Cardiovascular disease is the biggest killer in the Western world. The development of novel interventional treatment strategies, such as thrombolysis, angioplasty and stenting, has had a significant impact in reducing mortality from heart attacks and the market for interventional cardiac devices is estimated at $8 billion in 2005.
CryoTherapeutics is focusing on the development, demonstration of clinical benefit, and early-stage commercialization of a proprietary cryotherapy system for use in the treatment of coronary artery disease that causes heart attacks. The safety and efficacy of cryoenergy in the cardiovascular system has been demonstrated and CryoTherapeutics intends to extend the benefits of cryoenergy to the problem of diseased coronary arteries.
In the United States alone over half a million people die annually from a heart attack. While stents and other interventional therapies are effective in treating stable stenotic lesions they are not intended to treat unstable non-stenotic lesions. Studies have estimated that the majority of heart attacks are caused by non-significantly stenosed arteries that rupture without any warning. While non-occlusive in nature, unstable coronary plaque may ultimately lead to occlusion of the coronary artery following erosion of the fibrous cap. Removal of this cap exposes the fatty plaque, which triggers blood clot formation. It is these clots that occlude the coronary artery and lead to a sudden heart attack.
CryoTherapeutics is initially targeting the existing heart attack treatment market. Heart attack patients are those already undergoing a procedure for acute coronary syndrome (ACS) and therefore do not require any third party diagnostics to identify their unstable plaque. Treatment can be applied based on the identification of systemic and/or local markers that exist today, together with angiography to guide cryotherapy. CryoTherapeutics estimates the market represents an existing unmet need worth more than $1 billion annually.
It is predicted that within the next decade several million people worldwide will undergo some form of coronary diagnosis and of these; the majority will be diagnosed with a low-grade (less than 70%) stenosis and would be candidates for a therapeutic procedure related to non-critical plaque. Longer term The Company estimates the worldwide market of patients that could benefit from a coronary cryostabilization therapy for prevention of heart attack is estimated at in excess of $6 billion.
Cryotherapy has been used in the cardiovascular system for more than 40 years for treatments of arrhythmias and more recently peripheral vascular disease. The initial work leading to the formation of CryoTherapeutics led to the development key issued patents in the area of cryotherapy devices for treatment of arterial disease. Additional patents are in the filing process.
The market potential for coronary plaque treatment has attracted a number of companies with technologies ranging from pharmaceuticals to local phototherapy to drug-eluting stents. Although pharmaceutical approaches, such as statin drugs, have shown to play a valuable role, CryoTherapeutics expects interventional cardiologists will prefer a systemic drug based approach in combination with a localised device-based therapy.
Future competition is expected from technologies such as biodegradable stents and drug eluting balloons. However these approaches are not addressing the same potential market as CryoTherapeutics, their focus being on replacing stents in treatment of severe lesions and restenosis.