CellTolerance™ is a unique science-based
program designed with physicians and dietitians
New data presented at Digestive Disease Week
2024 reinforces the program’s unique clinical value for
patients
Initiation of discussions with clinic
networks to establish strategic partnerships for rapid expansion
into a market estimated at $1.5bn
Development of digital tools and unique
multi-scale datasets to create AI solutions for pharmaceutical and
nutrition companies
Regulatory News:
Mauna Kea Technologies (Euronext Growth: ALMKT), inventor
of Cellvizio®, the multidisciplinary platform for probe-based and
needle-based confocal laser endomicroscopy (p/nCLE), unveils its
new subsidiary CellTolerance1, fully dedicated to its unique
program for the detection and treatment of food intolerances
associated with Irritable Bowel Syndrome (IBS).
“CellTolerance™ represents a significant advancement in the
detection and treatment of food intolerances. By integrating
cutting-edge science with practical clinical applications, we are
about to revolutionize how millions of patients manage their
food-related Irritable Bowel Syndrome and their overall health. Our
commitment to leveraging AI and data analytics could not only
enhance patient outcomes but also provide invaluable insights to
the broader nutrition and pharmaceutical industries. We are excited
to embark on this journey and look forward to forming strategic
partnerships that will help us rapidly expand our reach and
impact”, said Sacha Loiseau, Chairman and CEO of Mauna Kea
Technologies.
A significant unmet medical need affecting 1 in 10
people
More than 50 million patients2 suffer from food intolerances
associated with IBS in the U.S. and Europe – nearly 1 person in 10
– and more than half of them could suffer from atypical food
allergies, which can be difficult to identify and treat. In a
recent large-scale survey3, 64% of IBS patients reported suffering
for more than 10 years, and 33% described their symptoms as
completely out of control. Current treatments frequently fail to
provide relief, leaving a substantial portion of this population
with ongoing discomfort and health issues.
Strong clinical science and real-world evidence of
CellTolerance™ proven to reduce symptoms in 96% of
patients4
CellTolerance™ is a unique program designed with physicians and
dietitians to detect and treat food intolerances through
personalized dietary monitoring, live cell-response visualization
via intestinal barrier microscopic response to selected foods and
supervised elimination diets. It is rooted in more than a decade of
research and peer-reviewed publications, including new data
presented at the Digestive Disease Week® (DDW) 2024 Conference held
in Washington, DC.
As part of a baseline medical workup for IBS, patients are asked
to respond to a standardized IBS-symptom severity score (IBS-SSS).
In one abstract presented at DDW5 researchers found that patients
who underwent a CellTolerance-guided food elimination diet saw a
significant reduction in their IBS-SSS compared to the pre-test
baseline (p = 0.04). More interestingly, patients saw a significant
worsening of symptoms when that particular food was reintroduced (p
= 0.04), underscoring the positive impact of identifying the
correct food with an accurate test like CellTolerance™. In a
separate oral presentation at DDW6, CellTolerance™ was presented as
a viable screening tool to detect food intolerances in patients who
have previously tested negative for IgE-mediated food allergies or
celiac disease but continue to have suspected food-related IBS
symptoms. Thanks to dedicated and visionary physicians, hundreds of
patients have already experienced a CellTolerance-guided
elimination diet and 96% have reported improvement of their
symptoms, higher than the difficult-to-implement low-FODMAP
diet7.
A new company dedicated to digital health and AI
solutions
To best develop the CellTolerance™ program, a new wholly owned
subsidiary will soon be incorporated (“CellTolerance”), with the
prospect of eventually operating as an independent, lean company
with specific agreements, ensuring the availability of the
Cellvizio technology platform as a key component of the
CellTolerance™ program.
CellTolerance will also aim at providing patients, providers and
partners with innovative digital tools to monitor patients and
collect a vast quantity of real world and clinical data. This
unique multi-scale dataset (endoscopy, endomicroscopy, clinical
data, etc.) will be leveraged to develop advanced AI models
offering unprecedented clinical insights. These insights could
empower pharmaceutical and nutrition companies to tailor
personalized treatments, optimize nutritional plans, and predict
individual responses to therapies and dietary interventions.
By integrating comprehensive data analytics and AI,
CellTolerance aims to transform healthcare delivery and nutrition
management, ultimately enhancing patient outcomes and advancing
medical research.
It is also envisioned that CellTolerance will quickly open its
capital to venture capital funds specializing in nutrition,
wellness, microbiome, gut health and related activities to fund the
development of its program independently.
