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17 Sep 2024
Series B venture round supports commercial expansion of system combining two optical techniques.
SpectraWAVE, the Massachusetts startup company whose technology combines two optical imaging techniques to aid treatment of coronary artery disease (CAD), has raised $50 million in a new round of venture funding.
The series B fundraising effort, led by the venture wing of medical technology giant Johnson & Johnson, will be used to support the commercial expansion of the firm’s “HyperVue” imaging system.
It combines optical coherence tomography (OCT) with near-infrared spectroscopy (NIRS) to optimize coronary stenting procedures, an intervention that is widely used but which SpectraWAVE says is followed by adverse events within two years for one in every five patients.
Clinical trial meta-analysis
SpectraWAVE’s CEO Eman Namati commented: “Intravascular imaging guidance is backed by a wealth of randomized clinical trials (RCT) and recently collated in a meta-analysis of 22 RCT studies and approximately 16,000 patients published this year in The Lancet, demonstrating significantly improved outcomes for patients undergoing coronary stenting.”
That study, published in March 2024, showed that intravascular imaging - using either ultrasound or OCT - improved patient outcomes, when compared with angiography-guided interventions using X-ray imaging.
Specific benefits identified by the authors included reduced risk of stent thrombosis, fewer heart attacks, and lower all-cause deaths.
“This evidence and broad recognition of impact has recently moved intravascular imaging to a 1A guideline recommendation in Europe, with an expectation that the US will follow in due time,” added Namati.
“Increasing both the capabilities and the ease of use of intravascular imaging systems is now critical to expand the use of imaging and improve care for these patients. That is our mission with HyperVue - simpler, faster, and better imaging to drive optimized stenting procedures for improved patient outcomes.”
The latest funding effort follows a previous $16 million venture round completed in 2019, while the HyperVue imaging platform gained 510(k) pre-market approval from the US Food & Drug Administration (FDA) in early 2023.
SpectraWAVE says that its combination of OCT and NIRS yields unrivaled visibility for cardiologists, even in complex cases, by simultaneously acquiring both compositional data and microstructural information.
While OCT imaging has been used to assist stent procedures for several years, the additional NIRS capability is said to identify those patients and types of arterial plaques that are at increased risk of major adverse cardiac events.
Procedural effiicency
Studies completed more than a decade ago at Harvard University'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 located within the catheter detects the NIRS light.
A 2013 paper published in Optics Express detailed the successful application of the approach in ex vivo human coronary arteries to identify the build-up of plaque, with co-author Guillermo Tearney going on to co-found SpectraWAVE in 2017.
The company says that previous intravascular imaging technologies resulted in compromises over image resolution, image depth, and ease of use, with HyperVue claimed to optimize both image quality and procedural efficiency.
“In addition to our commercial intravascular imaging system, we are developing a wire-free physiology software add-on to allow physicians rapid assessment of pressure drops in the coronaries using the same HyperVue hardware,” Namati also pointed out.
“This is an important step in our journey to enhance the clinical decision-making for these patients and establish an anchor point for future innovation in the cath[ether] lab.”
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