Oblique Back-illumination Microscopy Jerome Mertz June 15, 2012 Oblique Back-illumination Microscopy (OBM) Breakthrough imaging allows DIC-like images in thick samples • • • • 600μm field-of-view with 6.5μm resolution 240μm field-of-view with 2.5μm resolution No labeling or contrast required Video rate OBM offers superior imaging and high clinical impact in a simple, robust, and cost-effective platform Superior imaging capabilities with high clinical impact • Exquisite high resolution phase images (DIC-like) of in vivo tissue morphology • Simultaneous phase and amplitude microscopy with tissue imaging depth of 60-100μm – improves diagnostic imaging in thick tissue – applications in endoscopy • Works at video rate with a standard camera Simple, robust, cost effective, and safe • Add-on to current microscopes or endomicroscopes, with no moving parts • Noninvasive, no tissue labeling required • Illuminated using LEDs rather than expensive and unsafe lasers Both research and clinical applications are possible with OBM Research Applications • $3B US Microscope Market in 2011 with 6% CAGR through 20151 • Several Established Players: Leica, Carl Zeiss, Olympus, etc • 790 Potential Target Labs in US2 Clinical Applications3 • GI Endoscopy – > 10 MM Procedures / year – Colorectal, Gall, Esophageal • Blood flow analysis in plastic / reconstructive surgery – >1MM surgeries per year • Bladder imaging 1. 2. 3. Jon Groberg, Dane Leone, CFA, “Danaher: BEC is the key to continued success”, Macquarie (USA) Equities Research, 16 Aug 2011 Source: http://www.lltechimaging.com/ Source: Mauna Kea Investor Presentation, published June 2011 GI screening offers a compelling opportunity for OBM Colorectal Screenings • 3.1 MM colorectal screenings in US annually • High percentage of biopsied polyps are benign • Strong market opportunity for technologies that aid in biopsy site determination Barrett’s Esophagus • > 1 MM screenings in US annually • American Gastroenterological Assoc. recently increased recommended screening schedule for high risk patients • 85% mortality rate for Esophageal cancer (BE increases cancer risk) OBM combines high resolution imaging with tissue depth, wide field-of-view and video capabilities Technology OBM OCT1 Confocal fluorescence Endomicroscopy2 Lateral Resolution (μm) 2.5 / 6.5 3.5 1 - 3.5 Axial Resolution (μm) 6 1.8 3-8 Imaging Depth (μm) 0 - 80 100 5 - 100 Field of View (μm) 240 / 600 1.5 x 1.5 mm (scanning) 240 / 400 Frame Rate (Hz) 17.5 1 12 (200 optional) 1. Optical Coherence Tomography – data points based on lltech Light-CT 2. Confocal Laser Endomicroscopy – data points based on various CellVizio models Rigid endoscope market exceeds $500M annually; Karl Storz is the market leader Market Share (2010) Other 17% Market Size (2010): • $529M WW, 4% CAGR Olympus Medical 10% Karl Storz 39% • $176M US, 4% CAGR • Laparoscopic, Hysteroscopic uses Richard Wolf 16% Stryker 18% Source: “Rigid Endoscopes - Global Pipeline Analysis, Competitive Landscape and Market Forecasts to 2017”, Global Data, 31 May 2011 In vivo Imaging Technologies Technology Company Product Unit Cost Target Areas OCT St. Jude Medical Ilumien (OCT + FFR) Unknown Stent Placement, Vulnerable Plaque ID OPS Lekam Medical Ltd Cytoscan Unknown Microcirculation (possibly no sales since 2004) LIF SpectraScience wavSTAT Unknown Colorectal/esophageal Cancer Optical Spectroscopy Guided Therapeutics LuViva $18,5001 Cervical Cancer Circulation Imaging Novadaq PinPoint $75,0004 Lung, Colectomy, Lap Chole, MIS CLE Mauna Kea Technologies (via Leica) Cellvizio $160,0002 Barret's, Colorectal, Chole Multispectral Imaging Mela Sciences MelaFind $35,0003 Melanoma 1. Thomson Reuters Streetevents, “Edited Transcript: GTHP.OB-Q4 2011 Guided Therapeutics Inc. Earnings Conference Call”, 29 March 2012, 3:00PM GMT 2. Source: Mauna Kea Investor Presentation, published June 2011 3. Josh Jennings, M.D., Denis Kelleher, Ian Sanderson, Doug Schenkel, “Mela Sciences – Initiating with Outperform (1)”, Cowen and Company, 23 May 2012 4. Matt Miksic, Sachin Kulharni, Young Li, “ Novadaq: Overweight”, PiperJaffray, Company Note, 16 April 2012