Clinical Validation of Navari Prior to Market Launch

Purpose and goal

The aim of the project is to take Navari from preclinical to clinical phase by enabling the company´s first human clinical study and thereby strengthening the path towards market introduction. The goal of the project is to validate the safety, performance and usability of the technology in the surgical environment and to create a basis for regulatory steps, continued funding, partnerships and commercialization.

Expected effects and result

The project is expected to result in Navari taking a crucial step from preclinical development to clinical validation. Through the first-in-human clinical study, the company will generate important knowledge about the technology´s safety, performance and usability in the surgical environment. The project will also contribute to a clearer regulatory path forward, strengthened industrial validation and improved conditions for continued funding.

Planned approach and implementation

The project is being implemented in four work packages focusing on clinical validation, regulatory strategy, commercial validation and funding. The work is being driven by the Navaris team, with support from external domain expertise in selected areas to ensure quality and feasibility. The approach is intended to reduce key risks and create a basis for continued development and market introduction. The project starts in May and runs until November 2026.