CryoTherapeutics, a medical device company developing minimally invasive localized cryotherapy for the treatment of coronary artery disease, today announced a unique three-way collaboration with SpectraWAVE, an innovator in intravascular imaging and physiology and the Cardiovascular Research Foundation (CRF), the global leader in cardiovascular research, to lead the upcoming ICECAP clinical study. This study unites (1) a novel therapeutic approach addressing non-obstructive high-risk plaques, (2) state-of-the-art intravascular imaging capable of quantifying fibrous-cap thickness and lipidic burden using artificial intelligence, and (3) the scientific expertise of CRF—combining the best of therapy, imaging, and research to advance care.

CryoTherapeutics is dedicated to advancing the understanding of high-risk (“vulnerable”) plaques and exploring innovative approaches to stabilize them. Although often angiographically non-obstructive, these plaques can rupture without warning and are major drivers of myocardial infarction, which is the first cause of death worldwide. Building on encouraging results from the POLARSTAR Study, which demonstrated a strong safety profile and early indications of plaque stabilization, the company is now taking the next step in clinical development.

The ICECAP Study will leverage a multimodality approach that combines Near-Infrared Spectroscopy (NIRS) and next-generation Optical Coherence Tomography (OCT) imaging at the time of the procedure and at nine-month follow-up, in addition to Coronary CT Angiography (CCTA). This multimodal imaging approach will provide unique insights into lesion assessment, and the biological effects of localized cryotherapy over time, including assessment of fibrous-cap thickness and lipidic burden as markers of treatment effect. ICECAP will also incorporate AI-assisted analysis to standardize 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, VP Clinical Affairs of CryoTherapeutics. “This will be an important step in the development of our unique treatment approach to stabilize these high-risk plaques, preventing major adverse events.”

As part of this collaboration, SpectraWAVE will provide its HyperVue™ Imaging System, integrating next-generation comprehensive DeepOCT™ and NIRS technologies. The system offers high-resolution, deep imaging with AI-assisted analysis to capture detailed insights into plaque structure and composition, enabling investigators to understand the biological impact of cryotherapy. DeepOCT enables measurement of fibrous-cap thickness, while NIRS characterizes lipidic burden—together identifying non-obstructive high-risk plaques and supporting efficacy readouts.

“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, PhD, CEO of SpectraWAVE. “By leveraging the unique capability of our HyperVue imaging technology—from visualization 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.”

The ICECAP Study will be conducted in conjunction with the Cardiovascular Research Foundation (CRF), a globally recognized leader in cardiovascular innovation and education. Dr. Carlos Collet, MD, PhD, 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 Dr. Collet.

The ICECAP Study is planned across up to five centers in Belgium and the United Kingdom, with patient recruitment expected to begin in Q1 2026. “This dual-innovation setup underscores the scientific ambition and cutting-edge nature of this project,” said Dr. John Yianni, CEO of CryoTherapeutics. “Clinical centers involved in the study have expressed strong enthusiasm for participating in a truly first-of-its-kind trial.” With the therapeutic device, advanced imaging, and an experienced global research organization aligned from the outset, ICECAP is positioned to generate definitive evidence of safety and biological effect in this underserved patient population.

This collaboration reflects a shared commitment to innovation and scientific advancement in the cardiovascular field, with the potential to impact millions of patients in the future through innovation in both detection and treatment of non-obstructive high-risk plaques. The companies intend to share progress from ICECAP at major scientific meetings as data mature.

About CryoTherapeutics

CryoTherapeutics is a medical device company based in Liège, Belgium, developing a novel, minimally invasive, catheter-based cryotherapy system (CTS) designed to target coronary high-risk plaques, a major underlying cause of myocardial infarction (MI).

CryoTherapeutics’ catheter-based cryotherapy technology is designed to stabilize these high-risk plaques by temporarily cooling the plaques to temperatures between −10 to −20°C. The localized treatment aims to stabilize these plaques by reducing inflammation and increasing the fibrous-cap thickness, with the goal of lowering rupture risk and preventing future MI. Unlike traditional interventions such as stents or drug-coated balloons, this approach avoids implanting foreign materials or relying on long-term medical therapy.

The company’s mission is to advance innovative therapies that address this critical unmet need in cardiology.

For further information please visit www.cryotherapeutics.com.

About SpectraWAVE

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 million adults in the United States aged 20 and older, resulting in 2.5 million diagnostic angiograms and 1 million percutaneous coronary interventions (PCI) annually in cardiac cath labs. SpectraWAVE’s products, HyperVue™ with X1™-FFR bring intravascular imaging and wire-free physiology together on one platform for efficient, precise PCI planning. X1-FFR provides rapid physiology results from a single angiogram while HyperVue delivers comprehensive DeepOCT™ + NIRS imaging with simple, automated workflows to guide decision making.

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. HyperVue is not cleared for use outside of the United States.

For more information and complete indications for use, please visit www.spectrawave.com.

About the Cardiovascular Research Foundation (CRF)

CRF is a nonprofit organization dedicated to helping doctors improve the survival and quality of life for people with cardiovascular disease through research, innovation and education. CRF designs and manages landmark clinical studies, operates world-class core laboratories, and convenes leading global meetings in interventional cardiology.

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