Current treatments for atherosclerotic lesions such as stents do not address the underlying pathophysiology of the lesion that is at risk of rupturing and causing obstruction. Furthermore, such treatments present particular risks when applied in high-risk plaque (or vulnerable plaque) lesions, andare commonly associated with a number of problems such as re-narrowing of the vessel There are currently no medical device treatments specifically intended to treat high-risk plaque lesions. Cryotherapy has been shown to be safe, and in applications such as the treatment of atherosclerotic disease in the peripheral vessels (outside of the heart) it has been shown to be effective.
Cryotherapy has been used in several applications in medicine for more than 40 years. More recently it has also become one of the treatment options for heart arrhythmias and peripheral vascular disease.
Cryotherapeutics was formed based on initial development of a cryotherapy device, intended for cryotherapy applications for treatment of atherosclerosis. This development has allowed to secure a number of approved patents held by the company with several more patents pending. The CryoTherapeutics CTS system is comprised of a catheter that is inserted into the coronary artery for delivery of cryoenergy at temperatures below zero, and a console controlling the delivery of a cooling agent to achieve the required temperature for effective cryotherapy.
The extensive medical experience of using Cryotherapy across several applications and therapeutic areas, has confirmed cryoenergy is a very safe form of energy for use in the body. In particular, specific cardiovascular experience and pre-clinical investigations show its large potential for treatment of atherosclerosis and high-risk plaque in particular:
- Intravascular cryotherapy has proven clinical benefit in treatment of peripheral artery disease and cardiac arrhythmias.
- Preclinical studies have shown that cryotherapy can stabilize high-risk plaque in relevant animal models.
- Cryotherapy treats underlying pathophysiology of inflamed perivascular region.
- Using cryotherapy does not require a permanent implant, which has several major advantages (reduced antiplatelet therapy, regulatory).
The CryoTherapeutics CTS system allows to deliver cryoenergy locally to the high-risk plaque region and has the advantage that it does not involve leaving in place a permanent implant. The system is intended to apply cryotherapy at temperatures between –10° to – 20°C which does not involve ablation of tissue but rather enhances the vessel healing response.
As such, the cryotherapy of the high-risk plaque can stabilize the plaque and could prevent the rupture of the lesion and the subsequent heart attack.