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
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 registration document of Mauna Kea Technologies registered by the French Financial Markets Authority (Autorité des marchés financiers (AMF)) on June 13, 2016 under number R.16-054 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.