Mauna Kea's optical biopsy probe receives CE Mark

PARIS – Mauna Kea Technologies has announced CE Mark approval of its Cellvizio? UroFlex? confocal miniprobe for use during cytoscopy procedures. UroFlex is the first optical biopsy probe designed for urological applications, allowing physicians to obtain optical biopsies for the diagnosis, surveillance, and treatment of bladder cancer.

"Bladder cancer has a very high recurrence rate, and because it requires life-long surveillance and multiple repeat cystoscopy procedures, it is one of the most expensive cancers to treat on a per patient basis," said Maurizio Brausi, M.D., Professor and Chairman of Urology, AUSL Modena, Italy, and chairman of the EAU Section of Oncological Urology. "With optical biopsies, physicians have an immediate view of cells within the bladder and ureter, which gives us a whole new set of data allowing more informed treatment decisions. This could allow us to more effectively determine if we have removed all the cancerous cells during minimally invasive surgery to reduce repeat surgeries for the patient."

“This CE Mark extends the Cellvizio portfolio beyond the gastrointestinal tract and lungs into the important field of urology. Urologists throughout Europe can now offer Cellvizio optical biopsies to their patients. Once again, Mauna Kea Technologies takes the lead in making optical biopsies with Cellvizio available to a much larger population of patients and thus significantly increasing its potential market,” said Sacha Loiseau, CEO of Mauna Kea Technologies.