A BBI Newsletter

Eucomed (Brussels, Belgium), the European medical technology trade association, presented resolutions to the European Parliament last month calling for European Union action to prevent injuries from medical "sharps" and urging regulation of the reprocessing of single-use medical devices. The resolutions were presented during a seminar in Brussels co-sponsored by European Parliament members John Bowis and Minerva Malliori.

Eucomed and several other organizations signed on for the campaign against sharps injuries called on the EU institutions to "communicate clear policy and requirements to Member States in view of ensuring consistent compliance" with existing EU worker safety and health directives among healthcare providers, as well as "safer working practices, including the use of protective clothing, safe disposal and effective response in case of injury."

In a press statement, Eucomed said that injuries caused by needles and other sharp medical devices "remain a major threat to the health and safety of healthcare workers across the European Union today." It added that the "distress, sickness and absenteeism resulting from sharps injuries constitute a considerable strain on the already limited human resources in the medical profession."

Aligned with the med-tech trade group in the sharps campaign are the Standing Committee of Nurses of the EU, the European Dialysis and Transplant Nurses Association/European Renal Care Association, the European Medical Association, the International Alliance of Patients' Organizations, the European Federation of Public Service Employees and the European Institute of Medicine.

On the other issue, that of reuse of medical devices manufactured for single use, Eucomed said the practice "is widespread throughout the EU, presenting significant risks to the health and safety of patients and healthcare workers." The organization has consistently reminded the European Parliament that the EU's Medical Devices Directive does not regulate the reprocessing of single-use devices, although several countries France, Italy, Portugal, Spain, Sweden and the UK have enforced measures against reuse of single-use devices.

Joining that push are the Patients Association, the European Standing Committee of Doctors, the European Medical Association, the International Alliance of Patients' Organizations, the Standing Committee of Nurses of the EU and the European Institute of Medicine.

"Together we call on the EU to regulate all reprocessing of medical devices intended for single use," said the group's statement, which added that a patient "should be clearly told if and when he or she is to be treated with a reused single-use device contrary to the manufacturer's instructions." Such information given to patients also should include the warning that "this may expose the patient to infection and/or device malfunction," the statement said.

Medtronic opens Netherlands facility

Medtronic (Minneapolis, Minnesota) last month opened what it called its "largest and most integrated distribution center in the world" in Heerlen, in the province of Limburg, the Netherlands. "This new distribution center increases our capabilities to provide lifelong solutions to people with chronic disease at any place, at any time," said Hans Wijnands, vice president, Medtronic Benelux and Nordic.

More than 30,000 medical devices are sent each day from Heerlen to all over Europe, the Middle East, Africa, Asia, Canada and Latin America.

Consisting of more than 30,000 square meters, the facility distributes sophisticated medical devices such as pacemakers and defibrillators to provide therapy for cardiac disease, neurostimulators to treat Parkinson's disease patients, and pumps that help to control insulin levels of diabetes patients.

Medtronic said it chose the Trilandis business park in Heerlen for the distribution center "because of its central location in Europe, the excellent infrastructure and the presence of a highly qualified workforce in the region." More than 700 people work in the new Medtronic building in Trilandis, making the company one of the largest employers in the area. In total, the construction of the building involved an investment of more than EUR 30 million.

Next to the distribution center, another building houses Medtronic's Benelux and Nordic regional sales organization, and the European Information Technology and Financial Shared Services Center. The Financial Shared Services Center serves the financial needs of Medtronic on a European level.

Medtronic has two other major operations in the Netherlands. The Bakken Research Center in Maastricht employs about 160 scientists, researchers and technical experts, who work with medical specialists to develop new therapies and perfect existing therapies. Vitatron, an independently operating manufacturer of pacemakers, is established in Arnhem and is Europe's No. 2 pacemaker manufacturer. Vitatron has been a subsidiary of Medtronic since 1986.

Cytyc test to be basis of Scottish program ...

