Mauna Kea Technologies Announces That First Cellvizio Optical Biopsy Probe Designed for Urological Applications is Now CE Marked

Regulatory News :

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

In 2006, an estimated 104,400 new cases of bladder cancer were diagnosed in Europe, of which 82,800 were diagnosed in men and 21,600 in women.²

"This CE mark extends the Cellvizio portfolio beyond the gastrointestinal tract and lungs into the important field of urology,” said Sacha Loiseau, CEO of Mauna Kea Technologies. "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.”

Clinical studies have demonstrated that optical biopsies with Cellvizio could help urologists determine if they have removed all cancerous cells during transurethral resection of the bladder tumor (TURBT)³⁴⁵, the initial surgical procedure⁶ that a patient undergoes after the diagnosis of bladder cancer. The goal is to improve patient outcomes from the initial surgery and potentially avoid the need for a second TURBT procedure. Data also show that optical biopsies can help physicians characterize lesions during long-term surveillance of bladder cancer patients.⁷⁸⁹¹⁰

To date, clinicians have published over 140 scientific publications on Cellvizio, seven of which focused on urology indications. These data show how Cellvizio can help physicians make more informed assessments and treatment decisions for their patients. Studies also show that having microscopic information at the bedside also can help physicians more confidently rule out disease, allowing some patients 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 optical biopsy. The company researches, develops and markets innovative tools to visualize and detect cellular abnormalities during endoscopic procedures. Its flagship product, Cellvizio®, a probe-based Confocal Laser Endomicroscopy (pCLE) system, provides physicians and researchers high-resolution cellular views of tissue inside the body. Large, international, multicenter 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 patient 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 Administration and the European CE-Mark for use in the GI tract, biliary and pancreatic ducts and lungs.

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

¹ Businessweek. Research and Markets: European Markets for Urological Devices. http://www.businesswire.com/news/home/20120801006365/en/Research-Markets-European-Markets-Urological-Devices. Accessed November 29, 2012.
² Ferlay J, Autier P, Boniol M. Heanue M, Colombet M, Boyle P. Estimates of the cancer incidence and mortality in Europe in 2006. Ann Oncol 2007;18(3):581-592.
³ Bonnal J.L.; Gagnat A. Confocal Laser Endomicroscopy of Bladder Tumors Associated with Photodynamic Diagnosis: an Ex Vivo Pilot study. Urology, 2012.
⁴ Wu, K.; Liu, J.J.; Adams, W.; Sonn, G.A.; Mach, K.E.; Pan, Y.; Beck, A.H.; Jensen, K.C.; Liao, J.C. Dynamic Real-time Microscopy of the Urinary Tract Using Confocal Laser Endomicroscopy. Urology, 2011
⁵ Sonn, G.A.; Jones, S.-N.E.; Tarin, T.V.; Du, C.B.; Mach, K.E.; Jensen, K.C.; Liao, J.C. Optical biopsy of human bladder neoplasia with in vivo confocal laser endomicroscopy. The Journal of Urology, 2009.
⁶ MedicineNet. Bladder Cancer. http://www.medicinenet.com/bladder_cancer/page8.htm. Accessed November 26, 2012.
⁷ Chang, T.C.; Liu, J.J.; Hsiao, S.T.; Pan Y.; Mach K.E.; Leppert J.T.; Mc Kenney J.K.; Rouse R.V.; Liao, J.C. Interobserver Agreement of Confocal Laser Endomicroscopy for Bladder Cancer. Journal of Endourology, 2012.
⁸ Wu, K.; Liu, J.J.; Adams, W.; Sonn, G.A.; Mach, K.E.; Pan, Y.; Beck, A.H.; Jensen, K.C.; Liao, J.C. Dynamic Real-time Microscopy of the Urinary Tract Using Confocal Laser Endomicroscopy. Urology, 2011
⁹ Adams, W.; Wu, K.; Liu, J.J.; Hsiao, S.T.; Jensen, K.C.; Liao, J.C. Comparison of 2.6- and 1.4-mm Imaging Probes for Confocal Laser Endomicroscopy of the Urinary Tract. Journal of Endourology, 2011
¹⁰ Sonn, G.A.; Jones, S.-N.E.; Tarin, T.V.; Du, C.B.; Mach, K.E.; Jensen, K.C.; Liao, J.C. Optical biopsy of human bladder neoplasia with in vivo confocal laser endomicroscopy. The Journal of Urology, 2009.