5 Best Companies in Digital Pathology Market, March 2023

latest edition 5 Best Companies in Digital Pathology Market 2023 walks you through the new dawn in diagnostics, promising improved patient outcomes, accelerated research, and heightened accessibility to quality healthcare.

TissueGnostics
GmbH
A Trendse er for
Automated Microscopy and
Tissue Cytometry
Key Trends and Future
Prospects
The Growing Digital
Pathology Market
igital
Pathology
Market 2023
Best Companies in
Dr. Rupert Ecker
CEO
TissueGnos cs GmbH
March|Issue
10|2023
The Ethics of Digital
Pathology
Balancing Innova on
and Pa ent Privacy
Helping Technology
Technology
Technology
Work With You &
For You
For You
For You
5 Best Companies in Digital Pathology Market, March 2023
Note
he world of healthcare is experiencing a paradigm
Tshift, with the digital revolution reshaping various
medical domains. One such groundbreaking
innovation, the Digital Pathology Market, transforms
diagnostic practices, unlocking a new era of precision
medicine and patient care. With the convergence of cutting-
edge technology and medical expertise, this nascent field
promises to revolutionize pathology and improve global
healthcare outcomes.
Digital pathology involves digitizing traditional glass
slides, enabling pathologists and clinicians to examine and
analyze tissue samples on a computer screen. This method
expedites the diagnostic process and facilitates easy storage,
retrieval, and sharing of patient data, fostering seamless
collaboration among medical professionals across the
globe. Leveraging artificial intelligence and machine
learning algorithms, digital pathology systems are poised to
enhance accuracy and efficiency in diagnosing diseases,
from cancers to infectious conditions, thus reducing the
burden on healthcare systems.
One of the pivotal advantages of digital pathology lies in its
potential to democratize healthcare services. By bridging
the gap between medical experts and underserved regions,
telepathology becomes a reality, bringing world-class
diagnostics to remote areas with limited access to
specialized healthcare. Moreover, the ability to build vast
digital repositories of annotated pathology images paves the
way for groundbreaking research and development of
personalized treatment strategies.
However, embracing the digital pathology paradigm is not
without challenges. Implementing these systems demands
significant upfront investments in infrastructure and
technology, which may pose barriers for smaller healthcare
facilities. Moreover, data security, privacy, and
standardization concerns call for robust regulations to
safeguard patient information and ensure seamless
interoperability among different digital pathology
platforms.
Insights Care's latest edition 5 Best Companies in Digital
Pathology Market 2023 walks you through the new dawn
in diagnostics, promising improved patient outcomes,
accelerated research, and heightened accessibility to quality
healthcare. By embracing this technology, the global
healthcare community can unlock a future where precision
medicine becomes the norm, offering hope and healing to
millions worldwide.
Hope you have an amazing read!
-Pooja Shah
Pja Sh
Embracing the
Future of Diagnostics
TissueGnostics
GmbH
A Trendse er for Automated
Microscopy and Tissue Cytometry
08
Cover
Story
Balancing Innovation and
Patient Privacy
The Ethics of
Digital Pathology
28
The Growing Digital
Pathology Market
Key Trends and
Future Prospects
20
Aicl
KUB Technologies, Inc.
Empowering Surgeons to Reduce the
Number of Re-excision Surgeries
16
Paige
Bringing Confidence and
Accuracy to Every Diagnosis
24
Ctts
Ctts
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March, 2023
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Editor-in-Chief
Chidiebere Moses Ogbodo
Managing Editor
Pooja Shah
Executive Editor
Saloni Agrawal
Visualiser
David King
Art & Design Head
Mrunalinee Deshmukh
Co-designer
Paul Belin
Art & Picture Editor
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Manager
Emily Jones
Marketing Manager
Bill Thompson
Business Development
Executives
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Sales Executives
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SME-SMO Executives
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Description
Featuring
Person
Company Name
AXON Diagnostics
axondiagnostics.com
Paul Cornell
General Manager
Axon Diagnostics provides an HSCN based
centralised diagnostic reporting hub for
secure image sharing.
KUB Technologies
kubtec.com
Vikram Butani
Founder and CEO
KUB Technologies develops imaging systems
specializing in breast cancer.
Imsight Technology
imsightmed.com
Huangjing Lin
Chief Technology
Officer
Imsight is an innovative company using
artificial intelligence to aid diagnosis.
Paige
paige.ai
Andy Moye
CEO
Led by a team of experts in the various fields
Paige strives to transform cancer diagnostics.
TissueGnostics
GmbH
tissuegnostics.com
Dr. Rupert Ecker
CEO
TissueGnostics (TG) provides streamlined
solutions for both biomedical imaging and
image analysis.
igital
Pathology
Market 2023
Best Companies in
Cover
TissueGnostics
GmbH
A Trendse er for
Automated Microscopy and
Tissue Cytometry
Providing solu ons for automated
microscopy and image analysis, which
allow addressing variable ques ons in
a manifold of cells, ssues, markers,
staining methods and diseases, all based
on an enormous biological variability,
is a challenging task. It is the task that
TissueGnos cs not only took up but
matches and adheres to!
S t o r y
Dr. Rupert Ecker
CEO
TissueGnos cs GmbH
Understanding the biology or function of an organ
requires a detailed assessment of various cells and
structures in the intact tissue environment –to
understand their state, a measurement of the number and
characteristics of cells is required. It often involves varying
unanswered questions that require high-level intelligence,
attention to details and advanced computer assistance to
process and make useful meaning of available data.
TissueGnostics GmbH (TG) develops instruments and
software at the frontiers of automated microscopy and
tissue cytometry, which change the way that scientists and
clinicians seek knowledge on cells in different tissues and
diseases. When approaching microscopy, even experts are
often challenged by the profound knowledge of its manifold
techniques and technologies required to yield precise
results. But TissueGnostics GmbH is one step ahead in this
matter as it understands that not every user, or researcher,
may know microscopic methods to their core. Thus, it
provides a platform solution of tissue cytometers, for every
clinician or researcher to attain accuracy and performance.
Under the commendable leadership of Dr. Rupert Ecker,
the CEO, and the family-like team of experts at
TissueGnostics, they pioneered the manufacturing of tissue
cytometers that offer a flow cytometry-like workflow that is
applied to tissue sections, for better assessment,
understanding, and increased verifiable results.
From inception, Dr. Rupert Ecker, had a keen desire for
biomedical researchers to improve their scientific
knowledge in microscopy. Thus, he designed TG's product
platform based on the motto 'Precision that inspires,' which
allows scientists to conduct operations as follows:
Ÿ Whole-slide imaging (brightfield, fluorescence,
confocal, multispectral)
Ÿ High-end analysis of tissue sections, biopsies, cultured
cells, TMAs, smears, etc.
Ÿ Spatial phenotyping, single-cell analysis, molecular
single-cell profiling, machine-learning-based tissue
classification, and many more.
Let's learn more about TissueGnostics and how it is
contributing to advancing research on cells and tissues.
The Origination of the Company: TissueGnostics
The student Rupert Ecker was pursuing his Master's studies
when he began using methods of microscopy and image
analysis and elaborated on these technologies during his
Ph.D in the lab of Georg Steiner and his PhD supervisor
Prof. Michael Marberger at the Department of Urology in
Vienna, Austria. There, he realized that many researchers
were used to generate data with a variety of methods – such
as flow cytometry, ELISA, Northern/Southern/Western
blotting, and even mass spectrometry – but when it came to
microscopic images, they just wanted a 'nice picture' for
their publication.
But microscopy is much more than an 'expensive lens' of a
camera. Microscopy is a collection of versatile methods for
the generation of scientific data, whereby images have to be
considered raw data! To extract numerical data and real
knowledge from 'nice images,' researchers nowadays have
to apply appropriate methods of image analysis, including
techniques of machine and deep learning.
What started as an academic endeavor for Rupert Ecker
soon revealed its potential for use in biomedical research on
the broadest scale and clinical applications as well, also
showing a substantial commercial value. With the first
patents granted, Rupert Ecker being the co-inventor, had to
decide how he and his colleague wanted to finance global
patents, i.e., either by licensing them out or by
commercializing the idea themselves. But without a source
of funding, they would have had to stop the endeavor right
away. Thus, the inventors decided on the latter, and this
way, TissueGnostics was founded in April 2003.
Core Mission, Vision, and Values
TissueGnostics has been a trendsetter from the first moment
on and aims to remain at the frontiers of automated
microscopy and tissue cytometry, a field requiring high
precision and performance, and supply its solutions to every
researcher and clinician working with tissue sections and/or
cell cultures in 2D, 3D, or 4D.
While microscopy involves a manifold of techniques and
technologies, it certainly requires the user to have a
profound knowledge of those, to obtain feasible results.
Thus, TissueGnostics acts as a translator by providing high-
level solutions to users who are not experts in the field of
microscopy and/or image analysis. This is done through its
technology platform of tissue cytometers.
Unique Products and Services
When it comes to microscopy, there are many different
scientific questions around tissue cytometry—which require
automation and computer-assisted data processing. The vast
majority of the human body consists of solid tissues i.e.,
cell agglomerations that appear in an orderly manner
concerning the spatial organization, but follow different
organizational principles and structural patterns. That is
why all known life forms consist of different tissues and we
are also confronted with very different forms of diseases.
Providing solutions for automated microscopy and image
analysis, which allow addressing variable questions in a
manifold of cells, tissues, markers, staining methods and
diseases, all based on an enormous biological variability, is
a challenging task. It is the task that TissueGnostics not
only took up but matches and adheres to! It is the very
reason why its motto is 'Precision that inspires.'
With the company's product lines TissueFAXS, which is a
microscope-based open research platform, and the new
COLUBRIS – Tissue Cytometer with AI, TissueGnostics
offers a solution for virtually any question around cells in
tissues, whole slide imaging (WSI), and the spatial
distribution of cells in those tissues.
Innovations in Research & Development at TG
TissueGnostics has been founded out of a research need that
was largely identified by the founders. The main drivers of
innovation in TissueGnostics are (1) the team members
having a scientific background, like the founders
themselves, (2) feedback from users, who are all
Tgs so ware—both for
hardware control & whole slide
imaging as well as image
analysis & ssue cytometry—is
made in-house and cons tutes
the major enabling factor for
its customers' 'TissueGnos cs
experience' as well as our
commercial success on a global
scale.
5 Best Companies in Digital Pathology Market 2023
researchers in the field of biomedicine, and (3)
collaborative projects with academia.
These collaborative efforts—i.e., projects with
academia—form a constitutive element of TissueGnostics'
success. In addition to more than 20 Austrian national
collaborative research projects, TissueGnostics has been an
industry partner to six major EU-founded Marie
Skłodowska-Curie Innovative Training Networks
(ITN)/Doctoral Networks and additional EU programs,
such as COST Actions and other Framework 6, 7,
HORIZON 2020 and HORIZON EUROPE programs.
An important aspect for TG's R&D department is the fact
that microscopy as such is a largely unregulated area of
technology, and the same is true for image analysis. The
company's academic collaborations also address topics of
quality control and standardization. When it comes to
clinical diagnostics, the EU's new Medical Device
Regulation (MDR) and In-Vitro Diagnostics Device
Regulation (IVDR) as well as corresponding rules in other
countries, such as 510(k) section of the US FDA, are of
relevance, and TissueGnostics is working in accordance to
the ISO 13485 standard.
