PARIS--(BUSINESS WIRE)--
Regulatory News:
Mauna Kea Technologies (Paris:MKEA) (OTCQX:MKEAY) inventor of Cellvizio®, the multidisciplinary confocal laser endomicroscopy (CLE) platform, today announced the peer-reviewed publication of a clinical study1 demonstrating improved early stomach cancer detection with Cellvizio2 in Endoscopy, the official journal of the European Society of Gastrointestinal Endoscopy (ESGE) and affiliated societies.
The new data builds on a recently published meta-analysis3 of Cellvizio in stomach cancer and further establishes the superiority of biopsies guides by a combination of endoscopic imaging with Flexible spectral Imaging Colour Enhancement (FICE) and probe-based confocal laser endomicroscopy (pCLE) with Cellvizio, compared to standard FICE without pCLE for in vivo detection of pre-cancerous and cancerous gastric lesions.
According to JAMA Oncology4, the annual incident rate of stomach cancer exceeds 1.3 million cases worldwide, making it the 3rd most common malignancy globally by incidence and mortality (after cancers of the lung and the breast). An estimated 1 in 27 men and 1 in 68 women will develop stomach cancer before the age of 79 years.
Led by principal investigator Pr. Yan-Qing Li, Chief physician and Vice President of Qilu hospital of Shandong University, this key study enrolled 238 patients who were randomized in two groups (FICE-guided pCLE with targeted biopsies (using a Gastroflex UHD Confocal Miniprobe) or FICE with standard biopsies) at four clinical institutions in China. The diagnostic yield of gastric intestinal metaplasia (GIM), gastric intraepithelial neoplasia (GIN), and early gastric cancer (EGC) was compared between the two groups as a main outcome. Secondary outcomes include the number of necessary biopsies to achieve diagnosis and time taken for the procedure.
The key results from the study are as follows:
- Doubled diagnostic yield: On a per-biopsy analysis, FICE-guided pCLE with targeted biopsies more than doubled the diagnostic yield of GIM/GIN/EGC vs. FICE with standard biopsies, from 31.5% to 75.1% (p< 0.001).
- Reduced number of necessary biopsies by half: FICE-guided pCLE with targeted biopsies led to a 48.5% decrease in the number of biopsies per patient vs. FICE with standard biopsies (p<0.001).
- No change in procedure-time: Procedure time was not significantly different between the 2 groups (17 minutes in the pCLE group vs. 16 minutes in the control group).
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Confirmed clinical performance of Cellvizio:
- Sensitivity, specificity, positive predictive value and negative predictive value of pCLE were 87.5%, 98%, 87.5% and 98% for GIN and 95%, 94.6%, 90.5% and 97.5% for GIM.
- Inter-observer agreement and intra-observer agreement were excellent with kappa-values of 0.83 and 0.89, respectively.
The authors concluded, “Real-time pCLE and targeted biopsies after FICE improved the diagnostic yield for the detection of GIM, GIN, and EGC, and only required about half the number of biopsies versus FICE with standard biopsies. This may allow for a better regimen for endoscopic surveillance and subsequent treatment of patients with premalignant and malignant gastric abnormalities. All pCLE procedures were performed safely and successfully in participating patients.”
Sacha Loiseau, Ph.D., Founder and Chief Executive Officer of Mauna Kea Technologies, said, “This paper is a key milestone for demonstrating the role for Cellvizio in the early detection of gastric cancer. We are grateful to Pr. Yan-Qing Li, Pr. Xiu-Li Zuo and their team for their leadership in completing this important clinical study.”
About Mauna Kea Technologies
Mauna Kea Technologies is a
global medical device company focused on eliminating uncertainties
related to the diagnosis and treatment of cancer and other diseases
thanks to real time in vivo microscopic visualization. The Company’s
flagship product, Cellvizio, has received clearance to sell a wide range
of applications in more than 40 countries, including the United States,
Europe, Japan, China, Canada, Brazil and Mexico. For more information on
Mauna Kea Technologies, visit www.maunakeatech.com
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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
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registration document of Mauna Kea Technologies registered by the French
Financial Markets Authority (Autorité des marchés financiers (AMF)) on
Mau 31, 2017 under number D.17-0574 and available on the Company's
website (www.maunakeatech.com),
and to the development of economic situation, financial markets, and the
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or achievements by Mauna Kea Technologies that differ significantly from
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1 ClinicalTrials.gov
(NCT02515721)
2 Xiu-Li Zuo et al. Probe-based
endomicroscopy for in vivo detection of gastric intestinal metaplasia
and neoplasia: a multicenter randomized controlled trial. Endoscopy.
Published online 2017 DOI: 10.1055/s-0043-115382
3
Press-release Mauna Kea Technologies – March 2nd, 2017
4
Global, Regional, and National Cancer Incidence, Mortality, Years of
Life Lost, Years Lived With Disability, and Disability-Adjusted
Life-years for 32 Cancer Groups, 1990 to 2015: A Systematic Analysis for
the Global Burden of Disease Study - JAMA
Oncol. 2017 Apr 1;3 (4):524-548.
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