CryoTherapeutics has announced a collaboration with SpectraWAVE, and the Cardiovascular Research Foundation (CRF) to lead the upcoming ICECAP clinical study.
The study is planned across up to five centres in Belgium and the UK, with patient recruitment expected to begin in the first quarter of 2026, assessing the CryoTherapeutics’ minimally invasive, catheter-based cryotherapy system (CTS) designed to target coronary high-risk plaques, a major underlying cause of myocardial infarction (MI). The technology is designed to stabilise high-risk plaques through temporary cooling.
As part of the collaboration, SpectraWAVE will provide its HyperVue imaging system, integrating next-generation comprehensive DeepOCT and near-infrared spectroscopy (NIRS) and technologies. The multimodality imaging approach will provide insights into coronary lesion assessment and the biological effects of localised cryotherapy over time, including assessment of fibrous-cap thickness and lipidic burden as markers of treatment effect. ICECAP will also incorporate artificial intelligence (AI)-assisted analysis to standardise the detection of high-risk plaque features and measure change over time.
“Starting the ICECAP study with SpectraWAVE’s HyperVue imaging system will allow us to leverage their novel combination DeepOCT and NIRS assessment to evaluate the efficacy of our cryotherapy for non-obstructive high-risk plaques, alongside planned CCTA assessments,” said Danny Detiège, vice president for clinical affairs of CryoTherapeutics. “This will be an important step in the development of our unique treatment approach to stabilise these high-risk plaques, preventing major adverse events.”
“Partnering with CryoTherapeutics represents an exciting opportunity to pair our plaque identification capability with a novel therapeutic approach to address a major unmet need in cardiovascular disease,” said Eman Namati, chief executive officer of SpectraWAVE. “By leveraging the unique capability of our HyperVue imaging technology—from visualisation of cap-thickness to quantification of lipid burden—alongside CryoTherapeutics’ treatment modality, we aim to deepen our understanding of non-obstructive high-risk plaque behavior and help shape the future of how these high-risk lesions are treated. Together, we are advancing research that has the potential to meaningfully improve patient outcomes.”
Carlos Collet, CRF’s director of cardiovascular imaging, physiology, and translational therapeutics, will lead the trial’s scientific activities, with CRF serving as the Core Lab.
“This study will allow us to integrate for the first time AI-detection of high-risk plaques with a novel treatment approach without the use of a permanent implant to modify the course of high-risk atherosclerosis,” said Collet.
“This dual-innovation setup underscores the scientific ambition and cutting-edge nature of this project,” said John Yianni, chief executive officer of CryoTherapeutics. “Clinical centres involved in the study have expressed strong enthusiasm for participating in a truly first-of-its-kind trial.”
