PARIS--(BUSINESS WIRE)--Regulatory News:
Mauna Kea Technologies (Paris:MKEA) (OTCQX:MKEAY) (Euronext: MKEA, OTCQX: MKEAY) inventor of Cellvizio®, the multidisciplinary confocal laser endomicroscopy (CLE) platform, today announced the publication of a new study supporting the use of Cellvizio in urology for the real-time histological characterization of upper tract urothelial carcinoma (UTUC) lesions.
Urothelial carcinoma (UC) is the ninth most common cancer globally and the eighth most lethal neoplasm in men in the United States. It is the most costly cancer in the U.S. healthcare system on a per-patient basis. Between 5% and 10% of primary urothelial cancers originate in the ureter or renal pelvis and are collectively called UTUCs.1
The study titled, “Correlation Between Confocal Laser Endomicroscopy (Cellvizio®) and Histological Grading of Upper Tract Urothelial Carcinoma: A Step Forward for a Better Selection of Patients Suitable for Conservative Management,” was published in the European Urology Focus, an official publication of the European Association of Urology (EAU). The study was led by Dr Alberto Breda, Department of Urology, Fundaciò Puigvert, Autonoma University of Barcelona, in Barcelona, Spain.
In the study, 14 patients underwent flexible ureteroscopies with Cellvizio used to target biopsies, which were then taken and read for conclusive histopathological results. The pre-biopsy observations using Cellvizio were compared to the surgery-blinded histopathological results, demonstrating a high degree agreement (13 of 14 lesions accurately characterized across three levels of UTUCs) between the methods and substantial interobserver agreement (Kappa = 0.64). The study concluded that based on these findings, Cellvizio may be used in the following scenarios:
- Real-time characterization of UTUC lesions to rule out/in endourological management
- Enhanced follow-up of UTUC patients previously man-aged conservatively
- Enhanced characterization of potential Carcinoma In Situ (CIS) lesions
Dr. Breda commented, “CLE is a promising new technology providing a reliable real-time histological characterization of UTUC lesions. We believe that this could be helpful in patient stratification as we work to identify patients that could benefit from a conservative treatment of UTUC. Cellvizio may become a standard endoscopic tool to help the urologist evaluate in real-time the risk for patients affected by UTUC.”
Sacha Loiseau, Ph.D., Founder and Chief Executive Officer of Mauna Kea Technologies, added, “In the last two decades, there have been significant advances in endoscopic technology that have expanded the treatment options for patients with UTUC. We believe Cellvizio represents another meaningful addition for urologists that will help improve patient management and outcomes. We look forward to working with our global commercial partner in urology, Cook Medical, to highlight this important application of Cellvizio to their urology customers around the world.”
Mauna Kea Technologies’ exclusive partner for Cellvizio in the field of urology is Cook Medical, a world leader in medical devices and supplies for urology applications.
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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