A Medical Device Daily

Metabolon (Research Triangle Park, North Carolina), a company focused on metabolomics–driven biomarker discovery and analysis, reported a collaboration with the European Group for the Study of Insulin Resistance (EGIR; Pisa, Italy).

The EGIR has compiled large numbers of biological samples from studies conducted at 19 clinical research centers across Europe in an effort to understand insulin resistance and how it affects disease. Metabolon will discover and validate the biomarkers found in these samples that relate to insulin resistance. Those markers will be used to help further develop Metabolon's diagnostic test for pre–diabetic patients.

"This collaboration with EGIR will help Metabolon accelerate the development of Quantose IR, our diagnostic test for better screening of pre–diabetic patients," said Dr. John Ryals, president/CEO of Metabolon. "This routine test will help identify pre–diabetic patients years before they become diabetic. With this information in hand, doctors can intervene with lifestyle or drug therapies which may delay or prevent the onset of Type 2 diabetes."

Insulin resistance is estimated to affect about one–third of the adult population in the U.S. alone — about 75 million people. One of the primary contributors to the development of Type 2 diabetes, insulin resistance is characteristically an asymptomatic condition that precedes the development of diabetes by many years.

"We are [pleased] to be working with Metabolon in analyzing our samples," said Dr. Ele Ferrannini, principal investigator at the University of Pisa and coordinator of the EGIR's Relationship between Insulin Sensitivity and Cardiovascular Disease project. This biomarker discovery platform "will give us valuable insight into the biochemical changes related to insulin resistance," he said.

EGIR is a group of investigators with different research backgrounds — epidemiology, endocrinology, basic science and public health — interested in insulin resistance.

Italian distributor for Allium's stents

Allium Medical Group (Caesarea, Israel), a developer of anatomically and functionally compatible, large–caliber, removable, non–vascular stents, said that it has signed an exclusive distribution deal with Italian medical device distributor NGC Medical for both its ureteral and biliary stents. Financial details of the deal were not disclosed.

Allium is exhibiting four new products based on its stenting platform at the European Association of Urology World Congress in Milan this week. They include the Allium ureteral stent, Allium prostatic stent, Allium bulbar urethral stent and Allium bladder–neck stent.

Founded in 2001, Allium develops site–specific stents with applications in the urinary and gastrointestinal tract. It received CE–marking for its biliary and ureteral stents and commenced distribution of its biliary stents as of June 2007 in Italy, Sweden, Germany and Austria.

Dr. Paolo Cremascoli, president/CEO of NGC, based in the Milan area, said that these new Allium stent products are "the first easily removable, self–expandable, large–caliber, fully covered stent family especially designed for use in the urinary and biliary tracts."

He said initial sales were for first insertions at medical centers in northern Italy, and "based on successful results, we are now submitting bids to make the Allium stent widely available throughout Italy."

Dr. Daniel Yachia, president and chief scientific officer of the Allium Group, said, "NGC's support of this new product is testament to their commitment to innovations such as Allium's platform, which can be adapted to suit almost any stent–treatable site. Now every organ can have a stent of its own."

MHRA inspects Biopure's PA plant

Biopure (Cambridge, Massachusetts) reported that the UK's Medicines and Healthcare Products Regulatory Agency (MHRA) completed its inspection of the company's Pennsylvania manufacturing facility.

The company said the inspection report contained no "Critical" or "Major" deficiencies in compliance with good manufacturing practices. The MHRA report identified shortcomings characterized as "Other," with a request for a response detailing the company's corrective actions within 35 working days.

John Tomera, Biopure's director of regulatory affairs, said that the MHRA inspection result "attests to our efforts toward consistently maintaining quality standards. We anticipate being able readily to address all of the issues that were cited."

As previously reported, Biopure has pending with the MHRA a marketing authorization application to market Hemopure in the UK for acute anemia during elective orthopedic surgery where red blood cell transfusion is not available. The plant inspection is a routine part of the application procedure.

No inspection of the company's manufacturing facility in Massachusetts is scheduled at this time or expected to occur before the MHRA next communicates about the pending application, according to Biopure.

The company is a developer of oxygen therapeutics, which are intravenously administered to deliver oxygen to the body's tissues. Its Hemopure [hemoglobin glutamer 250 (bovine)], or HBOC–201, is approved for sale in South Africa for the treatment of acutely anemic surgical patients.

Biopure is developing Hemopure for other indications and is supporting the U.S. Navy's efforts to develop a potential out–of–hospital trauma indication.

New biomedical research center in UK

A new UK biomedical research center, the National Institute for Health Research, has been established in Manchester to drive the development, testing and uptake of new ways to prevent, diagnose and treat ill health.

UK officials said that the creation of this new center recognizes the international research of the partnership between the Central Manchester & Manchester Children's University Hospitals NHS Trust and the University of Manchester.

The new center will focus on "translational research" that takes advances in basicresearch out of the laboratory and into the hospital clinic. "This means that patients will benefit more quickly from new scientific breakthroughs," the Department of Health said in a statement.

UK Health Secretary Alan Johnson said, "Health research is vital for the health and wealth of the nation. We want to create a world–class health research system in which the NHS supports people conducting leading–edge research and gives patients better access to ground–breaking new medicines and treatments."