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Infraredx Announces the First Patient Enrolled in the PROSPECT II Study on the Detection and Treatment of the Vulnerable Plaques

Press releases may be edited for formatting or style | June 30, 2014

Absorb is a first-of-its-kind device which is under investigation in the US, and received CE Mark in 2011. Absorb functions similarly to a stent and is designed to open a blocked vessel and restore blood flow, but because it is made from bioresorbable materials similar to dissolving stitches, it dissolves completely over time.1 Absorb is called a scaffold to indicate its temporary nature. In data from international studies, regression of plaque has been observed at the site where Absorb has been implanted, a unique effect not typically seen with permanent metallic stents. Data from this sub-study, termed PROSPECT-ABSORB, will be analyzed in patients with and without a cholesterol signal at the site of the large plaque, making this the first large-scale study of the identification and preventive treatment of vulnerable plaques.

"We are proud to partner with global leaders in cardiovascular medicine and business to sponsor the PROSPECT II Absorb study," said Donald Southard, president and CEO of Infraredx. "This study, along with other outcomes studies Infraredx is sponsoring, is designed to prove that vulnerable plaques exist and can be detected in a highly specific manner with the TVC Imaging System. We believe that positive outcomes of these studies will establish our proprietary TVC Imaging NIRS-IVUS technology as the standard of care for guiding the 3 million PCIs performed worldwide each year, and position Infraredx as a leader in what we believe will become a multi-billion dollar intravascular imaging market. Most importantly, successfully treating these vulnerable plaques will improve the quality of life for our patients and result in significant cost savings to healthcare systems worldwide."

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"This important outcomes study results from the convergence of progress in multiple areas, including the success of the original PROSPECT Study, the development of the combined NIRS-IVUS imaging system, the new STEMI findings, the excellent outcomes data that can be obtained with the use of the Scandinavian registers, and the availability of new therapies such as Abbott's Absorb," said James Muller, M.D., co-founder and chief medical officer of Infraredx. "We also appreciate the strong interest of leading clinical investigators, and are pleased to join with the interventional cardiologists and the patients who will participate in this study to test the hypothesis that vulnerable plaques can be proactively detected and treated leading to positive outcomes for patients."

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