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Infraredx Announces TVC Imaging System to be Highlighted at the American College of Cardiology Event

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Cardiac imaging news Company’s First-in-Class Intravascular Technology for True Vessel Characterization to be Featured During Cardiovascular Innovations Educational Forum

BURLINGTON, Mass. – March 21, 2012 – Infraredx, Inc., a medical device company committed to advancing the diagnosis and management of coronary artery and other vascular diseases, today announced that its TVC Imaging System™ for the true vessel characterization of coronary artery disease will be featured in 11 oral and poster presentations, including a panel during the Cardiovascular Innovations Educational Forum, at the American College of Cardiology 61st Annual Scientific Session & Expo (ACC.12) and ACC-i2 with TCT, being held March 24-27, 2012, at the McCormick Place Convention Center in Chicago.

The TVC Imaging System is a first-in-class intravascular imaging system that holds the potential to revolutionize the management of coronary artery disease by providing information that is critical for evaluating vessel structure and composition, also known as true vessel characterization. The system’s improved image resolution delivers better clinical detail, providing more reliable vessel interpretation and assessment. The device is the only multimodality imaging system to combine both intravascular ultrasound (IVUS) and near-infrared spectroscopy (NIRS).

“We are pleased to present important new information on the TVC Imaging System at the ACC.12 meeting,” said James E. Muller, M.D., founder, chairman and chief medical officer of Infraredx. “Our IVUS image provides a high quality view of structures – vessel diameter, stent expansion – and our NIR data, obtained in the same pullback, provides accurate, automated detection of lipid core plaque. New data to be presented show that the versatile spectroscopy method can identify cap thickness as well as lipid core detection, and a comparison with non-invasive CTA shows the potential of CTA to serve as a screening tool for lipid core plaque. A potential screening strategy employing new technology will be featured in a special session in the Exposition Hall.”

The company will be exhibiting at booth #3054 during the conference. The schedule of oral and poster presentations at ACC.12 and ACC-i2 with TCT, including a panel during the Cardiovascular Innovations Educational Forum, is as follows:

Cardiovascular Innovations Educational Forum

On Sunday, March 25 at 3:55 p.m., Dr. James Muller will discuss the TVC Imaging System in a presentation titled “The Role of Invasive Imaging with IVUS, NIR, and OCT to Confirm the Presence of Vulnerable Plaques” during the panel discussion “The Role of Innovative Technologies in a Novel Strategy to Prevent First Coronary Event.” The panel, which is part of the Cardiovascular Innovations Educational Forum, will be held in Hall A2 of the CV Theater.

Case Sessions

On Saturday, March 24 from 2-5 p.m., the TVC Imaging System will be a subject of discussion during the “Live and Taped Case Session I: Multivessel PCI- Physiology and Imaging” session, being held during the i2 Live and Taped Cases (Session #2201) in Hall B of the ACC.12 Main Tent.

The session will be chaired by Gary S. Mintz, M.D., chief medical officer, Cardiovascular Research Foundation. Dr. Mintz will give a presentation titled “The Exploding World of Intravascular Imaging: IVUS, OCT, NIRS, etc - Practical Use during PCI” (Presentation #2201-13) from 3:45 to 4 p.m.

Emmanouil S. Brilakis, M.D., Ph.D., director, Cardiac Catheterization Laboratories, VA North Texas Health Care System, and associate professor of medicine, The University of Texas Southwestern Medical Center at Dallas, will present a taped case utilizing the TVC Imaging System from the University of Texas Southwestern Medical Center (Presentation #2201-15) from 4:15 to 5 p.m.

Oral Presentations

The TVC Imaging System will be a subject of discussion in a series of oral presentations, including:

Presentation Date/Time:     Saturday, March 24, 4:30-6 p.m.
Session Title:     Intravascular Imaging: Restenosis, Thrombosis and Stent Follow-up II: Very Late Stent Thrombosis and Late Catch-up
Presenter:     Co-chaired by Evelyn Regar, M.D., Ph.D., associate professor, department of interventional cardiology, Thoraxcenter, Erasmus MC
Session Type/Location:    i2 Symposium, Presentation #2611-2, Room S101A

Presentation Date/Time:     Sunday, March 25, 8-8:10 a.m.
Presentation Title:     Does Aggressive Statin Therapy Reduce Coronary Atherosclerotic Plaque Lipid Content? Results From: Reduction in YEllow Plaque by Aggressive Lipid LOWering Therapy (YELLOW) Trial
Session Title:    Intravascular Diagnostics
Presenter:     Annapoorna Subhash Kini, M.D., MRCP, FACC, associate director, Cardiac Cath Lab, Mt. Sinai Hospital       
Session Type/Location:     i2 Oral Contributions, Presentation #2508-6, Room S106B

Presentation Date/Time:    Sunday, March 25, 8:45-8:55 a.m.
Presentation Title:    Coronary Computed Tomographic Angiography Morphologic Characteristics of Lipid-core Plaques Identified by Intracoronary Near-Infrared Spectroscopy
Session Title:            Intravascular Diagnostics
Presenter:            James L. Smith, M.D., William Beaumont Hospital   
Session Type/Location:    i2 Oral Contributions, Presentation #2508-11, Room S106B

Presentation Date/Time:    Sunday, March 25, 9-9:10 a.m.
Presentation Title:    Spectroscopic Detection of Fibrous Cap Thickness Overlying Lipid Core Coronary Plaques with a Catheter-Based Near-Infrared Spectroscopy System
Session Title:            Intravascular Diagnostics
Presenter:            Sean Madden, Ph.D., director of systems engineering, Infraredx       
Session Type/Location:    i2 Oral Contributions, Session #2508-13, Room S106B

