CLINICAL

First-in-Human

The Problem

Coronary artery disease is a chronic disease, characterized by the formation of atherosclerotic plaque in the coronary arteries, which causes inflammation and can lead to narrowing or even obstruction of the vessel, and to major cardiac events such as heart attacks. Vulnerable plaque, or high-risk plaque, is a particular type of plaque that has a rich necrotic and lipid content in its core within the vessel wall, and a thin cap separating the necrotic core from the bloodstream.

This plaque which may not be restricting blood flow, is called high risk plaque because it is at high risk of rupturing, at which point a large amount of the core material would be released in the bloodstream and cause acute thrombus formation, resulting in a heart attack. There are currently no dedicated device treatments available for vulnerable plaque.

Current treatments being used such as stents do not address the underlying pathophysiology of the lesion and are commonly associated with a number of problems such as re-narrowing of the vessel and also a future significant risk of a major cardiac events.

POLARSTAR – Early safety and feasibility study (First-In-Human Pilot)

CryoTherapeutics’ innovative approach has shown promising results in its first clinical trial. In the first-in-human POLARSTAR study, the device demonstrated both safety and feasibility, with data showing reductions in inflammation and plaque volume over a nine-month period – key factors in preventing rupture and reducing cardiac risk. Feedback from interventional cardiologists involved in the trial has highlighted cryotherapy’s potential as the novel, minimally invasive approach to directly stabilizing VP and addressing residual cardiovascular risk beyond what is achievable with traditional treatments.
> Safety: No device-related adverse events at 90 days
> Plaque Stabilization: Trends toward reduced plaque burden and necrotic core volume at 9 months
> Physiology Preservation: Stable trans-lesional FFRCT over 9 months follow-up, confirming preservation of coronary flow dynamics

The study represents a key milestone in developing localized, minimally invasive treatments for vulnerable coronary plaque – an area of urgent unmet need in cardiology.