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
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 OCT Skin Imaging and Measurement System - Advancing Research & Management of
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)

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VivoSight OCT Skin Imaging and Measurement System - Advancing Research & Management of
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
VivoSight OCT Skin Imaging and Measurement System - Advancing Research & Management of
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 Skin Imaging and Measurement System - Advancing Research & Management of
VivoSight OCT
Treating Vascular Lesions More Intelligently

    Do you know the depth and diameter of
    the vessels you are attempting to treat?

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VivoSight OCT Skin Imaging and Measurement System - Advancing Research & Management of
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 OCT Skin Imaging and Measurement System - Advancing Research & Management of
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.

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VivoSight OCT Skin Imaging and Measurement System - Advancing Research & Management of
Autoimmune and
       Inflammatory Diseases

      Can you see beyond the skin surface
       to extract objective measures and
          identify sub-clinical disease?

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VivoSight OCT Skin Imaging and Measurement System - Advancing Research & Management of
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
VivoSight OCT Skin Imaging and Measurement System - Advancing Research & Management of
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

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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?

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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

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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

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Non-Melanoma Skin Cancer

                                  Nodular BCC

Can you see the extent of NMSC lesions or follow
     clearance progression non-invasively?

      Superficial BCC

                                Infiltrative BCC

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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

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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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