Technological Advancements Supporting TGs Solutions
While TissueGnostics relies on high-end hardware from
established partners like Carl Zeiss, Märzhäuser,
CrestOptics, Lumencor and others, the software—both for
hardware control & whole slide imaging as well as image
analysis & tissue cytometry—is made in-house and
constitutes the major enabling factor for its customers'
'TissueGnostics experience' as well as its commercial
success on a global scale.
At the heart of this technology are proprietary algorithms
for automated recognition of a single cell in tissue context,
interactive data analysis workflows, as well as machine
learning and deep learning-based solutions for the
classification of histological entities like tumour regions,
glands, glomeruli or leukocyte clusters in tissue sections. Its
newest platform COLUBRIS comes with machine learning-
based data mining to automatically identify molecular
signatures and cellular correlations in high-plex assays for
spatial biology.
Wise Words of Retain
To the aspiring entrepreneurs who desire to venture into the
digital pathology industry, Dr. Rupert Ecker advises, "While
I've always wanted to become a scien st,
though originally in astronomy, but I
finally decided to look in the opposite
direc on, into the microcosm rather than
the macrocosm and moved towards a
degree in cell biology. In addi on, I also
wanted to do something in my life that
helps science to progress. One way could
certainly have been to work on a certain
disease or a group of molecules, or a
specific signal transduc on cascade to
elucidate molecular and cellular
interac ons.
But what if I could develop a technology
that helps others to improve scien fic
knowledge?
This would mean a mul plica on, if not
poten a on, of my personal contribu on
to the scien fic community. The patents
derived during my PhD thesis and
experience obtained during my postdoc
at the Competence Center of Bio-
Molecular Therapeu cs—a joint venture
between the University of Vienna and
the Novar s Research Ins tute in
Vienna—opened the opportunity to
realize this dream in the form of a
company. And this not only allowed me
to realize my own goal in life but also
provided me with an opportunity to
make a living out of it.
With the founda on of the company, I
became the managing director, ini ally
one out of two. By 2017, however, I
became the sole manager and Chief
Execu ve Officer of TissueGnos cs
Global.
CEO's Journey
in his Own Words
technological developments are a challenging, yet most
rewarding endeavor, often even real fun, founding a
company and in particular looking for financing—ie.
fundraising with investors and public funding agencies—is
more of an organizational hurdle and a marathon. It is a
stony path, full of obstacles and unexpected traps."
"It would be my advice for entrepreneurs and founders to
focus on what they are best at, whether it is mainstream or
not. Because you can only win in a field which you love to
work in rather than being forced into."
Wrapping Up
TissueGnostics started as a small company located in the
th
heart of Europe, in Vienna, Austria, with its 20 anniversary
to take place in 2023, the company currently represents a
global structure with subsidiaries and offices in Europe,
UK, USA, China, South-East Asia, India, South America,
Africa, and Australia. While the company is present on all
continents, it is still far from being present in all countries
with relevant biomedical research activities.
th
"With our 20 anniversary and the years to come, we will
introduce novel and innovative products, broaden our
market presence and expand our global service into more
territories," concludes Dr. Ecker.
With the company's product
lines TissueFAXS, which is a
microscope-based open research
pla orm, and the new COLUBRIS
– Tissue Cytometer with AI,
TissueGnos cs offers a solu on
for virtually any ques on
around cells in ssues, whole
slide imaging (WSI), and the
spa al distribu on of cells
in those ssues.
Clients' Stories About TissueGnostics
"I have been working with the TissueFAXS cytometer and
the analysis software from TissueGnostics for more than 10
years. My focus was to determine markers in the tissue, not
only to determine the protein expression profile of the
marker but also the subcellular location within the tissue. In
comparison to FACS, TissueFAXS allows the investigation
of protein expression and their tissue location in a
quantitative multiplex manner. Looking into other systems,
the TissueGnostics systems still provide in my opinion the
best state-of-the-art and unique analysis platform. I
currently use TissueFAXS and the analysis software
StataQuest. I'm a strong TissueGnostics supporter and will
continue the investigation of protein expression with the
TissueFAXS analysis system in cancer tissue."
Dr. Franco Fortunato,
University Hospital Heidelberg,
Germany
"The addition of the TissueFAXS inverted PLUS to our
core facilities' repertoire has made a world of difference to
the ease of data collection and processing. The acquisition
software is remarkably well-designed, offering extreme
flexibility without compromising on the robustness and ease
of use for the whole system. This is extremely useful in our
facility as we cater for a multidisciplinary research
environment where we can easily change the imaging
strategy to the nature of the samples and the needs of the
scientist. The StrataQuest/HistoQuest/TissueQuest analysis
packages have relieved us from the burden of writing
customized analysis scripts and they turn out to be an
extremely powerful and flexible analysis suite. The
customer service we receive from TissueGnostics is by far
the best from any company out there. All enquiries are
quickly dealt with in a personal and professional manner
with final customer satisfaction in mind. If there is any
negative to be mentioned it would be that the system is so
popular, we will have to buy more systems soon."
Dr. Jan Soetaert,
Queen Mary University of London,
UK
"Due to cutting-edge technologies, such as single-cell
RNAseq analysis, a deep deconditioning of the
transcriptome of ex vivo isolated immune cells is possible.
Thus, activation specifications and other cell properties can
be characterized with high precision. The challenge now is
to detect immune cells with an 'expression profile of
interest' within tissues. The multiplex-imaging analysis
allows the visualization of such parameters. To highlight the
localization and interaction of immune cells within the
tissues, customized software packages are required,
providing comprehensive tools for image analysis. From
my point of view, StrataQuest ranks among the top imaging
software packages in the market. With this software and the
customized support, tailored algorithms can be developed,
enabling an evaluation of the imaging data generated with
most of the current imaging platforms."
Prof. Dr. Uwe Ritter,
Universitätsklinikum Regensburg,
Germany
While microscopy involves a
manifold of techniques and
technologies, it certainly requires the
user to have a profound knowledge
of those, to obtain feasible results.
Thus, TissueGnos cs acts as a
translator by providing high-level
solu ons to users who are not
experts in the field of microscopy
and/or image analysis. This is done
through its technology pla orm of
ssue cytometers.
5 Best Companies in Digital Pathology Market, March 2023
16 March 2023
Thanks to technology, the healthcare sector is
progressing at a revolutionary pace. The advanced
technology and medical gadgets being
manufactured are enabling healthcare professionals to
increase their success rates in operation rooms, research,
and the timely development of vaccines, drugs, and
medicines.
Now that healthcare has substantially modernized, there is
optimistic hope for surgeons in taking every measure to
achieve desired results in one surgery, reducing or
eliminating the need for another surgery, especially for
removing cancerous cells.
One of the most concerning issues amongst women
worldwide is Breast cancer. In order to remove the tumor
cells completely, women have to go through various
procedures, surgeries, and multiple rounds of treatment. As
the number of re-excision surgeries increases along with the
impaired tissue, the healthy tissue too gets affected.
Thankfully, there is medical imaging technology today that
can help surgeons effectively visualize surgery margins in
the operating theatre itself, significantly reducing the
excessive number of re-excision surgeries. The leading
manufacturer and provider of this ground-breaking imaging
technology is KUB Technologies, Inc.
Based in Stratford, Connecticut, KUBTEC is challenging
the status quo of breast cancer surgery and is committed to
reducing the excessive number of re-excision surgeries.
Leading the company in its innovation and growth is the
company's visionary Founder and CEO—Vikram Butani.
In the following excerpts, we will get to know more about
KUBTEC's journey in bringing empowering medical
technology solutions to the market and their specialties.
A Superior and Faster Solution
When Vikram founded KUBTEC in 2005, it was with a
mission to provide best-in-class specimen imaging for
pathology because he found out that most facilities were
using old X-ray film-based equipment or low-resolution
general-purpose cabinet systems; as their “standard of
care.” He thought there must be a better way, so he and his
team designed a superior solution with proprietary features
that added value and reduced turnaround time, enabling
them to provide results faster.
“Today, KUBTEC is an acknowledged leader in the field of
breast cancer margin management, and our systems can be
found in pathology, radiology, and ORs around the world.
So, our affinity for the pathology imaging space runs
through the entire fabric of Kubtec,” Vikram told us.
KUB
Empowering Surgeons to Reduce the Number of Re-excision Surgeries
Today, KUBTEC is an
acknowledged leader in the
field of breast cancer
margin management, and
our systems can be found
in pathology, radiology, and
ORs around the world.
Technologies, Inc.
17
March 2023
The Visionary Leader
Vikram Butani, the Founder and CEO of KUBTEC, comes
from a family of doctors. Not pursuing a career in medicine,
Vikram was looking for an opportunity that could make a
difference in healthcare. Reminiscing about the initial idea
for the company, Vikram says, “When I came across the
need for superior imaging of excised tissue in pathology, I
decided to pursue the challenge. My wife and I started the
company out of our spare bedroom.”
Further, he emphasizes that “Our commitment was and has
always been to provide more personalized and attentive
service and support to our customers and their patients.”
Vikram and his team built customer loyalty from a small
install base and then developed a portfolio to leverage the
company’s technological superiority into the OR and
biopsy suites, which were and still are the domains of
radiology. “While doing our research, we learned breast
cancer surgery has a very high re-excision rate. Studies
show that close to 30% of patients need to come back for a
second surgery as the surgeon was unable to clearly
visualize their margins at the time of surgery, and it's not
until they receive the final pathology report that they would
know if the operation was a success.”
That confirmed to Vikram and his team that there was a
very close relationship between the breast surgeons and the
pathology gross room, giving the team a whole new
direction to explore. The company set out to solve this
problem and launched the MOZART Specimen
Tomosynthesis (3D) system, which brings an element of
real-time pathology right into the OR, enabling surgeons
and radiologists to accurately identify positive or close
margins intraoperatively. “KUBTEC’s journey has been
part evolution, part revolution, with everything based upon
a constant stream of proprietary innovation created by the
company,” Vikram added.
On a Mission
Informing us more about the vision and mission statement
for the company, Vikram says, “Well, within the digital
pathology community, our mission is simple and practical.
We’re on a mission to improve patient turnaround time in
pathology.”
Pathology professionals play an important role in the
delivery of timely and effective patient care, so KUBTEC
creates proprietary products and services that enable them
to be more efficient by reducing specimen handling time.
Within a wider framework, the company is focused on
disease states where its technology can make a real
difference in the delivery of care for patients and providers.
KUBTEC is a privately held organization that does not
answer to Wall Street or anonymous institutional
shareholders. Vikram tells us, “Whenever we see an
opportunity to improve the delivery of care, we move
quickly.” In fact, the company's manifesto states that
“Impatience is our virtue.”
The goal of KUBTEC's management is to always be first to
market with new innovations. As such, it strives to make a
life-changing difference for breast cancer patients and
regards every surgery as an opportunity to improve
someone’s life.
In addition, the company values simply “doing the right
thing,” behaving ethically and thoughtfully, being
accountable, and “creating social change.” Vikram
underlines that “We champion our role as good corporate
citizens and are driven to make a difference by supporting
Vikram Butani
Founder and CEO
5 Best Companies in Digital Pathology Market 2023
18 March 2023
initiatives that reduce inequality and improve the health
and well-being of those everywhere.”
