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Hologic Breast Health Solutions

3Dimensions™ Launch Playbook


No Compromise. No Comparison
Contents
Calls to Action.........................................................................................................................................................3

Situation Analysis..................................................................................................................................................4

Section 1: Intro to New Products .....................................................................................................................5

3Dimensions™ Mammography System........................................................................................................8

SmartCurve™ Breast Stabilization System................................................................................................ 15

Clarity HD Technology.................................................................................................................................... 18

Intelligent 2D™ Imaging Technology........................................................................................................ 24

Quantra™ Breast Density Assessment Software (Version 2.2) ........................................................26

Section 2: File Size Guidance......................................................................................................................... 31

Section 3: Resistance Questions and Responses................................................................................ 33

Section 4: Additional Q&A............................................................................................................................. 39

Section 5: Ordering Information.................................................................................................................. 42

Contact List........................................................................................................................................................... 44

References............................................................................................................................................................ 45

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Calls to Action

1. Read through the PRODUCT SECTION of the launch playbook to further familiarize yourself
with the new products, including messaging, pricing, ordering detail, and timing (where
applicable).

2. Read and familiarize yourself with the OPPORTUNITY IDENTIFICATION section of this
document, to clearly understand the suggested targets for the respective products.

3 Read and familiarize yourself with the Q&A section of this document, to be able to address the
anticipated resistance questions by customers.

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Situation Analysis
Overview
Hologic revolutionized the mammography market with the initial introduction of Selenia® Dimensions® in 2008,
with US FDA approval in February 2011 as the first digital breast tomosynthesis (DBT) system. Hologic’s 3D
Mammography™ exam has been proven to offer superior sensitivity (detection) and specificity (reduced recalls)
compared to digital mammography. Hologic created the digital breast tomosynthesis (DBT) market, continued to
improve and expand the capabilities of the Selenia Dimensions platform, and went unchallenged until 2014, when
competitors like GE and Siemens finally attempted to introduce DBT systems. Competitors were years behind
Hologic and struggled to gain traction in the US, but even with new entrants, Hologic maintained greater than 90%
share of new DBT installs. With more than 10,000 gantries still to be converted to DBT, the competition continues to
try to catch-up in the attempt to capture some of this remaining ~$3B market opportunity. Fuji and GE both received
FDA approval of their new DBT systems in 2017. In order to further distance Hologic from the competition, we are
launching enhancements and an expansion of our 3D™ product offering that are described in this document.

OBJECTIVES OF NEW LAUNCHES


The objectives of new product launches are simple:
1. Provide the best mammography solution in the world to maintain Hologic’s premium market position by
further distancing ourselves from the competition.
2. Increase market share by gaining new customers
3. Support existing customers by providing backward compatibility and favorable upgrade paths to drive
incremental revenue for Hologic, while maintaining our loyal customer base.
NOTE: The 3Dimensions system is part of our complete line-up of 3D™ solutions that includes options for all
customers; see decision tree later in the document.

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CONFIDENTIAL 5
Section 1: Products

Section 1: Products

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CONFIDENTIAL 7
3Dimensions™ Mammography System
Overview & Messaging
Hologic’s new 3Dimensions mammography system is designed to be our most advanced 3D Mammography™
system. It will include the clinically proven 3D Mammography™ exam with the proven cancer detection that all
women deserve. And, being based on the Selenia Dimensions platform, it is intended to allow facilities to benefit
from all real-world learnings and capability enhancements made over
the last 7 years, with more than 5,000 successful installations worldwide.
The new system is also designed to offer additional advantageous
enhancements in terms of comfort, clarity and controls to keep Hologic
customers at the forefront of technology, ahead of all others.
ACCURATE RESULTS: The 3Dimensions system offers the clinically proven
3D Mammography™ exam, which is more accurate than conventional 2D
mammograms, detecting 20-65% more invasive breast cancers.§ It also
reduces callbacks by up to 40% compared to 2D alone.2-5 The 3D™ exam
is also the only breast tomosynthesis exam FDA approved as superior for
women with dense breasts compared to 2D alone.1-2

SUPERIOR CLARITY: The 3Dimensions system is our fastest and highest-


resolution breast tomosynthesis system available. It is equipped with our
Clarity HD technology**, which provides the option to activate our highest
resolution 3D™ images without compromising our fast 3.7 second scan time,
or low dose.

PATIENT COMFORT: The 3Dimensions system includes SmartCurve™


breast stabilization system, which is proven to provide a more comfortable
mammography experience preferred by more women over flat-paddle
compression. It offers an improved patient experience without compromise,
due to the curved compression surface and the accompanying algorithm
that preserves image quality.

ENHANCED CONTROLS: In addition to the features described above, the 3Dimensions system also includes
new ergonomic enhancements, which will allow for a more optimized workflow so that the technologist can more
efficiently examine the patient.

* Hologic data on file. 3Dimensions, Clarity HD and Intelligent 2D imaging technologies vs. Selenia Dimensions 3D™ imaging and C-View™
2D images.
** Upon commercial availability

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3Dimensions™ Mammography System
Key Messaging/Claims

The fastest, highest resolution breast tomosynthesis mammography system ever

The highest resolution breast tomosynthesis exam with greater comfort


Clinically proven to deliver a more comfortable mammogram
Superior-performing low dose 3D™ exam with more accuracy*

Designed for greater clinical confidence

Designed to enhance the technologist workflow

Features & Benefits


3D Mammography™ exam
Clinically proven exam:
• The 3D Mammography™ exam detects 20-65% more invasive breast cancers compared to 2D alone.§
• The only breast tomosynthesis exam FDA approved as superior for women with dense breasts compared
to 2D alone.1-2
• Reduces callbacks by up to 40% compared to 2D alone.2-5

SmartCurve™ Breast Stabilization system


Improve the patient experience without compromise due to the curved compression surface and accompanying
software algorithm, which preserves image quality.

Clarity HD technology*
Unlocks the full functionality of our fastest and highest-resolution detector, which enables the fastest and highest-
resolution 3D™ imaging in the industry, designed for improved diagnostic confidence.

Intelligent 2D™ Imaging Technology


Low dose 3D™ exams with a new 2D image that is designed for faster read times and improved diagnostic
confidence.

*Hologic data on file. 3Dimensions, Clarity HD and Intelligent 2D imaging technologies vs. Selenia Dimensions 3D™ imaging and C-View™
2D images.

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3Dimensions™ Mammography System
Improved workflow
Smart Positioning in MLO: The tube head moves +/- 15 degrees in the opposite direction in which the C-arm is
positioned, which is designed to allow the technologist greater access to the breast for easier positioning and
an improved workflow. This, in combination with the retractable face shield, is designed to further enhance the
technologist's workflow.

Stationary gantry controls: The new set of stationary c-arm controls on the side of the gantry are designed to allow
the technologist to easily move the c-arm away from or towards them, without reaching or crouching, for an improved
workflow.

Ease of manual paddle decompression: The amount of force needed to manually decompress the paddle device
has been improved. This feature is designed to enable technologists to manually decompress the breast more easily
while trying to position the patient properly, with less strain on the wrist.

Field light improvements: During both needle localization and Affirm® upright biopsy procedures, the length in
which the field light remains on has been extended. This enhancement is designed to improve workflow for the
radiologist during interventional procedures, to allow for more focus on what matters most—the patient.

Improved reliability:The new grid and assembly is designed to improve reliability to reduce the likelihood of grid
lines, and offer less system down time with the new grid drive mechanism, without compromising image quality or
dose.

Logistics
The 3Dimensions system is available for purchase as a 2D or 3D™ configuration, with the ability to upgrade to the 3D
Mammography™ exam in the future.

Standard
The below products/features come standard with every 3Dimensions purchase.

• SmartCurve breast stabilization system- license and • Touch screen control monitor
paddles (18x24cm and 24x29cm*) • X-ray exposure footswitch
• Clarity HD high-resolution 3D™ imaging- license • Powered console tabletop height adjustment
• Stationary gantry controls • Advanced connectivity license
• Smart positioning in MLO • Notices license
• Ease of manual paddle decompression • UPS
• Field light improvements
• New grid and assembly
• 3MP medical grade color image monitor for clear
display of the high-resolution 3D™ images, and a
monitor mount with a double-jointed articulating arm.

