SpectraWAVE, Inc.

SpectraWAVE, Inc. is a medical device company specializing in innovative imaging and physiology technologies for coronary intervention. The company manufactures the HyperVue Imaging System, which combines DeepOCT+NIRS (Optical Coherence Tomography and Near-Infrared Spectroscopy) imaging with integrated physiology assessment tools. The HyperVue platform enables clinicians to acquire comprehensive coronary artery images with rapid acquisition (sub-second pullbacks with minimal or no contrast) and automated AI-powered bedside analysis to support percutaneous coronary intervention (PCI) planning and optimization. SpectraWAVE's flagship innovation is X1-FFR, a wire-free, drug-free fractional flow reserve (FFR) physiology solution that calculates FFR from a single angiogram in approximately one minute, eliminating the need for guidewires, adenosine administration, and DICOM file management delays. X1-FFR received FDA 510(k) clearance in October 2025. The integrated HyperVue with X1-FFR platform is positioned for cath labs seeking to streamline coronary diagnostics and reduce procedure time while improving treatment precision. SpectraWAVE targets interventional cardiologists and cardiac catheterization labs, offering an integrated solution that combines structural vessel assessment (DeepOCT+NIRS) with functional physiology (X1-FFR) on a single console.