Regulatory Filings • Sep 17, 2015
Regulatory Filings
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Paris, September 17, 2015 – Mauna Kea Technologies (Euronext: MKEA, FR0010609263, PEA-SME eligible), inventor of Cellvizio®, the multidisciplinary confocal laser endomicroscopy (CLE) platform, today announced the publication of clinical study results involving the use of CLE with Cellvizio in the peer reviewed Journal of Urology. The investigators from the University of Florida, College of Medicine, Gainesville, evaluated the ability of probe-based confocal laser endomicroscopy (pCLE) to discriminate the various anatomic components of human kidney tumors during radical or partial nephrectomies (kidney ablation).
The authors report for a cohort of 20 patients that ex vivo CLE imaging on fresh specimen reveals normal renal structures with excellent correlation to histology. Tumor tissues can be readily distinguished from normal parenchyma with unique morphologic features to benign and malignant tumor subtypes published here as a first reference atlas for small renal masses (SRM).
Most early stage kidney cancers are renal cell carcinomas (RCCs), and most are diagnosed incidentally by imaging as SRM. SRM grew in incidence in recent decades and pose an increasingly common management dilemma in urology, as approximately 20% of these clinical stage 1 renal masses are benign and can benefit from active surveillance, with less than 2% of patients progressing to metastatic disease.
Doctor Li-Ming Su, Departments of Urology, University of Florida College of Medicine, Gainesville, stated: "The detection of small incidental renal masses is on the rise. Improved pre- and peri-operative diagnostics are needed to differentiate tumors requiring aggressive treatment from those more suitable for surveillance. Confocal laser endomicroscopy offers real time optical imaging that correlates very well with histopathology as shown in our ex vivo kidney tumor study. Our findings are a crucial stepping stone towards real time diagnostic optical "biopsy" of renal tumors that may in the future provide more relevant actionable data for better decision-making in the preoperative setting."
"The results of these recent studies on the use of Cellvizio for the first time in small renal masses add to the rapidly expanding body of literature confirming the potential opportunities to use our unique technology in surgical oncology including urology in order to rapidly and accurately identify the presence and the extent of cancer in real time, potentially leading to a less invasive procedure with patients left with a more functional kidney, and a much improved quality of life" said Sacha Loiseau, founder and CEO of Mauna Kea Technologies.
About 80,000 nephrectomies are performed in the US annually and an estimated 160,000 worldwide.
Mauna Kea Technologies is a global medical device company focused on protecting patients' lives while enabling physicians and surgeons to make better decisions thanks to direct visualization at the cellular level. 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
Eric Cohen Vice President Finance Tel: +33 (0)1 70 08 09 70 [email protected]
France and Europe NewCap - Investor Relations | Strategic Communication Florent Alba/Pierre Laurent Tel: +33 (0)1 44 71 94 94 [email protected]
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