*Upon commercial availability

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3Dimensions™ Mammography System
Requirements

File sizes will increase with the higher resolution imaging mode. Larger file size may require additional hardware
or software.

Output

• Output: DICOM Digital Mammography Image (MG) or DICOM Breast Tomosynthesis Image (BTO)

• Flexible Configurations: Output to SecurView® DX diagnostic workstation and PAC

Refer to FILE SIZE section of this document for additional requirements and output options.

Options

Additional options for purchase include:


• Intelligent 2D™ imaging technology license.
• Ergonomic upgrade: includes barcode scanner and fingerprint reader with powered memory console height
adjustment.
• Mobile configuration: includes all standard features, plus kit for mobile installation.
• 3D™ Biopsy options
• Image analytics upgrades: Quantra™ 2.2 breast density assessment software license and ImageChecker® CAD.
• Cenova software v3.0 is required for existing Cenova systems, ImageChecker CAD software and Quantra
software for those who implement 3Dimensions with Clarity HD high-resolution 3D™ imaging with Intelligent 2D™
imaging technology.
• I-View™ software license for contrast enhanced 2D imaging.

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3Dimensions™ Mammography System
Targeting
Hologic’s goal is to provide options that meet all customers’ needs. As such, Hologic’s screening portfolio has
expanded to meet the needs of more customers, with a broader portfolio of solutions.

Our goal is to drive volume and protect our install base by:
• Maximizing incremental revenue.
• Maintaining (or increasing) share and price of new premium gantry sales by owning the premium segment with
the new 3Dimensions mammography system.
• Farming the install base with upgrades.
• Increasing the revenue opportunity in mid-priced segments by repositioning Selenia Dimensions.
• Maintaining customer loyalty.

The following decision tree is intended to summarize the various EMEA customers and the screening portfolio
solutions available to them. While every customer situation is different, the decision tree is designed to be a
recommendation, based on Hologic’s understanding of customer segmentation and purchasing behavior.

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3Dimensions™ Mammography System
What is the current screening environment?

3D™ Imaging 2D/ 3D™ Imaging 2D Analog

3D™ system 2D system

How old is your 3D™ system? State of the Art or Standard of Care

< 4 years old > 4 years old State of the Art Standard of Care

Price Sensitive

No Yes Extremely Sensitive

Customized
Upgrades* 3Dimensions 3D™ Selenia Dimensions Selenia Dimensions
3Dimensions 2D
on a case by System 6000 3000
case basis

*SmartCurve, Clarity HD, Intelligent 2D

Innovators and Early Adopters: These are customers that purchased one of the first Selenia Dimensions systems,
whose 3D™ systems are starting to approach end-of-life. The 3Dimensions mammography system is designed to offer
new breakthroughs in image clarity and patient comfort. These customers may also have one or two 2D-only systems
that need to be converted, in addition to a 3D™ system. For the 3D™ systems in this segment that may not be ready
for replacement, the upgrade products will be an ideal solution for these customers, especially if a 2D system is
upgraded to 3Dimensions, as this will provide standardization across all 3D™ systems.

Early Majority: These customers may be in a mixed environment, who may have initially purchased one 3D™
system, and the remainder are 2D. These customers, depending on if they are interested in the state of the art or
the standard of care technology, and depending on budget, may either want to upgrade all systems to the latest
and greatest (3Dimensions), may only be interested in the standard of care (Selenia Dimensions), and/or they aren’t
ready to replace their 3D™ systems. These customers may choose to purchase the new product upgrades for
standardization.

Conservatives and Price driven: These customers are those who are only just switching from analog to digital, or
those who are still using only FFDM. The Selenia Dimensions 3000 2D system is a solution based on the customer’s
purchasing requirements. Some upgrade options may be available to further accommodate customers’ changing
business needs.

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3Dimensions™ Mammography System
Competitive Feature Landscape

The below chart is intended to provide an overview comparing the Hologic 3Dimensions mammography system and
feature set to that of the competitors.

3Dimensions™ Fuji ASPIRE Siemens


Features Mammography Sys- Cristalle/Innovalty GE Pristina™ GE SenoClaire Mammomat
tem (OUS) Inspiration

Tomosynthesis exam
FDA-approved Yes Yes1 No2 No3 Yes4
superior to 2D alone
Reduced recalls Yes No1 Unknown2 Unknown3 No4
Increased cancer
Yes No1 Unknown2 Unknown3 No4
detection

Generated 2D Yes; C-View


FDA-approved to software.
Insight Imaging –
replace FFDM within Intelligent 2D CE S-View- CE Marked Yes; V-Preview5 Yes; V-Preview5
CE Marked6
a tomosynthesis marked- pending FDA
exam approval

< 10 seconds for


Scan time 3.7 seconds < 4 seconds7 Unknown breast 4.5cm or < 25 seconds9
smaller8
Proven comfort with Self-controlled
Comfort solution Fit Sweet10 N/A Mood lighting12
SmartCurve compression11
# of Projections 15 1513 914 98 2515
Tomo Resolution 70µ high-resolution 100μ standard resolution
100μ16 100μ8 85μ16
(microns) 140µ standard resolution 150μ high-resolution13
15 screening/
Scan angle 15 2514 258 5012
40 diagnostic13
FBP (filtered back
Reconstruction Iterative13 Iterative ASIRT Iterative ASIRT8 Iterative12
projection)
Tube motion Continuous Continuous13 Step-and-shoot Step-and-shoot8 Continuous12

NOTE: References below apply to this chart only.


1. PMA P160031 retrieved on June 9, 2017 from https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMA/pma.cfm?id=P160031
2. PMA P130020/S002 Retrieved on June 9, 2017 from: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P130020
3. PMA P130020 Retrieved on June 9, 2017 from: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P130020
4. PMA P14001 retrieved on June 9, 2017 from https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P140011S003
5. PMA P130020/S001 Retrieved on June 9, 2017 from: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P130020
6. PMA P140011 retrieved on June 9, 2017 from https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P140011S003
7. www.itnonline.com Breast Tomosynthesis Systems Comparison Chart retrieved on June 9th, 2017 from https://www.itnonline.com/compare/76036/50483?products=1-5
8. Iordache, R. (2015) Quality Control for SenoClaire (GE Breast Tomosynthesis) retrieved on June 9, 2017 from http://amos3.aapm.org/abstracts/pdf/97-26965-352470-110105-667065451.pdf
9. www.healthcare.siemens.com retrieved on June 9, 2017 from https://www.healthcare.siemens.com/mammography/tomosynthesis
10. Fujifilm Amulet Innovality data sheet retrieved on June 9, 2017 from http://www.fujifilm.in/Products/medical/brochures/pdf/index/Amulet%20Innovality.pdf
11. www.ITN.com retrieved on June 9, 2017 from: https://www.itnonline.com/content/ge-healthcare-launches-senographe-pristina-mammography-system
12. Mammomat Inspirationwith PRIME Technology brochure retrieved on June 9, 2017 from https://static.healthcare.siemens.com/siemens_hwem-hwem_ssxa_websites-context-root/wcm/idc/groups/pub-
lic/@global/@imaging/@mammo/documents/download/mda1/nzez/~edisp/mammography_mammomat_inspiration_prime_mammography_screening_machine_product_brochure-feb-16-02678877.pdf
13. Van Egan, R. (2016) Protocol for the Quality Control of the Physical and Technical Aspects of Digital Breast Tomosynthesis Systems retrieved on June 9, 2017 from www.euref.org/downloads?down-
load=44:euref-tomo-protocol-version-0-10
14. GE Senographe Pristina Data Sheet, 2016
15. www.healthcare.siemens.com retrieved on June 9, 2017 from https://www.healthcare.siemens.com/mammography/tomosynthesis
16. www.ITNonline.com, Breast Tomosynthesis System Comparison Chart, retrieved on June 9, 2017 from: https://www.itnonline.com/compare/76036/50483?products=1-2-3-4-5

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SmartCurve™ Breast Stabilization System
Overview & messaging
Women cite pain and discomfort as one of the main reasons for delaying or avoiding mammography.8 Without regular
participation, the probability of cancer being missed, or presenting as more invasive at the time of diagnosis,
may increase.7

Customers feel the impact in terms of both lower patient volume and the possibility of lower patient satisfaction
scores. Hologic has spent years developing a paddle that can help improve the mammography experience for
women in an attempt to encourage regular
participation. The result of this ongoing research
is the new SmartCurve™ Breast Stabilization
System.

