PARIS — In a future visit to the doctor, a colored bar on a plastic strip may tell you some bad news — that you have colorectal cancer (CRC).
According to the National Cancer Institute (Bethesda, Maryland) in the U.S., any American has a 7% chance of developing colorectal cancer, the second-leading cause of death among of men after lung cancer, and also among women after breast cancer.
That is why CRC screenings are a priority for government health services worldwide, and considerable investments are being made today in developing that plastic diagnostic strip.
Yet the doctor’s office test can only tell you biochemically that tumor-producing activity is taking place somewhere in the digestive tract. Someone needs to go inside and have a look to determine the stage of the development and identify a possible treatment.
While new ingestible camera capsules for less-invasive examination of the gastrointestinal tract are available, there is no substitute in the case of a confirmed cancer for a direct visit with an endoscope that not only returns the best images but also provides a channel to remove tissue samples for biopsy or for direct intervention and treatment.
Two new views of the gastrointestinal tract were on display at United European Gastroenterology Week (UEGW), held in Paris last week, that provide unexpectedly vivid views that only a gastroenterologist could love.
The CellVizioGI endo-microscope from Mauna Kea Technologies (Paris) takes diagnosis up several magnitude with confocal images of cellular activity in mucosa using a laser-pulse tip measuring only 1.5 mm.
The real-time images at 12 frames per second create a video-like effect, enabling in vivo diagnosis of cellular processes. When image contrast is boosted with a chemical agent infused by tissue, the physician can directly identify and observe abnormal cellular activity.
Five medical centers in Europe presented papers at the meeting, with results from novel applications of CellVizioGI including the first-ever in vivo images of cell activity in the bile duct and a scan of the entire lining of the small bowel for 16 patients.
Sasha Loiseau, a former engineer with the National Aeronautics and Space Administration (NASA; Washington), who is the founder and chief executive of the French firm, said the Mauna Kea confocal endo-microscope was designed to “go where no man has gone before, but we did not imagine all the uses doctors might find for it.”
He said the CellVizio GI, which received FDA approval in September 2005, is an enabling technology for optical diagnosis that does not compete with traditional endoscopy.
Less invasive for patients, the technology presents a cost savings opportunity for payers by reducing unnecessary biopsies.
“A physician uses a biopsy forcep, exactly like the dozens of endoscope models displayed here in the expo, by placing it in the working channel of the endoscope,” Loiseau said. Once the tool arrives at the suspected tissue, the physician “randomly removes a dozen tissue samples, perhaps more. It is a hit-or-miss procedure, as he wants to be sure to find any problem tissue.”
He added: “The endo-microscope provides an alternative. Instead of forceps, the physician inserts a fiber cable for an optical diagnosis. This is a tool for people who grew up looking into microscopes and who can easily recognize the hallmarks of abnormal cellular activity in a suspect tissue.”
Loiseau said the device is “intuitive for physicians familiar with endoscopy. They typically need [just] 15 minutes of training before starting to use it.”
To date, just over 600 endoscopic procedures have been performed using CellVizio GI.
Ease of use and “the relevance of what this instrument provides,” will be key factors for the rapid adoption by physicians that Loiseau is banking on for Mauna Kea.
He said the company is marketing directly to clinics and not passing through a distribution agreement for the in vivo models of the endo-microscopes, which include CellVizio Lung, which also has received FDA approval. The clinical benchtop model is distributed exclusively through Leica Microsystems (Wetzlar, Germany).
“The current strategy to directly build an installed base and the relationships with practitioners comes out of the belief that we are the ones who know the technology best and how to promote it,” said Loiseau.
Sixty days ahead of the year-end closing, he said the final sales figure for Mauna Kea may vary “as much as 25%, depending on what agreements we are able to close, but I know we will finish 2007 with net sales above €3 million ($4.5 million).”
Loiseau added that he would be “very disappointed” if sales for 2008 are not double this year’s figure.
To offset the cash burn ahead of the hoped-for profits from sales, he told Diagnostics & Imaging Week that Mauna Kea will see a new round of “significant financing” that he expects to close by Christmas.
“We are ready to step on the gas,” Loiseau said. “This is not like where we were five years ago preparing the product — we are launching.”
Also at UEGW, Olympus (Tokyo), with an estimated 70% share of the market for endoscopes, unveiled what is arguably the highest evolution of its instruments, the Exera II pediatric high-definition television (HDTV) endoscope.
Combined with narrow-band imaging (NBI), the new endoscope displays the sharpest and most detailed images for optical diagnosis of hidden tissue structures in suspicious lesions of the mucosa.
“You are looking at four times greater resolution than traditional endoscopic displays,” said Mirko Feuring, product manager for Olympus Deutschland (Hamburg). “NBI enhances the image even further as it raises contrasts without using chemical agents.”
Exera II Pediatric was designed for children, but is equally effective for adults with stenosis, and at 12 mm, it meets a continual demand by physicians for smaller tips able explore ever more narrow regions.