SpectraWAVE has closed $50m in a Series B financing round for HyperVue, its cardiovascular imaging system cleared by the US Food and Drug Administration (FDA).
The financiers included Johnson & Johnson Innovation (JJDC), S3 Ventures, Lumira Ventures, SV Health Investors, Deerfield Management, NovaVenture, and Heartwork Capital.
The Massachusetts-based company plans to use the funds to develop new add-ons for the HyperVue system and advance the product’s commercial expansion in the US.
SpectraWAVE CEO Eman Namati said: “Intravascular imaging guidance is backed by a wealth of randomised 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.
“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. The reception to the product during our initial US launch has been fantastic, and this financing, supported by leading MedTech investors, will support our commercial expansion to bring HyperVue to more patients.”
The HyperVue system is designed to aid in coronary stenting procedures. It integrated two imaging technologies, namely DeepOCT images and near-infrared spectroscopy (NIRS), to optimise image quality and procedural efficiency by using no-flush catheter prep along with fast and long pullbacks designed to reduce and remove the use of contrast.
The system received a 510(k) clearance from the FDA in March 2023.
SpectraWAVE noted that it plans to add a wire-free physiology software feature to the HyperVue system. The software is expected to allow physicians to assess pressure drops in the coronaries.
One of the fastest-growing trends in diagnostic imaging is the use of AI. Medical imaging is forecast to be a major driver of the growth of AI in healthcare, as per a GlobalData AI in Healthcare report. The global revenue for AI platforms across healthcare is expected to reach about $18.8bn by 2027.
The use of AI in medical imaging and diagnostics received significant investment in the last year, with multiple companies raising capital to advance the use of AI in imaging. In October 2023, Philips and Quilbim partnered to develop AI-based imaging and reporting solutions for MR prostate examinations. The collaboration leveraged Philips’ high-speed MR imaging and Quibim’s QP-Prostate software to streamline diagnosis.
In October 2023, US-based Clarix Imaging raised $10m for its FDA-cleared point-of-care 3D imaging platform. Clarix Imaging’s device enables real-time assessment of specimens in the operating room for lumpectomy procedures.