The SmartCurve system is reduces the pain and


discomfort often associated with mammography
compression, without compromising the
accuracy due to the accompanying algorithms
that preserve image quality.

Our new curved compression surface mirrors


the curvature of the breast to better distribute
the compression force over the entire breast,
while also reducing pinching at the chest wall. Our new software recognizes the paddle and takes the paddle
geometry into account when creating the final image, with the intent to ensure that our exceptional image quality
is maintained with no compromise in cancer detection. This new breast stabilization system has been evaluated at
multiple clinical sites to study the improvement in comfort, satisfaction and preference over traditional flat-paddle
compression. It will be available in two sizes that will accommodate the vast majority of women.

Key messaging/claims
Mirrors the shape of a woman’s breast.

Clinically proven to deliver a more comfortable mammogram.9

Improves comfort in 93% of women (who reported moderate to severe discomfort with
standard compression paddles).9

95% of women surveyed would recommend facilities that use a 3Dimensions/SmartCurve system.9

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SmartCurve™ Breast Stabilization System
Features & Benefits
Curvature at chest wall: designed to reduce pinching.

Advanced image processing: the advanced processing software preserves image quality.

Side-to-side curvature: Distributes compression more evenly over the entire breast for a more uniform compression.

More comfortable breast stabilization: Reduces pain and anxiety with potential to improve patient satisfaction over
traditional flat-paddle compression.

Two paddle sizes: available in 18x24cm and 24x29cm*, designed to support a wide range of breast types.

Logistics
The SmartCurve system is intended for screening and should not be used for biopsy procedures or for I-View
procedures. It is not recommended for cleavage views, rolled views, or mosaic views of very large breasts.
The standard screening paddles are always included with the system and should be used for cases where the
SmartCurve system is not appropriate.

Standard
• The SmartCurve system is enabled by a software license.
— The license is enabled by default on the 3Dimensions mammography system
• Included: SmartCurve license and paddles (18x24cm and 24x29cm*).
• Integration:
— The SmartCurve system includes a radio frequency identification (RFID) tag that is recognized by the system.
— Special processing is automatically applied to all SmartCurve system images to compensate for the curvature
and ensure optimal image quality.
• Training:
— No special training is required for the SmartCurve system.
— Compression force is based on breast tautness as for standard flat paddles.

Requirements

• Installation on existing Selenia Dimensions systems require the latest software version (v1.9)
and purchase of a license.

*Upon commercial availability

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SmartCurve™ Breast Stabilization System
Targeting
Focus your SmartCurve™ breast stabilization system promotional efforts on these primary targets so that you
generate the greatest momentum in the shortest amount of time.

Purchasing New 3Dimensions System?

Yes No

Has other Dimensions Systems? Current Dimensions customer (2D or 3D™)?

Yes Yes No

Places high value on patient satisfaction?

Yes No

SmartCurve Upgrade opportunity

Existing Selenia Dimensions customers who place a high value on the patient experience.
• High-volume sites.
• Customers attuned to patient satisfaction metrics.
• Customers who are interested in increasing the participation rate in government screening programs.
• Customers who are interested in attracting private patients outside the government screening program (i.e.
competing for patient volume in the private setting).

New 3Dimensions customers who also have one or more Selenia Dimensions systems.
• Standard with all 3Dimensions™ system purchases.
• Opportunity to upgrade existing Selenia Dimensions systems to offer a consistent experience.

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Clarity HD
Overview & messaging
The new Clarity HD technology package enables the next
breakthrough in 3D Mammography™ imaging, with new imaging
capability designed to deliver unprecedented visibility of
fine detail retained from the 3D™ data for increased clinical
confidence, without compromising on scan time or dose.

Clarity HD technology* is an advanced technology package that


unlocks the full functionality of our fastest and highest-resolution
3D™ system available. It enables new imaging capabilities,
including our fastest and highest-resolution 3D™ images.

Clarity HD high-resolution 3D™ imaging is a result of new gantry


hardware and a new 3D™ algorithm that enables full detector
readout, resulting in consistent 70 micron tomosynthesis images
across all breast sizes for Hologic’s highest quality 3D™ image.

The resulting new 3D™ images are sharper, smoother, and more
detailed.** This new level of clarity is especially noticeable
when magnifying areas of concern in the breast. With its fine
clarity, the new 3D™ images are designed to increase diagnostic
confidence, including in large breasts.

Clarity HD is the prerequisite to the Intelligent 2D™ imaging


technology, which generates an entirely new 2D image from the
new high-resolution 3D™ data set. Clarity HD high-resolution 3D™
imaging can be used in either Combo mode, Combo HD
or Tomo HD modes with Intelligent 2D imaging technology.

The combination of Clarity HD’s 3D™ image + Intelligent 2D


image is:
• Filed with the FDA as non-inferior to C-View 2D software + 3D™
(standard resolution) images
• Superior to 2D alone, like the C-View 2D software + 3D™ exam
of today

These technologies were designed with the goal of improved performance over C-View 2D software +
tomosynthesis in mind.

Although real-world clinical performance remains important, bench tests have demonstrated a trend for better
radiologist detection.

*Clarity HD is not yet FDA approved or available in all international markets.


**Hologic data on file. 3Dimensions™ 3D™ images using Clarity HD high-resolution 3D™ images vs. Selenia Dimensions standard resolution 3D™ images

Key messaging/claims
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Clarity HD
The fastest, highest resolution breast tomosynthesis system ever

Designed to increase clinical confidence▼

Designed to achieve more accuracy with synthesized 2D the first time▼

Reduce callbacks by up to 40% compared to 2D alone.2-5

Detects 20-65% more invasive breast cancers compared to 2D alone.§

▼ Tomo HD with Intelligent 2D compared to Tomo HD with C-View.

Features & Benefits


Next breakthrough. The Clarity HD high-resolution 3D™ imaging enables the next breakthrough in 3D
Mammography™ imaging.

New imaging modes. The new imaging modes are designed to deliver unprecedented visibility of fine detail
retained from 3D™ data for increased clinical confidence.

No compromise. The higher-resolution 3D™ imaging does not compromise on scan time or dose.

The 3D Mammography™ exam consists of two imaging options—standard resolution and high resolution.
Figure 1: Standard resolution is our clinically proven resolution imaging option that customers have come to know from Hologic.
High-resolution is designed to further enhance the clinically proven 3D™ images by offering even sharper, less noisy images with
minimized artifacts, designed to further increase radiologists’ diagnostic confidence, without compromising scan time or dose.

Standard Tomo High-resolution Tomo

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Clarity HD
Imaging procedures for the 3D Mammography™ exam depend on the selected imaging option, as well as the mode
desired—Combo, Tomo HD, or Combo HD.

Imaging Mode NEW! High-resolution 3D™ imaging Standard resolution 3D™ imaging

Combo High-resolution + FFDM Standard + FFDM


Tomo HD High-resolution + Intelligent 2D™ imaging technology Standard + C-View™ software
High-resolution + FFDM + Intelligent 2D™ imaging
Combo HD Standard + FFDM + C-View™ software
technology

The 3Dimensions mammography system offers the proven 3D Mammography™ exam, which is now available in two
imaging options—standard resolution and high-resolution. The following chart compares the details of each imaging
option.