A market opportunity estimated at $1.5 billion8 to be
addressed through strategic partnerships
The CellTolerance™ program is intended to be launched at scale
in key markets such as the United States, France, Germany, Italy
and Switzerland. The addressable market in these countries is
highly significant, representing an opportunity estimated at $1.5
billion. To best capitalize on this opportunity and maximize the
reach of its program, CellTolerance intends to form strategic
partnerships with clinic networks which see the program as a unique
opportunity to expand their service offerings.
By working closely with networks of clinics, CellTolerance will
ensure continuous training and ongoing support for healthcare
professionals, enabling optimal use of its technologies. This
strategy aims to establish CellTolerance™ as the reference solution
for identifying and treating food intolerances while reducing
marketing costs through partners' marketing infrastructures.
***
About Digestive Disease Week® Digestive Disease Week®
(DDW) is the largest international gathering of physicians,
researchers and academics in the fields of gastroenterology,
hepatology, endoscopy and gastrointestinal surgery. Jointly
sponsored by the American Association for the Study of Liver
Diseases (AASLD), the American Gastroenterological Association
(AGA), the American Society for Gastrointestinal Endoscopy (ASGE)
and the Society for Surgery of the Alimentary Tract (SSAT), DDW is
an in-person and online meeting from May 18-21, 2024. The meeting
showcases more than 5,600 abstracts and hundreds of lectures on the
latest advances in GI research, medicine and technology. More
information can be found at www.ddw.org.
About Mauna Kea Technologies Mauna Kea Technologies is a
global medical device company that manufactures and sells
Cellvizio®, the real-time in vivo cellular imaging platform. This
technology uniquely delivers in vivo cellular visualization which
enables physicians to monitor the progression of disease over time,
assess point-in-time reactions as they happen in real time,
classify indeterminate areas of concern, and guide surgical
interventions. The Cellvizio® platform is used globally across a
wide range of medical specialties and is making a transformative
change in the way physicians diagnose and treat patients. For more
information, visit www.maunakeatech.com.
Disclaimer This press release contains forward-looking
statements about Mauna Kea Technologies and its business. All
statements other than statements of historical fact included in
this press release, including, but not limited to, statements
regarding Mauna Kea Technologies' financial condition, business,
strategies, plans and objectives for future operations are
forward-looking statements. Mauna Kea Technologies believes that
these forward-looking statements are based on reasonable
assumptions. However, no assurance can be given that the
expectations expressed in these forward-looking statements will be
achieved. These forward-looking statements are subject to numerous
risks and uncertainties, including those described in Chapter 2 of
Mauna Kea Technologies' 2023 Annual Report filed with the Autorité
des marchés financiers (AMF) on April 30, 2024, which is available
on the Company's website (www.maunakeatech.fr), as well as the
risks associated with changes in economic conditions, financial
markets and the markets in which Mauna Kea Technologies operates.
The forward-looking statements contained in this press release are
also subject to risks that are unknown to Mauna Kea Technologies or
that Mauna Kea Technologies does not currently consider material.
The occurrence of some or all of these risks could cause the actual
results, financial condition, performance or achievements of Mauna
Kea Technologies to differ materially from those expressed in the
forward-looking statements. This press release and the information
contained herein do not constitute an offer to sell or subscribe
for, or the solicitation of an order to buy or subscribe for,
shares of Mauna Kea Technologies in any jurisdiction in which such
offer, solicitation or sale would be unlawful prior to registration
or qualification under the securities laws of any such
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__________________________ 1 Wholly owned by Mauna Kea
Technologies, the company CellTolerance is in the process of being
incorporated. More information on: www.cell-tolerance.com 2
https://doi.org/10.1046/j.1365-2036.2003.01456.x 3 YouGOVSurvey to
patients with IBS, March 2024 4
https://doi.org/10.1053/j.gastro.2019.03.046 5
https://doi.org/10.1016/S0016-5085(24)03619-9 6
https://doi.org/10.1016/j.gie.2024.04.2600 7
https://dx.doi.org/10.1016/S0016-5085(20)31016-7 8 Source:
Company
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version on businesswire.com: https://www.businesswire.com/news/home/20240626399128/en/
Mauna Kea Technologies investors@maunakeatech.com
NewCap - Investor Relations Aurélie Manavarere / Thomas
Grojean +33 (0)1 44 71 94 94 maunakea@newcap.eu
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