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Vulnerable Plaque

October 17, 2006 — BURLINGTON, Massachusetts

InfraReDx, Inc., a company that is investigating the use of near-infrared (NIR) spectroscopy for the detection of lipid-rich coronary artery plaque, will present its progress at the Cardiovascular Research Foundation’s 18th annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium in Washington, D.C., October 22-27, 2006. In its initial appearance at TCT, the company will also display its novel catheter, as well as promising experimental data, at a booth (number 1266) in the exhibit hall.

Dr. James Muller, InfraReDx’s founder, CEO, president, and chief medical officer, will be participating in three sessions:

• Tuesday, October 24: He will be delivering a talk – “Approaches to the Vulnerable Plaque and the Vulnerable Patient: Today and Tomorrow” – at a session devoted to “Acute Coronary Syndromes and Myocardial Infarction.”
• Thursday, October 26: He will be participating in the main event of a vulnerable plaque symposium, addressing the question: Does focal plaque-directed therapy to stabilize the coronary tree make sense? Dr. Muller’s response will be yes: vulnerable plaque is a focal disease, the cure of which warrants the risks of local therapy
• Thursday, October 26: He will be moderating a discussion of regional plaque passivation strategies.

Also on the TCT schedule are relevant presentations by the following independent investigators: Dr. Sergio Waxman, M.D., associate professor of medicine at Tufts University School of Medicine, and director of interventional cardiovascular research at the Lahey Clinic; as well as Pavan K. Cheruvu, M.Sc., a student in the Health Sciences and Technology program of the Massachusetts Institute of Technology, and Craig Gardner, Ph.D., director of algorithm development at InfraReDx.

Dr.Waxman will deliver a talk on the progress of his study of InfraReDx’s NIR spectroscopy system in patients (Thursday, October 26). He will also participate in a panel presentation on evaluating the physical properties of vulnerable plaque (Thursday, October 26).

As part of the vulnerable plaque symposium on Thursday, Mr. Cheruvu will be presenting the results of a study – “Density and Distribution of Thin Cap Fibroatheroma and Ruptured Plaque in Human Coronary Arteries—A Pathologic Study.” Dr. Gardner will also be presenting the results of another study as an electronic abstract: “Identification of Thin-Capped Fibroatheroma through Blood with Probe-based Near-Infrared Spectroscopy in Human Coronary Autopsy Specimens.”;

InfraReDx, Inc., founded in 1998 and headquartered in Burlington, Massachusetts, is a privately-funded company developing a fiber-optic, catheter-based, near-infrared (NIR) spectroscopy system to identify vulnerable plaques in the coronary arteries. For more information, visit www.infraredx.com.

TCT is organized by the Cardiovascular Research Foundation, which is dedicated to research and education in the broad subspecialty of interventional cardiology and endovascular medicine. The TCT meeting is the primary annual meeting for the world-wide interventional cardiology community. For more information, visit www.crf.org.

Uncovering hear attack signs :

June 16, 2008

James E. Muller, MD
CEO, InfraReDx Inc.

The sudden death of Tim Russert of NBC news is a public reminder of the many tragic deaths caused by coronary artery disease. Each year in the United States approximately 300,000 individuals die suddenly of coronary disease — over 800 others died of this disease on the same day that the nation lost its brilliant commentator and journalist.

The cause of death, in retrospect, is not mysterious. Dr. Michael Newman, the physician of Mr. Russert, has stated that the death was due to a heart attack. The heart attack in turn, was caused by a thrombus in the left anterior descending coronary artery, identified by an autopsy, that blocked the flow of blood to the heart muscle. Dr. Newman stated it is likely that the thrombus resulted from rupture of a plaque that was rich in cholesterol.

While hindsight provides a clear view, it was not possible with conventional medical tests to detect the problem in advance. Dr. Newman reported that Mr. Russert, who had a low HDL (good) cholesterol, and was known to have some degree of coronary atherosclerosis, passed a stress test in April, 2008. The successful performance on a stress test indicates that Mr. Russert did not have fixed blockages in his artery.

Unfortunately the stress test was not able to identify a dangerous plaque hidden in the wall of the artery. As reported by Dr. Newman it is highly likely that a cholesterol plaque not detectable by conventional tests was present in the artery. Even coronary angiography, in which blood flow through the vessels is directly visualized, would not have been able to find such a non-obstructive plaque. Conventional therapy, which Mr. Russert was receiving, was not able to stabilize this plaque and prevent his death.

There are extensive efforts underway to develop new tools for the detection of cholesterol plaques, and new preventive therapies.

The first need is for a non-invasive screening tool to identify individuals in the high risk population (such as Mr. Russert) who are in need of more extensive testing. There have been major advances in the development of non-invasive multi-slice computed tomography (MSCT). These devices, which require the use of a contrast agent and exposure to radiation, can now deliver excellent pictures of both the lumen and the wall of the coronary artery. MRI has also shown promise. It is likely that non-invasive devices will be able to identify vulnerable patients with a high probability of having a lipid-rich cholesterol plaque.

The second need is for a more precise technology that can confirm preliminary non-invasive findings that a cholesterol plaque is indeed present. Intracoronary catheters utilizing ultrasound, spectroscopic and optical measurement techniques have been developed for this purpose. Studies are in progress to determine if the signs of a cholesterol plaque detected by the non-invasive measures can be confirmed by these more precise invasive measures.

