Medical Device Daily European Editor and Staff Reports

In the increasingly crowded competition for in vitro diagnostics, bioMérieux (Marcy l'Etoile, France) is fighting hard to hold its place as the world's seventh-ranked supplier against muscular competition such as market leader Roche Diagnostics (Basel, Switzerland/Indianapolis) or the new market entrant, Siemens Healthcare Diagnostics (Tarrytown, New York), based on Siemens' acquisition of the former Bayer diagnostics unit, which took less than a year to acquire enough companies to rank second in sales.

Seven new product launches by bioMérieux this year and two more acquisitions kept sales better than even, with 1.9% growth in the first half of the year at €528.2 million ($760 million).

The acquisition of AB Biodisk (Stockholm, Sweden) beefed up bioMérieux's capabilities across the board for research, product development and manufacturing, as well as what the company called "very profitable" sales of €13 million ($18.7 million). (Medical Device Daily, June 19, 2008).

With the more recent $60 million acquisition of AviaraDx (San Diego) earlier this month (MDD, Sept. 12, 2008), bioMérieux doubled down its bet on a strategy it calls "theranostics," in honor of the long-term vision of Dr. Christophe Mérieux for personalized, predictive medicine linking diagnostics with therapies.

Also called "tailored therapy" and "translational medicine" by the pharmaceutical industry, Mérieux's disruptive vision is beginning to play out in the marketplace, with bedside tests becoming linked as companions for drug therapies to measure their efficacy.

Taking on AviaraDx does not add to bioMérieux's muscle, nor boost its market position — in fact, the company is expected to produce an $8 million loss this year for its new owners on what are described as "limited sales."

But with a unique molecular technology for classifying tumor tissue in massive market segments for metastatic cancer where the origins of the cancer are unknown, and for breast cancer, AviaraDx does bring to life the theranostics vision and the first go-to-market products.

AviaraDx, with its 19 employees, will be reorganized as an independent legal entity called bioTheranostics.

In the new company, AviaraDx will join with bioMérieux's 12-person theranostics business unit created earlier this year in Cambridge, Massachusetts (MDD, Feb. 14, 2008).

Stéphane Bancel, CEO of bioMérieux, said the new bioTheranostics "should have limited sales until 2012 and break even around that year," consistent with the company's long-term strategic goals and financial objectives.

Richard Ding, who as vice president of the theranostics group moved up to become CEO for the new bioTheranostics unit, told MDD that there already are cancer therapies that cannot be applied without companion diagnostics and he expects these linked tests will become a requirement from the FDA.

"But it will take time for this market to materialize," he added.

Traders on the Euronext exchange in Paris greeted the company's news with an 8.6% loss on the stock across three successive sessions.

Placement draws $8.3M to CMA

The CMA Microdialysis (Solna, Sweden) subsidiary of Skanditek (Stockholm, Sweden) has completed a private placement of new shares amounting to SEK 56 million (about $8.3 million) from Investor Growth Capital, a subsidiary of Investor AB.

Within a period of three years, CMA's board of directors will have an opportunity to arrange an additional private placement in an amount of SEK 14 million.

CMA will hold an extraordinary general meeting on Oct. 16.

Prior to the private placement, Skanditek's shareholding in CMA amounts to 77.95%. Following implementation of the private placement, Skanditek's shareholding in CMA will be reduced to 49.93% and CMA will switch from being a Skanditek subsidiary to an associated company.

CMA is a pioneer within organ diagnostics and tissue chemistry monitoring. The company's medical devices are used in intensive care across the globe to monitor biochemical processes in organs such as the brain, liver and abdomen. The unique technology provides opportunities to detect changes in organ chemistry, thereby predicting the onset of complications and disease processes.

The company was founded in 1984.

Skanditek is an industrial holding company with investments in Swedish companies. The portfolio comprises nine investments in the electronics, biomedical technology and services sectors.

CMA was awarded a large grant from VINNOVA, the Swedish governmental agency for innovation systems, in 2007. The grant has enabled the development of a new technical platform offering the opportunity for real-time monitoring of blood glucose and other metabolic markers.

"The aim of the growth capital is to accelerate our efforts to develop a new real-time system for monitoring metabolic markers, including blood glucose. Our vision is to offer real-time solutions that can streamline the many manual routines of modern intensive care by delivering quicker and more accurate clinical decisions," said CMA president/CEO Philip Siberg.

The aim of the growth capital is to accelerate CMA's growth plans and to prepare for a future international roll-out of the company's new technology platform.

As a part of the intensified growth agenda, CMA will simultaneously invest SEK 27.5 million ($4.1 million) in the affiliate company, Dipylon Medical.