Where Innovation has No End
When asked about what keeps the company apart from the
competitors in the industry, Vikram responded with,
“Innovation, Innovation, Innovation.”
He adds, “Not just in product technology but also in the
way we support our customers. We live in a totally
connected world where customer expectations for support
are more than just a 24-hour 1-800 number.”
He continues, “From the very first system we installed in
2005, all KUBTEC systems feature remote support where
we can troubleshoot any of our systems and automatically
perform software updates right from our Technical Center.”
KUBTEC XPERT and MOZART systems feature
KUBALERT, which conducts on-board diagnostics and
sends out a report to preempt a system failure. The
company recently introduced the KUBTEC App, which
will help the user reach a factory support engineer
instantaneously through the app to eliminate any downtime.
3D Tomosynthesis Technology
3D tomosynthesis technology is one of the major solutions
offered by KUBTEC. Revealing more about this technology
solution, Vikram tells us, "3D tomosynthesis, embodied in
the KUBTEC MOZART system, enables surgeons to make
better intraoperative decisions based upon an image that
accurately reflects the true anatomy of the specimen."
He adds, “Clinical studies have shown that use of the
MOZART system reduces re-excisions by 50%, preserves
healthy tissue for better cosmesis, improves surgical
efficiency, and lowers costs. That’s good news for the
patient, the hospital, and the payer.”
Empowering Clinicians with Technology
Only KUBTEC uses tomosynthesis to provide clinicians
and pathology professionals with three-dimensional images
of surgical specimens. This enables them to identify the
exact location of the tumor and its proximity to all edges of
the specimen. If additional tissue excision is required, they
can do it right there as part of the index procedure.
What’s more, the data-rich 3D image enables the use of
artificial intelligence to automatically flag when the biopsy
clip is too close to the edge of the specimen; a KUBTEC
patented technology that the company is further developing
to identify other features.
Constantly Improving the Customer Experience
KUBTEC’s team is strongly focused on providing a quality
customer experience all the time. It constantly looks to
improve the customer experience by making the process
more efficient.
Explaining what helped the company gain significant
leadership in the market, Vikram says, “We were the first to
introduce a larger imaging area of 8“x8” in 2005 and
16“x16” in 2007, when all that was available was 4“x4”.”
Moreover, KUBTEC was the first company to integrate an
optical camera and introduce its proprietary blender
technology and the first to offer a density profile feature that
is useful for the bone decalcification process.
Partnering with Early-adopters and Innovators
Innovative technology solutions are rapidly becoming an
integral part of every sector. Giving his take on the impact
of technology adaptation in the healthcare sector, Vikram
says, “In my experience, a lot of healthcare providers are
cautious about adopting new technologies, mainly because
of their facility’s documented protocols and strict
regulatory requirements.”
However, Vikram adds, “Our job is to seek out innovators
or 'early-adopters' of new digital technology solutions and
partner with them to acquire detailed insights into their
pain points and ever-evolving demands to ensure our
systems consistently meet their requirements now and in the
future.”
This partnership helps KUBTEC to establish early
technology adoption at Centers of Excellence around the
world that can influence a “new” standardization of care.
Offering Valuable Guidance
Vikram has been in the healthcare industry for years,
focused on creating advanced pathology solutions. With
him, there is vast wisdom in researching and developing
19
March 2023
medical devices. From his expertise, he offers the new
aspirants in the pathology space the following words of
guidance:
He says, “I am a great believer in being laser-focused on
patient outcomes, and with that, you uncover customer pain
points or their unmet needs. Technology has come so far,
and there is a lot of room to make the pathology process
more efficient and more effective.”
“Few people focus on pathology as it is not as glamorous
as some of the other departments. If you have something
that you believe can make a difference and help improve
workflow, then speak to the pathologists, speak to the PAs,
and speak to the laboratory professionals before you take
off on a business venture,” marks Vikram.
The Way Onwards
Expanding on the plans for the company, Vikram says,
“We’ve just launched a new product, the GammaPRO
system, which is a highly advanced Wireless Sentinel
Lymph Node Localization Technology, and we have other
new platforms in the pipeline for this year and next.”
The offices of KUBTEC were moved into their current
building in 2021, and already the team has outgrown it. The
company has acquired some land adjacent to its HQ in
Stratford, CT, and will be breaking ground on a new
manufacturing facility later this year. “We are constantly
hiring for engineers, sales, and manufacturing, which is a
great challenge to have in today's economic environment,”
Vikram stated.
"You have a much better view with
specimen tomosynthesis of exactly
what needs to be removed. I avoid
excessive tissue being taken from the
patient, and the patient likes it,
because the cosmetic result is better."
"Specimen tomosynthesis is a no-
brainer. If you're a breast surgeon and
you want to provide the best care, this
is it. To identify whether you've done
the right operation, you need this."
Cary Kaufman, MD, FACS Associate
Clinical Professor of Surgery,
Bellingham Regional Breast Center
"For my practice, and many breast
cancer centers of excellence around
the world. Using 3D specimen
tomosynthesis during surgery has
helped the best surgeons reduce their
re-excision rates even more." Sheldon
M. Feldman, MD, FACS Chief of Breast
Surgery and Breast Surgical Oncology
and Director of Breast Cancer Services
at Montefiore Health System, New
York, NY
"3D tomography has radically
streamlined breast cancer surgery by
allowing surgeons to better visualize
the breast and affected area, even
through dense breast tissue, in the
operating room." Roshni Rao, MD, FACS
Chief of Breast Surgery Program at
New York-Presbyterian/Columbia
University Irving Medical Center
Marcum Tech Top 40:
2019, 2020, 2021
Kornfeld H, Mulder L, Spivey T, Cortina
C, Madrigrano A, Kopkash K. Breast J.
2019;25:766-768. 3. Park KU, Kuerer
HM, Rauch GM, Leung JWT, Sahin AA,
Wei W, Li Y, Black DM. Digital Breast
Tomosynthesis for Intraoperative
Margin Assessment during Breast-
Conserving Surgery. Ann Surg Oncol
2019:26:1720-28.
20 March 2023
21
March 2023
Pathology
Digital
The Growing
Market
athology has undergone a significant transformation
Pin recent years, shifting from conventional practices
to digitized methods. This revolutionary shift,
known as digital pathology, involves acquiring, managing,
and interpreting pathology information through digital
slides and images. As the healthcare industry continues to
embrace technological advancements, the digital pathology
market has experienced substantial growth.
Let's explore key trends driving this market's expansion and
highlight them!
Advantages of Digital Pathology
The adoption of digital pathology has been fueled by its
numerous advantages over traditional methods. One of the
primary benefits is improved efficiency in slide preparation
and sharing. Digital slides can be easily created, stored, and
distributed electronically, leading to faster and more
convenient access to patient data for medical professionals.
Additionally, digital pathology eliminates the need for
physical slide transportation, reducing the risk of slide loss
or damage. This enhanced workflow efficiency allows
pathologists to focus more on data analysis and critical
decision-making, ultimately improving patient care.
Enhanced Collaboration and Telepathology
Digital pathology has opened doors to enhanced
collaboration among pathologists, enabling them to share
cases, exchange opinions, and seek expert consultations
regardless of geographical barriers. Telepathology, a
subfield of digital pathology, has gained traction due to its
ability to facilitate remote diagnosis and consultations.
Telepathology has proven particularly valuable in
underserved areas and regions facing a shortage of qualified
pathologists. It allows local pathologists to seek advice
from experts in larger healthcare centers, leading to more
accurate diagnoses and better patient outcomes.
Artificial Intelligence (AI) Integration
The integration of artificial intelligence (AI) has
revolutionized the field of digital pathology. AI algorithms
Key Trends and Future Prospects
22 March 2023
can analyze large volumes of digital pathology data with
incredible speed and accuracy. This capability has many
applications, including automated tumor detection, grading,
and prognosis prediction.
By harnessing the power of AI, pathologists can leverage
precise and data-driven insights to enhance diagnostic
accuracy, leading to more effective and personalized
treatment plans for patients. As AI technology advances, the
scope for its integration into digital pathology is expected to
expand further.
Growing Application in Drug Development and
Research
The digital pathology market is not limited to clinical
diagnosis alone; it has also found significant applications in
drug development and research. Pharmaceutical companies
are increasingly incorporating digital pathology in
preclinical and clinical trials to evaluate drug efficacy and
assess the impact on tissue samples.
The ability to analyze vast amounts of pathology data with
AI-driven algorithms expedites the drug development
process and reduces the risk of adverse effects.
Additionally, digital pathology is vital in biomarker
discovery and validation, offering valuable insights for
precision medicine approaches.
Integration of Cloud-Based Solutions
The advent of cloud-based solutions has further propelled
the growth of digital pathology. Cloud-based platforms
provide secure and scalable storage options for vast
amounts of digital pathology data. This eliminates the need
for on-premises infrastructure and lowers the overall
operational costs for healthcare institutions.
Cloud-based solutions also enable seamless data sharing
and remote access to digital slides, promoting global
collaboration and second opinions among pathologists and
researchers. As data security measures improve, more
healthcare providers are expected to embrace cloud-based
digital pathology solutions.
Regulatory Advancements
The digital pathology market has witnessed supportive
regulatory advancements in recent years. Regulatory
bodies, such as the U.S. Food and Drug Administration
(FDA) and the European Medicines Agency (EMA), have
issued guidelines for validating and using digital pathology
systems in clinical settings.
These regulatory approvals have instilled confidence in
healthcare providers, encouraging them to adopt digital
pathology for routine diagnostic practices. As more
countries develop their own guidelines and regulations, the
global digital pathology market will likely witness
accelerated growth.
Future Prospects
The future of the digital pathology market looks promising,
with several factors contributing to its expansion:
Increasing Digitalization of Healthcare: As the healthcare
industry embraces digital transformation, digital pathology
will become an integral part of the diagnostic ecosystem,
leading to broader adoption.
AI Advancements: As AI algorithms become more
sophisticated, they will play a central role in streamlining
pathology workflows, enabling accurate diagnoses, and
assisting in personalized treatment strategies.
Expansion of Telepathology: Telepathology is set to grow
significantly, bridging the gap between expert pathologists
and underserved regions, thereby improving global
healthcare access.
Rise of Personalized Medicine: Digital pathology, coupled
with AI, will be crucial in advancing personalized medicine,
tailoring treatment plans based on a patient's unique
characteristics and disease profile.
Conclusion
The growing digital pathology market presents a
transformative shift in pathology, offering numerous
advantages such as enhanced efficiency, collaboration, and
data-driven insights. The integration of AI, the widespread
adoption of whole slide imaging, and the rise of cloud-
based solutions are key trends driving its expansion. With
supportive regulatory advancements and the increasing
digitalization of healthcare, the prospects for digital
pathology are promising. As technology evolves, pathology
is poised to make further strides in precision diagnostics
and personalized medicine, benefiting patients worldwide.
