Pancreatic cancer remains difficult to
diagnose accurately using conventional methods often leading to
late-stage diagnoses or unnecessary surgeries
New publications confirm once more
Cellvizio’s far superior ability to accurately classify the
risk of pancreatic cystic lesions with 98% sensitivity and
accuracy, surpassing conventional methods
Regulatory News:
Mauna Kea Technologies (Euronext Growth: ALMKT), inventor
of Cellvizio®, the multidisciplinary probe and needle-based
confocal laser endomicroscopy (p/nCLE) platform, today announces a
new body of evidence supporting the use of Cellvizio® for the
classification and risk stratification of pancreatic cystic lesions
(PCLs), presented at the Digestive Disease Week® (DDW) 2024
Conference held in Washington, DC.
Conventional diagnostic testing of PCLs which involves
performing an endoscopic ultrasound (EUS) and then collecting and
testing the cyst fluid through fine needle aspiration (FNA) is
considered as suboptimal at accurately diagnosing and risk
stratifying PCLs. Cellvizio® can be added to EUS as an adjunct via
the existing FNA needle (“EUS-nCLE”), providing real-time imaging
of the cyst characteristics and aiding in appropriately gauging the
potential risk posed by the cyst prior to any surgical
intervention.
In one publication1 pooling two separate studies with a combined
sample size of 420 patients, the sensitivity and diagnostic
accuracy of EUS-nCLE for classifying mucinous vs. non-mucinous PCLs
was 98% and 97%, respectively, compared to 74% and 81% for fluid
analysis (CEA) + cytology, 77% and 80% for CEA + cytology +
glucose, and 76% and 86% for next generation sequencing (NGS),
respectively. This sharp positive increase in sensitivity and
accuracy with Cellvizio (EUS-nCLE) would translate to a marked
reduction in late-stage diagnoses of advanced pancreatic cancer and
unnecessary surgeries on benign or low-grade lesions, totaling as
many as 2,000 unnecessary surgeries per year in the United
States2.
In a second publication3 evaluating data from 65 patients
enrolled in a multi-year study, EUS-nCLE demonstrated high accuracy
in preoperatively predicting dysplasia in branch duct intraductal
papillary mucinous neoplasms (BD-IPMNs), with high interobserver
agreement of 0.711.
A third publication4, using the same patient data, concluded
that improved preoperative accuracy can be achieved by
incorporating nCLE in the preoperative risk stratification of
BD-IPMNs, improving the decision criteria for evaluating a
patient’s candidacy for surgery, and ultimately improving patient
management.
"The combination of these publications and presentations from
DDW underscore, once again, the critical role Cellvizio can play as
a key adjunct to the tools physicians use to diagnose and manage
pancreatic cysts,” said Sacha Loiseau, Ph.D., Chairman and Chief
Executive Officer of Mauna Kea Technologies. “Pancreatic cancer
remains one of the more elusive cancers, often termed the ‘silent
killer’ because of its lack of symptoms and discovery by incidental
imaging. Obtaining an accurate diagnosis is critical to ensure only
patients who need surgery receive it, and to ensure the correct
risk stratification of malignant cysts. This new corpus of data
confirms that there is no combination of techniques which is
superior to direct microscopic observation of the pancreatic cystic
lesion in real time with Cellvizio. We are confident that with all
the confirmatory positive data and the growing support from many
experts around the world, nCLE with Cellvizio is fast approaching
its prime time and the status of standard of care, thus creating a
very significant market opportunity for Mauna Kea.
About Pancreatic Cysts
The prevalence of pancreatic cystic lesions in the adult
asymptomatic population ranges from 2.4% to 24.3%5. With the large
majority of pancreatic cystic lesions being discovered through
incidental imaging and an estimated 40% of surgeries being
performed unnecessarily on benign or low-grade dysplasia lesion
patients, there is a need for more accurate classification methods,
including risk stratification, earlier in the patient’s diagnostic
workup. Conventional diagnostic testing involves performing an
endoscopic ultrasound (EUS) and then collecting and testing the
cyst fluid through fine needle aspiration (FNA). In some advanced
facilities, next generation sequencing (NGS) may be performed to
provide additional data. The gold standard remains resection of
suspicious tissue, often introducing complications such as chronic
pancreatitis, even if the cyst is benign. Although most facilities
employ a combination of a range of conventional diagnostic methods,
sensitivity, specificity, and accuracy remain critically low,
potentially exposing patients to unneeded surgical procedures.
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 "Accuracy of real-time EUS-guided confocal laser
endomicroscopy interpretation for discerning specific types of
pancreatic cystic lesions: Insights from a multicenter prospective
study” 2 “Cost-effectiveness of consensus guideline based
management of pancreatic cysts: The sensitivity and specificity
required for guidelines to be cost-effective” 3 "Improving
pre-surgical risk stratification through EUS confocal
endomicroscopy: Insights from an interobserver agreement study
among pancreaticobiliary pathologists in the classification of
dysplasia for IPMNs” 4 "Pre-operative risk stratification of IPMNs
using Fukuoka guidelines and confocal endomicroscopy imaging” 5
“State-of-the-Art Update of Pancreatic Cysts”
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version on businesswire.com: https://www.businesswire.com/news/home/20240613291581/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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