1. Lightlab Imaging Leads Global Advancement of Intracoronary Imaging

     

    Finishes 2008 with More Than 300 Systems in 20 Countries and a 45% Increase in Per-System Catheter Utilization

    Total OCT Image Procedures Performed Surpass 10,000

    Westford, MA, January 5, 2009 -- LightLab Imaging Inc. today announced several important developments in the field this past year that are the culmination of sustained clinical and technology investment by the company.  These advances significantly increase the Company’s leadership position in intravascular optical coherence tomography, or OCT.  OCT is a new high-resolution, high-speed imaging modality that uses advanced photonics for intravascular imaging and tissue characterization. LightLab is using its unique portfolio of highly proprietary technology to design, manufacture and sell intravascular OCT systems that aid interventional cardiologists in the diagnosis and treatment of coronary artery disease.

    With a ten-fold higher resolution than intravascular ultrasound, OCT is poised to become the gold standard imaging modality when high resolution images are essential. As of December 31, 2008, Light Lab has more than 300 M2™ and M2x™ systems in 20 countries in Europe, Asia, the Middle East and South America. Per-system catheter utilization increased 45% in 2008 over 2007, and the number of imaging catheters sold in 2008 increased 90% from 2007 levels.  The number of clinical OCT procedures using LightLab Imaging OCT systems has now surpassed 10,000, providing LightLab with unsurpassed “real-world” experience with OCT.  

    “From all perspectives, LightLab is recognized as the clear global leader in intravascular OCT,” said David Kolstad, LightLab Imaging’s President and CEO.  “During 2008, we continued to execute strategies that will further extend our leadership position in the year ahead. Among them, we expect to shortly announce the initiation of patient enrollment in a major clinical study of our intravascular OCT system here in the United States.  In addition, in October we became the only reimbursed intravascular OCT imaging product in the world when we received a favorable reimbursement coverage decision from the Japanese Ministry of Health, Labor and Welfare that provided OCT payment at a level above IVUS.”

    OCT is rapidly becoming indispensable in the evaluation of coronary stents.  This November, OCT was recognized in a special meeting article in the European Heart Journal in which the European Society of Cardiology and the European Association for Percutaneous Cardiovascular Interventions together with European regulatory bodies recommended OCT as a modality for assessing stent coverage and neointima formation in clinical studies designed to support regulatory submissions for new stents in Europe.  

    Clinical Research Leadership 

    During 2008, clinicians continued to demonstrate the enhanced value of LightLab by deploying its M2 and M2x OCT imaging systems in critically important clinical studies. All OCT images acquired in the groundbreaking Horizons AMI OCT data study, presented at the 2008 American Heart Association Congress, were generated using LightLab Imaging OCT systems.  At TCT in October, LightLab Imaging OCT systems were used in 30 clinical presentations and 18 abstracts, more than 3 times the number of presentations and abstracts than all other competitors combined. A number of additional important studies are expected in the coming year, further establishing the important role of OCT in interventional cardiology.

    “We have exciting plans for 2009, in cardiology and other applications. We continue to build on our proprietary technology platform and leadership position, with increased levels of investment ensuring that our OCT offerings remain the products and services of choice by the world’s foremost clinicians,” added Mr. Kolstad.

    About LightLab Imaging

    LightLab Imaging Inc. is the pioneer and leader in the development of Optical Coherence Tomography (OCT) for vascular and other applications.   With a proprietary platform and catheter technology protected by over 50 patents, OCT is a high-resolution imaging modality that applies advanced photonics to medical imaging.   With the ability to resolve real-time images to 15 micrometers, the LightLab Imaging OCT Imaging Systems offer physicians more information, and more precise information, than ever before available.

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    1. From all perspectives, LightLab is recognized as the clear global leader in intravascular OCT.
    2. We have exciting plans for 2009, in cardiology and other applications. We continue to build on our proprietary technology platform and leadership position, with increased levels of investment ensuring that our OCT offerings remain the products and services of choice by the world's foremost clinicians.
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