VivoSight OCT Skin Imaging and Measurement System - Advancing Research & Management of
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VivoSight OCT Skin Imaging and Measurement System Advancing Research & Management of: § Immune and Inflammatory Diseases § Non Melanoma Skin Cancer § Vascular Conditions § Microneedle Research § Skin Ageing and Skin Quality Healthy Skin for Happy Living
VivoSight Optical Coherence Tomography An optical analogue of ultrasound using laser scanning VivoSight scans a 6 x 6 mm2 patch of skin and produces up to 500 cross-sectional slices (frames) per scan. Each frame visualizes 1 mm deep creating a 3D image block that can be reviewed frame by frame and at any depth. VivoSight resolution defines skin architecture to generate accurate measurements VivoSight scan of healthy, normal skin (6 mm x 1 mm) Healthy Skin for Happy Living
VivoSight Dynamic Scanning Analyzes Vascular Morphology Superficial Vascular Plexus Automatically Calculate: • Depth of the superficial plexus • Modal vessel diameter • Density of vessels at this level Vascular Density by Depth Automatically Calculate: • Vessel density by depth in the dermis • Visualize and compare density by depth before and after treatments Normal scan of volar forearm Same site after exposure to capsaicin Healthy Skin for Happy Living
Advance Your Research and Development Program with VivoSight Accelerate development timelines and reduce costs § Visualize & quantify treatment effects § Scan in-vivo and ex-vivo targets § Multiple skin and vascular measurements § Rapid scan time < 30 seconds § Automated report generation with batch processing VivoSight Scan Screen and User Interface Video camera view of skin surface facilitates targeting and probe placement Top-down, birds eye view View 3D surface at any depth texture and 3D in the 6x6 mm2 vascular network image stack Annotation tools to mark up Up to 500 cross-sectional slices (frames) images for easy reference can be viewed individually or as a video Healthy Skin for Happy Living
VivoSight OCT Treating Vascular Lesions More Intelligently Do you know the depth and diameter of the vessels you are attempting to treat? Healthy Skin for Happy Living
Selective Photothermolysis Laser treatment of vascular lesions is based on the Theory of Selective Photothermolysis (Anderson and Parrish, Science 1983) which requires: • Wavelength that is preferentially absorbed by the desired target structure • Laser pulse width that is less than or equal to the thermal relaxation time of the vessel targeted as determined by Vessel Diameter • Sufficient radiant exposure, Fluence, to reach a damaging temperature in the target. Vessel Depth can impact fluence requirements. Start with Vessel Measurements for Better Targeting Vascular Plexus Profile: • Depth of the superficial plexus • Modal vessel diameter • Density of vessels at this level Vessel depth and diameter measurements will guide laser pulse width and fluence settings. Changes in Vascular Density: • Quantify the density of vessels by depth in the dermis Quantify treatment effect by measuring vessel density before and after treatments. Healthy Skin for Happy Living
VivoSight Images of PWS and Rosacea VivoSight measurements show the high variability in vessel morphology, diameter and depth, demonstrating the need for variable laser pulse duration and fluence settings. Healthy Skin for Happy Living
Autoimmune and Inflammatory Diseases Can you see beyond the skin surface to extract objective measures and identify sub-clinical disease? Healthy Skin for Happy Living
Researchers are Finding Value in Quantification and Monitoring of Atopic Dermatitis (AD) VivoSight Dx capabilities relevant to inflammatory disease include: • Epidermal remodeling and thickness measurement • Alterations in vascular morphology, depth and density as a measure of inflammation • Optical attenuation as a proxy for collagen density • Skin surface roughness Epidermal Alterations 1 OCT image of healthy individual OCT image captured from an OCT image captured from an with no history of AD uninvolved site on an eczema involved site on a different eczema patient, showing slightly extended patient, showing what appears to rete-pegs and an undulating DEJ be inflammatory acanthosis (Long thin epidermal papillae/rete-pegs) Vascular Alterations 1 VivoSight images show morphologic differences and variable superficial vascular plexus (SVP) depth for different EASI scores. Healthy Skin for Happy Living
