Medical Device Daily and Staff Reports

Building on its installed base for point-of-care immunoassays, bioMérieux (Marcy l’Etoile, France) reported the European launch of a test using its VIDAS emergency panel that helps the diagnosis and prognosis of heart failure.

The U.S. launch is expected to follow in six months pending FDA 510(k) clearance.

A CE-marked test developed through a licensing agreement with Roche Diagnostics (Basel, Switzerland), the N-terminal pro-B-type natriuretic peptide (NT-proBNP) is a quantitative marker of heart stress providing diagnostic information to help distinguish congestiveheart failure from other disease states with similar clinical symptoms, such as lung disease or pulmonary embolism.

NT-proBNP also can be used to assess the prognosis of patients with established heart failure or acute coronary syndrome, and according to bioMérieux, it also has the potential to detect early stages of heart failure in the absence of clinically obvious symptoms.

BNP is secreted by the left ventricle when the heart is unable to pump blood efficiently, as in the case of a heart failure. The bioMérieux-Roche test is cleaved from the precursor protein proBNP in quantities directly proportional to its biologically active counterpart BNP and in close correlation with the severity of heart failure.

Citing a Canadian study for routine assessment of emergency department patients with dyspnea that reported a reduction in direct medical costs of 15% or $949 per patient, bioMérieux said its NT-proBNP measurement could lead to important healthcare cost-savings.

Heart failure is the leading cause of hospitalization in people over 65 years of age, affecting up to 17 million people worldwide, and has become a major healthcare cost issue expected to continue to rise in the coming years due to the worldwide aging population and increased survival rate from acute coronary events.

In April 2005, Roche granted a nonexclusive license agreement to bioMérieux relating to the development, manufacturing and marketing of immunoassays linked to the BNP biomarker.

This is the third launch of a VIDAS menu extension year-to-date, according to bioMérieux CEO Stéphane Bancel. The VIDAS franchise figures prominently in bioMérieux’s strategy, saying it hopes to leverage the installed base of 20,000 units to boost growth.

In June, 2007 bioMérieux reported immunnoassay revenues for the first half of 2007 were up only 1% at €143 million ($202 million) and the company reported a slow take-up of VIDAS routine tests.

In 2006, bioMérieux revenues reached €1 billion ($1.41 billion) with 83% of sales generated outside of France.

French firm seizes Wavelight Aesthetic opportunity

The break-up of Wavelight AG (Erlangen, Germany) took a new turn last week when the German optical laser manufacturer reported that it is selling its spin-off unit, Wavelight Aesthetic (Erlangen), to Quantel (Les Ulis, France).

Quantel, a specialist in laser technologies that derives nearly half of its sales for medical-related devices, has been struggling with slowing sales and delayed product deliveries and found itself scrambling to raise the financing needed to seize the opportunity presented in the Wavelight unit.

Quantel found the €7.6 million ($10.7 million) required to move on the deal by using a French bond called OCEANE (obligation convertible échangeable en action nouvelle ou existante ), which purchasers can convert into shares of the company.

Wavelight reported the agreement for the acquisition on Sept. 19, according to terms that were to be concluded by Oct 1.

A portion of the purchase of Wavelight by Quantel is fixed at €4.6 million ($6.5 million) and the remainder will vary according to Wavelight Aesthetic’s performance, though Quantel will not be required to pay greater than €1.5 million ($2.1 million), bringing the total acquisition cost to €6.1 million ($8.6 million).

Quantel CEO Alain de Salaberry said the Wavelight unit will be merged with Quantel Medical to create a Dermatology Division that is expected to generate sales of €20 million ($28.2 million) in 2008.

Wavelight reported at the end of July annual sales of €10 million ($14.1 million) while Quantel’s Medical division reported €7.4 million ($10.4 million).

Wavelight agrees to continue manufacturing certain laser units for Quantel over the next 18 months, and Quantel agreed to keep the current Wavelight esthetic management team in place

Combining the two companies’ products lines creates more covergence than conflict, said de Salaberry, adding he expects strong profitability in what he characterized as a “very large and fast-growing market.”

An analyst with Investir France said that 2007 should have been the year for big growth in profitability for Quantel with the introduction of new dermatology lasers but results instead have been “very disappointing,” with a 27% drop in net income reported mid-year. The price of the stock has steadily declined from €26 ($36) in February to €20 ($28.2) at the end of September.

News of the Wavelight acquisition budged the stock upward by 70 cents.

Located in France and the U.S., through its Big Sky Laser (Bozeman, Montana) subsidiary, Quantel generated €19.6 million in 2006 sales, with 81% credited to international markets, split between scientific, industrial and medical applications for lasers.

New Austrian hospital buys Elekta systems

Elekta (Stockholm, Sweden) reported signing an agreement with Vöcklabruck Hospital in Austria that includes supplying a new oncology department with fully digital image-guided radiation treatment systems, as well as software for networking, information management and treatment planning.

The 10-year agreement is valued at about 15 million.

Vöcklabruck Hospital is a newly built facility declared one of the most modern in Europe.

Two Elekta Synergy systems will be installed at the hospital’s new radio-oncology department in the spring of 2008.

The hospital also will use Mosaic electronic medical records developed by Impac Medical Systems, patient fixation and positioning technology developed by Medical Intelligence and treatment planning software from 3D Line. All three companies are part of the Elekta Group.