NEW! High-resolution 3D™ imaging Standard resolution 3D™ imaging

Resolution 70 micron pixel 100 micron pixel


Binning No Yes
Scan angle 15 degrees 15 degrees
# of projections 15 15
Scan time 3.7 seconds 3.7 seconds
Standard dose* 1.45 mGy 1.45 mGy
Synthesized 2D Intelligent 2D imaging technology C-View software
Reconstruction time** < 5 seconds < 5 seconds
File size (BTO)
Uncompressed 5208 MB 2480 MB
JPEG lossless 1302 MB 620 MB
JPEG 2000 lossless 651 MB 310 MB
File size (SCO)
Hologic lossless 357 MB 170 MB

*Dose representative of tomosynthesis scan and Tomo HD


** On average

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Clarity HD
Each of the imaging options for the 3D Mammography™ exam comes with a number of features and benefits, as
shown below.

NEW! High-resolution 3D™ imaging + Standard resolution 3D™ imaging +


Intelligent 2D imaging technology C-View software

• Small and large breasts reconstructed,


unbinned at 70 micron tomosynthesis
pixel size • Fast 3.7 second scan time, regardless of breast
thickness
• Sharper, less noisy images
Features • Reveals more than FFDM alone
• Better representation of contrast
• Clinically proven
• Skin line improvement
• Minimized artifacts

• Greater margin/lesion conspicuity

Benefits • Ability to see more faint calcifications • Detects 20-65% more invasive cancers compared
to 2D alone§
• Designed to improve diagnostic
confidence • Reduces callbacks by 40% compared to 2D alone.2-5
• No increase in dose
• No change to 3.7 second scan time

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Clarity HD
Logistics
Standard
• Standard with all 3Dimensions systems*.
• Included: Clarity HD license.

Requirements
• High-resolution 3D™ imaging mode is a prerequisite for Intelligent 2D imaging software.
— Clarity HD is not compatible with C-View software.
• File sizes will increase with the higher-resolution imaging mode, by approximately 2.1x the current standard
resolution file size—larger file size may require additional hardware/software or other infrastructure/connectivity
products.
• Like all 3D™ systems, or optional upgrade quotes today, your Connectivity Specialist should be involved to assess
the site and provide recommendations for successful implementation.

Output
• Output: DICOM Digital Mammography Image (MG) or DICOM Breast Tomosynthesis Image (BTO)
• Flexible Configurations: Output to SecurView DX diagnostic workstation and PACS

Options
• Being a combination of both software and hardware, Clarity HD is an upgradeable option for existing Selenia
Dimensions systems.
• Cenova software v3.0 (in development) is required for existing Cenova systems, ImageChecker CAD software and
Quantra software customers that implement 3Dimensions with Clarity HD high resolution 3D™ imaging + Intelligent 2D.

Timing
Clarity HD high-resolution 3D™ imaging is pending FDA approval, with anticipated availability in winter 2017.
Clarity HD high-resolution 3D™ imaging will be available at launch in EMEA.
As with any FDA submission, there is always variability, and as such, specifics are not available.

*Upon FDA approval and/or commercial availability

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Clarity HD
Targeting
Primary targets for Clarity HD include:
• High-volume facilities with a mixed 2D/3D™ system environment with 2D gantries approaching replacement.
— For those mixed high-volume facilities where the 3D™ system is not ready to be replaced, but that want to offer
standardization across all systems, particularly with the new 3D™ system that replaced a 2D system.
• Customers looking to upgrade to Intelligent 2D imaging technology from C-View software.
• Existing Hologic 3D™ exam customers considering a competitive system for their next system.

New 3Dimensions Customers

When is the Customer Purchasing?

Q4 FY17 Q1 FY18

Is the Site’s Infrastructure Ready for Larger File Size?

No Yes

Standard resolution 3D™ Exam + High-resolution 3D™ Exam +


C-View Software Intelligent 2D Imaging Technology

Existing 3Dimensions Customers

Is the Site’s Infrastructure Ready for Larger File Size?

No Yes

Standard resolution 3D™ Exam + High-resolution 3D™ Exam +


C-View Software Intelligent 2D Imaging Technology

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Intelligent 2D™ Imaging Technology
Overview & messaging
Finding breast cancer and saving lives is the main goal of radiologists. While the 3D Mammography™ exam stands out
with its clinical performance superior to 2D alone, some radiologists would prefer to reduce patient dose and longer
read times, as compared with 2D alone.

Additionally, some radiologists are seeking improvements in the overall 3D™ exam image quality, especially when
FFDM is replaced by C-View™ 2D images. That’s why the scientists at Hologic created Clarity HD and Intelligent 2D™
imaging technology.

Intelligent 2D imaging technology is designed to achieve more accuracy in its new 2D images, starting with the
sharp and smooth 70 micron tomosynthesis data.* It combines this data with new machine learning algorithms to
create 2D images with unprecedented image clarity and detail retained from 3D™ data, so radiologists can easily and
confidently analyze subtly mammographic features and lesion morphology.

Designed for improved accuracy and conspicuity, Intelligent 2D imaging technology’s new machine learning
algorithms retain and accentuate more details than before possible, for improved radiologist detection of important
tomosynthesis details, such as calcifications, speculated lesions, round lesions, and lobular lesions.**

The new Intelligent 2D image’s resolution and contrast, which now includes 3 contrast pre-set options, are designed
to enable full field digital mammography-like (FFDM-like) representation of parenchymal tissue. The resulting new
2D images provide a comprehensive overview of the 3D™ images. The new 2D images also contain Mapping
information, which allows radiologists to quickly move from suspicious areas on the 2D to the corresponding 3D™
slice, saving radiologists valuable time during the read.***

Key messaging/claims

Superior image quality, compared to 2D alone.

Exceptional 2D image resolution and contrast.

Streamlined workflow.

Lower dose.

Improved patient experience.

Reveal more details in low-dose, high-resolution 3D™ exams.

*Intelligent 2D imaging technology is not yet FDA approved or available in all international markets.
**Hologic data on file. Intelligent 2D images as compared with C-View 2D images.
***Requires SecurView DX diagnostic workstation mapping feature with minimum v9.0.1 software

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Intelligent 2D™ Imaging Technology
Features & Benefits
Exceptional image quality. Low dose. Novel 2D image created from new machine learning algorithms and high-
resolution 3D™ data, increasing the low dose 3D™ exam’s image quality while maintaining superior performance over
2D alone.

Improved performance. New 2D images with robust 3D™ correlation, maintaining more lesion detail than before
possible, designed to increase radiologists’ detection and confidence.

Faster 3D™ exam workflow. Read times may be expedited with its increased image quality, detectability and instant
2D/3D™ mapping feature*

Intelligent 2D™ imaging technology eliminates the FFDM x-ray portion of the 3D™ exam by generating 2D data from
the 3D™ data. This not only lowers the patient dose to that of 2D alone, but it also reduces the scan time by about
50%, which expedites the exam and improves patient comfort.

C-View Image Intelligent 2D Image


Figure 2: Calcifications. On the C-View 2D image, calcifications are not perceived at lower resolution;
on the Intelligent 2D image, fine calcifications are retained from the Clarity HD high-resolution 3D™ images.

FEATURE BENEFIT
Resolution Input and output 70 microns
3D™ details • Retain and accentuate round and lobular lesions (new feature!)
• Improved visualization of true, fine calcifications
• Improved visibility of speculated lesions
• Overall better image quality, less noise and fewer artifacts
Contrast 3 site-configuration window/level options
Read time savings • Retention of important tomosynthesis details
• New smart mapping feature*, which links 2D areas to the 3D™ slice
File size Same as FFDM

* Requires SecurView® DX diagnostic workstation Focus tool with minimum v9.0.1 software

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Intelligent 2D™ Imaging Technology
Logistics
As with any 3D™ purchase decision, a technical support assessment should occur prior to purchase and
implementation; site preparation and education is the key to success.

Standard

• Included standard: Intelligent 2D Imaging Technology software license.

