Reminder summary....NEW PRODUCT PORTFOLIO CONCEPT RESEARCH AND DIAGNOSTICS MARKET SEGMENTS GLOBAL DIGITAL PATHOLOGY MARKET *Source: Markets&Markets Digital Pathology Market –Forecast

Judit Eszter Illés Head of Marketing

Technical Training

May 18, 2020

The future of 3DHISTECH's product portfolio:

division into

Research (RX) and diagnostics (DX) products.

Reminder summary.

NEW PRODUCT PORTFOLIO CONCEPT

Market backround:• digital pathology market is growing dinamically in RX and DX

Professional background:• the workflow in the RX and DX fields are completely different• the DX workflow in pathology is regulated by strict protocols, rules,

regulations and law

Goal of the company:• to be significant market player also in the DX market

Strategy:• we created two parallel product/system portfolios for the RX and the

DX markets to meet the needs of the professionals in both segments

NEW PRODUCT PORTFOLIO CONCEPTRESEARCH AND DIAGNOSTICS MARKET SEGMENTS

GLOBAL DIGITAL PATHOLOGY MARKET

*Source: Markets&Markets Digital Pathology Market – Forecast for 2022

• According to forecast the market will grow dinamically

• Annual growth estimate ~ 12,3%

• Contains:• Routine diagnostics• Research labs• Molecular pathology• Clinical, pre-clinical trials• Education• etc.

(*)


DIGITAL PATHOLOGY MARKET SHARE BY END-USERS 2018 (%)

*Source: www.envisionintelligence.com

4

1

X

(*)


MAIN MARKET DRIVERS

*Source: Markets&Markets Digital Pathology Market – Forecast for 2022

• Continuous and dynamic increase of cancer cases

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MAIN MARKET DRIVERS

• Continuous and dynamic increase of cancer cases

• Increased focus on improving workflow efficiency

• Higher demand for faster diagnostic tools

• Increasing number of governments’ initiatives

• Stricter regulations in the DX segment.

• These accelerated technological advancements of producers ofdigital pathology systems


• The market is not matured

• Not a lot of players

• Highly innovative products and complex solutions

• Require sophisticated integration

• Very high investments


↓

• The winning strategy: being there and having the flexibility to answer market and regulatory needs!

7X


COMPANY BACKGROUND

• Digitalisation in pathology first appeared in RESEARCH

• 3DHISTECH also started its developments in this segment~ 25 years ago

• As the first European manufacturer, 3DHISTECH is one of the market leaders in the world with ~ 2.000 sold systems worldwide

• In 2019 the majority of our sales were realized in Research

8X


COMPRISON OF PAST AND FUTURE SOLUTIONS

From 2020, 3DHISTECH is committed to meet the needs of users:

RESEARCH market segment DIAGNOSTICS market segment

TWO PARALLEL PRODUCT PORTFOLIOS

TAILORED EXACTLY TO THE NEEDS

OF BOTH RESPECTIVE MARKET SEGMENTS!

9X

NEW PRODUCT PORTFOLIO CONCEPT IN RX AND DX MARKETS

DIFFERENCES BETWEEN THE NEEDS OF SEGMENTS – WORKFLOW

LIS »

• Difference in workflows

• Difference in the purposeof the tests(end result)

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DX RX

DIAGNOSIS / CONCEPT on request form: suspected diagnosis concept to verify

SUBJECT case project

IN FOCUS single case (of a patient) slides

HISTORY OF DATA case history, current patient status blind cases, specimen

DATA HANDLING data of patient and doctors must be documented batch data, batch analysis

ADDITIONAL INFORMATION macro images

AREA OF STUDY field of view (FOV) - single field of interest is annotated whole slide imaging, tissue segmentation

TELECONSULTATION images, case description, case history - in closed system

REPORT reporting in a closed system excel output from an open system (raw data)

INTEGRATION NEEDS LIS / PIS / HIS integration (pooled patient data)

IMAGE FORMAT DICOM (PACS) TIFF, JPEG, BIGTIFF

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DX RX

DIAGNOSIS / CONCEPT on request form: suspected diagnosis concept to verify

SUBJECT case project

IN FOCUS single case (of a patient) slides

HISTORY OF DATA case history, current patient status blind cases, specimen

DATA HANDLING data of patient and doctors must be documented batch data, batch analysis

ADDITIONAL INFORMATION macro images

AREA OF STUDY field of view (FOV) - single field of interest is annotated whole slide imaging, tissue segmentation