Presentation Date/Time:     Monday, March 26, 10:30 a.m.-noon (Session); 10:40-10:50 a.m. (Presentation)
Presentation Title:     Optical Coherence Tomography and Near-Infrared Spectroscopy
Session Title:    Establishing a Cardiac Catheterization Imaging/Physiology Program
Presenter:     Session co-chaired and presentation given by Emmanouil S. Brilakis, M.D., Ph.D., director, Cardiac Catheterization Laboratories, VA North Texas Health Care System and associate professor of medicine, The University of Texas Southwestern Medical Center at Dallas
Session Type/Location:    i2 Symposium, Session #2629-2 (Session) and #2629-4 (Presentation), Room S101A

Presentation Date/Time:     Monday, March 26, 4:30-4:40 p.m.
Presentation Title:     Distal Embolization during PCI: Predicting Distal Embolization Using Grayscale IVUS, RF-IVUS, OCT, and NIRS
Session Title:    Controversies in Intravascular Imaging
Presenter:     Emmanouil S. Brilakis, M.D., Ph.D., director, Cardiac Catheterization Laboratories, VA North Texas Health Care System, and associate professor of medicine, The University of Texas Southwestern Medical Center at Dallas
Session Type/Location:     i2 Symposium, Presentation #2639-10, Room S101A

Poster Presentations

Presentation Date/Time:     Saturday, March 24, 9:30-10:30 a.m.
Session Title:    Intravascular Diagnostics
Poster Discussant:     Emmanouil S. Brilakis, M.D., Ph.D., director, Cardiac Catheterization Laboratories, VA North Texas Health Care System, and associate professor of medicine, The University of Texas Southwestern Medical Center at Dallas
Session Type/Location:     i2 Poster Contributions, Presentation #2527-2, Hall A

Presentation Date/Time:     Sunday, March 24, 9:30 a.m.-noon
Presentation Title:     In Vivo Lipid Core Plaque Burden and Spatial Distribution in Patients with Unstable Angina and NQMI: A Near-Infrared Spectroscopy Study
Session Title:    Intravascular Diagnostics
Presenter:     Brijeshwar Singh Maini, M.D., FACC, chair, Structural Heart Program,
and co-chair, cardiovascular research, Pinnacle Health System
Session Type/Location:     i2 Poster Contributions, Session #2527-549, Hall A

Presentation Date/Time:     Monday, March 26, 9:30-10:30 a.m.
Presentation Title:     Distribution of Lipid Core Rich Plaques in Coronary Bifurcations Assessed by Near-Infrared Spectroscopy
Session Title:    New Tools for Invasive Evaluation of the Coronaries: What Else Can I See?
Presenter:     Jung Ho Heo, M.D., Kosin University Gospel Hospital, Busan Korea
Session Type/Location:     ACC Moderated Poster Contributions, Presentation #1203-299, Hall A

About TVC Imaging System™

The TVC Imaging System™ is a first-in-class intravascular imaging system that holds the potential to revolutionize the management of coronary artery disease by providing information that is critical for evaluating vessel structure and composition, also known as true vessel characterization. The TVC Imaging System helps interventional cardiologists identify which patients are prone to complications during stenting. The TVC system enables cardiologists to predict peri-procedural heart attacks by assessing not only the degree of stenosis, but also the presence and extent of lipid core plaques (LCP) of interest.

In a single pullback, the TVC Imaging System provides rapid and automated detection of LCPs during the cardiac catheterization procedure. The device is the only multimodality imaging system to combine both intravascular ultrasound (IVUS) and near-infrared spectroscopy (NIRS). Through IVUS technology, the TVC Imaging System provides clear and relevant information about vessel structure in real time. The system’s enhanced IVUS image provides a clear view of the vessel and plaque, providing more reliable vessel interpretation and assessment. The system’s NIRS technology enables interventional cardiologists to reliably visualize the presence of LCP and predict the risk of peri-stenting myocardial infarction. The multimodality images are obtained simultaneously and require no post-processing or image manipulation. The TVC Imaging System is the only device approved by the U.S. Food and Drug Administration for the detection of LCP.

About Infraredx, Inc.

Infraredx, Inc. is a privately-funded medical device company dedicated to helping provide practitioners with the information needed for enhanced clinical decision making in treating coronary artery disease.  The company is committed to improving the safety and efficacy of coronary stenting and ultimately serving as part of a strategy to prevent initial coronary events. Through its TVC Imaging System™, Infraredx is changing the way coronary artery disease is diagnosed and treated. The TVC Imaging System is the only intravascular imaging system that enables true vessel characterization through simultaneous structural and compositional imaging data obtained in a single pullback. Through the use of both intravascular ultrasound (IVUS) and near-infrared spectroscopy (NIRS) technologies, the system helps interventional cardiologists identify which patients are prone to stenting complications by assessing not only the degree of stenosis, but also the presence of lipid core plaque. Founded in 1998, Infraredx is headquartered in Burlington, Mass. For more information, visit www.infraredx.com.

Contacts:

Susan Heins (media)

Pure Communications, Inc.

864-286-9597

sjheins@purecommunicationsinc.com

Grant Frazier

Vice President of Marketing

Infraredx, Inc. 781-345-9632

gfrazier@infraredx.com

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