Requirements
• Required: A 3Dimensions mammography system or Selenia Dimensions 3D™ system with Clarity HD
high-resolution 3D™ imaging upgrade.
• SecurView DX diagnostic workstation software minimum v9.0.1 for mapping feature

Output
• Intelligent 2D Imaging Technology software license.
• Flexible Configurations: Output to SecurView DX diagnostic workstation and PACS.
• Basic workflow between the 2 generated 2D products (Intelligent 2D and C-View) doesn’t change.
• Similar to changing vendors, the image appearance will be different.

Options
• Cenova software minimum 3.0 for 2D CAD or 2D/3D™ Quantra breast density software support of Clarity HD and
Intelligent 2D imaging technologies
• Customers who previously purchased C-View 2D software will have a more flexible upgrade price versus
new users.
• ImageChecker CAD for Hologic 2D images

C-View software will continue to be sold and supported. With the next Selenia Dimensions software release,
anticipated enhancements include a new and improved approach to reducing artifacts from metal/large objects
and improved skin line (less bright, less dark shadow).

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Intelligent 2D™ Imaging Technology
Timing
Intelligent 2D imaging technology will be available at launch in EMEA.

Intelligent 2D imaging technology is pending FDA approval, with anticipated availability in winter 2017.
As with any FDA submission, there is always variability, and as such, specifics are not available.

Targeting
Targets for Intelligent 2D imaging technology are those who want the best in breast imaging, where budget is not
a concern.

Does the Customer have C-View™ 2D Software?

No (New or existing 3D™ system) Yes

Would the same 3D™ Performance at a low 2D dose Would increased accuracy, confidence and faster
interest the customer? workflow interest the customer?
Tertiary Primary Secondary
Target No Target Yes Target Yes

Is the customer more interested in patient


Is the customer more interested in a time-tested performance
experience or expediting tomosynthesis
on a budget, or the latest, best-in-class technology?
read time?

Patient Expediting tomosynthesis Time-tested performance Best-in-class technology


experience read time

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Quantra™ Breast Density Assessment Software
Overview & messaging
Quantra Breast Density Assessment Software (Version 2.2) is a software application that is used to analyze a
patient’s breast density. Quantra 2.2 enables standardization by providing reproducible and consistent breast density
assessment, eliminating inter- and intra-radiologist variability due to subjectivity.

Quantra 2.2 has an improved software algorithm that analyzes a patient’s breast density. The results for each image,
breast, and patient, are intended to aid radiologists by segregating the patient’s breast density into categories, which
may be useful in the reporting of consistent BIRADS 5th Edition-like composition categories as mandated by certain
state regulations.*

Quantra 2.2 analyzes the pattern and texture of the patient’s breast tissue, which is intended to provide consistent
scoring. This scoring method helps radiologists overcome the challenges of visually assessing breast density.

Quantra 2.2 produces adjunctive information and is not a diagnostic aid. The ACR (American College of Radiology)
recommends that radiologists make a visual assessment of a patient’s breast composition when reading a scan.
Quantra can run on Hologic 2D or 3D Mammography™ images.

Key messaging/claims
Standardize breast analysis to provide personalized care.

Our next-generation software enables fast, consistent breast density assessment across the entire patient
population

Take advantage of machine learning to quickly and accurately assess breast density.

Improve assessment with unbiased algorithms that analyze each patient’s breast texture and pattern.

Elevate the standard of care and standardize reporting across the whole radiology practice.

Includes texture and pattern analysis for more consistent, more reliable scoring.

Features & Benefits


Quantra 2.2 provides a breast density assessment on a 4-point scale by:
• Mathematically calculating volumetric breast density
• Quantitatively analyzing pattern and texture

Quantra 2.2 helps:


• Overcome the radiologic challenge of mammographic breast density scoring
• Offers an unbiased breast density assessment that supports compliance with state-specific density notification
laws*
• Objectively supports management of breast density protocols for adjunctive screening

*Not applicable outside the U.S.

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Quantra™ Breast Density Assessment Software
While Quantra 2.1 and 2.2 both offer measurement of volumetric breast density using the same methodology, the difference in
Quantra 2.2 lies in the method used to estimate breast density categories, as well as tissue texture and pattern.

Quantra™ 2.1 Quantra™ 2.2

Uses only volumetric breast density for density categorization Uses parenchymal tissue texture and pattern for density
(more aligned with ACR BI-RADS® 4th Edition) categorization (more aligned with ACR BI-RADS® 5th Edition)

This method faces some challenges in categorization of This method has relatively enhanced accuracy of (a) and (d)
extremely fatty (a) and extremely dense (d) breasts categories*

Logistics
Standard
• Quantra 2.2 Breast Density Assessment Software (Version 2.2) license.
• Applications reinforcement in the form of on-demand video is available if not scheduled with on-site gantry training.

Requirements
• Cenova customers will need Cenova 3.0 to run Quantra 2.2; customers on Hologic Service Contract are entitled to
the upgrade at no charge.
• Minimum system requirements are Windows 7, 2 GHz Processor Speed, 4 GB memory, 130 GB HDD Free Disk
Space, DVD-ROM, and a 100 Mbps-capable Network Interface Controller.
• Quantra 2.2 is only available for images generated by the 3Dimensions system and Selenia Dimensions systems.

Output

• The performance of the Quantra 2.2 application has been evaluated only for images labeled as the 4 standard
screening views:
Ο LCC: left craniocaudal
Ο RCC: right craniocaudal
Ο LMLO: left mediolateral oblique
Ο RMLO: right mediolateral oblique

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Quantra™ Breast Density Assessment Software
Upgrade information
• Cenova 3.0 is only for Hologic FFDMs including 3Dimensions.
• Cenova will be a mandatory upgrade for Hologic FFDM Quantra customers under service contract or warranty; Quantra
customers with non-Hologic FFDMs cannot be upgraded to Cenova 3.0.
• ImageChecker® CAD customers with non-Hologic FFDMs cannot be upgraded to Cenova 3.0.
• Mixed environments of Hologic and non-Hologic FFDMs using the same Cenova server needing/wanting Quantra 2.2/
Cenova 3.0 will need to buy a new Cenova 3.0 server and migrate all necessary licenses for Hologic FFDMs to the
Cenova 3.0 and leave their non-Hologic FFDMs and licenses on their existing Cenova server.
• Upgrading to Cenova 3.0 requires Windows 7 OS (a hardware upgrade from XP to Windows 7 may be necessary).

Timing
Quantra 2.2 will be available at launch in EMEA. Quantra 2.2 is pending FDA approval, with anticipated availability in
winter 2017. As with any FDA submission, there is always variability, and as such, specifics are not available

Targeting

Are you currently assessing mammographic breast density, visually/subjectively?

Yes No

Current Hologic gantry customer?

Yes (8,801) No

Current Cenova user? New Hologic gantry system sale (Dimensions or 3Dimensions

Yes (4,888) No (3,913) Yes No

Service contract?
1* Portfolio sell messaging with new gantry installs,
professional on-site Apps Training for Quantra software.
Yes (1,888) No (3,700)
3 Qualify for interest in demo license towards full license pur-
chase, cross sell with service contract to protect investment

2 Portfolio sell messaging with current Cenova/ImageChecker CAD installed base: if you currently
have a Cenova server, Quantra 2.2 is a license upgrade (less financial capital outlay than an
additional server).
*NOTE: Non-Hologic gantries have not been validated with the current Quantra 2.2 algorithm. Therefore, they would not be a current target unless
purchasing a Dimensions system.

*Note: data on file at Hologic

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Section 2: File Size
Guidance

Section 2: File Size Guidance

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File Size Guidance
The introduction of the Clarity HD high-resolution 3D™ imaging produces our sharpest, fastest and highest-resolution
3D™ images ever, which is intended to help accelerate screening and analysis. The higher resolution images result in
a larger file size, approximately 2.1x that of the standard 3D™ images.

As part of the total solution, Hologic has identified the SW/HW requirements necessary to support the larger file
size, as it relates to our SecurViewDX product. Below are the minimum system requirements. Refer to the FILE SIZE
CHECKLIST document (separate document) for additional talking points to be discussed with customers.
Be sure to consult your Connectivity Specialist to ensure an accurate integration and seamless transition.