-Pooja Shah
Check should be drawn in favor of :
INSIGHTS SUCCESS MEDIA TECH LLC
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24 March 2023
Andy Moye
Chief Execu ve Officer
Paige
25
March 2023
Paige
Bringing Confidence and
Accuracy to Every Diagnosis
In the realm of cancer diagnosis, the human naked eye
may sometimes fall short in detecting subtle
abnormalities that could be indicative of disease.
However, with the remarkable advancements in artificial
intelligence (AI), the chances of error can be significantly
reduced, ultimately revolutionizing the accuracy and
effectiveness of cancer diagnostics. Leading this
transformative journey is Paige, a pioneering company at
the forefront of utilizing AI to advance the field of digital
pathology.
Paige leverages the power of AI and deep learning
algorithms to empower pathologists and clinicians with an
unparalleled level of precision in cancer diagnosis. By
combining the expertise of medical professionals with state-
of-the-art computational pathology solutions, Paige's
platform revolutionizes the interpretation of medical
images, leaving little room for oversight. Its AI-driven
technology detects even the most subtle signs of cancer,
to help ensure fewer potential abnormalities are
overlooked. By reducing the chance of human
error, Paige is drastically improving diagnostic
accuracy and equipping healthcare
professionals with the tools they need to make
timely and informed treatment decisions.
As one of the leading companies in the digital
pathology market of 2023, Paige continues to
push the boundaries of what is possible in
cancer diagnosis. By harnessing the potential
of AI, Paige is transforming the landscape of
pathology, enabling earlier detection,
personalized treatment plans, and improved
patient outcomes.
In an interview with Andy Moye, the
Chief Executive Officer of Paige shares
the company's unwavering commitment to leveraging AI's
potential in healthcare and revolutionizing the field of
digital pathology in a new era of accurate and efficient
cancer diagnosis.
Following are excerpts from the interview:
Kindly tell us the source of inspiration. What led you to
venture into the field of digital pathology?
For nearly two decades, I have been an industry leader in
the fields of molecular diagnostics, biotechnology, and life
sciences specializing in pathology, oncology, genomics, and
precision medicine. My journey in pathology began at US
Labs in 2005 when digital pathology was still in its infancy
stage but showing great promise. I helped develop and
deliver a system that enabled pathologists to send their
samples to a central lab for analysis. Then I moved to Caris
Diagnostics, where I ran a lab with more advanced digital
pathology capabilities and saw what digital pathology could
do. When I became head of commercial operations for
Philips in 2016, I saw the potential AI applications could
add to digital pathology and how truly transformative it
could be.
Now, as the CEO of Paige, we are dedicated to advancing
digital pathology with the use of cutting-edge artificial
intelligence technology for cancer detection. Our goal is to
create industry-leading AI products and collaborate with
labs around the world to improve access to quality patient
care.
With Paige's AI, pathologists can focus their attention on
areas suspicious of cancer and see cancer on a slide they
could potentially miss with the naked eye. It is a tool
pathologists can use, similar to a second pair of eyes, to
help detect every bit of cancerous tissue with confidence.
5 Best Companies in Digital Pathology Market 2023
26 March 2023
Brief us about the company and shed some light on your
operations there in contributing to the company's
growth.
At Paige, we believe that better technology is the answer to
better patient care. Our mission is to develop and deliver a
new generation of diagnostic and biomarker AI
applications, empowering pathologists and transforming
oncology.
Led by a team of experts in the fields of life sciences,
oncology, pathology, technology, machine learning, and
healthcare, Paige is uniquely positioned to transform the
field of pathology. Our access to highly specialized, diverse
global data has provided Paige with one of the largest data
sets used to develop AI software. This enabled us to build
the first-ever FDA-approved AI pathology product, Paige
Prostate Detect, as well as best-in-class detection
algorithms for uncovering cancer features from H&E-
stained whole slide images alone.
Can you elaborate upon the core values, mission, and
vision on which the company is built?
Paige operates under the guidance of the principles of being
A.D.E.P.T. This means that we are dedicated to being
accountable, disruptive, execution-focused, patient-centric,
and trusting. We strive to create a supportive environment
for the development of innovative products for clinicians,
with the ultimate goal of transforming the world of cancer
care through the use of artificial intelligence.
We remind clinicians that along with techniques like IHC,
PCR, NGS, and ISH, AI is another powerful tool that can
help pathologists in arriving at accurate diagnoses more
efficiently and confidently. Digital pathology and AI will
never replace pathologists, but it certainly supports them in
their assessment.
Our Paige Prostate Suite and Paige Breast Suite are
examples of tools that help pathologists identify even the
smallest and most complex cancers. For instance, the use of
the Paige Breast Lymph Node has shown a 25 percent
1
improvement in pathologist sensitivity , allowing for the
detection of metastatic lesions that may have been
previously missed by the naked eye. This has a direct
impact on patient treatment and care.
What diagnostic tools does the organization find to be
essential in conducting its pathology operations?
2
Paige's products include :
Ÿ The Paige Platform is a comprehensive platform that
powers a lab's complete digital pathology workflow,
consisting of cloud storage, seamless access to Paige
and third-party AI applications, and a secure connection
to laboratory information systems (LIS) and other
clinical information systems.
27
March 2023
Ÿ FullFocus®, an FDA-cleared whole-slide image viewer
that delivers advanced digital slide review tools, and
FullFolio™, our AI-powered clinical worklist.
Ÿ The Paige Prostate Suite is comprised of Paige Prostate
Detect, Paige Prostate Grade & Quantify, Paige Prostate
Perineural Invasion, and the Paige Prostate Biomarker
Suite.
Ÿ The Paige Breast Suite, including both Paige Breast
Detect, Paige Breast Neoplasm, Paige Breast Mitosis,
and Paige Breast Lymph Node, as well as
HER2Complete™.
Ÿ Integrations with leading third-party AI including
Mindpeak IHC biomarker algorithms and others on the
way.
What endeavors is the organization currently pursuing
to improve its pathology measures for patients?
Paige is actively collaborating with numerous organizations
in the medical and pathology industries, forming strong
partnerships with esteemed institutions and teaching
hospitals such as Oxford and the University Medical Center
in Utrecht.
Additionally, we partner with Quest Diagnostics to enhance
their capabilities and simplify the interface between their
technologies to benefit pathologists.
Paige has also established technology partnerships with
Microsoft and Leica Biosystems, while also partnering with
other companies worldwide to enhance digital pathology.
The ultimate goal of these collaborations is to drive a new
era of diagnostics and precision treatment that can
significantly improve the lives of patients through digital
pathology and AI.
How do you envision scaling your organization's
services and operations in 2023 and beyond?
Paige aims to provide an impressive portfolio of AI
applications to pathologists. We are creating new
applications for breakthrough cancer treatment, including
for sub-specialties, over the next few months.
What are some of the testimonials or recognition that
accurately highlight your organization's position in the
market?
Our partnership with Paige brings us a big step closer to our
shared goal of making the pathological diagnosis of breast
cancer quicker, more accurate and more reproducible. I am
extremely excited that we will combine our respective
strengths in analyzing H&E and IHC-stained tissue samples
to make the vision of utilizing AI within pathology a reality.
Felix Faber, CEO of Mindpeak
At Paige, we believe that
be er technology is the answer
to be er pa ent care. Our mission
is to develop and deliver a new
genera on of diagnos c and
biomarker AI applica ons,
empowering pathologists and
transforming oncology.
1
Based on an investigational clinical study involving 3
pathologists and data from 148 patients
2
In the United States, FullFocus® (K201005) and Paige
Prostate Detect (DEN200080) are cleared for clinical
use with Philips Ultrafast Scanner and for use with
H&E-stained slides only. All other Paige Prostate and
Paige Breast Suite applications and use cases are limited
to Research Use Only and not for use in diagnostic
procedures.
28 March 2023
Innovation
he integration of digital pathology into the healthcare
Tlandscape has brought about revolutionary
advancements, promising increased efficiency, accuracy,
and collaboration among medical professionals. However, as
with any technology, the implementation of digital pathology
raises ethical considerations, particularly concerning patient
privacy and data security. Striking a delicate balance between
innovation and protecting patient information is essential to
ensure that the benefits of digital pathology are maximized while
respecting individual rights and maintaining trust in the
healthcare system.
Let's dive into detail for further understanding!
Patient Data Privacy
Patient data privacy is a critical ethical concern in the context of
digital pathology. As medical institutions transition from
physical slides to digital images, vast amounts of sensitive
patient data are being generated, stored, and shared
electronically. Ensuring that this data is protected from
unauthorized access, breaches, and potential misuse is of utmost
importance.
Healthcare providers and technology developers must adhere to
stringent data privacy regulations, such as the Health Insurance
Portability and Accountability Act (HIPAA) in the United States
and the General Data Protection Regulation (GDPR) in the
29
March 2023
30 March 2023
European Union. These regulations govern patient data
collection, storage, and transmission, aiming to safeguard
individual privacy and confidentiality.
Informed Consent
Respecting patient autonomy and obtaining informed
consent are crucial ethical principles in the practice of
medicine, including digital pathology. Patients have the
right to understand how their data will be used, who will
have access to it, and how it will contribute to their
diagnosis and treatment.
Obtaining informed consent for the use of patient data in
digital pathology is particularly challenging due to the
large-scale nature of data processing and analysis.
Therefore, healthcare institutions should prioritize clear
communication and transparency with patients, ensuring
that they are fully aware of how their data will be utilized
and can make informed decisions about their participation
in research and diagnostic processes.
AI-Driven Pathology
The integration of artificial intelligence (AI) into digital
pathology raises additional ethical concerns. AI algorithms
can analyze vast amounts of patient data and assist
pathologists in diagnosing diseases with impressive
accuracy. However, the "black box" nature of some AI
systems, where the decision-making process is not fully
transparent, can lead to concerns about accountability and
potential bias.
To address these issues, it is essential for AI developers and
healthcare professionals to thoroughly validate and explain
AI models, ensuring that they are free from inherent biases
and that their decision-making processes are
comprehensible to human operators. Moreover, AI should
be used as an aid rather than a replacement for human
pathologists, maintaining a human-in-the-loop approach to
diagnostic decision-making.
Security and Data Breaches
The digital nature of pathology data introduces new risks
related to cybersecurity and data breaches. Unauthorized
access to patient data could result in serious consequences,
including identity theft, misdiagnoses, and compromised
patient privacy.
Healthcare institutions and technology providers must
invest in robust cybersecurity measures to safeguard patient
data from potential threats. Regular security audits,
encryption protocols, and employee training on data
protection are essential steps to minimize vulnerabilities.
Access to Digital Pathology in Underserved Regions
While digital pathology offers numerous benefits, it is
crucial to consider its impact on healthcare disparities.
Underserved regions and resource-constrained areas may
not have access to the necessary technology and
infrastructure to implement digital pathology fully.
Ethical considerations should involve strategies to ensure
equitable access to digital pathology services, bridging the
gap between well-established healthcare centers and
underserved communities. Initiatives, such as telepathology,
can significantly provide expert consultations to remote
regions, enhancing access to quality diagnostics and
treatment options.
Avoiding Commercial Exploitation
As the digital pathology market grows, there is a risk of
commercial exploitation by technology vendors and service
providers. Healthcare institutions should carefully assess
vendor relationships to ensure they do not compromise
patient data privacy or expose patients to unnecessary
services or costs.