TELECONSULTATION images, case description, case history - in closed system

REPORT reporting in a closed system excel output from an open system (raw data)

INTEGRATION NEEDS LIS / PIS / HIS integration (pooled patient data)

IMAGE FORMAT DICOM (PACS) TIFF, JPEG, BIGTIFF

IVDR / MDR / FDA

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COMPRISON OF CURRENT AND FUTURE SOLUTIONS

NO CHANGES

• We offered solutions for both market segments also in the past

• Committed to continuous development of our products /solutions

• In our hardware product portfolio

CHANGES

• We adjusted the features of our products/systems to the special needs of the specific segments (RX and DX)

• We created a complex solution especially for DX segment(Pannoramic Pathology Diagnostic System)


13X

We offered solutions for each step of the Routine pathology workflow also in the past

Routine pathology


WORKFLOW AND SOLUTIONS - PAST

Quant Center

Image Analysis

Platform

MacroStation

REGISTRATION GROSSING SECTIONING STAINING SLIDE SCANNING SPECIAL ORDERSANALYSIS &

CONSULTATIONREPORTING

Track&Sign Laboratory Information System

PANNORAMIC Digital Slide Scanners

CaseManager Pathology Information System

CaseCenter

CaseViewer

Solutions 3DHISTECH offers for Research labs


Quant Center Image Analysis Platform

CaseViewer

TMA MASTER II and TMA GM PANNORAMIC Digital Slide Scanners CaseCenter

PREPARATIONS SLIDE SCANNING SLIDE STORAGE, VISUALISATION, ANALYSIS

15X

PANNORAMIC SCANNER FAMILY


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SCANNERS HARDWAREscanning

capacity

PANNORAMIC Midi II 12 BF FL BF FL

PANNORAMIC 250 Flash III 300 BF FL BF

PANNORAMIC Desk II DW 1 BF BF

PANNORAMIC 1000 1000 BF BF

PANNORAMIC Confocal 11 BF FL

PANNORAMIC Scan II 150 BF FL

RESEARCH DIAGNOSTICS

PANNORAMIC SCANNER FAMILY – TYPE OF SCANNER ILLUMINATION

17

1

X


MIDI II (12) Scan II (150) P250 Flash III (300) Confocal (12) Desk II DW (1) P1000 (1000)

MIDI II (12) Desk II DW (1) P250 Flash III (300) P1000 (1000)

DIAGNOSTICS (DX) HARDWARE PORTFOLIO

BR

IGH

TFIE

LD

RESEARCH (RX) HARDWARE PORTFOLIO

BR

IGH

TFIE

LDFL

UO

RES

CEN

TFL

UO

RES

CEN

T

SCANNER FAMILY – TYPE OF SCANNER ILLUMINATION

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PANNORAMIC SCANNER FAMILY – HW&SW

SCANNERS HW + SWscanning

capacity RESEARCH DIAGNOSTICS

PANNORAMIC Desk II DW 1 PANNORAMIC Scanner SW 3.0 PANNORAMIC Diagnostic Scanner SW 1.0

PANNORAMIC Midi II 12 PANNORAMIC Scanner SW 3.0 PANNORAMIC Diagnostic Scanner SW 1.1

PANNORAMIC 250 Flash III 300 PANNORAMIC Scanner SW 3.0 PANNORAMIC Diagnostic Scanner SW 1.0

PANNORAMIC 1000 1000 PANNORAMIC 1000 Scanner SW 3.0 PANNORAMIC Diagnostic Scanner SW 1.0

PANNORAMIC Confocal 11 PANNORAMIC Scanner SW 3.0

PANNORAMIC Scan II 150 PANNORAMIC Scanner SW 3.0

192

1

X

Scanning Profile –

FLEXIBLE

Output resolution

Image SettingImage Quality

Compression typeUse compensation image

Focus Quality

Sample detectionAutothreshold

Manual ThresholdDrew scan area

Objective type

Focus settingLimite the rangeFocus Distance

Scan SettingsStop and Go

FlashColor Matrix

Filter Setting

Multilayerselection

Single LayerZ - layer scanning

Extended focusscanning

Preview typeBrightfieldDarkfieldPre scan

Focus modeInterpolate

AutoCoarse

File Format


SCANNING PROFILE SETTINGS

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Scanning Profile –

STANDARDIZED

Output resolution

Image Setting

Image QualityCompression type

Sample detectionAutothreshold

Manual ThresholdDrew scan area

Objective type

Focus settingLimite the rangeFocus Distance

Scan Settings

Stop and GoFlash

Filter Setting

Multilayerselection

Z - layer scanningExtended focus

Preview typeBrightfieldDarkfieldPre scan

Focus mode

InterpolateAuto

Coarse

File Format


SCANNING PROFILE SETTINGS

Fully Automated

FullyAutomated

FullyAutomated

FullyAutomated

Fixed

Fixed

Fixed

Fixed

Fixed

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NEW PRODUCT PORTFOLIO CONCEPTIN RX AND DX MARKET SEGMENTS

RX DX

*diversed scanning profile settings *settings are fixed or automated

*anyone can start scanning without password *starting scanning with user password only (security)