To experience the optimal performance when the SecurView workstation is used along with the Clarity HD high-
resolution 3D™ imaging, the below table provides the guidelines for the minimum recommended hardware and
software levels

SecurView Clusters (# clients)


Specifications Standalone Small (2-4) Medium (5-7) Large (8-10)
Software 10.2.0 10.2.0 10.2.0 10.2.0
SA/CL computer T7910 T7910 T7910 T7910
Windows OS Win 7 Win 7 Win 7 Win 7
Manager server T630/R730 T630/R730 T630/R730
Windows Server OS Server 2008 Server 2008 Server 2008

Network 1 Gb 1 Gb 1 Gb NIC teaming/ 10 Gb 1 Gb NIC teaming/ 10 Gb

In addition to the above SecurView cluster chart, the below software/hardware may also be required. Be sure to
consult your Connectivity Specialist for additional guidance.
Selenia Dimensions systems
• Clarity HD option (Requires new detector, computer, and linear grid assembly. Consult with your Connectivity
Specialist before quoting this option to existing Selenia Dimensions users).
CAD + Quantra™ Software
• Cenova™ software 3.0
SecurXchange Router and Archive
• R720 server
• Minimum XX TB storage (TBD depending on Connectivity Specialist recommendations)

For customers using PACS, it is recommended that customers work with their individual PACS vendor to ensure an
accurate integration. Consult with your Connectivity Specialist for additional support.

It is imperative that you help set expectations around the larger file size with your customers in advance of selling in,
to ensure proper preparations. Be sure to leverage the sales tools that are available to you, such as the FILE SIZE
CHART, the FILE SIZE CHECKLIST, and the CLARITY HD SELL SHEET to assist in conversations.

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Section 3: Resistance
Questions & Responses

Section 3:
Resistance Questions & Responses

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Resistance Questions & Responses
The following questions are the anticipated resistances that you may inherit with your customers, followed by the
applicable response.

“I would like to add SmartCurve, but not convinced I will see an impact on patient volume.”
• Redirect the conversation to the value provided through the improvement in comfort and
the exam experience.
Ο Discuss patient satisfaction due to added comfort during compression– this may help with GE sensory
suite and patient compliance.
Ο Creating an environment where patients want to come.
— Keeping your current patients.
— Encourage others to come to the facility = increase in volume.
Ο Share the value of adding MammoPad for greater comfort.

“How do you justify the price for the SmartCurve upgrade?”


• Emphasize that SmartCurve is more than just a paddle
Ο In addition to the innovative design, the development effort has included the software to ensure that
the image quality is maintained.
• Redirect the conversation to the value provided through the improvement in comfort and
the exam experience.
Ο Discuss fear of discomfort as the primary reason women delay or avoid mammograms.
Ο Creating an environment where patients want to come.
— Keeping your current patients.
— Encourage others to come to the facility = increase in volume.

“I bought C-View previously, and was promised an improved C-View. Now there is a new product
and I have to pay for it.”
There is an improvement to the C-View product.

With the release of the latest software version (presuming customer is on a service contract), we did make updates
to certain components of the tomo image processing, some if which will benefit the C-View images indirectly. These
improvements include:
1. New and improved approach to reducing artifacts from high attenuated objects such as large popcorn calcs and
metal objects.
2. Improved skin line (less bright, less dark shadow).

However, some of the greater enhancements to the synthesized 2D image is not available on C-View. For customers
looking for improvements in the contrast detail and calcifications, they will need to upgrade to Intelligent 2D, which
is fueled by the Clarity HD high-resolution 3D™ imaging. For these customers looking to upgrade to Intelligent 2D,
the same limited time window will apply to purchase Clarity HD as part of the Intelligent 2D upgrade at a discounted
price.

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Resistance Questions & Responses
"Why is your new gantry more money than what I can buy from another vendor?”
While other vendors have introduced a new second gantry, or are entering the US market with their first tomo
product at a lower price, Hologic continues to maintain its premium standing in the mammography market by adding
more value at the same price.
• While the patient experience is important, equally important is the clinical data.
• The new 3Dimensions system continues to leverage our clinically proven technology.
• The new SmartCurve system is also clinically proven to provide a better experience for the patient—no other
vendor has been able to provide this.
• The improvements in the patient experience don’t compromise workflow, dose, or most importantly,
image quality.
• Hologic has taken all the benefits and clinical claims from the existing Selenia Dimensions product, and has
made it better without compromising on anything—at a comparable price.
• Other vendors still do not have clinically proven technology. Why roll the dice based on cost?

“I’m concerned about the impact of the larger file size to my facility.”
• Use pre-launch messaging: "Designed to"
• Ο Provide superior clarity of fine details
Ο Enable our fastest and highest resolution tomosynthesis images
Ο No compromise on scan time or dose
• As a result of the forthcoming high resolution 3D™ imaging capabilities, there will be an increase in file size—
approximately 2x the size of the standard resolution images.
• Depending on your facility’s connectivity infrastructure, certain hardware components may be required to ensure
there is no impact to customer’s workflow.
• Our Connectivity team will perform a full evaluation of your customer’s infrastructure once the basic information
has been identified.

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Resistance Questions & Responses
“Will investing in high-resolution 3D™ imaging provide greater clinical efficacy or just a sharper image?"
• The 3Dimensions mammography system is designed to provide the option to activate our highest-resolution
3D™ images.
• Ο While initial studies have shown sharper images and improvements in identification of fine calcifications, at
the time of launch of the Clarity HD high-resolution 3D™ imaging & Intelligent 2D imaging technology, clinical
studies will show an increase in clinical efficacy, but additional data is needed to further support new claims.
Ο Further clinical studies are needed to show clinical efficacy with the new higher resolution images, combined
with the Intelligent 2D imaging technology. These efforts will begin after the launch of these products.
• The same clinical efficacy that results from our 3D Mammography™ exam standard resolution images, will still
apply to the higher-resolution images
• Clarity HD high-resolution 3D™ imaging is designed to provide sharper images that highlight finer calcifications
that may be hard to see in the standard resolution 3D™ images, which is designed to increase diagnostic
confidence.

Displeased customer: “I can’t go with high-resolution 3D™ imaging, so what are my options to improve C-View
images?”
For Everyone
• Review the Guide to Addressing Customer Concerns.
• Be empathetic and ask questions.
• Respond by highlighting the design intent and evidence based medicine, such as the recent papers from Italy,
PA, and DE, all demonstrating the comparable clinical performance of Tomo HD mode to Combo mode.
• Cover the 3D™ imaging + C-View 2D image enhancements in Selenia Dimensions v1.9 software:
1. New and improved approach to reducing artifacts from high attenuated objects such as large popcorn calcs
and metal objects.
2. Large breast imaging enhancements, such as improved tomo skin line (details forthcoming from tomo
science team)
• Just like pharma drugs in the pipeline, not all medical products come to market. Some C-View software R&D
efforts, including those shown prior years at RSNA, did not make it through the new product pipeline process for
performance reasons.
• Recommend that the customer implements 1.9 software

For Specific Customers Concerned with Image Noise


• Our default tomo patient radiation dose remains at 1.45 mGy, although there is a new clinical configuration choice
to increase the tomo dose to 1.8 mGy.
Ο Raising the dose (mA) increases the amount of X-rays, thereby lessening image noise. At this dose, there’s also
a slight change to the exposure method in order to maintain image clarity.
■ ( mA) x length of exposure time (S) = mAs

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Resistance Questions & Responses
Important notes:
• Requires the Selenia Dimensions v1.9 software and the HDT detector introduced ~2013, so work with your FE to
understand the equipment status prior to bringing this up to the customer. And, position a Service Contract as
needed.
• Raising the dose requires a physicist check.
• Warning: This change will not address all customer concerns. Truly the ideal solution is the high-resolution
tomo offering.