The Scottish Cervical Screening Program has selected Cytyc's (Boxborough, Massachusetts) ThinPrep Pap Test as the new technology for total conversion of all cervical screening centers in Scotland, the company said last month. The contract with Cytyc UK (Crawley, UK) is for five years, with a commitment to full conversion in Scotland by March of next year.

The Scottish Health Minister announced a year ago this month that Scotland would invest in the Scottish Cervical Screening Program to implement liquid-based cytology. That decision was based on the results of a multi-site pilot study conducted at four hospital screening centers in Scotland. The ThinPrep Pap Test was the exclusive liquid-based method used at each screening site.

Results of the pilot study, according to a Cytyc statement, showed a reduction in the number of unsatisfactory and inconclusive tests, an increase in the detection of high-grade cervical lesions and increased laboratory productivity as compared to the conventional Pap smear.

Some 400,000 women participate in the Scottish Cervical Screening Program annually.

... positive results seen in UK study

The initial report to the UK Department of Health on a pilot study evaluating liquid-based cytology (LBC) for cervical cancer screening indicated positive results in disease detection, specimen adequacy, lab productivity and cost-effectiveness, according to the two U.S. companies supplying the tests used in the study. The report evaluated a number of factors, including disease detection, specimen adequacy, productivity, and cost-effectiveness.

Cytyc's ThinPrep Pap Test is being used at two of the sites in the study and TriPath Imaging's (Burlington, North Carolina) SurePath Liquid Based Pap Test is being used in a third site.

The report, posted last month on the National Cancer Screening Program's web site, summarized results from the first six months of a 12-month pilot study. Besides showing "significant increases" in the detection of moderate and severe dyskaryosis compared to the conventional Pap smear, the study also reported that for all sites combined, there was an 82.7% reduction in the rate of inadequate smears in the six-month pilot period.

Regarding laboratory productivity, the pilot study indicated that "productivity of laboratories increased with LBC because 9% more slides can be primary screened per hour" and that "LBC has resulted in a reduction in the backlog of smears at laboratories, and hence in reporting times of smears." According to the interim report, the cost-effectiveness analysis found that "LBC is cost-saving across both technologies."

The pilot studies are not designed as a comparison of the different technologies, according to the National Cancer Screening Program.

Gambro shifts monitor development work

Gambro AB (Stockholm, Sweden) has unveiled a plan to strengthen development of monitors within its renal products business. Development responsibility and resources for hemodialysis monitors will be shifted to existing development units in Medolla, Italy, from Lund, Sweden, while responsibility and resources for development of renal intensive care monitors will be transferred to Lund from Medolla.

Gambro said the development units in Lund/ Malmo, Sweden would have a continued responsibility for machines (cyclers) in the peritoneal dialysis area as well as for water treatment systems.

In announcing the changes, Gambro said the actions would enable Gambro Renal Products "to more efficiently develop and launch new products." It said the refocusing of capabilities and resources will leverage on joint technology platforms and "will strengthen its competitiveness and leading position on the world market." Gambro said that it has made "major investments" in recent years to strengthen the overall competitiveness of Gambro Renal Products, including expansion of production capacity for dialyzers and dry concentrates, along with an entirely new logistics system in Europe.

The announced changes in the hemodialysis monitor area will take place from 2003 through 2005 and will involve elimination of between 25 and 30 white-collar positions in Lund this year. The move of development work in the renal intensive care area to Lund is expected to be completed by the end of next year.

CellFactors seeking to advance Skeletex

Privately-held CellFactors plc (Newport, Wales) is setting out to raise 3.5 million from the issue of 70 million new shares at 5 pence per share to advance its Skeletex bone repair product and license it out to orthopedic and dental companies. The company's shares are not traded publicly, but the 5 pence price is at a discount to previous funding rounds.

