NearWave

Executive Summary

NearWave is a San Francisco-based medical device company developing a novel, non-invasive diagnostic scanner that utilizes frequency-domain near-infrared spectroscopy (fdNIRS) to quantitatively measure deep tissue biomarkers such as oxygen saturation and hemoglobin concentrations. This technology addresses a critical unmet need in point-of-care diagnostics by enabling real-time, non-invasive assessment of tissue health, which could improve outcomes in areas like wound healing, peripheral artery disease, and surgical monitoring. The handheld device is currently marketed for investigational/research use only, indicating it is pre-commercial and undergoing clinical validation. Despite being founded in 2018, the company remains at an early stage with limited publicly available financial or regulatory milestones. If successfully validated and cleared by regulators, NearWave’s platform could compete with or complement existing near-infrared spectroscopy systems while offering deeper tissue penetration and quantitative accuracy. However, the path to commercialization involves significant technical, regulatory, and commercial risks, and the company has not yet disclosed key partnerships or funding rounds. The diagnostic imaging market is competitive, and NearWave must demonstrate clear clinical utility and cost-effectiveness to gain adoption. Overall, NearWave presents an intriguing but early-stage opportunity with potential for high impact if key milestones are achieved.

Upcoming Catalysts (preview)

• Q4 2026FDA Submission for 510(k) Clearance40% success
• Q3 2026Publication of Clinical Validation Study65% success
• Q2 2026Strategic Partnership or Series A Funding50% success