The third need is for more effective preventive therapy. While it is not reported what medications Mr. Russert was receiving, it is likely that this event occurred despite the use of statin therapy, aspirin, and anti-hypertensive medications. Research is being conducted on novel pharmacologic agents and the development of stents that might have a favorable risk-benefit ratio for stenting of cholesterol rich vulnerable plaques.

While three building blocks of a potentially more effective preventive strategy are already in clinical use –MSCT, intravascular diagnostic methods and stents – the approaches are not individually validated for primary prevention of sudden death. Nor is their use together in a screen, confirm and treat strategy tested.

The unfortunate loss of one of our leading national figures has occurred before a more effective preventive strategy could be developed, but an improved preventive therapy for our leading cause of death may not be far from realization. The loss of Tim Russert, plus the continuing deaths of so many others, supports the need for accelerated efforts to test these novel individual approaches and their combined use in a comprehensive strategy for prevention of sudden coronary death.

June 16 2008

Symptoms Of A Heart Attack

October 6, 2008InfraReDx, Inc. announced today that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its catheter-based LipiScan™ Coronary Imaging System. The LipiScan device uses near-infrared spectroscopy to identify lipid core containing plaques of interest in the coronary arteries in patients already undergoing cardiac catheterization. Such plaques, which cannot be detected by commonly-used tests such as a treadmill examination and even coronary angiography, are suspected to be the cause of most sudden cardiac deaths and non-fatal heart attacks.

The availability of this novel tool culminates a decade-long biomedical engineering effort to create an instrument that could perform spectroscopy in the arteries of patients with coronary artery disease. The identification of the chemical composition of coronary plaques is expected to be of value to cardiologists in the selection of medical, stenting or surgical therapy for coronary lesions. The device is also expected to be of value to the pharmaceutical industry as a means to assess the effect of novel anti-atherosclerotic agents on lipid core plaque burden.

“The InfraReDx team is pleased that the LipiScan System has been validated in tissue samples and a clinical study and has been cleared by the FDA for use in patients. We understand the great potential of interventional cardiology and anticipate that this novel tool will assist physicians with the complex decisions they face in the management of patients with coronary artery disease,” says James E. Muller, M.D., cardiologist, co-founder, President and CEO of InfraReDx, Inc.

Dr. Muller noted that the creation of this novel device was greatly aided by the support and expertise of Sanderling Ventures of San Mateo, California. “Robert McNeil, Ph.D., Chairman of the Board of InfraReDx, and Timothy Mills, Ph.D., InfraReDx Board member are managing directors of Sanderling and both have extensive experience in medical device development,” said Dr. Muller. “Sanderling was a seed investor in Advanced Cardiovascular Systems, a company that pioneered development of balloon angioplasty and was acquired by Guidant.”

“While angioplasty and stenting were major advances, stenting has not been capable of preventing heart attacks due to the difficulty in identifying lesions likely to rupture and cause thrombosis. With the development of the LipiScan Coronary Imaging System, Sanderling is again contributing to a major step forward in providing a useful tool with which interventional cardiologists may improve the care of cardiac patients.”

“There is a real unmet medical need to identify lipid core containing plaques of interest in the coronary arteries, which before now we could not do,” says James Goldstein, M.D., Director of Research and Education at William Beaumont Hospital in Royal Oak, Michigan, who is also an investigator in the SPECTACL clinical trial for the device and a consultant for InfraReDx. “The ability to detect lipid core containing plaques of interest may go a long way in providing information to help prevent heart attacks in the near future.”

How the LipiScan Coronary Imaging System Works
Near-infrared (NIR) spectroscopy is commonly used to measure the chemical composition of unknown substances. The LipiScan Coronary Imaging System utilizes advanced optical technology, much of it developed for telecom uses, to deliver and retrieve NIR light from coronary plaques. The light reflected back at different wavelengths is analyzed to detect the chemical composition of the coronary plaques. At the completion of the catheter pullback, the LipiScan console instantly displays the scan results on a “chemogram”, a digital color-coded map of the location and intensity of lipid core containing plaques of interest in the artery. A Lipid Core Burden Index is also reported, which is a measure of the total amount of lipid core containing plaques of interest in the coronary artery. The LipiScan catheter interrogates each artery in less than 2 minutes and does not require the interruption of the flow of blood.

Successful Clinical Trial Results
The SPECTACL clinical trial documented the similarity of near-infrared spectra obtained from 106 patients undergoing coronary angiography compared to spectra obtained in autopsy specimens in which the gold-standard of histology was available. For more information, visit the InfraReDx website at www.infraredx.com.

About InfraReDx, Inc.
InfraReDx, Inc. is a privately-owned medical device company with expertise in near-infrared (NIR) spectroscopic technology and its application to coronary imaging. The company, located in Burlington, MA, was founded in 1998 to meet the unmet medical need for the detection and identification of lipid core containing plaques of interest in the coronary arteries. To meet this medical need, the Company developed The LipiScan Coronary Imaging System, an easy-to-use, catheter-based coronary imaging system that uses near-infrared spectroscopic technology to detect and characterize the composition of coronary artery plaques in patients undergoing catheterization. Funding for the development of the LipiScan System has been provided by a group of over 80 private investors and Sanderling Ventures. A Series C Funding round in 2007 raised $17 million. For more information, visit the InfraReDx website at www.infraredx.com.