CryoTherapeutics, a medical device company developing minimally invasive localized cryotherapy for the treatment of coronary artery disease, today announced the successful treatment of the first patient in its ICECAP clinical trial. The milestone marks an important step in evaluating whether localized cryotherapy can help stabilize vulnerable coronary plaques before they lead to myocardial infarction.
During ICECAP screening, the first patient with stable angina was identified as having a non-obstructive high-risk coronary plaque. Although these plaques do not significantly restrict blood flow, they are increasingly recognized to cause heart attacks as they can rupture unexpectedly.
The ICECAP study is designed to evaluate the efficacy and safety of localized cryotherapy applied to non-obstructive, high-risk coronary plaques identified through a multimodal imaging strategy combining non-invasive and invasive technologies, while also assessing changes in fibroatheroma cap thickness over time. Patients are screened using coronary CT imaging and AI-enabled plaque characterization tools to identify high-risk plaque features. During the procedure, intravascular imaging, including near-infrared spectroscopy (NIRS) and optical coherence tomography (DeepOCT), is used to further confirm high-risk plaque morphology and guide treatment. Follow-up imaging will assess biological response to cryotherapy over time.
ICECAP brings together a multidisciplinary ecosystem of clinical, imaging, and data science collaborators, including the Cardiovascular Research Foundation (CRF), HeartFlow, and Medis Medical Imaging. Together, they contribute expertise spanning intravascular imaging, coronary CT analysis, quantitative image analysis, AI-assisted plaque assessment, and cardiovascular clinical research to advance a next-generation approach to identifying and treating vulnerable plaque.
"Treating the first patient in ICECAP is an important milestone for CryoTherapeutics and the clinical development of our technology," said Dr. John Yianni, CEO of CryoTherapeutics. "We are excited to work with our clinical and technology partners to generate the evidence needed to evaluate localized cryotherapy and advance the field."
"We are in a new phase of the detection and treatment of high-risk plaques. In the ICECAP study, we are combining state-of-the-art plaque assessment with a novel therapy to stabilize vulnerable plaques," said Dr. Carlos Collet, MD, PhD, Director of Cardiovascular Imaging, Physiology, and Translational Therapeutics, CRF.
Patient recruitment is active and will expand to up to five centers across Belgium and the United Kingdom in the coming months.
About CryoTherapeutics
CryoTherapeutics is a medical device company based in Liège, Belgium, developing a novel catheter-based cryotherapy system designed for research into coronary plaque stabilization. The investigational system delivers localized cooling (-10 to -20°C) to non-obstructive plaques identified through advanced imaging.
CryoTherapeutics' technology explores cryothermal processes that address vulnerable plaque pathophysiology a major contributor to myocardial infarction without permanent implants.
Cautionary Statement: CryoTherapeutics' cryotherapy system is an investigational device. It is not approved or cleared for commercial use in any jurisdiction and is limited to use in approved clinical studies.
For further information, please visit www.cryotherapeutics.com.
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Contacts:
Media Contact
Dr. Freskida Goni
Communications Consultant, CryoTherapeutics
freskida@cernere.eu