Transparency in financial arrangements and avoiding
conflicts of interest between vendors and healthcare
providers is essential to maintaining the integrity of digital
pathology services.
Conclusion
Digital pathology holds immense promise in transforming
healthcare by improving efficiency, accuracy, and
collaboration among medical professionals. However,
ethical considerations are paramount in its implementation
to protect patient data privacy, ensure informed consent,
and prevent potential bias or commercial exploitation.
Healthcare institutions, technology developers, and
regulatory bodies must work together to balance innovation
and patient privacy. By adhering to robust data protection
measures, promoting transparency in AI-driven diagnostic
processes, and addressing healthcare disparities through
equitable access, the ethics of digital pathology can be
upheld, building trust and confidence in the future of
diagnostic medicine.
-Pooja Shah
5 Best Companies in Digital Pathology Market, March 2023
Be er Health and
a better way of life.
5 Best Companies in Digital Pathology Market, March 2023
5 Best Companies in Digital Pathology Market, March 2023

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5 Best Companies in Digital Pathology Market, March 2023

  • 1. TissueGnostics GmbH A Trendse er for Automated Microscopy and Tissue Cytometry Key Trends and Future Prospects The Growing Digital Pathology Market igital Pathology Market 2023 Best Companies in Dr. Rupert Ecker CEO TissueGnos cs GmbH March|Issue 10|2023 The Ethics of Digital Pathology Balancing Innova on and Pa ent Privacy
  • 5. he world of healthcare is experiencing a paradigm Tshift, with the digital revolution reshaping various medical domains. One such groundbreaking innovation, the Digital Pathology Market, transforms diagnostic practices, unlocking a new era of precision medicine and patient care. With the convergence of cutting- edge technology and medical expertise, this nascent field promises to revolutionize pathology and improve global healthcare outcomes. Digital pathology involves digitizing traditional glass slides, enabling pathologists and clinicians to examine and analyze tissue samples on a computer screen. This method expedites the diagnostic process and facilitates easy storage, retrieval, and sharing of patient data, fostering seamless collaboration among medical professionals across the globe. Leveraging artificial intelligence and machine learning algorithms, digital pathology systems are poised to enhance accuracy and efficiency in diagnosing diseases, from cancers to infectious conditions, thus reducing the burden on healthcare systems. One of the pivotal advantages of digital pathology lies in its potential to democratize healthcare services. By bridging the gap between medical experts and underserved regions, telepathology becomes a reality, bringing world-class diagnostics to remote areas with limited access to specialized healthcare. Moreover, the ability to build vast digital repositories of annotated pathology images paves the way for groundbreaking research and development of personalized treatment strategies. However, embracing the digital pathology paradigm is not without challenges. Implementing these systems demands significant upfront investments in infrastructure and technology, which may pose barriers for smaller healthcare facilities. Moreover, data security, privacy, and standardization concerns call for robust regulations to safeguard patient information and ensure seamless interoperability among different digital pathology platforms. Insights Care's latest edition 5 Best Companies in Digital Pathology Market 2023 walks you through the new dawn in diagnostics, promising improved patient outcomes, accelerated research, and heightened accessibility to quality healthcare. By embracing this technology, the global healthcare community can unlock a future where precision medicine becomes the norm, offering hope and healing to millions worldwide. Hope you have an amazing read! -Pooja Shah Pja Sh Embracing the Future of Diagnostics
  • 6. TissueGnostics GmbH A Trendse er for Automated Microscopy and Tissue Cytometry 08 Cover Story
  • 7. Balancing Innovation and Patient Privacy The Ethics of Digital Pathology 28 The Growing Digital Pathology Market Key Trends and Future Prospects 20 Aicl KUB Technologies, Inc. Empowering Surgeons to Reduce the Number of Re-excision Surgeries 16 Paige Bringing Confidence and Accuracy to Every Diagnosis 24 Ctts Ctts
  • 8. Copyright © 2023 Insights Success Media and Technology Pvt. Ltd., All rights reserved. The content and images used in this magazine should not be reproduced or transmitted in any form or by any means, electronic, mechanical, photocopying, recording or otherwise, without prior permission from Insights success. Reprint rights remain solely with Insights Success Media and Technology Pvt. Ltd. Insights Care is powered by Insights Success Media and Technology Pvt. Ltd. March, 2023 sales@insightscare.com Follow us on : www.facebook.com/InsightsCare/ https://twitter.com/Insightscare Contact Us: Insights Success Media Tech LLC 555 Metro Place North, Suite 100, Dublin, OH 43017, United States Phone - +1614-602-4132 Email: info@insightscare.com For Subscription: www.insightscare.com Insights Success Media and Technology Pvt. Ltd. Survey No.133/134, Brand Square, Office No. 512, Kunjir Chowk, Pimple Saudagar, Pune, Maharashtra 411027. Phone - India: 7410033802, 8956487823 Email: info@insightscare.com For Subscription: www.insightscare.com We are also available on : Editor-in-Chief Chidiebere Moses Ogbodo Managing Editor Pooja Shah Executive Editor Saloni Agrawal Visualiser David King Art & Design Head Mrunalinee Deshmukh Co-designer Paul Belin Art & Picture Editor Deepanjali Jena Business Development Manager Emily Jones Marketing Manager Bill Thompson Business Development Executives Anna Smith, Jack Miller Sales Executives Mike, Carl, John Technical Head Jacob Smile Assistant Technical Head Prashanth Hiremath Technical Consultants David, Robert Digital Marketing Manager Alina Sege Assistant Digital Marketing Manager Sagar Lahigade SME-SMO Executives Gemson Research Analyst Eric Smith Circulation Manager Tanaji Fartade
  • 9. Description Featuring Person Company Name AXON Diagnostics axondiagnostics.com Paul Cornell General Manager Axon Diagnostics provides an HSCN based centralised diagnostic reporting hub for secure image sharing. KUB Technologies kubtec.com Vikram Butani Founder and CEO KUB Technologies develops imaging systems specializing in breast cancer. Imsight Technology imsightmed.com Huangjing Lin Chief Technology Officer Imsight is an innovative company using artificial intelligence to aid diagnosis. Paige paige.ai Andy Moye CEO Led by a team of experts in the various fields Paige strives to transform cancer diagnostics. TissueGnostics GmbH tissuegnostics.com Dr. Rupert Ecker CEO TissueGnostics (TG) provides streamlined solutions for both biomedical imaging and image analysis. igital Pathology Market 2023 Best Companies in
  • 10. Cover TissueGnostics GmbH A Trendse er for Automated Microscopy and Tissue Cytometry Providing solu ons for automated microscopy and image analysis, which allow addressing variable ques ons in a manifold of cells, ssues, markers, staining methods and diseases, all based on an enormous biological variability, is a challenging task. It is the task that TissueGnos cs not only took up but matches and adheres to! S t o r y
  • 12. Understanding the biology or function of an organ requires a detailed assessment of various cells and structures in the intact tissue environment –to understand their state, a measurement of the number and characteristics of cells is required. It often involves varying unanswered questions that require high-level intelligence, attention to details and advanced computer assistance to process and make useful meaning of available data. TissueGnostics GmbH (TG) develops instruments and software at the frontiers of automated microscopy and tissue cytometry, which change the way that scientists and clinicians seek knowledge on cells in different tissues and diseases. When approaching microscopy, even experts are often challenged by the profound knowledge of its manifold techniques and technologies required to yield precise results. But TissueGnostics GmbH is one step ahead in this matter as it understands that not every user, or researcher, may know microscopic methods to their core. Thus, it provides a platform solution of tissue cytometers, for every clinician or researcher to attain accuracy and performance. Under the commendable leadership of Dr. Rupert Ecker, the CEO, and the family-like team of experts at TissueGnostics, they pioneered the manufacturing of tissue cytometers that offer a flow cytometry-like workflow that is applied to tissue sections, for better assessment, understanding, and increased verifiable results. From inception, Dr. Rupert Ecker, had a keen desire for biomedical researchers to improve their scientific knowledge in microscopy. Thus, he designed TG's product platform based on the motto 'Precision that inspires,' which allows scientists to conduct operations as follows: Ÿ Whole-slide imaging (brightfield, fluorescence, confocal, multispectral) Ÿ High-end analysis of tissue sections, biopsies, cultured cells, TMAs, smears, etc. Ÿ Spatial phenotyping, single-cell analysis, molecular single-cell profiling, machine-learning-based tissue classification, and many more. Let's learn more about TissueGnostics and how it is contributing to advancing research on cells and tissues. The Origination of the Company: TissueGnostics The student Rupert Ecker was pursuing his Master's studies when he began using methods of microscopy and image analysis and elaborated on these technologies during his Ph.D in the lab of Georg Steiner and his PhD supervisor Prof. Michael Marberger at the Department of Urology in Vienna, Austria. There, he realized that many researchers were used to generate data with a variety of methods – such as flow cytometry, ELISA, Northern/Southern/Western blotting, and even mass spectrometry – but when it came to microscopic images, they just wanted a 'nice picture' for their publication. But microscopy is much more than an 'expensive lens' of a camera. Microscopy is a collection of versatile methods for the generation of scientific data, whereby images have to be considered raw data! To extract numerical data and real knowledge from 'nice images,' researchers nowadays have to apply appropriate methods of image analysis, including techniques of machine and deep learning. What started as an academic endeavor for Rupert Ecker soon revealed its potential for use in biomedical research on the broadest scale and clinical applications as well, also showing a substantial commercial value. With the first patents granted, Rupert Ecker being the co-inventor, had to decide how he and his colleague wanted to finance global patents, i.e., either by licensing them out or by commercializing the idea themselves. But without a source of funding, they would have had to stop the endeavor right away. Thus, the inventors decided on the latter, and this way, TissueGnostics was founded in April 2003. Core Mission, Vision, and Values TissueGnostics has been a trendsetter from the first moment on and aims to remain at the frontiers of automated microscopy and tissue cytometry, a field requiring high precision and performance, and supply its solutions to every researcher and clinician working with tissue sections and/or cell cultures in 2D, 3D, or 4D. While microscopy involves a manifold of techniques and technologies, it certainly requires the user to have a profound knowledge of those, to obtain feasible results. Thus, TissueGnostics acts as a translator by providing high- level solutions to users who are not experts in the field of microscopy and/or image analysis. This is done through its technology platform of tissue cytometers. Unique Products and Services When it comes to microscopy, there are many different scientific questions around tissue cytometry—which require automation and computer-assisted data processing. The vast
