News - Cellvizio - Sep 5, 2017

Cook Medical Announces Commercial Launch of Cellvizio for Urology

Cook Urology to market private-labeled version of Cellvizio globally

Paris and Boston, September 05, 2017 – Mauna Kea Technologies (Euronext: MKEA, OTCQX: MKEAY) inventor of Cellvizio®, the multidisciplinary confocal laser endomicroscopy (CLE) platform, today announced that Cook Medical’s Urology division has formally announced the global commercial launch of a private-labeled version of Cellvizio (click here) under a strategic partnership announced by the two companies in December 2015. Cook Medical is a world leader in medical devices and supplies.

Urology represents a significant new market opportunity for Cellvizio, which can be used in a variety of urological applications, including endoscopic procedures for the characterization of tissue microstructures, including urethra, bladder and ureter. The Cook commercial launch is expected to benefit from a June 2017 study published by the European Association of Urology evaluating the effectiveness of Cellvizio in the characterizing of upper tract urothelial carcinoma (UTUC) lesions and identifying Cellvizio as an effective tool for the real-time characterization upper urinary tract cancer.

This commercial launch is also expected to benefit from the recently announced FDA 510(k) clearance of the CelioFlex™ UHD Confocal Miniprobes™ for use of Cellvizio in robotic-assisted surgery procedures. An estimated 100,000 robotic-assisted, radical prostatectomy surgical procedures are performed annually in the U.S.

Sacha Loiseau, Ph.D., Founder and Chief Executive Officer of Mauna Kea Technologies, commented, “We are pleased that our partners at Cook Medical have continued to invest in this collaboration and welcome the opportunity to increase clinical awareness within the urology community of Cellvizio’s capacity to improve patient outcomes through real-time microscopic imaging. We view urology as an important illustration of Mauna Kea’s ongoing strategy to partner with leading healthcare organizations to accelerate the global commercialization of Cellvizio in a variety of clinical applications.”