CryoCath Technologies Inc announced the U.S. Patent and Trademark Office has granted the Company a new method and device patent, US 6,546,932, providing broad coverage for CryoCath's arteriogenesis program, a novel therapy for the more than 500,000 patients worldwide suffering from chronic cardiac ischemia. Cardiac ischemia is inadequate blood flow to a region of the heart, often resulting in severe angina (chest pain).

The patent describes the method by which a flexible catheter is used to deliver cryotherapy in the range of -20 degrees C to -80 degrees C to trigger an angiogenic response in any tissue. Angiogenesis is the term used to describe the formation of new blood vessels. Arteriogenesis, a subset of angiogenesis, refers to the formation of new arteries, the type of blood vessel that carries oxygenated blood to the tissues. The patent also covers various catheter configurations and the combination of cryotherapy and drugs to stimulate the formation of new blood vessels.

"The broad claims of this patent should effectively block any other company from using cryotherapy alone, or cryotherapy combined with drugs, to stimulate the formation of new blood vessels, to treat ischemia," said Steven G. Arless, President and CEO of CryoCath. "An element of our growth strategy is to enhance the value of our intellectual capital. This angiogenesis patent builds on our field-dominating cardiovascular cryotherapy patent portfolio, and protects a promising market segment for CryoCath."

Each year there are approximately 260,000 chronic ischemia patients worldwide who have no surgical or interventional option. In addition to these "no option" patients, another conservatively estimated 300,000 patients (Medtech Insight 2002) undergoing bypass surgery or angioplasty cannot be fully revascularized, making the total available market for cryo-induced arteriogenesis therapy in excess of US$500 million worldwide.

In 2002 CryoCath reported the results of its POLAR trial, a safety and feasibility study of the use of catheter cryotherapy to treat patients with cardiac ischemia. In the POLAR trial, 18 of 19 patients with severe angina experienced a one CCS class reduction in angina score and 11 of 19 experienced a two-class reduction six months after their cryotherapy procedures. In addition, patients could exercise an average of 23% longer on the treadmill six months after cryotherapy. Other measures used to assess the patients' responses to treatment suggested meaningful improvement, including Seattle Angina Questionnaire, exercise time to symptom onset (chest pain) and exercise time to ECG change.