Problem

NearWave addresses the slow, uncertain feedback loop in breast-cancer treatment selection, especially for patients receiving neoadjuvant chemotherapy before surgery. Physicians may wait roughly three to 12 months to determine whether a regimen is working, even though the company says about 70% of women do not fully respond. During that period, patients can endure ineffective treatment and its side effects, while clinicians lack timely information to adjust dosage, switch therapies, or proceed to surgery. The main use case is identifying within about a week whether chemotherapy is producing a meaningful response, rather than waiting for tumor-size changes or surgical pathology.

The economic and clinical pain is substantial: NearWave says faster treatment decisions could reduce patient side effects by as much as 50% and lower costs in cases where patients can move directly to surgery. The company’s rationale is that functional imaging can reveal treatment response before conventional imaging shows tumor shrinkage; its investigational-studies material says this type of functional information is not part of current standard-of-care imaging.

Product / Service

NearWave develops the NearWave Scanner, a handheld, battery-powered frequency-domain near-infrared spectroscopy device paired with a mobile companion app. The system shines near-infrared light into tissue and measures optical absorption and scattering at depths of approximately 1–2.5 cm, producing quantitative information about metabolic biomarkers such as tissue oxygen saturation and hemoglobin concentrations. Its hardware supports real-time one- and two-dimensional imaging, and the company describes the device as cable-free, fully integrated, and optimized for rapid mapping.

The scanner’s measurements feed prediction models intended to identify whether a breast-cancer therapy is likely to produce a pathologic complete response. The approach is non-invasive, uses no ionizing radiation or injectable contrast, and is designed to provide clinicians and researchers with faster, quantitative feedback. It remains an investigational, research-use product rather than a cleared standard clinical device; a recruiting Indiana University study is evaluating feasibility in patients receiving neoadjuvant chemotherapy, with an estimated completion in January 2027.

Market

NearWave competes in medical-device diagnostics and oncology, specifically functional or metabolic breast imaging and treatment-response monitoring. Its offering is differentiated from conventional screening and structural imaging by aiming to measure biological response during therapy rather than simply detect or size a lesion. The competitive set therefore includes existing standard imaging workflows as substitutes, while third-party market data names Delphinus Medical Technologies and QT Imaging among adjacent competitors; QT, for example, is developing a breast-imaging system based on acoustic CT.

The company appears commercially early but not pre-revenue. Y Combinator reported that NearWave had sold four systems for $123,000 and had received FDA agreement on its proposed regulatory pathway. NearWave also announced a $1.2 million pre-seed round, while its latest clinical-trial evidence shows that the core breast-cancer application was still being evaluated in a small, 15-person recruiting study as of February 2026. Thus, the evidence supports initial research-system sales and funded development, but not broad clinical commercialization or established recurring revenue.