Mauna Kea Technologies Announces Positive Results on Needle-Based Endomicroscopy as a Real-Time Detection Tool for Lung Cancer
28 Giugno 2021 - 5:45PM
Business Wire
New peer-reviewed evidence in the
prestigious Thorax journal shows lung cancer can be accurately
diagnosed with Cellvizio® AQ-Flex™ 19 Confocal Miniprobe™ used
through fine needles
Regulatory News:
Mauna Kea Technologies (Euronext: MKEA) (Paris:MKEA)
(OTCQX:MKEAY) inventor of Cellvizio®, the multidisciplinary probe
and needle-based confocal laser endomicroscopy (p/nCLE) platform,
today announces the publication in a high impact journal, Thorax,
on nCLE as a real-time detection tool for lung cancer. The
peer-reviewed article entitled “Bronchoscopic needle based confocal
laser endomicroscopy (nCLE) as a real-time detection tool for
peripheral lung cancer” (DOI: 10.1136/thoraxjnl-2021-216885)
provides further evidence that bronchoscopic nCLE imaging of
peripheral lesions suspected of lung cancer is feasible, safe, and
enables real-time malignancy detection at the needle tip with very
high accuracy.
The U.S. Preventive Services Task Force (USPSTF) new
recommendation, published last March, nearly doubles the number of
people eligible for lung cancer screening and is estimated to
increase the number of screening-detected lung cancer cases at
early stage by 27%1. Despite the development of novel technologies,
transbronchic biopsy diagnostic yield and accuracy remain low
(between 30 and 65%)2 with an inability to confirm with high level
certainty that the biopsy needle is sampling within the targeted
lesion. There is a growing evidence that nCLE imaging has the
potential to significantly increase diagnostic yield and accuracy
of transbronchic needle biopsies3, consistent with the company’s
goal of delivering advanced imaging techniques and improved patient
outcomes.
“This new study provides further confirmation that bronchoscopic
nCLE imaging in peripheral lung cancer is feasible, safe, and
allows real-time malignancy detection at the tip of the needle with
an accuracy equal to 95%,” said J. T. Annema, M.D. Ph.D., Professor
of Pulmonary Endoscopy, Amsterdam University Medical Center.
Professor Annema also added that “physicians can differentiate,
with high reproducibility (with excellent and substantial inter and
intra-observers equal to 0.82 and 0.78, respectively) between
malignant tissue and airway/lung parenchyma, demonstrating the
potential of nCLE imaging as a real-time guidance tool to reduce
the bronchoscopic near miss rate of peripheral lung cancer.”
“This study brings very strong additional clinical data to our
formal evaluation of the interventional pulmonology market,” said
Robert L. Gershon, Chief Executive Officer of Mauna Kea
Technologies. “Thanks to its in vivo cellular imaging capability,
Cellvizio can be used as a real-time detection tool for lung cancer
with very high accuracy. In 2021, an estimated 235,760 Americans
will be diagnosed with lung cancer4 and will be receiving an
average of 1.6 lung nodule biopsies of which 40% to 60% will be
bronchoscopic5. This represents an expected 150,000 to 225,000
bronchoscopic biopsy procedures in 2021 alone. Importantly, this
annual procedure run-rate is expected to grow as a result of more
early-stage screening-detected lung cancer cases, which represents
a very compelling market opportunity to further expand the use of
Cellvizio in the years to come.”
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 June 17, 2021 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 Ito Fukunaga M, Wiener RS, Slatore CG. The 2021 US Preventive
Services Task Force Recommendation on Lung Cancer Screening: The
More Things Stay the Same…. JAMA Oncol. 2021;7(5):684–686.
doi:10.1001/jamaoncol.2020.8376.
https://www.uspreventiveservicestaskforce.org/uspstf/sites/default/files/file/supporting_documents/lung-cancer-newsbulletin.pdf
2 Ost DE, Ernst A, Lei X, Kovitz KL, Benzaquen S, Diaz-Mendoza J,
Greenhill S, Toth J, Feller-Kopman D, Puchalski J, Baram D,
Karunakara R, Jimenez CA, Filner JJ, Morice RC, Eapen GA, Michaud
GC, Estrada-Y-Martin RM, Rafeq S, Grosu HB, Ray C, Gilbert CR,
Yarmus LB, Simoff M; AQuIRE Bronchoscopy Registry. Diagnostic Yield
and Complications of Bronchoscopy for Peripheral Lung Lesions.
Results of the AQuIRE Registry. Am J Respir Crit Care Med. 2016 Jan
1;193(1):68-77. doi: 10.1164/rccm.201507-1332OC. PMID: 26367186;
PMCID: PMC4731617. 3 Wijmans L, Yared J, de Bruin DM, Meijer SL,
Baas P, Bonta PI, Annema JT. Needle-based confocal laser
endomicroscopy for real-time diagnosing and staging of lung cancer.
Eur Respir J. 2019 Jun 20;53(6):1801520. doi:
10.1183/13993003.01520-2018. PMID: 31023849. 4 Source: SEER -
Cancer Stat Facts: Lung and Bronchus Cancer :
https://seer.cancer.gov/statfacts/html/lungb.html 5 Chiu YW, Kao
YH, Simoff MJ, Ost DE, Wagner O, Lavin J, Culbertson RA, Smith DG.
Costs of Biopsy and Complications in Patients with Lung Cancer.
Clinicoecon Outcomes Res. 2021 Mar 17;13:191-200. doi:
10.2147/CEOR.S295494. PMID: 33762834; PMCID: PMC7982449.
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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