Mauna Kea Technologies Announces it has Signed its 15th Hospital in Europe for Irritable Bowel Syndrome (IBS) Food Allergy Ap...
05 Maggio 2021 - 05:45PM
Business Wire
Confirming the Role and added value of
Cellvizio for the Identification and Management of IBS Patients
with Atypical Food Allergies
Regulatory News:
Mauna Kea Technologies (Paris:MKEA) (OTCQX:MKEAY)
(Euronext: MKEA) inventor of Cellvizio®, the multidisciplinary
probe and needle-based confocal laser endomicroscopy (p/nCLE)
platform, continues to expand its European customer base in
healthcare centers treating patients with Irritable Bowel Syndrome
(IBS), a chronic functional disorder of the gastrointestinal system
which affects approximately 7.1% of the European population1. To
date, more than 15 centers in Europe, including prominent groups
such as the Helios group in Germany and the group Hexagon Santé in
France, have adopted Cellvizio to address the unmet need of
assessing atypical food allergies in real time with a higher degree
of accuracy compared to standard of care diagnostic methods.
In a study published in 2019, Annette Fritscher-Ravens, M.D.,
Ph.D., Head of Experimental Endoscopy Unit at the University
Hospital Schleswig-Holstein in Kiel, Germany, confirmed with
Cellvizio that more than 50% of patients with IBS could have a
nonclassical food allergy (Gastroenterology 2019; 157:109–118, DOI:
https://doi.org/10.1053/j.gastro.2019.03.046). Despite negative
results from skin tests and serologic analysis of immunoglobulin E,
the current standard of care for diagnosis, 70 % of patients in
this study showed an immediate visible disruption of the intestinal
mucosal barrier upon exposure to food antigens using pCLE.
Two-thirds of those patients with IBS who had abnormal mucosal
reactions to certain foods using Cellvizio, experienced
significative improvement of IBS symptoms after a 12-month
exclusion diet, confirming the atypical food allergy diagnosis.
“Many patients suffer from symptoms typical of IBS. Often there
is an underlying atypical food allergy or allergy-like reaction
limited to the intestine, which can not be detected by standard
allergy testing. Cellvizio allows to more accurately differentiate
patients with atypical food hypersensitivity from IBS patients,
allowing physician to provide tailored treatment for each patient
and to develop new therapeutic approaches,” said Christian Sina,
M.D., Gastroenterologist & Director, Fresenius Kabi Professor
of Nutritional Medicine.
“The growing adoption of Cellvizio for this novel application
combined with the large population suffering from IBS symptoms
represent a compelling market size and business opportunity for the
company,” said Robert L. Gershon, Chief Executive Officer of Mauna
Kea Technologies. “ Mauna Kea will continue to expand its business
in Europe with the aim of establishing Cellvizio as the leading
technique in identifying atypical food allergies providing patients
with a long-awaited answer to their condition. IBS represents 25%
to 50% of all referrals to gastroenterologists and is second only
to the common cold for the number of days of work missed2. Using
Cellvizio to identify those patients with an atypical food allergy
can significantly relieve the health economic burden in Europe,
reducing direct medical costs to healthcare systems and indirect
costs related to work absenteeism or work impairment while
improving many patients’ quality of life”.
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
revolutionizing the way physicians diagnose and treat patients —
making a transformative change in medicine. For more information,
visit www.maunakeatech.com.
Disclaimer
This press release contains forward-looking statements
concerning Mauna Kea Technologies and its activities. Such forward
looking statements are based on assumptions that Mauna Kea
Technologies considers to be reasonable. However, there can be no
assurance that the anticipated events contained in such
forward-looking statements will occur. Forward- looking statements
are subject to numerous risks and uncertainties including the risks
set forth in the Universal Registration Document of Mauna Kea
Technologies registered by the French Financial Markets Authority
(Autorité des marchés financiers (AMF)) on August 7, 2020 under
number 926346434_20200807 and available on the Company's website
(www.maunakeatech.com), and to the development of economic
situation, financial markets, and the markets in which Mauna Kea
Technologies operates. The forward-looking statements contained in
this release are also subject to risks unknown to Mauna Kea
Technologies or that Mauna Kea Technologies does not consider
material at this time. The realization of all or part of these
risks could lead to actual results, financial conditions,
performances or achievements by Mauna Kea Technologies that differ
significantly from the results, financial conditions, performances
or achievements expressed in such forward-looking statements. This
press release and the information it contains do not constitute an
offer to sell or to subscribe for, or a solicitation of an order to
purchase or subscribe for, Mauna Kea Technologies shares in any
country.
1 Sperber AD, Dumitrascu D, Fukudo S, et al The global
prevalence of IBS in adults remains elusive due to the
heterogeneity of studies: a Rome Foundation working team literature
review Gut 2017;66:1075-1082. 2 American College of
Gastroenterology Task Force on Irritable Bowel Syndrome, Brandt LJ,
Chey WD, Foxx-Orenstein AE, Schiller LR, Schoenfeld PS, Spiegel BM,
Talley NJ, Quigley EM. An evidence-based position statement on the
management of irritable bowel syndrome. Am J Gastroenterol. 2009
Jan;104 Suppl 1:S1-35.
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United States Mike
Piccinino, CFA Westwicke, an ICR Company 443-213-0500
France and Europe NewCap -
Investor Relations Thomas Grojean +33 (0)1 44 71 94 94
maunakea@newcap.eu