Diagnostics & Imaging Week International Editors

Mauna Kea Technologies (Paris) closed a $30 million financing round led by U.S.-based Psilos Group to expand commercialization of its Cellvizio endomicroscope, primarily in the American market.

The funding from Psilos, which specializes in medical technology with over $500 million in investments, inspired the French-based investment fund Seventure and the original investor in Mauna Kea, Creadev, to also up their stakes in this third financing round for the company.

Cellvizio was launched commercially in the U.S. market during Digestive Disease Week in May 2007 and Mauna Kea founder and CEO Sacha Loiseau told Diagnostics & Imaging Week the privately held company will report €3 million ($4.5 million) in sales for the past year.

Approved for gastroenterological and pulmonary procedures, the Cellvizio GI and Cellvizio-Lung provide cellular level images of potentially cancerous tissue in real time through a one millimeter probe inserted in the working channel of any endoscope.

The microscopic view of cells is displayed on a screen in the operating theater adjacent to the endoscope’s macro view allowing a clinician to perform what is called an “optical biopsy” of suspect tissue; thereby significantly reducing the number of tissue samples extracted for lab analysis from an average of 24 to half a dozen.

During the U.S. funding road show in 2007, Cellvizio was the subject of studies published in the November issues of both Clinical Gastroenterology and Hepatology and Gastrointestinal Endoscopy.

In an editorial covering two of the studies, Kenneth Wang, MD, of the Mayo Clinic (Rochester Minnesota) said as the wave of diagnostic endoscopy wanes, micro-endoscopy reported the “dawning of the age of the endoluminal gastroenterologic surgeon.”

One of the studies led by Thomas Wang, MD, PhD, of Stanford University (Stanford, California) concluded “confocal imaging using Cellvizio GI (gastrointestinal) can be performed in vivo to assess the functional behavior of tissue in real time for providing pathologic interpretation, representing a new method for histologic evaluation.”

A second study led by Alexander Meining, MD, from Klinikum rechts der Isar (Munich, Germany) tested the accuracy of Cellvizio GI images with traditional biopsy results, comparing tissue analysis with 119 video sequences of both normal and neoplastic areas.

The pathologist and gastroenterologist found 92% agreement for accuracy, sensitivity and specificity for the real-time optical biopsy versus the delayed lab results.

Mauna Kea has renamed its U.S. operations Cellvizio Inc., and will move from Boston to Philadelphia in 1Q08.

The company expects to maintain direct distribution of its two approved products in the U.S., as well as in the larger European markets of France, Germany, Spain and the UK. Mauna Kea has a distributor in Italy and Loiseau told MDD that distributors will likely be sought for smaller European markets and Asian markets.

A tabletop version of Cellvizio for research labs is sold by Leica Microsystems (Wetzlar, Germany) in the U.S., Japanese and European markets.

Loiseau said the third funding round also will enable Mauna Kea to expand clinical trials to reinforce the patient benefits of optical biopsy, and will allow exploration of new clinical applications.

The competing commercially available confocal endomicroscope is from Pentax (Tokyo) based on technology developed by Optiscan Imaging (Victoria, Australia).

Loiseau said Cellvizio holds a competitive advantage with a probe independent of a specific endoscopy line and a miniaturization that allows penetration to areas where clinicians have never seen cellular activity in vivo, including alveoli in the lungs and exploration of mucosa of the small bile duct.

Mauna Kea’s market lead could stretch to six years, said Loiseau, noting that is how long it required for the company to move from start-up to approval of its technology by the FDA.

bioMérieux boosts sales by 8% in 2007

Strong 4Q instrument sales helped bioMérieux (Marcy L’Etoile, France) finish 2007 with a 7.4% increase in sales from organic growth and an additional 0.5% growth in sales due to acquisitions.

Total sales for this growing giant in in vitro diagnostics were €1.06 billion ($1.59 billion) a bare 2.5% greater than 2006 due to unfavorable exchange rates against with a strong Euro worldwide.

Using a like-for-like method for measuring sales to exclude effects of expansions, acquisition and other events, bioMérieux showed a 10.2% increase in North American sales, for example, where pure reporting of sales revenues showed a decline of 2.3%.

All regions of the world showed organic growth like-for-like in 2007, with Asia-Pacific reporting a 12% increase and the region embracing Europe, the Middle East and Africa (EMEA) reporting a 5.6% increase.

Discounting a modest growth in France, the rest of the EMEA region turned in an overall increase of 7.8%, chiefly in Germany and the UK.

