Heartscape Technologies, Inc.
Heartscape Technologies, Inc. is a privately held venture funded company engaged in the development and marketing of the PRIME ECG® System (PRIME), a breakthrough medical device that is designed to allow more accurate and rapid diagnosis of heart attacks (acute myocardial infarction or AMI) and ischemia. PRIME is a patented, FDA approved product with an annual US market opportunity of approximately $1 billion.
Market Need
Each year in the United States, 4.7 million people present to hospital emergency departments with chest pain of suspected cardiac origin. Approximately 900,000 of them are experiencing a heart attack. Current diagnostic tests are not sufficiently sensitive to allow diagnosis for many, which can result in delayed treatment costing lives and additional suffering for AMI victims. For others, rule-out is equally challenging adding cost and inconvenience for those who are unnecessarily admitted for further testing or observation.
Unique Patented Design
PRIME has been designed with the ideal mix of sophistication and user-friendliness to encourage widespread adoption in clinical practice. Proprietary software creates a series of intuitive, color displays flagging potential areas of concern. Via a simple touch screen, the physician or caregiver can quickly view the images suggestive of poor blood flow (tissue ischemia, injury or death) or other heart problems. These easily interpreted graphics contrast markedly with the conventional ECG signal display that is often challenging to interpret.
The PRIME ECG® test can detect serious heart attacks (STEMI) that may be missed by a traditional 12-lead electrocardiogram. The PRIME ECG system utilizes 80 data collection points that provides a 360-degree view of the electrical activity of the heart. The system displays information in several formats including 3D color images for rapid identification of areas of possible ischemia and infarction. This increased spatial view of the heart assists emergency physicians and cardiologists to better risk stratify and manage difficult to diagnose chest pain patients in the hospital emergency department.
Chest pain patients who have a non-diagnostic 12-lead ECG can remain in an emergency room or an observation unit for hours pending diagnosis. Such delay can prevent timely intervention resulting in irreversible cardiac damage seriously affecting both mortality and morbidity. Further testing may include serial ECGs and cardiac markers, echocardiography, nuclear imaging and diagnostic cardiac catheterization. These tests add cost and can introduce new risks to the patient. Not every hospital can provide urgently required imaging or cardiac catheterization 24/7.
PRIME ECG is non-invasive and easily performed at bedside. When used immediately following the initial non-diagnostic 12-lead, PRIME can reveal important information that may reduce time to intervention while avoiding unnecessary delay associated with the need to conduct more costly and invasive diagnostic tests. Studies in thousands of patients over more than ten years have shown increased early detection of acute myocardial infarction as well as improved identification of important conditions such as right ventricle and posterior involvement in the presence of inferior MI prompting more appropriate intervention.
