PARIS & BOSTON--(BUSINESS WIRE)--Regulatory News:
Mauna Kea Technologies (Paris:MKEA) (OTCQX:MKEAY) (Euronext: MKEA) inventor of Cellvizio®, the multidisciplinary probe and needle-based confocal laser endomicroscopy (p/nCLE) platform, today announced a mutual decision to terminate the development and distribution agreements with Cook Medical.
“Mauna Kea announced a change in commercial strategy in the Fall of 2015 which included moving to an expanded marketing system to commercialize Cellvizio in new clinical applications through strategic sales partnerships with established medical device companies,” said Robert L. Gershon, Chief Executive Officer of Mauna Kea Technologies. “In December 2015, the Company signed the first of these strategic partnerships when it announced a multi-year worldwide exclusive marketing partnership agreement with Cook Medical to use the Cellvizio platform in urological applications. Mauna Kea agreed to develop a private-label version of Cellvizio for Cook Medical to sell in markets around the world, with specific emphasis on the characterization of upper urinary tract urothelial cancer, and the detection and surveillance for cancer recurrence among the more than 500,000 people living with bladder cancer in the U.S. alone.”
Mr. Gershon continued: “Mauna Kea was understandably excited by the prospect of combining our innovative, confocal laser endomicroscopy technology with an established medical devices and supplies company with global expertise in sales, marketing and medical education in the urology market. Unfortunately, due to the lack of commercial activity to-date, we have decided to terminate the agreement. While we have been disappointed by the lack of commercial progress in the urology market to-date, we are encouraged by the significant progress we have made in the areas of product development, clearance and clinical validation of our Cellvizio technology in the Urology market in recent years. Specifically, there have been 16 publications studying the use of confocal laser endomicroscopy in urology over the last three years. These publications detail the clinical studies observing more than 150 patients, at 10 hospitals and academic institutions around the world and include some of the most prominent thought leaders in urology. In addition to building our level of clinical validation for Cellvizio in the area of urology in recent years, we have also made progress in introducing 3 new FDA-cleared and CE-marked products for cystoscopy, ureteroscopy and prostatectomy including robotic-assisted laparoscopic surgery which we believe reflects a growing appreciation for our differentiated technology among urologists around the world. We look forward to sharing an update on our progress in each of our markets around the world during 2018, as well as our strategic growth priorities for 2019, during our year-end financial results call on March 20, 2019.”
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/approval in a wide range of applications in more than 40 countries, including the United States, Europe, Japan, China, Russia, 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 April 27, 2018 under number D.18-0429 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.