Competition in Europe continued to be aggressive in microplates and the immunoassay lines edged up only slightly. The strong growth came from clinical applications of bacteriology lines, significantly with Vitek 2, and molecular biology products. Sales of industrial applications were up by 7.8%.

bioMérieux reported its Vidas line returned to growth, lifted by sales of the Vidas Brahms PCT and other medical assays.

In North America, gains were driven by the bacteriological and molecular biology lines. For industrial applications, the company credited a 14.4% growth to the strong start for Tempoand sustained growth in the Vitek 2 lines and the BacT/Alert sterility control reagents.

The FDA granted 510(k) clearance in the fourth quarter for the Vidas Brahms PCT, making bioMérieux first to market in the U.S. with an automated test for procalcitonin (PCT), a biomarker for severe sepsis and septic shock used to screen patients admitted to intensive care units.

Eroding the reporting of annual performance was a “currency effect” that cost bioMérieux €29 million ($43.5 million) and the €44 million ($66 million) impact of divesting its hemostasis business and discontinuing in North America microplate immunoassays operations.

The second half of 2007 saw a sustained business demand and bioMérieux said its installed base grew by 3,800 new instruments placed with customers, to 49,000 systems worldwide.

The company said it expects to sustain its current growth rate into 2008 and said that including new business development agreements it could reach an 8.5% increase.

The week previous bioMérieux reported a strategic agreement with Quidel (San Diego) to become the primary distributor outside the U.S. for QuickVue rapid diagnostic point-of-care tests. Japan and Scandinavia also were excluded from the distribution agreement.

The two companies said they also will co-develop new rapid tests in the area of infectious diseases by combining Quidel’s rapid test development capability and bioMérieux’s library of antibodies and antigens.

Quidel’s product line includes tests for the diagnosis of influenza, respiratory syncytial virus, fecal occult blood, Strep A, pregnancy, bacterial vaginosis, H. pylori and chlamydia.

bioMérieux has more tan 1,900 sales, marketing and service representatives in 150 countries worldwide.

In another development, Agence France Press (AFP) on Jan 22 reported Merck & Co. signed an agreement with bioMérieux to co-develop an immuonassay test for infectious disease that is promoted as a “theranostic” test by bioMérieux. No financial information about the agreement was reported.

Theranostic tests are a convergence of diagnostics with drug therapy where levels of measured analytes can predict a patient’s probable reaction or success with the therapy, allowing a more personalized drug therapy to be applied, and then measured again.

“Theranostic is a new business unit for us that we really believe in,” Stéphane Bancel, chief executive of bioMérieux, told AFP. He said he has formed a research and development team of a dozen people to focus on the Merck project.

In September, bioMérieux signed an agreement to develop a theranostic test for breast cancer with the French pharmaceutical firm Ipsen (Paris).

FDA licenses French firm’s blood assays

The FDA licensed 14 new tests for determining a person’s blood type, a process termed essential to a safe U.S. blood supply and safe transfusions. The tests are manufactured by Diagast (Loos Cedex, France).

“These 14 new tests will provide blood establishments and transfusion services with additional choices to help assure safe, well-matched transfusions,” said Jesse Goodman, MD, director of FDA’s Center for Biologics Evaluation and Research. “The tests offer a broader diversity of reliable blood-typing tests and will help protect against product shortages.”

Knowing the blood types for blood donors and patients is critical, FDA said. Patients may experience serious, possibly life-threatening reactions from mismatched transfused blood. The most familiar blood types are A, B, O, and Rh.

The Olympus PK System Blood Group and Phenotyping Reagents use monoclonal antibodies to test for the A, B, O, and Rh factors as well as for other factors that signify a rarer blood type.

Adept secures foothold in European markets

Adept Technology (Livermore, California) acquired privately held Cerebellum Automation (Chavanod, France), a specialist in robotics and motion-control solutions for the medical imaging and medical packaging. Adept will purchase all outstanding shares of Cerebellum for a total estimated at $1.2 million over two years.

The French start-up, founded in 2004, has built a strong base of manufacturing customers in France and Western Europe. Adept was eager to acquire the company’s product CIDE, a robotic and motion-control software development package, and ApproFlex, a feeding and small-part-handling system designed for manufacturers.

“Cerebellum complements our strong position in Germany and gives us a greatly expanded footprint in the French automation market, which is the third-largest in Europe,” said Adept CEO Robert Bucher.

Med-tech manufacturers using Cerebellum motion control architecture for medical imaging products include Sanmina-SCI (San Jose, California), Stereotaxis (St. Louis) and the European diagnostic imaging division of GE Healthcare (Waukesha, Wisconsin).

For three years Cerebellum has developed products for use under Adept strategic alliances that targeted new markets and applications for the U.S. firm’s automation controller platform.