Cryoablation system
CoolCryo is a cardiac cryoablation system based on liquid nitrogen as the cooling medium. Liquid nitrogen is a commonly used and cost-effective cooling medium, and its application significantly reduces the operational costs. Thanks to the heated and moldable tip, procedures can be performed more quickly. The entire system, including the cryoapplicator, is intended to be used for minimally invasive, transmural cryoablation of the heart.
Arrythmia
Arrhythmia stands out as one of the prevailing concerns among patients seeking care in cardiology offices. Depending on its type, arrhythmia may result in circulatory failure and significantly elevate the risk of stroke.
Ablation
It is a recommended method for the therapy of heart rhythm disorders. It is a percutaneous cardiological procedure aimed at isolating the area of heart tissue responsible for the occurrence of arrhythmias. The procedure involves creating a small scar that blocks the conduction of electrical impulses responsible for inducing arrhythmia.
Why is it worth it?
Possibility
of transmural
cryoablation
Greater precision hanks to the moldable tip.
Heated applicator
tip
The lowest cryoablation temperature on the market.
Patent protection
CoolCryo is a heart cryoablation system consisting of a control console and a cryoapplicator available in various variants. The system allows minimally invasive access to the heart. Moreover, the technology used guarantees shorter, more effective and cheaper treatments.
CoolCryo market
In recent years, the global aging process has intensified due to a consistently low birth rate and an increased average life expectancy. It is estimated that in the coming decades, the proportion of elderly people in the total population will significantly increase, leading to a rise in the number of individuals with cardiovascular diseases. If the current upward trend is maintained, it is expected that the number of patients with atrial fibrillation in the European Union alone will increase to 14 million by 2060. The latest NOMED-AF study shows that in Poland, as many as 1,250,000 people aged up to 65 years suffer from atrial fibrillation, which constitutes 19.2% of the population. One of the methods for treating atrial fibrillation is the use of cryoablation. Cryothermia is the only method of cardiac muscle ablation that simultaneously preserves tissue collagen. This unique feature constitutes the main advantage over high-temperature energy sources, as it allows the surgeon to safely ablate tissue anywhere in the heart without significant impact on adjacent structures. Furthermore, compared to other methods of treating atrial fibrillation, performing cryoablation is characterized by shorter procedure times compared to radiofrequency (RF) ablation, greater procedural consistency among operators, and a higher likelihood of procedural success in a single session. Additionally, the 2020 ESC guidelines on the diagnosis and treatment of atrial fibrillation, developed in collaboration with the European Association of CardioThoracic Surgery (EACTS), recommend concomitant surgical treatment of atrial fibrillation during other cardiac surgical procedures. They indicate that surgical ablation using cryothermia is safe and effective in restoring sinus rhythm. It should also be noted that among the available methods, cryoablation is the least invasive for the endocardium and generates highly repeatable ablation lines. In order to shorten the treatment time as much as possible, the CoolCryo system uses widely available liquid nitrogen as a cooling agent, which, compared to argon or nitric oxide used in available cryoablation systems, ensures a lower freezing temperature and works in a more efficient physical phenomenon, thanks to which it allows obtaining lines ablation procedures in a shorter time. The solution used in the CoolCryo system will not only ensure a quick cryoablation process, thus shortening the surgical procedure, but will also reduce the risk of having to repeat treatments.
Project progress
At the beginning of 2023, the animal testing phase was completed. Currently, systems necessary for conducting clinical trials are being prepared. Simultaneously, the documentation required to obtain permission for conducting these trials is being compiled. On August 4, 2023, the company signed a contract for CRO services (clinical trial management). Regardless of the planned certification path in the European market in accordance with MDR standards, the company is analyzing potential scenarios for FDA approval of the CoolCryo product in the USA.
* The aforementioned project signifies a product that has not yet received approval as a medical device from the relevant regulatory authority. Competitive advantages and other aspects of the aforementioned project will be substantiated thorough testing and research.