Better Control of Flares Through Monitoring of Sub-clinical AD Unlike visual scores, dynamic OCT has the potential to quantify sub-clinical AD that allows for determination of treatment duration or when to start new, proactive therapies Visualize and quantify sub-clinical AD for advanced, proactive management Bieber T. Ann Dermatol. 2010 May;22(2):125-137 Quantification of Pharmaceutical Treatment Effects on AD Recently, a correlation between clinical improvement of AD and dynamic OCT imaging metrics has been demonstrated on patients undergoing a systemic therapy Significant OCT metrics for pharmaceutical treatment effects: • Vascular plexus depth • Epidermal thickness Baseline • Collagen density • Vesicle density OCT imaging biomarkers quantify pharmaceutical treatment effects to more efficiently accelerate drug development cycles 90 days after dupilumab Healthy Skin for Happy Living
Microneedle & Transdermal Applications Can you image and measure insertion depth, swelling or degradation of microneedles in-vivo and see the vascular response and skin changes? Do you know the depth and diameter of the vessels you are attempting to treat? Healthy Skin for Happy Living
Visualize micro-channel creation and monitor the time course of needle degradation or swelling VivoSight Dx capabilities to advance your microneedle and drug delivery research include: • In-vivo imaging of microneedles in real time • Measure microneedle dimensions, penetration depth, dissolution and swelling VivoSight image with vascular overlay. Microneedle penetrates 800 μm deep [2] • Measure inflammatory response via vascular changes • Understand morphology of device created skin defects • Observe kinetics of pore closure and skin recovery • Verify reproducibility, consistency of results VivoSight images of hydration profile of microneedles over a 34 minute period VivoSight imaging and measurement of microneedle changes over 60 minutes in-vivo Proportion of needle affected Air gap between skin and Pore size shown to slightly reduce increases linearly with time substrate shrinks over 20 min with time as the needle dissolves Healthy Skin for Happy Living
Vascular Dynamics and Skin Changes VivoSight can monitor the inflammatory response over time after MAP removal VivoSight scans prior to MAP application and after MAP removal showing measurable changes in the superficial vascular plexus. Plexus Depth: 430 µm Plexus Depth: 241 µm Modal Diameter: 36 µm Modal Diameter: 57 µm Vessel Density: 9% Vessel Density: 40% Skin blood flow returns to Modal vessel diameter Plexus depth increase normal after about 25 min decreasing by about 30% to normal levels VivoSight produces 3-D surface images, top down and frame views, to monitor hole closure after MAP removal Immediately after MAP removal 21 hours after MAP removal Healthy Skin for Happy Living
Non-Melanoma Skin Cancer Nodular BCC Can you see the extent of NMSC lesions or follow clearance progression non-invasively? Superficial BCC Infiltrative BCC Healthy Skin for Happy Living
See the whole picture with VivoSight to inform and optimize treatment planning and monitoring Aid decision making with more information than can be obtained through clinical assessment or dermoscopy Lesion Assessment Obtain images of sub-surface, sub-clinical tumor tissue • White asterisks mark hyporeflective tumor nests • Thin arrows mark dark peripheral borders • Thick white arrows mark the DEJ • Black asterisk marks thinning epidermis Image courtesy of Themstrup [4] • Thick black arrow marks a hair casting a shadow Treatment Monitoring Topical Treatment of BCC Lesion [5] Laser Treatment of BCC Lesion [6] Before imiquimod therapy 1 week with imiquimod therapy 1 month with imiquimod 4 weeks post therapy cysts have Pre laser treatment Immediate post showing replaced the BCC islands reduced vascularity Mohs Surgery Margin Assessment Prior to Mohs Surgery [7] Lesion is outlined with Reflective marker casts a Example showing lesion reflective marker shadow on VivoSight image outside of marker shadow, perimeter must be expanded Healthy Skin for Happy Living
