SpectraWAVE intravascular imaging receives FDA premarket approval

08 Mar 2023

Company's HyperVue platform combining OCT and near-IR now moves towards launch.

SpectraWAVE, the Massachusetts-based developer of medical imaging systems for treatment of coronary artery disease, has announced FDA 510(k) premarket approval of its HyperVue platform.

The system, combining OCT imaging with near-infrared spectroscopy (NIRS), has also now been used in a "first-in-human clinical study" of 100 participants, which ran from July to December 2022.

"This is a landmark day for SpectraWAVE, but more importantly, a critical step towards improving outcomes for patients with coronary artery disease," said company CEO Eman Namati.

"Our proprietary imaging system pushes the technological limits of optical coherence tomography, both in image quality and depth, while combining it with spectroscopy for the first time."

The potential impact of OCT as an imaging technique within blood vessels has become apparent as the image resolution possible using the technique has increased, in particular for identifying early signs of coronary blockage or monitoring placement of stents. Advances in miniaturized catheter design have also made OCT imaging attractive.

However, the technique does not inherently identify the biochemical species and molecules in the tissues themselves, a key aspect of diagnosing coronary disease.

The solution is to design dual modality platforms, in which an imaging catheter contains both intravascular OCT and diffuse near-infrared spectroscopy, to simultaneously acquire both compositional data and microstructural information.

Early studies a decade ago at Harvard's Wellman Center for Photomedicine led to a proof-of-concept device in which a single high-speed wavelength-swept light source supplied light for both OCT and NIRS modalities, illuminating the tissue through a single-mode fiber and collecting the back-scattered OCT light with the same fiber. A separate collection fiber close by within the catheter detects the NIRS light.

A 2013 Optics Express paper describing the successful application of this principle to ex vivo human coronary arteries to identify the build up of plaque was co-authored by Guillermo Tearney, who went on to be a co-founder of SpectraWAVE in 2017 and is the named inventor of SpectraWAVE's implementation of the technology.

Stent positioning guided by intravascular imaging

Tearney was also involved in an initial 2016 clinical trial investigating in vivo dual use of multimodality OCT and near-infrared autofluorescence, which safely obtained image data from locations on an artery wall and identified a biomarker associated with potentially dangerous plaque.

SpectraWAVE was founded the following year to commercialize the company's proprietary HyperVue imaging system, combining NIRS with an OCT implementation named DeepOCT. Its most recent funding round saw the company raise $13.2 million of series A-2 financing in February 2021, earmarked for use scaling up product development and operations ahead of a regulatory filing.

With FDA approval now granted, SpectraWAVE indicated that use of its technology to guide the placement of coronary stents is one focus area. OCT as a stand-alone technique for monitoring the progress of stent deployment has been under investigation for some time, with a 2016 study indicating the advantages compared to ultrasound methods.

"Clinical evidence strongly suggests that patients benefit from intravascular imaging-guided stent optimization," said Ziad Ali from the Cardiovascular Research Foundation in New York. "After completing the first-in-human procedures, it's clear SpectraWAVE has built something truly special with a combination of DeepOCT and NIRS, paired with a workflow and AI-enabled image analysis."