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Dec 11th, 2012
Mauna Kea Technologies announces that first Cellvizio optical biopsy probe designed for urological applications is now CE marked
The UroFlex™ confocal miniprobe allows physicians to obtain optical biopsies that may facilitate the diagnosis, surveillance and treatment of patients with bladder cancer.
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Mauna Kea Technologies (NYSE Euronext: MKEA, FR0010609263), leader in the optcal biopsy market and developer of Cellvizio®, the fastest way to see cancer, announced that its UroFlex™ confocal miniprobe received CE mark approval for use during cystoscopy procedures. UroFlex is the frst optcal biopsy probe designed for urological applicatons and allows the company to enter the €1 billion European urology device market.i The new probe allows physicians to obtain optcal biopsies that may facilitate the diagnosis, surveillance and treatment of patents with bladder cancer.

“Bladder cancer has a very high recurrence rate, and because it requires life-long surveillance and multple repeat cystoscopy procedures, it is one of the most expensive cancers to treat on a per patent basis,” said Maurizio Brausi, MD, Professor and Chairman of Urology, AUSL Modena, Italy and chairman of the EAU Secton of Oncological Urology. “With optcal 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 efectvely determine if we have removed all the cancerous cells during minimally invasive surgery to reduce repeat surgeries for the patent.”

In 2006, an estmated 104,400 new cases of bladder cancer were diagnosed in Europe, of which 82,800 were diagnosed in men and 21,600 in women.ii

“This CE mark extends the Cellvizio portolio beyond the gastrointestnal tract and lungs into the important feld of urology,” said Sacha Loiseau, CEO of Mauna Kea Technologies. “Urologists throughout Europe can now ofer Cellvizio optcal biopsies to their patents. Once again, Mauna Kea Technologies takes the lead in making optcal biopsies with Cellvizio available to a much larger populaton of patents and thus signifcantly increasing its potental market.”

Clinical studies have demonstrated that optcal biopsies with Cellvizio could help urologists determine if they have removed all cancerous cells during transurethral resecton of the bladder tumor (TURBT)iiiivv, the inital surgical procedurevi that a patent undergoes afer the diagnosis of bladder cancer. The goal is to improve patent outcomes from the inital surgery and potentally avoid the need for a second TURBT procedure. Data also show that optcal biopsies can help physicians characterize lesions during long-term surveil - lance of bladder cancer patents.viiviiiixx

To date, clinicians have published over 140 scientfc publicatons on Cellvizio, seven of which focused on urology indicatons. These data show how Cellvizio can help physicians make more informed assessments and treatment decisions for their patents. Studies also show that having microscopic informaton at the bedside also can help physicians more confdently rule out disease, allowing some patents to go home and avoid unnecessary procedures and surgeries.

About Mauna Kea Technologies
Mauna Kea Technologies is a global medical device company dedicated to the advent of optcal biopsy. The company researches, develops and markets innovatve tools to visualize and detect cellular abnormalites during endoscopic procedures. Its fagship product, Cellvizio®, a probe-based Confocal Laser Endomicroscopy (pCLE) system, provides physicians and researchers high-resoluton cellular views of tssue inside the body. Large, internatonal, multcenter clinical trials have demonstrated Cellvizio's ability to help physicians more accurately detect early forms of disease and make treatment decisions immediately. Designed to improve patent outcomes and reduce costs within a hospital, Cellvizio can be used with almost any endoscope. Cellvizio has 510(k) clearance from the U.S. Food and Drug Administraton and the European CE-Mark for use in the GI tract, biliary and pancreatc ducts and lungs.

For more informaton on Mauna Kea Technologies, visit www.maunakeatech.com

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