The Full Suite of VivoSight Skin Measurements Quantify your treatment’s impact by measuring: • Surface Roughness Roughness measures including peak to trough, average roughness and 3D image • Epidermal Thickness, Variation and Contrast Average epidermal thickness over the entire 6 x 6 mm scan area • Vascular Plexus Profile Depth of the superficial plexus, Modal vessel diameter, Density of vessels at this level • Changes in Vascular Density Quantify the density of vessels by depth in the dermis • Beam Attenuation Proxy measure for collagen content Healthy Skin for Happy Living
Companion Products Maximize Versatility and Performance Laboratory Fixture Increased utility for laboratory research Precision fixture for the VivoSight OCT handheld probe converts VivoSight into a powerful OCT microscope for scanning laboratory samples. Fine adjustment in all 3 axes makes sample analysis easy, convenient and accurate. Dermatoscope DermoScan dermatoscope USB port Combine dermoscopy with VivoSight OCT in a single workstation. Dermatoscope images are displayed onscreen. DermoGenius Ultra Polarized Software Upgrades VivoSight Dx software updates two to three times per year Customers with support contracts receive an annual software update to their VivoSight free of charge. From time to time, Michelson may also release new major software upgrades which will be available for an extra fee. References 1. Byers RA, Maiti R, Danby SG, Pang EJ, Mitchell B, Carre MJ, Lewis R, Cork MJ, Matcher SJ. Sub-clinical assessment of atopic dermatitis severity using angiographic optical coherence tomography. Biomedical Optics Express (BOE), Vol. 9, No. 4, 1 Apr 2018. 2. S. Sharma, et al., Rapid, low cost prototyping of transdermal devices for personal healthcare monitoring, Sensing and Bio-Sensing Resear(2016), http://dx.doi.org/10.1016/j.sbsr.2016.10.004 3. R.F. Donnelly et al. Evaluation of the clinical impact of repeat application of hydrogel-forming microneedle array patches. Drug Delivery and Translational Research (Feb 2020). https://doi.org/10.1007/s13346-020-00727-2 4. Themstrup L, De Carvalho N, Nielsen SM, Olsen J, Ciardo S, Schuh S, Nørnberg BM, Welzel J, Ulrich M, Pellacani G, Jemec GBE. In vivo differentiation of common basal cell carcinoma subtypes by microvascular and structural imaging using dynamic optical coherence tomography. Exp Dermatol. 2018;27(2):156–65. 5. C. A. Banzhaf, L. Themstrup, H. C. Ring, M. Mogensen and G. B. E. Jemec. Optical coherence tomography imaging of non-melanoma skin cancer undergoing imiquimod therapy. Skin Research and Technology 2013; 0: 1–7 6. De Carvalho N, Schuh S, Kindermann N, Kästle R, Holmes J, Welzel J. Optical coherence tomography for margin definition of basal cell carcinoma before micrographic surgery—recommendations regarding the marking and scanning technique. Skin Res Technol. 2017;00:1–7. https://doi.org/10.1111/srt.12407R Healthy Skin for Happy Living
VivoSight Specifications Morphologic and Angiographic Imaging of Skin • Uses a low-power 1300nm laser • Up to 1 mm depth penetration • Scanning area of 6 x 6 mm • < 7.5 µm lateral resolution • < 5.5 µm axial resolution • Eye-safe Power Supply Voltage 100-240V~ 50-60Hz Nom. (Earthed supply) Maximum Power 250VA Mains Input Connector IEC 320 C13 Socket 10A Fuse T 5AL 250V Weight and dimensions Dimensions (W x D x H) 0.55 x 0.57 x 1.61 m (Monitor at maximum height) Weight 56 kg For more information please contact: Michelson Diagnostics Cell (408) 504-7391 Compliant with European CE Mark. Email: craig.fortier@vivosight.com FDA cleared for clinical use 510(k) K093520. VivoSight is a Multi-Beam Optical Coherence Tomography (OCT) system indicated for use in the two-dimensional, cross-sectional, real-time imaging of external tissues of the human body. This indicated use allows imaging of tissue microstructure, including skin, to aid trained and competent clinicians in their assessment of a patient's clinical conditions. Healthy Skin for Happy Living 1028.DO.113 Issue 1
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