BEDFORD, Mass.–(BUSINESS WIRE)–SpectraWAVE, Inc., a medical imaging company focused on improving the treatment and outcomes for patients with coronary artery disease (CAD), today announced a $50M Series B funding round led by Johnson & Johnson Innovation – JJDC, Inc. joined by S3 Ventures, Lumira Ventures, SV Health Investors, Deerfield Management, NovaVenture, Heartwork Capital, and undisclosed parties. The funding round will advance commercial expansion and product additions to the Company’s 510k-cleared HyperVue Imaging System.
“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,” said Eman Namati, Ph.D., Chief Executive Officer of SpectraWAVE. “This evidence and broad recognition of impact has recently moved intravascular imaging to a 1A guideline recommendation in Europe, with an expectation that the United States will follow in due time. 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 reception to the product during our initial U.S. launch has been fantastic, and this financing, supported by leading MedTech investors, will support our commercial expansion to bring HyperVue to more patients.”
Intravascular imaging is an essential tool to optimize coronary stenting procedures, providing key insights into plaque morphology, plaque modification decisions, stent and balloon sizing and landing zone selection, confirmation of treatment optimization, and future adverse event risk. Prior intravascular imaging technologies offer compromises in image resolution, image depth, and ease of use. HyperVue is the first intravascular imaging technology to combine two important imaging technologies, DeepOCT and NIRS, while optimizing for image quality and procedural efficiency in the cath lab, including no-flush catheter prep, fast and long pullbacks designed to reduce and remove the use of contrast, and the most comprehensive AI-driven workflow and image analysis offering.
Namati continued, “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. 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 lab.”
About SpectraWAVE, Inc.
SpectraWAVE, located in Bedford, Mass., is a privately held medical device company founded in 2017 to provide unrivaled optical and computational insights to improve the treatment and outcomes for patients with coronary artery disease (CAD). CAD, the buildup of plaque in the wall of the arteries that supply blood to the heart, affects 20.5 million adults aged 20 and older. In CAD patients that undergo percutaneous stent placement, it is estimated that one in five patients experience adverse events within two years. SpectraWAVE’s flagship HyperVue™ Imaging System combines next generation DeepOCT™ images and near infrared spectroscopy (NIRS) with workflows optimized for the cardiac catheterization lab, and serves as a central hub for future enhancements that will continue to empower interventionalists in their treatment decision making and optimization. The HyperVue Imaging System is intended for the imaging of coronary arteries and is indicated in patients who are candidates for transluminal interventional procedures. The NIRS capability of the system is intended for the identification of patients and plaques at increased risk of major adverse cardiac events. For more information and complete indications for use, please visit www.spectrawave.com.