“We don't have tomosynthesis for screening, so why do I need the new 3Dimensions system?”
• Do you forsee 3D™ screening in the future?
Ο EUSOBI Declaration 09.2016 with more than 30 countries endorsing tomosynthesis in screening
• What is your purchasing cycle for capital equipment?
Ο Hologic sets the standard in both 2D & 3D™ imaging, so you can enjoy state of the art today while knowing that
the future is secure. (no risk for buying today)
■ Direct detector technology, dynamic AEC, paddle shift system, F.A.S.T paddle™ mode, Bi-Angular tube, and a
platform for future technologies)
• Improved ergonomics increase workflow efficiency and patient satisfaction
Ο Improved ergonomics (park mode, side buttons, compression release ease, field light improvements)
Ο SmartCurve compression surface with proven patient comfort even for 2D today

"I have heard that self-compression improves the patient experience. Why didn't Hologic pursue this solution?"
The approach of self-compression did not align with some of the key design goals of Hologic's effort to improve
the patient experience. Hologic believes that fear of discomfort is the primary reason that women delay or avoid
mammograms. An important goal of our R&D effort was to address the root cause of pain and to demonstrate a clear
improvement in comfort compared to conventional flat paddles. Clinical testing of SmartCurve at multiple clinical
sites has shown that 93% of women who experienced moderate to severe discomfort with standard paddles found
SmartCurve to be more comfortable.
Self-compression, by contrast, has been shown to provide no improvement in patient comfort, and is being
promoted as a way to help patients tolerate more pain by giving them control over compression.
In addition, two of the key design goals that were satisfied by the SmartCurve solution were to ensure no disruption
in workflow for the technologist and no impact on exam time. These are particularly important requirements for high
volume screening centers.
The self-compression approach takes responsibility for proper compression out of the hands of the trained
technologist, and can add minutes to the exam time.

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Section 4:
Additional Q&A

Section 4:
Additional Q&A

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No Compromise. No Comparison.
Additional Q & A
Are you discontinuing Selenia Dimensions?
No, we have no plans to discontinue Selenia Dimensions. We are enhancing and expanding our 3D™ product line-up
based on this current platform, and have no plans to discontinue it.

When will Clarity HD and Intelligent 2D be available?


Available at launch in EMEAC. Clarity HD and Intelligent 2D are pending FDA approval. Anticipated approval and
commercial availability is Winter 2017.

Why can’t you switch between standard resolution and high-resolution 3D™ imaging on the fly?
Each imaging option is a license that requires a service intervention to activate, as well as a physicist review.

If a customer purchases 3Dimensions system as a 3D™ configuration, but isn’t ready for the higher-resolution
3D™ imaging (file size), how will they activate the Clarity HD license after installation?
Once a customer chooses to activate this option, the license is to be activated through the service engineering team,
by creating a service order with the Clarity HD part number for 3Dimensions systems only.

Can a customer who buys a Selenia Dimensions system purchase the new products (SmartCurve, Clarity HD
and Intelligent 2D), once commercially available, at point of sale?
No. The new products are not available at point of sale for Selenia Dimensions systems. If a customer wants the
benefit of the new products, including the price point, they should purchase 3Dimensions. The new products will be
available post-install for Selenia Dimensions systems, but customers will pay significantly more, versus purchasing
3Dimensions initially.

For customers on a service contract, is Clarity HD included at no cost?


Since Clarity HD technology consists of both hardware and software, this upgrade is not included in the service contract.

What is included in the Clarity HD option upgrade for Selenia Dimensions customers?
The Clarity HD option consists of both hardware and software upgrades, which includes the product license, high-
resolution detector, computer, and linear grid assembly. The customer must also upgrade to the latest software, v1.9.
Estimated time to install an upgrade is approximately a day and a half, with a half day for the physicist. Note, this may
vary by customer. Clarity HD high-resolution 3D™ imaging offers 70μm, unbinned high-resolution 3D™ images at the
same dose, imaging speed and reconstruction time. File size will be larger.

My customer just installed their Selenia Dimensions system a few months ago- why do they need a new detector?
The detector that is required for the Clarity HD option upgrade must be tested for high-resolution 3D imaging, to
ensure acceptable image quality. The detector that is included in all Selenia Dimensions systems, regardless of age,
is not tested for high-resolution, and therefore must be replaced. The 3Dimensions system is designed to perform
high-resolution 3D imaging.

Why have we changed to a linear grid after years of HTC™?


First ask the customer, “What is your understanding of the HTC grid?” to determine if this question is arrived from
competition or truly a customer concern. Then respond with the fact that the HTC grid was originally designed for analog,
due to the narrow range of contrast. As Hologic’s technology has evolved, particularly image processing, the need for the
HTC grid has diminished. The linear grid offers equivalent image quality without compromising on dose in a 2D exam.

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Additional Q & A
Why is the new the high-resolution 3D imaging called Clarity HD?
High-resolution refers to the number of pixels. High-definition refers to the ability to see something well.
One can have high definition without high resolution, and one can have high resolution without high definition. But
typically, people would think of the two terms interchangeably.
EXAMPLE:
• High-definition without high-resolution: Tomo is a good example of this. Its resolution is inferior to FFDM, but
cancers appear with greater definition.
• High-resolution without high definition: Your digital camera is high resolution. Smear some Vaseline on it and
take a picture. The picture is high resolution (lots of pixels) but the resultant picture will be very poor definition.

Why are we no longer binning in tomo, whereas before it was explained as a competitive benefit?
The original purpose of binning was to achieve an acceptable scan time and reduce image noise by combining data
from adjacent pixels. The 3Dimensions system is equipped with our fastest and highest-resolution detector, which
allows for equivalent scan times and noise levels without a need for binning. Unlike competitors, we maintain our
3.7 second scan time, use the same 1.45 mGy dose level across all breast thicknesses, and we maintain our clinically
proven image quality, while actually enhancing the images to see more fine details through increased spatial
resolution. This functionality is a result of our detector and electronic technology.

If a patient had her mammogram using SmartCurve, how will they know where the lesion is for the biopsy? Why
didn’t we make a SmartCurve compression surface with a biopsy cut-out?
The software included with the SmartCurve system will compensate for the lesion location and will correspond to the
location with any flat paddle, including the biopsy paddles.

How is compression thickness calculated with the SmartCurve?


The compression thickness that is captured in the DICOM header represents the average breast thickness and is
based on the geometry of the paddle.

What kind of QC test is required with the SmartCurve? If there is no QC test, why not?
There is no QC test required for SmartCurve. A correction table is applied based on the paddle geometry as part of
the generation of the final image. All necessary parameters are captured as part of calibration done at the factory.

Why didn’t you make a SmartCurve for small breasts?


The goal for the first release of the product was to accommodate the large majority of breast sizes, which is satisfied
by the 18x24cm and 24x29cm paddle sizes. We are considering a small paddle version for the future.

My customer is worried that the compression on the pectoral muscle will be too tight in the MLO view when
using the SmartCurve.
The clinical testing of the SmartCurve system has shown improvement in comfort for both the MLO view and CC view
as compared to compression with a standard flat paddle. There was no patient feedback that compression was too
tight in the area of the pectoral muscle. In addition, image quality, as determined by radiologist review, has been
shown to be equivalent to the standard paddle for both views.

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No Compromise. No Comparison.
Section 5:
Ordering Information

Section 5:
Ordering Information

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No Compromise. No Comparison. 41
Ordering Information
The following is a list of all part numbers, as it relates to the ordering details for 3Dimensions, including additional
upgrades, as well as the ordering details for Selenia Dimensions customers to upgrade to the new 3Dimensions product
features.

