Mauna Kea (ENT:MKEA) said today that it and Cook Medical have mutually decided to terminate their development and distribution agreement.
The deal, originally inked in late 2015, included the development of Mauna Kea’s Cellvizio confocal laser endomicroscopy systems for urologic applications. Paris-based Mauna Kea said that it agreed to develop a private-label version of the Cellvizio with an emphasis on characterizing upper urinary tract urothelial cancer.
“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,” Mauna Kea CEO Robert Gershon said in a prepared statement.
Mauna Kea said that while it is disappointed at the lack of commercial progress in the urology market, the company is “encouraged by the significant progress we have made in the areas of product development, clearance and clinical validation” of the Cellvizio tech in the urology market.
“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,” CEO Gershon said in a press release.
Cook Medical has not yet officially commented on the termination of the agreement.
In December 2017, Mauna Kea said that it won expanded FDA 510(k) clearance for its Cellvizio confocal laser endomicroscopy platform and its Confocal Miniprobe devices.