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Imatron: Speed Saves

Executive Summary

Imatron's electron beam tomography, or EBT, offers clinicians a valuable tool to detect the early presence of heart disease, by looking for calcium deposits that are a surrogate for plaque build-up, and to help them begin treatment or lifestyle changes before heart attacks occur. But adoption or acceptance of EBT has been slow in coming, the result of physician skepticism, consumer ignorance, and most importantly, insurer resistance. Some physicians are skeptical because EBT measures neither restenosis no so-called vulnerable plaque. Things are looking up for Imatron, however. Sales of EBT systems are increasing rapidly due to greater acceptance in the medical community and the launch of the company's own sales force.

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The Unstable State of Plaque Detection

Recent research points to unstable, rather than stenotic plaque, as a major cause of heart attacks. Cardiologists, as much as entrepreneurs and large companies, are therefore driving the creation of new cardiac detection platforms based on characterizing arterial plaque in order to identify patients that are unaware that they are at risk of suffering a myocardial infarction. First-generation detection tools are well along in development, but the scientific understanding about plaque is evolving so rapidly, technologies may be obsolete by the time they are ready for commercialization. Finally, looking for heart attack risk in symptomless patients means screening apparently healthy patients based on risk factors. Clinicians aren't yet prepared for the treatment implications and payers aren't ready for the economic burden of widespread screening, and this presents one of the greatest challenges for companies introducing new plaque detection technologies.

The Coming of Age of Vulnerable Plaque

Traditional scientific wisdom holds that heart attacks originate from severe blockages of the artery created by atherosclerosis, the progressive build up of plaque in the coronary arteries. Recent research indicates, however, that certain kinds of "vulnerable plaque" may trigger acute coronary events, creating demand for new diagnostic tools to identify and characterize the plaque and new treatments. The field is moving at a dizzying pace and is beginning to attract a handful of start-ups and venture capitalists; these see a huge opportunity, but also recognize the challenges inherent in changing entrenched approaches to treatment.

Optical Detection: From Physicists to Physicians

Several companies formed in the 1990's are poised to validate the clinical potential of light-based diagnostics as they guide through clinical trials products for a wide variety of applications in cancer, dermatology, gastrointestinal and cardiovascular diseases. Developers of the new optical imaging technologies ultimately hope to improve the way physicians diagnose diseases, by enabling insight into conditions where detection is currently inadequate. They hope to improve outcomes by detecting diseases at earlier stages, before pathological changes become visible. Finally, they aim to develop non-invasive systems that offer rapid diagnosis at the point of care, so that physicians can see and treat patients in a single visit. For now, though, companies are approaching the market cautiously. Most have a strategy of getting their products approved for adjunctive applications rather than attempting to win approval for the devices as standalone diagnostic systems that replace current screening methods.

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