
Current Stage
FDA 510(k) cleared and work commenced to onatin CE Mark to access EU market.
Manufacturing partnerships in place, with supply chain ready to scale.
Clinical evaluations underway in leading U.S. Children's hospitals, including first clinical sales.
Investment Highlights
Large, global market: Millions of CVAD procedures annually across neonatal, pediatric, and adult populations.
Strategic relevance: Strong alignment with global medtech leaders seeking differentiated solutions in vascular access and patient safety.
First-mover advantage: Unique technology that solves both placement and surveillance, areas of high clinical and commercial need currently not served in Neonatal and Pediatric patient populations.
Proven leadership: Experienced medtech team with track record in commercialisation, regulatory approvals, and scaling.
Capital raise: $3M Series A to accelerate U.S. commercial rollout, scale manufacturing
Exit potential: Clear acquisition pathways with major vascular access and critical-care device companies.
Problem and Solution
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