  • 13. majority of the human body consists of solid tissues i.e., cell agglomerations that appear in an orderly manner concerning the spatial organization, but follow different organizational principles and structural patterns. That is why all known life forms consist of different tissues and we are also confronted with very different forms of diseases. Providing solutions for automated microscopy and image analysis, which allow addressing variable questions in a manifold of cells, tissues, markers, staining methods and diseases, all based on an enormous biological variability, is a challenging task. It is the task that TissueGnostics not only took up but matches and adheres to! It is the very reason why its motto is 'Precision that inspires.' With the company's product lines TissueFAXS, which is a microscope-based open research platform, and the new COLUBRIS – Tissue Cytometer with AI, TissueGnostics offers a solution for virtually any question around cells in tissues, whole slide imaging (WSI), and the spatial distribution of cells in those tissues. Innovations in Research & Development at TG TissueGnostics has been founded out of a research need that was largely identified by the founders. The main drivers of innovation in TissueGnostics are (1) the team members having a scientific background, like the founders themselves, (2) feedback from users, who are all Tgs so ware—both for hardware control & whole slide imaging as well as image analysis & ssue cytometry—is made in-house and cons tutes the major enabling factor for its customers' 'TissueGnos cs experience' as well as our commercial success on a global scale. 5 Best Companies in Digital Pathology Market 2023
  • 14. researchers in the field of biomedicine, and (3) collaborative projects with academia. These collaborative efforts—i.e., projects with academia—form a constitutive element of TissueGnostics' success. In addition to more than 20 Austrian national collaborative research projects, TissueGnostics has been an industry partner to six major EU-founded Marie Skłodowska-Curie Innovative Training Networks (ITN)/Doctoral Networks and additional EU programs, such as COST Actions and other Framework 6, 7, HORIZON 2020 and HORIZON EUROPE programs. An important aspect for TG's R&D department is the fact that microscopy as such is a largely unregulated area of technology, and the same is true for image analysis. The company's academic collaborations also address topics of quality control and standardization. When it comes to clinical diagnostics, the EU's new Medical Device Regulation (MDR) and In-Vitro Diagnostics Device Regulation (IVDR) as well as corresponding rules in other countries, such as 510(k) section of the US FDA, are of relevance, and TissueGnostics is working in accordance to the ISO 13485 standard. Technological Advancements Supporting TGs Solutions While TissueGnostics relies on high-end hardware from established partners like Carl Zeiss, Märzhäuser, CrestOptics, Lumencor and others, the software—both for hardware control & whole slide imaging as well as image analysis & tissue cytometry—is made in-house and constitutes the major enabling factor for its customers' 'TissueGnostics experience' as well as its commercial success on a global scale. At the heart of this technology are proprietary algorithms for automated recognition of a single cell in tissue context, interactive data analysis workflows, as well as machine learning and deep learning-based solutions for the classification of histological entities like tumour regions, glands, glomeruli or leukocyte clusters in tissue sections. Its newest platform COLUBRIS comes with machine learning- based data mining to automatically identify molecular signatures and cellular correlations in high-plex assays for spatial biology. Wise Words of Retain To the aspiring entrepreneurs who desire to venture into the digital pathology industry, Dr. Rupert Ecker advises, "While I've always wanted to become a scien st, though originally in astronomy, but I finally decided to look in the opposite direc on, into the microcosm rather than the macrocosm and moved towards a degree in cell biology. In addi on, I also wanted to do something in my life that helps science to progress. One way could certainly have been to work on a certain disease or a group of molecules, or a specific signal transduc on cascade to elucidate molecular and cellular interac ons. But what if I could develop a technology that helps others to improve scien fic knowledge? This would mean a mul plica on, if not poten a on, of my personal contribu on to the scien fic community. The patents derived during my PhD thesis and experience obtained during my postdoc at the Competence Center of Bio- Molecular Therapeu cs—a joint venture between the University of Vienna and the Novar s Research Ins tute in Vienna—opened the opportunity to realize this dream in the form of a company. And this not only allowed me to realize my own goal in life but also provided me with an opportunity to make a living out of it. With the founda on of the company, I became the managing director, ini ally one out of two. By 2017, however, I became the sole manager and Chief Execu ve Officer of TissueGnos cs Global. CEO's Journey in his Own Words
  • 15. technological developments are a challenging, yet most rewarding endeavor, often even real fun, founding a company and in particular looking for financing—ie. fundraising with investors and public funding agencies—is more of an organizational hurdle and a marathon. It is a stony path, full of obstacles and unexpected traps." "It would be my advice for entrepreneurs and founders to focus on what they are best at, whether it is mainstream or not. Because you can only win in a field which you love to work in rather than being forced into." Wrapping Up TissueGnostics started as a small company located in the th heart of Europe, in Vienna, Austria, with its 20 anniversary to take place in 2023, the company currently represents a global structure with subsidiaries and offices in Europe, UK, USA, China, South-East Asia, India, South America, Africa, and Australia. While the company is present on all continents, it is still far from being present in all countries with relevant biomedical research activities. th "With our 20 anniversary and the years to come, we will introduce novel and innovative products, broaden our market presence and expand our global service into more territories," concludes Dr. Ecker. With the company's product lines TissueFAXS, which is a microscope-based open research pla orm, and the new COLUBRIS – Tissue Cytometer with AI, TissueGnos cs offers a solu on for virtually any ques on around cells in ssues, whole slide imaging (WSI), and the spa al distribu on of cells in those ssues.
  • 16. Clients' Stories About TissueGnostics "I have been working with the TissueFAXS cytometer and the analysis software from TissueGnostics for more than 10 years. My focus was to determine markers in the tissue, not only to determine the protein expression profile of the marker but also the subcellular location within the tissue. In comparison to FACS, TissueFAXS allows the investigation of protein expression and their tissue location in a quantitative multiplex manner. Looking into other systems, the TissueGnostics systems still provide in my opinion the best state-of-the-art and unique analysis platform. I currently use TissueFAXS and the analysis software StataQuest. I'm a strong TissueGnostics supporter and will continue the investigation of protein expression with the TissueFAXS analysis system in cancer tissue." Dr. Franco Fortunato, University Hospital Heidelberg, Germany "The addition of the TissueFAXS inverted PLUS to our core facilities' repertoire has made a world of difference to the ease of data collection and processing. The acquisition software is remarkably well-designed, offering extreme flexibility without compromising on the robustness and ease of use for the whole system. This is extremely useful in our facility as we cater for a multidisciplinary research environment where we can easily change the imaging strategy to the nature of the samples and the needs of the scientist. The StrataQuest/HistoQuest/TissueQuest analysis packages have relieved us from the burden of writing customized analysis scripts and they turn out to be an extremely powerful and flexible analysis suite. The customer service we receive from TissueGnostics is by far the best from any company out there. All enquiries are quickly dealt with in a personal and professional manner with final customer satisfaction in mind. If there is any negative to be mentioned it would be that the system is so popular, we will have to buy more systems soon." Dr. Jan Soetaert, Queen Mary University of London, UK "Due to cutting-edge technologies, such as single-cell RNAseq analysis, a deep deconditioning of the transcriptome of ex vivo isolated immune cells is possible. Thus, activation specifications and other cell properties can be characterized with high precision. The challenge now is to detect immune cells with an 'expression profile of interest' within tissues. The multiplex-imaging analysis allows the visualization of such parameters. To highlight the localization and interaction of immune cells within the tissues, customized software packages are required, providing comprehensive tools for image analysis. From my point of view, StrataQuest ranks among the top imaging software packages in the market. With this software and the customized support, tailored algorithms can be developed, enabling an evaluation of the imaging data generated with most of the current imaging platforms." Prof. Dr. Uwe Ritter, Universitätsklinikum Regensburg, Germany While microscopy involves a manifold of techniques and technologies, it certainly requires the user to have a profound knowledge of those, to obtain feasible results. Thus, TissueGnos cs acts as a translator by providing high-level solu ons to users who are not experts in the field of microscopy and/or image analysis. This is done through its technology pla orm of ssue cytometers.
  • 18. 16 March 2023 Thanks to technology, the healthcare sector is progressing at a revolutionary pace. The advanced technology and medical gadgets being manufactured are enabling healthcare professionals to increase their success rates in operation rooms, research, and the timely development of vaccines, drugs, and medicines. Now that healthcare has substantially modernized, there is optimistic hope for surgeons in taking every measure to achieve desired results in one surgery, reducing or eliminating the need for another surgery, especially for removing cancerous cells. One of the most concerning issues amongst women worldwide is Breast cancer. In order to remove the tumor cells completely, women have to go through various procedures, surgeries, and multiple rounds of treatment. As the number of re-excision surgeries increases along with the impaired tissue, the healthy tissue too gets affected. Thankfully, there is medical imaging technology today that can help surgeons effectively visualize surgery margins in the operating theatre itself, significantly reducing the excessive number of re-excision surgeries. The leading manufacturer and provider of this ground-breaking imaging technology is KUB Technologies, Inc. Based in Stratford, Connecticut, KUBTEC is challenging the status quo of breast cancer surgery and is committed to reducing the excessive number of re-excision surgeries. Leading the company in its innovation and growth is the company's visionary Founder and CEO—Vikram Butani. In the following excerpts, we will get to know more about KUBTEC's journey in bringing empowering medical technology solutions to the market and their specialties. A Superior and Faster Solution When Vikram founded KUBTEC in 2005, it was with a mission to provide best-in-class specimen imaging for pathology because he found out that most facilities were using old X-ray film-based equipment or low-resolution general-purpose cabinet systems; as their “standard of care.” He thought there must be a better way, so he and his team designed a superior solution with proprietary features that added value and reduced turnaround time, enabling them to provide results faster. “Today, KUBTEC is an acknowledged leader in the field of breast cancer margin management, and our systems can be found in pathology, radiology, and ORs around the world. So, our affinity for the pathology imaging space runs through the entire fabric of Kubtec,” Vikram told us. KUB Empowering Surgeons to Reduce the Number of Re-excision Surgeries Today, KUBTEC is an acknowledged leader in the field of breast cancer margin management, and our systems can be found in pathology, radiology, and ORs around the world. Technologies, Inc.
