Regulatory News:
Ikonisys SA (Euronext Growth Paris: ALIKO), a company
specializing in the early and accurate detection of cancers through
a unique fully automated solution for medical analysis
laboratories, is pleased to announce that Hospitex has renewed its
contract as the European Authorized Representative and Importer for
Novodiax. Novodiax, a U.S.-based company specialized in
immunohistochemistry, is the exclusive provider of CE IVD-IHC (in
vitro diagnostics and immunohistochemistry) medical devices for
real-time oncological diagnostics on tissue samples. With its
innovative platform, Novodiax ensures the safety of organ
transplant procedures by screening for potential malignancies in
real time.
Under this partnership, Ikonisys Group will oversee importation,
warehousing, regulatory compliance, and technical support for
Novodiax’s groundbreaking technology, ensuring swift access for
healthcare providers across Europe. This technology delivers rapid
oncological insights into donor tissues, allowing transplant teams
to make informed decisions regarding organ suitability, thereby
reducing the risks of post-transplant malignancy.
Moreover, Ikonisys has strengthened its position in Europe by
securing exclusive distribution rights for the Italian market
through its Italian subsidiary, Ikonisys Srl. This strategic move
consolidates the Group's role as a European representative and
importer and enhances its ability to provide localized support,
streamline operations, and accelerate market access in Italy. With
direct distribution in a key European market, Ikonisys is set to
increase brand visibility, foster closer relationships with
customers, and drive growth across the region.
Current Landscape of the Organ Transplantation in
Europe
Organ transplantation is a vital component of healthcare in
Europe, with approximately 34,000 transplants performed annually.
Demand continues to rise, as over 150,000 patients are currently on
transplant waiting lists across the continent. In 2023, Europe
recorded more than 7,000 kidney transplants, 4,000 liver
transplants, and 2,500 heart transplants. This substantial increase
highlights the urgent need for safe and reliable diagnostics in
these procedures. Rapid diagnostic tools, such as Novodiax’s
technology, can significantly impact decision-making, especially
since up to 5% of organ recipients face the risk of post-transplant
malignancies.
Novodiax’s innovative IHC technology facilitates faster and more
accurate diagnostics, improving the quality and safety of
transplantation procedures by ensuring each organ’s compliance with
rigorous oncological safety standards before transplantation.
Strategic Alignment with Ikonisys Group’s Global
Vision
This partnership fully aligns with Ikonisys Group’s strategy to
establish itself as a global leader in next-generation cancer
diagnostics. The agreement with Novodiax is a pivotal step toward
achieving Ikonisys Group’s vision of becoming a world-class
provider in the evolving field of oncology diagnostics.
About Novodiax
Novodiax is a biotechnology company specializing in the
development and commercialization of rapid, high-quality
immunohistochemistry (IHC) and immunocytochemistry (ICC) diagnostic
assays. Known for their innovative ultra-fast testing platforms,
Novodiax focuses on providing pathologists and clinicians with
tools that significantly speed up diagnostic workflows, delivering
results in minutes instead of hours. The company’s flagship
products, which include novel ihcDirect® and ihcSlide™ systems,
utilize proprietary technology to offer reliable, real-time
diagnostics in clinical and research settings. By enabling faster
and more efficient diagnostic processes, Novodiax aims to improve
patient care and support precision medicine across a wide range of
applications, from oncology to infectious diseases.
For more information: https://www.novodiax.com/
About Hospitex
Hospitex is the world leading company for cytology standardized
monolayer preparations. With CYTOfast it re-invented cytological
diagnostics. Hospitex offers a full range of integrated solutions
aimed at streamlining diagnostic processes in cytology. The global
shortage of expertise in pathology requires tools and technologies
that enable diagnostic safety, efficiency and capacity building. In
this area, Hospitex is recognized as the precision diagnostics
player in cytology.
For more information: https://www.hospitex.com/en/
About Ikonisys
Ikonisys SA is a cell-based diagnostics company based in Paris
(France), New Haven (Connecticut, USA) and Milan (Italy)
specialized in the early and accurate detection of cancer. The
company develops, produces and markets the proprietary
Ikoniscope20® and Ikoniscope20max® platforms, fully-automated
solutions designed to deliver accurate and reliable detection and
analysis of rare and very rare cells. Ikonisys has received FDA
clearance for several automated diagnostic applications, which are
also marketed in Europe under CE certification. Through its
breakthrough fluorescence microscopy platform, the company
continues to develop a stream of new tests, including liquid biopsy
tests based on Circulating Tumor Cells (CTC).
For further information, please go to www.Ikonisys.com
Disclaimer
This press release contains forward-looking statements about the
Company's prospects and development. These statements are sometimes
identified by the use of the future tense, the conditional tense
and forward-looking words such as "believe", "aim to", "expect",
"intend", "estimate", "believe", "should", "could", "would" or
"will" or, where appropriate, the negative of these terms or any
other similar variants or expressions. This information is not
historical data and should not be construed as a guarantee that the
facts and data set forth will occur. This information is based on
data, assumptions and estimates considered reasonable by the
Company. It is subject to change or modification due to
uncertainties relating to the economic, financial, competitive and
regulatory environment. This information contains data relating to
the Company's intentions, estimates and objectives concerning, in
particular, the market, strategy, growth, results, financial
situation and cash flow of the Company. The forward-looking
information contained in this press release is made only as of the
date of this press release. The Company does not undertake to
update any forward-looking information contained in this press
release, except as required by applicable law or regulation. The
Company operates in a competitive and rapidly changing environment
and therefore cannot anticipate all of the risks, uncertainties or
other factors that may affect its business, their potential impact
on its business or the extent to which the materialization of any
one risk or combination of risks could cause results to differ
materially from those expressed in any forward-looking information,
it being recalled that none of this forward-looking information
constitutes a guarantee of actual results.
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version on businesswire.com: https://www.businesswire.com/news/home/20241112631688/en/
Hospitex Marco Testini Investor Relations
marco.testini@hospitex.com
Ikonisys Alessandro Mauri CFO investors@ikonisys.com
NewCap Louis-Victor Delouvrier Investor Relations
Ikonisys@newcap.eu Tel.: +33 (0)1 44 71 94 92
NewCap Nicolas Merigeau Media Relations
Ikonisys@newcap.eu Tel.: +33 (0)1 44 71 94 98
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