Background

Cardiovascular disease is the leading cause of death in the United States. Although mortality from heart disease has declined steadily over the past three decades in the U.S., the total burden of coronary disease is predicted to increase substantially over the next 30 years due to the increasing size of the elderly population.  Current medical imaging in cardiovascular indications is mainly dependent on intravenous or intra-arterial injections (via cardiac catheterization) of iodinated contrast media. The main disadvantage of current iodinated x-ray contrast agents is that they permit only a very short time interval between administration and imaging, with the result that the agent quickly diffuses out of the blood pool and the contrast is lost. NSI is developing N1177-iv to extend the clinical utility of CT imaging for the indications of angiography of the heart and peripheral blood vessels.

Cardiovascular Marketplace

According to AHA’s Heart Disease and Stroke Statistics for 2005, more than 70 million Americans have one or more types of cardiovascular disease (CVD).  The main types and prevalence estimates for these types are: (Note: Due to overlapping, it is not possible to add these conditions to arrive at a total.)

• High blood pressure — 65 million
• Coronary heart disease — 13 million
• Myocardial infarction (heart attack) — 7.1 million   
• Angina pectoris (chest pain) — 6.4 million
• Congestive heart failure — 4.9 million
• Stroke —5.4 million
• Congenital cardiovascular defects — 1 million 

This year, an estimated 700,000 Americans will have a new coronary attack, and about 500,000 will have a recurrent attack.  According to AHA, an additional 175,000 silent (undiagnosed) first heart attacks occur each year. For 2005, the estimated direct and indirect cost of CVD is $393.5 billion; of heart disease is $142.1 billion; and of stroke is $56.8 billion. In 2002 an estimated 1,204,000 angioplasty procedures, 515,000 bypass procedures, 1,463,000 diagnostic cardiac catheterizations, 63,000 implantable defibrillators and 199,000 pacemaker procedures were performed in the United States. (Source:  Health Care Financing Review, 2001 Medicare and Medicaid Statistical Supplement, CMS, April 2003)

Used in conjunction with CT, N1177-iv could help in diagnosing more than half the Americans with cardiovascular diseases.

Coronary Heart Disease (CHD)

Prevalence at Estimated Launch of N1177-iv in 2010-2011

Year/Age	2010	2011	2012	2013	2014	2015
45-49	454,417	459,075	463,732	468,390	473,047	477,705
50-54	423,698	432,522	441,346	450,169	458,993	467,817
55-59	1,463,964	1,456,240	1,448,516	1,440,792	1,433,069	1,425,345
60-64	1,550,093	1,536,330	1,522,568	1,508,804	1,495,042	1,481,279
65-69	1,996,360	1,953,174	1,909,986	1,866,801	1,823,614	1,780,429
70-74	1,928,467	1,936,946	1,945,424	1,953,902	1,962,380	1,970,858
75-79	2,553,541	2,617,810	2,682,079	2,746,349	2,810,618	2,874,887
80-84	2,128,234	2,196,608	2,264,982	2,333,356	2,401,730	2,470,103
85+	1,618,363	1,700,149	1,781,934	1,863,719	1,945,505	2,027,290
Total	14,527,777	14,702,345	14,876,912	15,051,480	15,226,048	15,400,616