Medical Device Daily and Staff Reports

Tyco International (Pembroke, Bermuda) completed its acquisition of Florèane Medical Implants (Trèvoux, France) last week by filing notice of a compulsory minority buyout offer.

Shares were suspended from trading on the Euronext exchange in Paris on Sept. 6, awaiting the formal announcement by Tyco Healthcare Trèvoux (also Trèvoux) with the French financial regulatory authority, Autoritè des Marchès Financiers (AMF), which was filed on Sept 21.

Investors still holding the 62,141 shares that Tyco had not acquired until this final offer gained €1.50 ($2.10) over the buyout price of €30 ($42), offered in 2005 (Medical Device Daily; Sept. 23, 2005).

The value of the acquisition at 2005 currency values, when the largest transaction took place, was $145 million (€120 million).

Tyco said it now holds 98.4% of the capital in Florèane, and the company’s listing will be removed from the stock exchange.

Florèane designs sophisticated implants for abdominal wall reinforcement and reconstruction, as well as for urological and gynecological surgery.

The company holds a portfolio of some 70 families of patents, including Parietex, a dual-sided mesh fixation device that is absorbed by the body over 12 months. The intent is to minimize tissue trauma while providing mechanical properties equivalent to metal mesh.

New Florèane products include Uretex for the treatment of female stress urinary incontinence and Pariefix, a laparoscopic mesh fixation.

General surgery products account for about 78% of company sales, with urology and gynecology making up the remainder.

Some Florèane products are manufactured by a subsidiary company, Sofradim (Trèvoux), which manages the entire product catalog and distribution.

Florèane reported 2006 sales of €33 million ($46.2 million) and generated net income of €3 million ($4.2 million). European sales generated 82% of revenues, and the U.S. accounted for 17% of sales.

New diabetes care guideline issued

The International Diabetes Federation (IDF; Brussels, Belgium) has issued a new guideline for diabetes care that includes the management of post-meal glucose. The guideline emphasizes that people with diabetes should have their blood glucose levels closely monitored after meals in order to improve diabetes control and reduce complications, particularly cardiovascular disease.

IDF, an umbrella organization of more than 200 member associations in 160 countries, said this new approach will assist in developing effective strategies for managing diabetes. The new evidence-based global guideline was unveiled last week at the annual meeting of the European Association for the Study of Diabetes (EASD).

The guideline recommends that people with diabetes try to keep post-meal blood glucose levels to less than 7.8 mmol/l (140 mg/dl) two hours following a meal, a timeframe which conforms to guidelines published by most of the leading diabetes and medical organizations.

The guideline offers a series of recommendations identifying how diabetes care could be optimized. Topics addressed in the guideline include post-meal hyperglycemia, treatment strategies and regimens, self-monitoring of blood glucose, and non- pharmacologic and pharmacologic therapies.

“Diabetes is now recognized as one of the largest epidemics humanity has ever faced and a leading cause of death,” said Professor Stephen Colagiuri, chair of the IDF Task Force on Clinical Guidelines. “It accounts for 3.8 million deaths per year, many of which are related to cardiovascular disease.”

Until recently, a key recommendation for good diabetes management was to lower fasting or pre-meal blood glucose levels, but recent studies suggest a link between post-meal glucose control and improved outcomes in people with diabetes. Existing global guidelines do not include the management of post-meal glucose.

The guideline also includes the 1,5-anhydroglucitol blood test, GlycoMark, and continuous glucose monitoring as emerging technologies for measuring post-meal glucose.

GlycoMark is an FDA-approved test for monitoring intermediate glycemic control by measuring the levels of a monosaccharide 1,5-anhydroglucitol (1,5-AG) in blood. Studies have shown that the 1,5-AG test is a specific index of postprandial hyperglycemia (elevated after-meal glucose levels) and short-term glycemic control — providing a useful complement to A1C testing.

GlycoMark is being used in clinical practices and is available at major reference laboratories, including Quest Diagnostics, LabCorp, Esoterix, Mayo Medical Laboratories, ARUP Laboratories and Specialty Laboratories.

In a study published in the journal Diabetes Care, the GlycoMark test reflected after-meal glucose levels more robustly than the A1C test. The study also showed that GlycoMark was able to reveal dramatically different after-meal glucose levels in patients with similar A1C levels.

GlycoMark is being commercialized by a partnership between Toyota Tsusho America (New York), Nippon Kayaku (Tokyo) and the BioMarker Group (Kannapolis, North Carolina), with product activities centered in the North Carolina Research Campus in Kannapolis.

CSO named for Cardio BioSciences

Cardio BioSciences (Braine L’Alleud, Belgium) reported the appointment of Vinciane Gaussin, PhD, as chief scientific officer. She previously was an assistant professor in the department of cell biology and molecular medicine at the University of Medicine and Dentistry of New Jersey since 2000.

The addition of Dr. Gaussin to our management team represents an important milestone in our mission to position Cardio BioSciences as a global leader in the field of regenerative therapies for heart failure,” said CEO Christian Homsy, MD.

He added: “Over 20 million people worldwide suffer from chronic heart failure, but in spite of the aggressive approaches used to treat heart patients, no effective means are available to repair a damaged heart — yet. Fortunately, the regenerative potential of stem cells guided toward a cardiac lineage are expected to change this scenario, and we are looking forward with great anticipation to our first-in-man procedure scheduled for the first half of next year.”