  • 19. 17 March 2023 The Visionary Leader Vikram Butani, the Founder and CEO of KUBTEC, comes from a family of doctors. Not pursuing a career in medicine, Vikram was looking for an opportunity that could make a difference in healthcare. Reminiscing about the initial idea for the company, Vikram says, “When I came across the need for superior imaging of excised tissue in pathology, I decided to pursue the challenge. My wife and I started the company out of our spare bedroom.” Further, he emphasizes that “Our commitment was and has always been to provide more personalized and attentive service and support to our customers and their patients.” Vikram and his team built customer loyalty from a small install base and then developed a portfolio to leverage the company’s technological superiority into the OR and biopsy suites, which were and still are the domains of radiology. “While doing our research, we learned breast cancer surgery has a very high re-excision rate. Studies show that close to 30% of patients need to come back for a second surgery as the surgeon was unable to clearly visualize their margins at the time of surgery, and it's not until they receive the final pathology report that they would know if the operation was a success.” That confirmed to Vikram and his team that there was a very close relationship between the breast surgeons and the pathology gross room, giving the team a whole new direction to explore. The company set out to solve this problem and launched the MOZART Specimen Tomosynthesis (3D) system, which brings an element of real-time pathology right into the OR, enabling surgeons and radiologists to accurately identify positive or close margins intraoperatively. “KUBTEC’s journey has been part evolution, part revolution, with everything based upon a constant stream of proprietary innovation created by the company,” Vikram added. On a Mission Informing us more about the vision and mission statement for the company, Vikram says, “Well, within the digital pathology community, our mission is simple and practical. We’re on a mission to improve patient turnaround time in pathology.” Pathology professionals play an important role in the delivery of timely and effective patient care, so KUBTEC creates proprietary products and services that enable them to be more efficient by reducing specimen handling time. Within a wider framework, the company is focused on disease states where its technology can make a real difference in the delivery of care for patients and providers. KUBTEC is a privately held organization that does not answer to Wall Street or anonymous institutional shareholders. Vikram tells us, “Whenever we see an opportunity to improve the delivery of care, we move quickly.” In fact, the company's manifesto states that “Impatience is our virtue.” The goal of KUBTEC's management is to always be first to market with new innovations. As such, it strives to make a life-changing difference for breast cancer patients and regards every surgery as an opportunity to improve someone’s life. In addition, the company values simply “doing the right thing,” behaving ethically and thoughtfully, being accountable, and “creating social change.” Vikram underlines that “We champion our role as good corporate citizens and are driven to make a difference by supporting Vikram Butani Founder and CEO 5 Best Companies in Digital Pathology Market 2023
  • 20. 18 March 2023 initiatives that reduce inequality and improve the health and well-being of those everywhere.” Where Innovation has No End When asked about what keeps the company apart from the competitors in the industry, Vikram responded with, “Innovation, Innovation, Innovation.” He adds, “Not just in product technology but also in the way we support our customers. We live in a totally connected world where customer expectations for support are more than just a 24-hour 1-800 number.” He continues, “From the very first system we installed in 2005, all KUBTEC systems feature remote support where we can troubleshoot any of our systems and automatically perform software updates right from our Technical Center.” KUBTEC XPERT and MOZART systems feature KUBALERT, which conducts on-board diagnostics and sends out a report to preempt a system failure. The company recently introduced the KUBTEC App, which will help the user reach a factory support engineer instantaneously through the app to eliminate any downtime. 3D Tomosynthesis Technology 3D tomosynthesis technology is one of the major solutions offered by KUBTEC. Revealing more about this technology solution, Vikram tells us, "3D tomosynthesis, embodied in the KUBTEC MOZART system, enables surgeons to make better intraoperative decisions based upon an image that accurately reflects the true anatomy of the specimen." He adds, “Clinical studies have shown that use of the MOZART system reduces re-excisions by 50%, preserves healthy tissue for better cosmesis, improves surgical efficiency, and lowers costs. That’s good news for the patient, the hospital, and the payer.” Empowering Clinicians with Technology Only KUBTEC uses tomosynthesis to provide clinicians and pathology professionals with three-dimensional images of surgical specimens. This enables them to identify the exact location of the tumor and its proximity to all edges of the specimen. If additional tissue excision is required, they can do it right there as part of the index procedure. What’s more, the data-rich 3D image enables the use of artificial intelligence to automatically flag when the biopsy clip is too close to the edge of the specimen; a KUBTEC patented technology that the company is further developing to identify other features. Constantly Improving the Customer Experience KUBTEC’s team is strongly focused on providing a quality customer experience all the time. It constantly looks to improve the customer experience by making the process more efficient. Explaining what helped the company gain significant leadership in the market, Vikram says, “We were the first to introduce a larger imaging area of 8“x8” in 2005 and 16“x16” in 2007, when all that was available was 4“x4”.” Moreover, KUBTEC was the first company to integrate an optical camera and introduce its proprietary blender technology and the first to offer a density profile feature that is useful for the bone decalcification process. Partnering with Early-adopters and Innovators Innovative technology solutions are rapidly becoming an integral part of every sector. Giving his take on the impact of technology adaptation in the healthcare sector, Vikram says, “In my experience, a lot of healthcare providers are cautious about adopting new technologies, mainly because of their facility’s documented protocols and strict regulatory requirements.” However, Vikram adds, “Our job is to seek out innovators or 'early-adopters' of new digital technology solutions and partner with them to acquire detailed insights into their pain points and ever-evolving demands to ensure our systems consistently meet their requirements now and in the future.” This partnership helps KUBTEC to establish early technology adoption at Centers of Excellence around the world that can influence a “new” standardization of care. Offering Valuable Guidance Vikram has been in the healthcare industry for years, focused on creating advanced pathology solutions. With him, there is vast wisdom in researching and developing
  • 21. 19 March 2023 medical devices. From his expertise, he offers the new aspirants in the pathology space the following words of guidance: He says, “I am a great believer in being laser-focused on patient outcomes, and with that, you uncover customer pain points or their unmet needs. Technology has come so far, and there is a lot of room to make the pathology process more efficient and more effective.” “Few people focus on pathology as it is not as glamorous as some of the other departments. If you have something that you believe can make a difference and help improve workflow, then speak to the pathologists, speak to the PAs, and speak to the laboratory professionals before you take off on a business venture,” marks Vikram. The Way Onwards Expanding on the plans for the company, Vikram says, “We’ve just launched a new product, the GammaPRO system, which is a highly advanced Wireless Sentinel Lymph Node Localization Technology, and we have other new platforms in the pipeline for this year and next.” The offices of KUBTEC were moved into their current building in 2021, and already the team has outgrown it. The company has acquired some land adjacent to its HQ in Stratford, CT, and will be breaking ground on a new manufacturing facility later this year. “We are constantly hiring for engineers, sales, and manufacturing, which is a great challenge to have in today's economic environment,” Vikram stated. "You have a much better view with specimen tomosynthesis of exactly what needs to be removed. I avoid excessive tissue being taken from the patient, and the patient likes it, because the cosmetic result is better." "Specimen tomosynthesis is a no- brainer. If you're a breast surgeon and you want to provide the best care, this is it. To identify whether you've done the right operation, you need this." Cary Kaufman, MD, FACS Associate Clinical Professor of Surgery, Bellingham Regional Breast Center "For my practice, and many breast cancer centers of excellence around the world. Using 3D specimen tomosynthesis during surgery has helped the best surgeons reduce their re-excision rates even more." Sheldon M. Feldman, MD, FACS Chief of Breast Surgery and Breast Surgical Oncology and Director of Breast Cancer Services at Montefiore Health System, New York, NY "3D tomography has radically streamlined breast cancer surgery by allowing surgeons to better visualize the breast and affected area, even through dense breast tissue, in the operating room." Roshni Rao, MD, FACS Chief of Breast Surgery Program at New York-Presbyterian/Columbia University Irving Medical Center Marcum Tech Top 40: 2019, 2020, 2021 Kornfeld H, Mulder L, Spivey T, Cortina C, Madrigrano A, Kopkash K. Breast J. 2019;25:766-768. 3. Park KU, Kuerer HM, Rauch GM, Leung JWT, Sahin AA, Wei W, Li Y, Black DM. Digital Breast Tomosynthesis for Intraoperative Margin Assessment during Breast- Conserving Surgery. Ann Surg Oncol 2019:26:1720-28.
  • 23. 21 March 2023 Pathology Digital The Growing Market athology has undergone a significant transformation Pin recent years, shifting from conventional practices to digitized methods. This revolutionary shift, known as digital pathology, involves acquiring, managing, and interpreting pathology information through digital slides and images. As the healthcare industry continues to embrace technological advancements, the digital pathology market has experienced substantial growth. Let's explore key trends driving this market's expansion and highlight them! Advantages of Digital Pathology The adoption of digital pathology has been fueled by its numerous advantages over traditional methods. One of the primary benefits is improved efficiency in slide preparation and sharing. Digital slides can be easily created, stored, and distributed electronically, leading to faster and more convenient access to patient data for medical professionals. Additionally, digital pathology eliminates the need for physical slide transportation, reducing the risk of slide loss or damage. This enhanced workflow efficiency allows pathologists to focus more on data analysis and critical decision-making, ultimately improving patient care. Enhanced Collaboration and Telepathology Digital pathology has opened doors to enhanced collaboration among pathologists, enabling them to share cases, exchange opinions, and seek expert consultations regardless of geographical barriers. Telepathology, a subfield of digital pathology, has gained traction due to its ability to facilitate remote diagnosis and consultations. Telepathology has proven particularly valuable in underserved areas and regions facing a shortage of qualified pathologists. It allows local pathologists to seek advice from experts in larger healthcare centers, leading to more accurate diagnoses and better patient outcomes. Artificial Intelligence (AI) Integration The integration of artificial intelligence (AI) has revolutionized the field of digital pathology. AI algorithms Key Trends and Future Prospects
  • 24. 22 March 2023 can analyze large volumes of digital pathology data with incredible speed and accuracy. This capability has many applications, including automated tumor detection, grading, and prognosis prediction. By harnessing the power of AI, pathologists can leverage precise and data-driven insights to enhance diagnostic accuracy, leading to more effective and personalized treatment plans for patients. As AI technology advances, the scope for its integration into digital pathology is expected to expand further. Growing Application in Drug Development and Research The digital pathology market is not limited to clinical diagnosis alone; it has also found significant applications in drug development and research. Pharmaceutical companies are increasingly incorporating digital pathology in preclinical and clinical trials to evaluate drug efficacy and assess the impact on tissue samples. The ability to analyze vast amounts of pathology data with AI-driven algorithms expedites the drug development process and reduces the risk of adverse effects. Additionally, digital pathology is vital in biomarker discovery and validation, offering valuable insights for precision medicine approaches. Integration of Cloud-Based Solutions The advent of cloud-based solutions has further propelled the growth of digital pathology. Cloud-based platforms provide secure and scalable storage options for vast amounts of digital pathology data. This eliminates the need for on-premises infrastructure and lowers the overall operational costs for healthcare institutions. Cloud-based solutions also enable seamless data sharing and remote access to digital slides, promoting global collaboration and second opinions among pathologists and researchers. As data security measures improve, more healthcare providers are expected to embrace cloud-based digital pathology solutions. Regulatory Advancements The digital pathology market has witnessed supportive regulatory advancements in recent years. Regulatory bodies, such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), have issued guidelines for validating and using digital pathology systems in clinical settings. These regulatory approvals have instilled confidence in healthcare providers, encouraging them to adopt digital pathology for routine diagnostic practices. As more countries develop their own guidelines and regulations, the global digital pathology market will likely witness accelerated growth. Future Prospects The future of the digital pathology market looks promising, with several factors contributing to its expansion: Increasing Digitalization of Healthcare: As the healthcare industry embraces digital transformation, digital pathology will become an integral part of the diagnostic ecosystem, leading to broader adoption. AI Advancements: As AI algorithms become more sophisticated, they will play a central role in streamlining pathology workflows, enabling accurate diagnoses, and assisting in personalized treatment strategies. Expansion of Telepathology: Telepathology is set to grow significantly, bridging the gap between expert pathologists and underserved regions, thereby improving global healthcare access. Rise of Personalized Medicine: Digital pathology, coupled with AI, will be crucial in advancing personalized medicine, tailoring treatment plans based on a patient's unique characteristics and disease profile. Conclusion The growing digital pathology market presents a transformative shift in pathology, offering numerous advantages such as enhanced efficiency, collaboration, and data-driven insights. The integration of AI, the widespread adoption of whole slide imaging, and the rise of cloud- based solutions are key trends driving its expansion. With supportive regulatory advancements and the increasing digitalization of healthcare, the prospects for digital pathology are promising. As technology evolves, pathology is poised to make further strides in precision diagnostics and personalized medicine, benefiting patients worldwide. -Pooja Shah