Part Number Product description Additional requirements

3Dimensions Configurations

3DM-SYS-INTL2D Standard 2D configuration

3DM-SYS-INTL2D-MOB Standard 2D configuration, mobile-ready

Standard 2D configuration without x-ray, for sites that install the AWS in a
3DM-SYS-INTL2D-NS
separate room from the gantry (by law)

3DM-SYS-INTL3D Standard 3D™ configuration

3DM-SYS-INTL3D-MOB Standard 3D™ configuration, mobile-ready

Standard 3D™ configuration without x-ray, for sites that install the AWS in a
3DM-SYS-INTL3D-NS
separate room from the gantry (by law)

Options

Only applicable on 3Dimensions


3DM-LIC-CHD Clarity HD license for 3Dimensions 3D™ systems only
systems
Upon commercial availability. Only
DIM-LIC-SW-UP Upgrade to latest Dimensions system software applicable on Selenia Dimensions
systems (at this time).
Only applicable for Selenia
SmartCurve breast stabilization system with paddles and license for
DIM-ASY-SCS Dimensions systems. Minimum
installed Selenia Dimensions systems*
software v1.9 (DIM-LIC-SW-UP)
Upon commercial availability. Only
applicable on 3Dimensions systems.
Clarity HD license and new detector for existing Selenia Dimensions
DIM-LIC-CHD-UP Requires standard tomo license and
systems*
minimum software v1.9
(DIM-LIC-SW-UP)
Upon commercial availability. Only
applicable on 3Dimensions systems.
Clarity HD license and certified remanufactured detector for existing
RM-DIM-LIC-CHD-UP Requires standard tomo license and
Selenia Dimensions systems *
minimum software v1.9
(DIM-LIC-SW-UP)
Upon commercial availability. Only
applicable on 3Dimensions systems.
Clarity HD license and new detector for exsisting Selenia Dimensions
DIM-LIC-CHD-UP-NG Requires standard tomo license and
systems* with no grid minimum software v1.9
(DIM-LIC-SW-UP)
Upon commercial availability. Only
applicable on 3Dimensions systems.
Clarity HD license and certified remanufactured detector for existing
RM-DIM-LIC-CHD-UP-NG Requires standard tomo license and
Selenia Dimensions systems* with no grid
minimum software v1.9
(DIM-LIC-SW-UP)
Upon commercial availability.
3DM-LIC-TRIAL-CHD Clarity HD 6-month trial license for 3Dimensions systems only Requires standard tomo license and
minimum software v1.9

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Comparison. FOR INTERNAL USE ONLY — DO NOT DISTRIBUTE
Ordering Information

Part Number Product description Additional requirements

Applicable on 3Dimensions and


Selenia Dimensions systems.
Requires 3DM-LIC-CHD,
DIM-LIC-I2D Intelligent 2D license for 3Dimensions or Selenia Dimensions systems DIM-LIC-CHD-UP, DIM-LIC-CHD-UP-
NG, or RM-DIM-LIC-CHD-UP-NG and
minimum software v1.9
(DIM-LIC-SW-UP)
Upon commercial availability. Only
applicable on 3Dimensions systems.
3DM-LIC-TRIAL-I2D Intelligent 2D 6-month trial license for 3Dimensions systems only
Requires 3DM-LIC-CHD and minimum
software v1.9 (DIM-LIC-SW-UP)
Includes barcode scanner, fingerprint reader, and memory height for Only applicable on 3Dimensions
3DM-KIT-ERGO
3Dimensions systems systems
Includes 10cm perforated localization paddle, 10cm perforated
Only available on 3Dimensions at
DIM-KIT-XPP-SCR magnification paddle, 15cm spot contact paddle, 15cm magnification
time of launch
paddle, 15cm ultrasound paddle, 15cm perforated localization paddle
Includes 15cm localization rectangular opening paddle, 10cm localization Only available on 3Dimensions at
DIM-KIT-XPP-INTV
rectangular opening paddle time of launch
Includes crosshair paddle, magnification crosshair paddle, 10cm
Only applicable on 3Dimensions
3DM-KIT-NLOC localization rectangular opening paddle, 10cm rectangular localization
systems
magnification paddle
Only applicable on 3Dimensions
3DM-KIT-3D-UP Upgrade to standard resolution 3D™ license with sliding tomo face shield*
systems
Only applicable on 3Dimensions
3DM-KIT-GENIUS Gantry foot cover with Genius™ artwork*
systems
Only applicable on 3Dimensions
3DM-LIC-TRIAL-3D Tomo trial license for 3Dimensions systems*
systems
Available on both 3Dimensions and
STLC-00004 Includes Affirm upright device, license, and accessory kit
Selenia Dimensions systems
Available on both 3Dimensions and
ASY-09880 Includes lateral arm, license, and accessory kit
Selenia Dimensions systems
Available on both 3Dimensions and
ASY-06484 Upgrade license from 2D to 3D biopsy
Selenia Dimensions systems
Available on both 3Dimensions and
SDM-LIC-0005 C-View license for standard resolution tomo Selenia Dimensions systems
Available on both 3Dimensions and
ASY-08109 I-View license Selenia Dimensions systems

*Upon commercial availability to Selenia Dimensions

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Comparison. FOR INTERNAL USE ONLY — DO NOT DISTRIBUTE 43
Contact List

Congratulations!

You have made it to the end of the Playbook. If you have any questions or suggestions, please feel free to contact
the following:

Function Point of Contact

Marketing EMEAC: Kathleen Lott


General: Mike Stow
3Dimensions and Clarity HD: Mallory Berko
Smart Curve: Dave Mislan
Intelligent 2D: Mallory Berko
Quantra 2.2: Valerie Chu
Sales Excellence Vai Sharma
Sales Training Deb Burnham

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Comparison. FOR INTERNAL USE ONLY — DO NOT DISTRIBUTE
References

* Versus 2D mammography alone

§ Results from Friedewald, SM, et al. "Breast cancer screening using tomosynthesis in combination with digital
mammography." JAMA 311.24 (2014): 2499-2507; a multi-site (13), non-randomized, historical control study of
454,000 screening mammograms investigating the initial impact the introduction of the Hologic Selenia Dimensions
on screening outcomes. Individual results may vary. The study found an average 41% increase and that 1.2 (95% CI:
0.8-1.6) additional invasive breast cancers per 1000 screening exams were found in women receiving combined 2D
FFDM and 3D™ mammograms acquired with the Hologic 3D Mammography™ System versus women receiving 2D
FFDM mammograms only.

1. FDA submissions P080003, P080003/S001, P080003/S004, P080003/S005.

2. Friedewald SM, Rafferty EA, Rose SL, et al. Breast cancer screening using tomosynthesis in combination with
digital mammography. JAMA. 2014 Jun 25;311(24):2499-507.

3. Zuckerman SP, Conant EF, Keller BM, et al. Implementation of Synthesized Two-dimensional Mammography in a
Population-based Digital Breast Tomosynthesis Screening Program. Radiology. 2016 Dec;281(3):730-736.

4. Skaane P, Bandos A, Eben EB, et al. Two-view digital breast tomosynthesis screening with synthetically
reconstructed projection images: comparison with digital breast tomosynthesis with full-field digital
mammographic images. Radiology. 2014 Jun;271(3):655-63.

5. .Bernardi D, Macaskill P, Pellegrini M, et. al. Breast cancer screening with tomosynthesis (3D mammography) with
acquired or synthetic 2D mammography compared with 2D mammography alone (STORM-2): a population-based
prospective study. Lancet Oncol. 2016 Aug;17(8):1105-13.

6. McDonald ES, Oustimov A, Weinstein SP, et al. Effectiveness of Digital Breast Tomosynthesis Compared With
Digital Mammography: Outcomes Analysis From 3 Years of Breast Cancer Screening. JAMA Oncol. 2016 Jun
1;2(6):737-43.

7. Rafferty EA, Durand MA, Conant EF, et al. Breast Cancer Screening Using Tomosynthesis and Digital
Mammography in Dense and Nondense Breasts. JAMA. 2016 Apr 26;315(16):1784-6.

8. Padoan M, et al. Study of socioeconomic characteristics, diagnosis and outcome of women participating or not
participating in mammogram screening. Ann Ig. 2014;26(6):518-525.

9. In an internal study comparing Hologic’s flat paddle to the SmartCurve™ compression surface (18 x 24cm).

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Comparison. FOR INTERNAL USE ONLY — DO NOT DISTRIBUTE 45
www.hologic.com | [email protected] | +1.781.999.7300

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