Mauna Kea Technologies
Cellvizio’s in Vivo Microscopic Images Depict Easily-Recognizable Features of Malignant and Benign Tissues in Bile and Pancreatic Ducts

Mauna Kea Technologies / 

23.11.2009 

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Preliminary Data From International, Multi-Centric Registry Presented During an
Oral Presentation at GASTRO 2009 

LONDON, Nov. 23, 2009 (GLOBE NEWSWIRE) -- Clinical investigators have defined a
series of descriptive criteria which may improve how physicians interpret
confocal microscopic images of tissue inside the bile and pancreatic ducts with
Cellvizio(R), the world's smallest microscope. These findings are a result of
the preliminary results of a multi-centric international registry study
presented today during an oral presentation at the GASTRO 2009 conference,
taking place in London, England from November 21-25. The investigators are
currently evaluating those unique features on the larger set of data from the
study to determine the predictive value of the criteria in determining
malignancy. 

'The tiny Cellvizio mini-probe easily fits into narrowing bile and pancreatic
ducts and offers us clear, reproducible microscopic images with definable
features of this suspicious tissue for the first time,' said lead investigator
Yang Chen, MD, FACP, FACG, Clinical Practice Director of the Division of
Gastroenterology and Director of Endoscopy, the University of Colorado
Hospital, Aurora, Colorado. 'Once the full data analysis is complete, we will
have a much greater understanding of how to properly interpret these in vivo
microscopic images, so we can differentiate malignant from benign tissues in
real time. Ultimately, we believe this new imaging tool will help us identify
and treat patients with pancreaticobiliary disease more quickly and
effectively, which is crucial given how fast pancreatic and bile duct cancers
advance.' 

Tissue sampling techniques traditionally used to diagnose pancreatic or bile
duct cancer are associated with low sensitivity, around 50 percent, which means
nearly one out of two cancers are missed in this difficult to image area. 

The Cellvizio ERCP registry study was a longitudinal registry of patients
undergoing Endoscopic Retrograde Cholangiopancreatography (ERCP) imaging
procedures to investigate whether their bile and/or pancreatic ducts had
narrowed into strictures because of cancer or inflammation. In this study, the
Cellvizio mini-probe was used along with the ERCP procedure to offer physicians
a microscopic-level view of the tissue lining these ducts so they could
identify and document suspicious lesions, rather than take random tissue
samples. A follow-up period of one year was included in the study to confirm
negative findings. 

In this preliminary analysis, 77 patients with indeterminate strictures in
their bile or pancreatic ducts underwent an evaluation with the Cellvizio
system during ERCP. Physicians were able to insert the mini-probe through a
catheter or a cholangiopancreatoscope (CP) in all 77 patients. At the time of
this presentation, 42 of the patients either had tissue confirmed malignant or
had undergone a follow-up exam showing benign tissue more than three months
after the initial procedure. 

'We are encouraged by these interim results as we believe Cellvizio(R) is
aiding physicians in identifying the cause of the stricture that is seen in the
bile duct, and the interpretation criteria presented should help in documenting
their diagnosis,' said Sacha Loiseau, Founder, President and CEO of Mauna Kea
Technologies. 'We are committed to realizing Cellvizio's potential in ERCP
clinical practice through our efforts to offer physicians an effective tool
that complements current practice and that may improve how they diagnose and
determine treatment for pancreaticobiliary and other gastrointestinal
diseases.' 

Three additional United States (U.S.) sites (Beth Israel Deaconess Medical
Center, Boston; New York Presbyterian Hospital/Columbia University Medical
Center, New York; University of Pittsburgh Medical Center, Pittsburgh) and two
European sites (Klinikum rechts der Isar, Munich, Germany; Insitut
Paoli-Calmettes, France) are participating in the study, which ultimately
enrolled 130 patients. Enrollment closed in early October, but follow up
continues in the study and full results will be announced at a later date. This
study was conducted under local IRB approval at each participating center, and
each patient included in the study provided adequate informed consent. 

About Pancreatic Cancer: 

Pancreatic cancer is a disease in which malignant (cancer) cells are found in
the tissues of the pancreas. Depending on the extent of the cancer at the time
of diagnosis, the prognosis is generally regarded as poor; less than 5 percent
of those diagnosed are still alive five years after diagnosis. Estimated new
cases and deaths from pancreatic cancer in the U.S. in 2009: New cases: 42,470;
Deaths: 35,240. In the United Kingdom (UK), pancreatic cancer is the fifth most
common cause of cancer death. In 2007, more than 7,700 people in the UK died
from pancreatic cancer. Worldwide, more than 230,000 people were diagnosed with
pancreatic cancer in 2002, that latest year that worldwide statistics are
available. 

About Cholangiocarcinoma: 

Cholangiocarcinoma is a cancer of the bile ducts, which drain bile from the
liver into the small intestine. Cholangiocarcinoma has an annual incidence of
1-2 cases per 100,000 in the Western world, but rates of cholangiocarcinoma
have been rising worldwide over the past several decades. 

About Mauna Kea Technologies and Cellvizio: 

Mauna Kea Technologies believes that in continuously pushing the limits of
observation of life and by helping physicians design new medical references and
guidelines, it can improve patient care and reduce healthcare costs. Its
flagship product, Cellvizio(R), is the world's smallest and most flexible
microscope and the first system designed to provide live, real-time images of
internal human tissues at the cellular level during endoscopic procedures. This
new, advanced imaging technique helps physicians more effectively assess the
tissues of interest and differentiate normal versus abnormal tissues that may
be indicative of cancer, so patients potentially can be treated earlier and may
undergo fewer biopsies. Physicians and thought leaders at more than 60 top
medical institutions around the world have completed over 3,000 of these
procedures and have published more than 25 peer-reviewed papers on the
technology in medical journals. Cellvizio has premarket notification 510(k)
clearance from the United States Food and Drug Administration and the European
CE-Mark for use in the gastrointestinal and pulmonary tracts. For more
information visit www.maunakeatech.com. 

CONTACT:  Lazar Partners
          Media Contact:
          Erich A. Sandoval
          917-497-2867
          esanodval@lazarpartners.com

News Source: NASDAQ OMX



23.11.2009  Financial News distributed by DGAP. Media archive at www.dgap-medientreff.de and www.dgap.de

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Company:      Mauna Kea Technologies
              
               
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