*self-calibration (once, at start) *continuous self-calibration (per 4 hours or per 200 slides)

*error reports stay within the internal system *central log service = error reports are sent from the internal system to technicians

*color profile is diversed *color profile is fixed (reproducible colors)

MAIN DIFFERENCES IN FEATURES

NEW PRODUCT PORTFOLIO CONCEPTIN RX AND DX MARKET SEGMENTS

RX DX

*diversed scanning profile settings *settings are fixed or automated

*anyone can start scanning without password *starting scanning with user password only (security)

*self-calibration (once, at start) *continuous self-calibration (per 4 hours or per 200 slides)

*error reports stay within the internal system *central log service = error reports are sent from the internal system to technicians

*color profile is diversed *color profile is fixed (reproducible colors)

MAIN DIFFERENCES IN FEATURES

We are not a scanner manufacturer, but integrated digital pathology workflow supplier!

NEW PRODUCT PORTFOLIO CONCEPTIN RX AND DX MARKETSSCANNERS HW & SW RESEARCH

PANNORAMIC Desk II DW Pannoramic Scanner Software 3.0

PANNORAMIC 250 Flash III Pannoramic Scanner Software 3.0

PANNORAMIC 1000 Pannoramic 1000 Scanner Software 3.0

PANNORAMIC Midi II Pannoramic Scanner Software 3.0

PANNORAMIC Confocal Pannoramic Scanner Software 3.0

PANNORAMIC Scan II Pannoramic Scanner Software 3.0

TMA HW & SW RESEARCH

TMA MASTER II

TMA GRAND MASTER

SERVER BASED APPLICATIONS RESEARCH

Track&Sign

Case Manager

Case Center (DX) / Slide Center (RX) √

Clinical Viewer (DX) / Slide Viewer (RX) √

Instant Viewer √

Teleconsultation / E-Exam / Pathonet.com √

QUANT CENTER RESEARCH

Nuclear Quant √ HER2, Er, Prg √

Membrane Quant √ HER2, Er, Prg √

FISH Quant √

Pattern Quant √

HistoQuant √

Cell Quant √

Densito Quant √

CISH Quant √

TMA Control Software 3.2

Pannoramic Diagnostic Scanner SW 1.0



√

Clinical

Study for

IVDR will

be run

Clinical

Study for

IVDR will

be run

have IVD

already

DIAGNOSTICS

√

√

DIAGNOSTICS

DIAGNOSTICS

DIAGNOSTICS


√

√

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SERVER BASED APPLICATIONS

Track&Sign

CaseManager

CaseCenter (DX) / SlideCenter (RX)

CaseViewer (DX) / Slide Viewer (RX)

Instant Viewer

Teleconsultation / E-Exam / Pathonet.com

1

X


COMPLEX SOLUTION IN CLINICAL ROUTINE (DX)PANNORAMIC PATHOLOGY DIAGNOSTIC SYSTEM

• SCANNERS (P1000, P300, DESK II) + NEW DX SCANNER SOFTWARES

• + Case Manager 2.1

• + Case Center 3.0

• + Case Viewer 2.5

• + Breast quantification panel (IVD: HER2, Er, Pr)

The products of PPDS for routine pathology can not be purchased individually, only as a package.

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PANNORAMIC MANAGEMENTSYSTEM

X

NEW PRODUCT PORTFOLIO CONCEPTCOMPLEX SOLUTION IN DX – PANNORAMIC MANAGEMENT SYSTEM

26X

NEW PRODUCT PORTFOLIO CONCEPTImage analysis for DX applications

• Quick (quantification starts with one click)

• Decision is made by the doctor: area of annotation, diagnosis

• Quant modules help the diagnosis (IVD: HER2; Er; Pr) with calculations

The doctor has a presumed diagnosis.


