Harbinger Medical Inc., ("Harbinger" or "the Company") is a venture backed medical device company that has pioneered Wedensky Modulation technology, with the purpose of developing it into a non-invasive risk stratification system. The Harbinger system goal is to address a key problem in cardiac risk stratification: the identification of patients at elevated risk for Sudden Cardiac Death (SCD). SCD is the largest cause of death among the 20 million adults at elevated cardiac risk worldwide, killing over 850,000 people each year.
An implantable cardioverter defibrillator (ICD) is highly effective at terminating arrhythmias that lead to SCD. However, identification of patients at risk of SCD is difficult, because current tests lack predictive accuracy. The most commonly used method is the measurement of ejection fraction ("EF"), the fraction of blood pumped out from the left ventricle with each heart beat. However, EF is a mechanical measurement of heart function, and SCD is the result of an electrical problem in the heart. Because of this, EF is often a poor predictor of patient susceptibility to life-threatening arrhythmia, and many physicians are reluctant to perform ICD implants. Other long established diagnostic tests not only lack predictive accuracy, but have other problems. "None of the tests are any good," said one cardiologist, speaking for many in an April, 2008 Wall Street Journal article.
Consequently, only a minority of patients currently indicated for ICD implantation actually receives an ICD, and large numbers of patients at risk of SCD are not indicated for ICD therapy. Meanwhile, the majority of patients who receive expensive ICD implants never experience a life-threatening arrhythmia, and are sometimes subjected to unnecessary, excruciatingly painful shocks.
The Harbinger system is a non-invasive, twenty minute test performed on patients at rest. The Harbinger system provides information for at-risk patients by assessing the vulnerability of the heart to potentially lethal arrhythmias. This is accomplished through Wedensky Modulation, which is the response of the heart’s myocardial cells to sub-threshold stimulation during myocardial depolarization and repolarization. Analysis of the Wedensky Modulation leads to a risk stratification score known as the WMI (Wedensky Modulation Index).
Two international clinical studies have demonstrated the ability of the Harbinger system to identify patients at risk of SCD. The most recent was the Harbinger ICD Patient ("HIP") Study, a prospective, international, multi-center observational study of post-MI patients who received an ICD. The study began enrolling patients in 2003, and a total of 268 of the 334 patients completed the one-year follow-up. The HIP study data showed the WMI positively predicted arrhythmic events in post-MI patients with statistical significance.
The results of the study have been submitted for publication in the near future. Three abstracts were accepted for the US Heart Rhythm Society meeting in May 2008, and four additional abstracts have been accepted at Cardiostim in June 2008. Additional abstracts and manuscripts based on the HIP study are planned to be published this year and next year to further review the study results.
The Harbinger technology has broad patent protection, with twenty issued and pending patents. The Harbinger system has already received FDA market clearance to report Wedensky Modulation data, and also CE mark for the European market. Harbinger is in the process of seeking expanded claims from the FDA based on the HIP study results.
The Harbinger system consists of a computer, proprietary software, and a special single-use electrode set. It is a flexible product structure that can either be manufactured as a standalone system or integrated into existing diagnostic systems. A second generation product with improved aesthetics is currently under development.
Harbinger Medical is a venture capital financed company with an experienced Board of Directors and world-class Medical and Clinical Advisory Boards. It is headquartered in suburban Minneapolis, MN.