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  • 26. 24 March 2023 Andy Moye Chief Execu ve Officer Paige
  • 27. 25 March 2023 Paige Bringing Confidence and Accuracy to Every Diagnosis In the realm of cancer diagnosis, the human naked eye may sometimes fall short in detecting subtle abnormalities that could be indicative of disease. However, with the remarkable advancements in artificial intelligence (AI), the chances of error can be significantly reduced, ultimately revolutionizing the accuracy and effectiveness of cancer diagnostics. Leading this transformative journey is Paige, a pioneering company at the forefront of utilizing AI to advance the field of digital pathology. Paige leverages the power of AI and deep learning algorithms to empower pathologists and clinicians with an unparalleled level of precision in cancer diagnosis. By combining the expertise of medical professionals with state- of-the-art computational pathology solutions, Paige's platform revolutionizes the interpretation of medical images, leaving little room for oversight. Its AI-driven technology detects even the most subtle signs of cancer, to help ensure fewer potential abnormalities are overlooked. By reducing the chance of human error, Paige is drastically improving diagnostic accuracy and equipping healthcare professionals with the tools they need to make timely and informed treatment decisions. As one of the leading companies in the digital pathology market of 2023, Paige continues to push the boundaries of what is possible in cancer diagnosis. By harnessing the potential of AI, Paige is transforming the landscape of pathology, enabling earlier detection, personalized treatment plans, and improved patient outcomes. In an interview with Andy Moye, the Chief Executive Officer of Paige shares the company's unwavering commitment to leveraging AI's potential in healthcare and revolutionizing the field of digital pathology in a new era of accurate and efficient cancer diagnosis. Following are excerpts from the interview: Kindly tell us the source of inspiration. What led you to venture into the field of digital pathology? For nearly two decades, I have been an industry leader in the fields of molecular diagnostics, biotechnology, and life sciences specializing in pathology, oncology, genomics, and precision medicine. My journey in pathology began at US Labs in 2005 when digital pathology was still in its infancy stage but showing great promise. I helped develop and deliver a system that enabled pathologists to send their samples to a central lab for analysis. Then I moved to Caris Diagnostics, where I ran a lab with more advanced digital pathology capabilities and saw what digital pathology could do. When I became head of commercial operations for Philips in 2016, I saw the potential AI applications could add to digital pathology and how truly transformative it could be. Now, as the CEO of Paige, we are dedicated to advancing digital pathology with the use of cutting-edge artificial intelligence technology for cancer detection. Our goal is to create industry-leading AI products and collaborate with labs around the world to improve access to quality patient care. With Paige's AI, pathologists can focus their attention on areas suspicious of cancer and see cancer on a slide they could potentially miss with the naked eye. It is a tool pathologists can use, similar to a second pair of eyes, to help detect every bit of cancerous tissue with confidence. 5 Best Companies in Digital Pathology Market 2023
  • 28. 26 March 2023 Brief us about the company and shed some light on your operations there in contributing to the company's growth. At Paige, we believe that better technology is the answer to better patient care. Our mission is to develop and deliver a new generation of diagnostic and biomarker AI applications, empowering pathologists and transforming oncology. Led by a team of experts in the fields of life sciences, oncology, pathology, technology, machine learning, and healthcare, Paige is uniquely positioned to transform the field of pathology. Our access to highly specialized, diverse global data has provided Paige with one of the largest data sets used to develop AI software. This enabled us to build the first-ever FDA-approved AI pathology product, Paige Prostate Detect, as well as best-in-class detection algorithms for uncovering cancer features from H&E- stained whole slide images alone. Can you elaborate upon the core values, mission, and vision on which the company is built? Paige operates under the guidance of the principles of being A.D.E.P.T. This means that we are dedicated to being accountable, disruptive, execution-focused, patient-centric, and trusting. We strive to create a supportive environment for the development of innovative products for clinicians, with the ultimate goal of transforming the world of cancer care through the use of artificial intelligence. We remind clinicians that along with techniques like IHC, PCR, NGS, and ISH, AI is another powerful tool that can help pathologists in arriving at accurate diagnoses more efficiently and confidently. Digital pathology and AI will never replace pathologists, but it certainly supports them in their assessment. Our Paige Prostate Suite and Paige Breast Suite are examples of tools that help pathologists identify even the smallest and most complex cancers. For instance, the use of the Paige Breast Lymph Node has shown a 25 percent 1 improvement in pathologist sensitivity , allowing for the detection of metastatic lesions that may have been previously missed by the naked eye. This has a direct impact on patient treatment and care. What diagnostic tools does the organization find to be essential in conducting its pathology operations? 2 Paige's products include : Ÿ The Paige Platform is a comprehensive platform that powers a lab's complete digital pathology workflow, consisting of cloud storage, seamless access to Paige and third-party AI applications, and a secure connection to laboratory information systems (LIS) and other clinical information systems.
  • 29. 27 March 2023 Ÿ FullFocus®, an FDA-cleared whole-slide image viewer that delivers advanced digital slide review tools, and FullFolio™, our AI-powered clinical worklist. Ÿ The Paige Prostate Suite is comprised of Paige Prostate Detect, Paige Prostate Grade & Quantify, Paige Prostate Perineural Invasion, and the Paige Prostate Biomarker Suite. Ÿ The Paige Breast Suite, including both Paige Breast Detect, Paige Breast Neoplasm, Paige Breast Mitosis, and Paige Breast Lymph Node, as well as HER2Complete™. Ÿ Integrations with leading third-party AI including Mindpeak IHC biomarker algorithms and others on the way. What endeavors is the organization currently pursuing to improve its pathology measures for patients? Paige is actively collaborating with numerous organizations in the medical and pathology industries, forming strong partnerships with esteemed institutions and teaching hospitals such as Oxford and the University Medical Center in Utrecht. Additionally, we partner with Quest Diagnostics to enhance their capabilities and simplify the interface between their technologies to benefit pathologists. Paige has also established technology partnerships with Microsoft and Leica Biosystems, while also partnering with other companies worldwide to enhance digital pathology. The ultimate goal of these collaborations is to drive a new era of diagnostics and precision treatment that can significantly improve the lives of patients through digital pathology and AI. How do you envision scaling your organization's services and operations in 2023 and beyond? Paige aims to provide an impressive portfolio of AI applications to pathologists. We are creating new applications for breakthrough cancer treatment, including for sub-specialties, over the next few months. What are some of the testimonials or recognition that accurately highlight your organization's position in the market? Our partnership with Paige brings us a big step closer to our shared goal of making the pathological diagnosis of breast cancer quicker, more accurate and more reproducible. I am extremely excited that we will combine our respective strengths in analyzing H&E and IHC-stained tissue samples to make the vision of utilizing AI within pathology a reality. Felix Faber, CEO of Mindpeak At Paige, we believe that be er technology is the answer to be er pa ent care. Our mission is to develop and deliver a new genera on of diagnos c and biomarker AI applica ons, empowering pathologists and transforming oncology. 1 Based on an investigational clinical study involving 3 pathologists and data from 148 patients 2 In the United States, FullFocus® (K201005) and Paige Prostate Detect (DEN200080) are cleared for clinical use with Philips Ultrafast Scanner and for use with H&E-stained slides only. All other Paige Prostate and Paige Breast Suite applications and use cases are limited to Research Use Only and not for use in diagnostic procedures.
  • 30. 28 March 2023 Innovation he integration of digital pathology into the healthcare Tlandscape has brought about revolutionary advancements, promising increased efficiency, accuracy, and collaboration among medical professionals. However, as with any technology, the implementation of digital pathology raises ethical considerations, particularly concerning patient privacy and data security. Striking a delicate balance between innovation and protecting patient information is essential to ensure that the benefits of digital pathology are maximized while respecting individual rights and maintaining trust in the healthcare system. Let's dive into detail for further understanding! Patient Data Privacy Patient data privacy is a critical ethical concern in the context of digital pathology. As medical institutions transition from physical slides to digital images, vast amounts of sensitive patient data are being generated, stored, and shared electronically. Ensuring that this data is protected from unauthorized access, breaches, and potential misuse is of utmost importance. Healthcare providers and technology developers must adhere to stringent data privacy regulations, such as the Health Insurance Portability and Accountability Act (HIPAA) in the United States and the General Data Protection Regulation (GDPR) in the
  • 32. 30 March 2023 European Union. These regulations govern patient data collection, storage, and transmission, aiming to safeguard individual privacy and confidentiality. Informed Consent Respecting patient autonomy and obtaining informed consent are crucial ethical principles in the practice of medicine, including digital pathology. Patients have the right to understand how their data will be used, who will have access to it, and how it will contribute to their diagnosis and treatment. Obtaining informed consent for the use of patient data in digital pathology is particularly challenging due to the large-scale nature of data processing and analysis. Therefore, healthcare institutions should prioritize clear communication and transparency with patients, ensuring that they are fully aware of how their data will be utilized and can make informed decisions about their participation in research and diagnostic processes. AI-Driven Pathology The integration of artificial intelligence (AI) into digital pathology raises additional ethical concerns. AI algorithms can analyze vast amounts of patient data and assist pathologists in diagnosing diseases with impressive accuracy. However, the "black box" nature of some AI systems, where the decision-making process is not fully transparent, can lead to concerns about accountability and potential bias. To address these issues, it is essential for AI developers and healthcare professionals to thoroughly validate and explain AI models, ensuring that they are free from inherent biases and that their decision-making processes are comprehensible to human operators. Moreover, AI should be used as an aid rather than a replacement for human pathologists, maintaining a human-in-the-loop approach to diagnostic decision-making. Security and Data Breaches The digital nature of pathology data introduces new risks related to cybersecurity and data breaches. Unauthorized access to patient data could result in serious consequences, including identity theft, misdiagnoses, and compromised patient privacy. Healthcare institutions and technology providers must invest in robust cybersecurity measures to safeguard patient data from potential threats. Regular security audits, encryption protocols, and employee training on data protection are essential steps to minimize vulnerabilities. Access to Digital Pathology in Underserved Regions While digital pathology offers numerous benefits, it is crucial to consider its impact on healthcare disparities. Underserved regions and resource-constrained areas may not have access to the necessary technology and infrastructure to implement digital pathology fully. Ethical considerations should involve strategies to ensure equitable access to digital pathology services, bridging the gap between well-established healthcare centers and underserved communities. Initiatives, such as telepathology, can significantly provide expert consultations to remote regions, enhancing access to quality diagnostics and treatment options. Avoiding Commercial Exploitation As the digital pathology market grows, there is a risk of commercial exploitation by technology vendors and service providers. Healthcare institutions should carefully assess vendor relationships to ensure they do not compromise patient data privacy or expose patients to unnecessary services or costs. Transparency in financial arrangements and avoiding conflicts of interest between vendors and healthcare providers is essential to maintaining the integrity of digital pathology services. Conclusion Digital pathology holds immense promise in transforming healthcare by improving efficiency, accuracy, and collaboration among medical professionals. However, ethical considerations are paramount in its implementation to protect patient data privacy, ensure informed consent, and prevent potential bias or commercial exploitation. Healthcare institutions, technology developers, and regulatory bodies must work together to balance innovation and patient privacy. By adhering to robust data protection measures, promoting transparency in AI-driven diagnostic processes, and addressing healthcare disparities through equitable access, the ethics of digital pathology can be upheld, building trust and confidence in the future of diagnostic medicine. -Pooja Shah
  • 34. Be er Health and a better way of life.