The Pannoramic Pathology Diagnostic System:

• has to be integrated with a LIS, it is not a stand-alone solution

• we will run a Clinical Study for IVDR with PPDS as one system

• during manufacturing: testing according to strict rules

• delivery process: more rigorous and better documented

Converting the scanner of it to a RX scanner:

• for FL technology: light source+ camera + filters can be purchased additionally

• RX software can be also installed: two different types of software can run the same scanner

COMPLEX SOLUTION IN DX

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NEW PRODUCT PORTFOLIO CONCEPTRX PRODUCT PORTFOLIO

The products of our Research (RX)

portfolioCAN BE ORDEREDINDIVIDUALLY.

PANNORAMIC Desk II DW

PANNORAMIC Midi II

PANNORAMIC Confocal

PANNORAMIC Scan II

PANNORAMIC 250 Flash III

PANNORAMIC 1000 PANNORAMIC 1000 Scanner Software 3.0

TMA MASTER II

TMA GRAND MASTER

Slide Center √

Slide Viewer √

Instant Viewer √

Teleconsultation / E-Exam / Pathonet.com √

Pattern Quant √

HistoQuant √

Cell Quant √

Densito Quant √

Nuclear Quant √

Membrane Quant √

FISH Quant √

CISH Quant √

SCANNERS HW & SW

TISSUE MICROARRAYERS HW & SW

SERVER BASED APPLICATIONS

QUANT CENTER APPLICATIONS Image Analysis Platform

TMA Control Software 3.2

PANNORAMIC Scanner Software 3.0

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RX PRODUCT PORTFOLIO

TMA GRAND MASTER AND TMA MASTER II – HW&SW

• With the new TMA software 3.2 we will take an other step to complete our workflow

• As a result of the improved PCR system function we can send the samples to molecular analysis.

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Image analysis in RX

• Quant modules help the verification with calculations

• Lots of data - statistics

• The whole slide is processed for analysis

• Researcher can go down to cell level

The doctor has a concept to verify.

Pattern Quant

HistoQuant

Cell Quant

Densito Quant

Nuclear Quant

Membrane Quant

FISH Quant

CISH Quant

31

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Teleconsultation / E-exam / Publication portalfor Universities and medical students

TELECONSULTATION function in Case Center• E-learning, real time consultation and case show for students

E-AXAM modul (E-school) in Case Center• Surface for teachers – exam questionner• Surface for students – test (slides are opened with Case Viewer / Instant Viewer• Exam is closed: student can check the result

PUBLICATION Portal (Pathonet)• 1. Online web page• 2. Product for Universities (within Case Center)• Purpose: slide sharing, case description, consultation, own slide collection *

THE KEY FOCUS OF EDUCATON:• SALES PRODUCTS• DIGITALIZATION WILL BE NATURAL FOR THE NEW GENERATION OF

PATHOLOGISTS!

32

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• DX Pannoramic Management System – from 1st of July

• New P250/300 capacity – Q2

• New Flash Desk – Q3

• New RX Case Viewer 2.4. – Q2

• New RX scanner software solutions – May-June

• New DX software solutions - July

• New RX Slide Center version– summer

• New RX Slide Viewer version - summer

• New TMA software 3.2. – Q3

• Product&Service Catalogue and Ordering Guide (RX/DX)

• Price list

• Product Launch Kits

• Release notes and new product announcements

NEW PRODUCT PORTFOLIO CONCEPT - AVAILABILITY

Follow the launch procedure.

• Marketing support (RX and DX concept focus)

▪ Exhibitions and symposiums (at this moment we are virtually involved due to

Covid-19 situtation)

▪ Distributor Meeting topics

▪ Product brochures

▪ Webpage update

▪ Product videos and webinars

▪ Online media news (Tissuepathology.com)

▪ Newsletters / Social Media news



• Marketing support (RX and DX concept focus)

▪ Exhibitions and symposiums (at this moment we are virtually involved due to

Covid-19 situtation)

▪ Distributor Meeting topics

▪ Product brochures

▪ Webpage update

▪ Product videos and webinars

▪ Online media news (Tissuepathology.com)

▪ Newsletters / Social Media news



Future of Technical Trainings:

Division into RX and DX parts

THANK YOU

FOR YOUR ATTENTION!

Documents

Reminder summary....NEW PRODUCT PORTFOLIO CONCEPT RESEARCH AND DIAGNOSTICS MARKET SEGMENTS GLOBAL DIGITAL PATHOLOGY MARKET *Source: Markets&Markets Digital Pathology Market –Forecast