Medical Device DailyContributing Writer
and Staff Reports

While the European Union agonizes over whether to allow stem cell research and how to regulate innovative therapies, the European parliament is now preparing to cast a shadow over a further high-technology approach to medicines development.

In September the European Parliament (Brussels, Belgium) will vote on nanosciences and nanotechnologies - and the preparatory debates in the parliament's committees suggest caution and constraint - might predominate over enthusiasm and enterprise.

Miloslav Ransdorf, a Czech member of the parliament, has drafted a report on behalf of the parliament's committee industry and research, which emphasizes the need to respect high ethical principles, and recommends taking a precautionary approach to the new possibilities.

Ransdorf, a scientist, is not negative about the prospects for nanomedicine. He describes it as "a promising interdisciplinary domain with breakthrough technologies," capable of offering "impressive benefits for the early diagnosis and smart and cost-effective treatment of diseases such as cancer, cardiovascular problems, diabetes, Alzheimer's and Parkinson's."

But he insisted that while nanotechnology "is leaping technical hurdles," its ultimate success "will depend on winning over consumers." In his view, the novelty of the technology "raises questions about how these new substances will behave in the environment, including the human body," and he warned that public uncertainties about health, safety and environmental effects could restrict investment and prevent companies from launching products involving nanotechnologies. "The coming years will therefore be decisive in demonstrating that researchers and industry take those concerns seriously," he said in presenting his report.

He urged setting up ethical committees to provide independent scientific advice and informing the public to create "awareness of the possible risks and the benefits associated with the use of discoveries in the field of nanotechnologies."

Reader for skin test is approved

Predictive medicine company PreMD (Toronto) said its second-generation spectrometer, or color reader, for the Prevu(x) Point of Care (POC) Skin Sterol Test now has the CE mark.

"The CE mark allows the new reader to be marketed in the European Union," said Dr. Brent Norton, president and CEO. "This stand-alone, portable reader is designed to offer users greater flexibility, which we believe will enhance the market appeal of Prevu(x) POC."

The new reader was developed in conjunction with Boehringer Ingelheim microParts and will be manufactured in the U.S. by Jabil Circuit.

Prevu(x) non-invasively measures the amount of cholesterol (sterol) that has accumulated in the skin tissues, as opposed to blood. No fasting or other patient preparation is required for the test.

The company said clinical studies have shown that as cholesterol accumulates on artery walls it also accumulates in other tissues, including the skin. High levels of skin sterol are correlated with higher incidence of coronary artery disease. Pewvu POC is cleared for sale in Canada, the U.S. and Europe.

PreMD's cardiovascular products, branded as the Prevu(x) Skin Sterol Test, are licensed worldwide to McNeil Consumer Healthcare. The company's cancer tests include ColorectAlert, LungAlert and a breast cancer test.

The company's research and product development facility is at McMaster University (Hamilton, Ontario).

ICON shares priced at $63.50

ICON (Dublin, Ireland) reported the pricing of a secondary offering of 1 million of its American Depositary Shares (ADSs), representing ordinary shares, The shares are priced at EUR 0.06 per share, totaling $63.50 per ADS.

The ADSs being offered represent about 7% of ICON's total issued and outstanding share capital. The ADSs are being offered by Dr. Ronan Lambe, one of ICON's co-founders and a member of its board of directors, and Poplar Ltd., the sole beneficial owner of which is Dr. John Climax, ICON's other co-founder and its chairman.

The company will not receive any proceeds from the offering of the ADSs.

The offering is expected to close on Friday, subject to customary conditions. William Blair & Co. is the sole book-running, lead manager of the offering. In addition, Bear, Stearns & Co. and Jefferies & Co. are co-managers.

ICON is a contract research organization providing clinical research and development services on a global basis to the pharmaceutical, biotechnology and medical device industries. As of June 30, ICON had about 3,600 employees and operations in 45 locations in 30 countries.

T V offers North American-based certification

North American medical device manufacturers now have a faster way of obtaining CE certification for exports to Europe. T V Rheinland Group, a leader in compliance testing and certification, is now offering North American-based CE certification for medical devices, on behalf of the Notified Body T V Rheinland Product Safety.

"Unlike most compliance and certification companies, T V Rheinland of North America [Newtown, Connecticut] now has CE certifiers located within the U.S., which translates to accelerated time to market for companies looking to get their medical devices into the European Union," says Tamas Borsai, manager of the medical division at TUV Rheinland of North America. "Our new CE certification capability, combined with our extensive offering of other global medical device certifications will allow our customers to get efficient one-stop shopping for all of their regulatory needs."

TUV Rheinland of North America is a wholly owned subsidiary of T V Rheinland Group. TUV Rheinland of North America also has offices in Austin, Boston, Chicago, Detroit, Orlando, Portland, Raleigh, San Diego, San Francisco, Toronto and Mexico.