LightLab Imaging Leads Global Advancement of Intracoronary Imaging

Tuesday, January 6, 2009 General News
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WESTFORD, Mass., Jan. 5 LightLab Imaging Inc. todayannounced several important developments in the field this past year that arethe culmination of sustained clinical and technology investment by thecompany. These advances significantly increase the Company's leadershipposition in intravascular optical coherence tomography, or OCT. OCT is a newhigh-resolution, high-speed imaging modality that uses advanced photonics forintravascular imaging and tissue characterization. LightLab is using itsunique portfolio of highly proprietary technology to design, manufacture andsell intravascular OCT systems that aid interventional cardiologists in thediagnosis and treatment of coronary artery disease.

With a ten-fold higher resolution than intravascular ultrasound, OCT ispoised to become the gold standard imaging modality when high resolutionimages are essential. As of December 31, 2008, Light Lab has more than 300M2(TM) and M2x(TM) systems in 20 countries in Europe, Asia, the Middle Eastand South America. Per-system catheter utilization increased 45% in 2008 over2007, and the number of imaging catheters sold in 2008 increased 90% from 2007levels. The number of clinical OCT procedures using LightLab Imaging OCTsystems has now surpassed 10,000, providing LightLab with unsurpassed"real-world" experience with OCT.

"From all perspectives, LightLab is recognized as the clear global leaderin intravascular OCT," said David Kolstad, LightLab Imaging's President andCEO. "During 2008, we continued to execute strategies that will furtherextend our leadership position in the year ahead. Among them, we expect toshortly announce the initiation of patient enrollment in a major clinicalstudy of our intravascular OCT system here in the United States. In addition,in October we became the only reimbursed intravascular OCT imaging product inthe world when we received a favorable reimbursement coverage decision fromthe Japanese Ministry of Health, Labor and Welfare that provided OCT paymentat a level above IVUS."

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

Clinical Research Leadership

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

"We have exciting plans for 2009, in cardiology and other applications. Wecontinue to build on our proprietary technology platform and leadershipposition, with increased levels of investment ensuring that our OCT offeringsremain the products and services of choice by the world's foremostclinicians," added Mr. Kolstad.

About LightLab Imaging

LightLab Imaging Inc. is the pioneer and leader in the development ofOptical Coherence Tomography (OCT) for vascular and other applications. Witha proprietary platform and catheter technology protected by over 50 patents,OCT is a high-resolution imaging modality that applies advanced photonics tomedical imaging. With the ability to resolve real-time images to 15micrometers, the LightLab Imaging OCT Imaging Systems offer physicians moreinformation, and more precise information, than ever before available.Contact: Brad Cilley Vice President, LightLab Imaging Inc. 978/399-1025 Press: Steve DiMattia 646/201-5445

SOURCE LightLab Imaging


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