Paul Bailey, CEO, said, "It is a very difficult climate for businesses in our sector to raise money. The price is very sensible given the market sentiment towards biotech, but very frustrating for us." In July, the company launched an ultimately unsuccessful offer to raise 8 million ($12.6 million). Before that, it raised 4.2 million, with much coming from private investors rather than venture capitalists. 1.125 million has already been committed to the current funding round, comprising a 1 million investment from a private individual and 125,000 from members of CellFactors' board.

Following last year's failed fundraising, Bailey joined CellFactors as chief operating officer from the Safeway supermarket chain, with a plan to develop a more commercial strategy. He became CEO in January, replacing Iain Cubitt, who left the company. Since then, Bailey relocated CellFactors from Cambridge, UK, to Newport, consolidating three offices and installing a pilot manufacturing plant for Skeletex on a single site. "There have been a lot of changes to the business in the last six months," Bailey said. "We have moved from an R&D focus to a commercial focus and have talked to potential customers in orthopedic, dental and big pharma companies about what their requirements are of our products."

Skeletex is being assessed by five orthopedic firms and two dental companies. Bailey said he hopes to set up joint ventures to develop the product that would include up-front payments, development milestones and royalties for CellFactors. "The [orthopedic] industry has recognized that biological add-ons will differentiate and extend the life of their metal and plastic products," he said.

CellFactors also intends to step up commercialization of its NeuCell library of conditionally immortalized human neural cell lines as a research tool. However, Bailey said the market is small and might provide revenues of 500,000 per annum in the next two years.

With the shortage of funding, CellFactors has slowed down overall development of its whole cell therapy products. However, it is still seeking to advance one, Volonte, a dopamine-producing cell line for the treatment of Parkinson's disease, to preclinical proof of principle in two years. "We have broken down the IP into core and non-core areas and are seeking to license, or even sell, some of it," Bailey said.

Prionics test boosted by EC

The European Commission's Scientific Steering Committee has recommended the Prionics-Check LIA BSE-Test for the EU Surveillance Program. Prionics (Zurich, Switzerland) said the test is "the first rapid BSE test that is easy to use both manually and when integrated into a fully automated system."

The Prionics-Check LIA was evaluated by the European Commission in a field study carried out by bovine spongiform encephalitis (BSE) experts at two different national reference centers and four routine diagnostic laboratories. The company said the large-scale study, which it described as "the first of its kind," focused not only on the technical specifications of the BSE test but also on "its precision in field use, particularly under adverse conditions."

Prionics said the LIA not only fulfilled all requirements, but also demonstrated 100% sensitivity, "underlining its suitability for reliable detection of BSE animals," and 100% specificity, "which means that it would not incorrectly identify samples from healthy animals as BSE positive."

The company said the LIA was designed to complement the most successful BSE test worldwide, the Prionics-Check Western, which it said has established itself among BSE experts as the reference for BSE rapid tests due to its "unmatched precision and reliability." Marketing Director Karl Kalf said the two tests form "a 100% reliable complementary testing system."

Prionics, which was set up in 1997 by three scientists from the University of Zurich, is the market leader in BSE testing.

Primagen to develop cancer diagnostics

Primagen Holding (Amsterdam, the Netherlands), a provider of molecular diagnostic tests for infectious diseases and cancer, said it has been awarded a contract to design and develop molecular diagnostic tests for OncoGenome Sciences (Liege, Belgium). It said the contract involves the design of five genomics-based diagnostic tests to detect cancer at a much earlier stage of disease and at a higher level of accuracy than other tests currently on the market.

Bob van Gemen, CEO of Primagen, said the contract recognizes "the expertise and skills of Primagen in the design and development of molecular tests." He said the contract "fits very well with our ongoing business," citing the company's current products, Retina Mitox and Retina Rainbow, which he said are examples of corporate mission to improve treatment of individual patients with molecular tests that have "high predictive value."

Herman Spolders, CEO of OncoGenome Sciences, said, "With the help of Primagen we are leveraging our patent portfolio by using the most efficient way to develop products ... for introduction in the market as soon as possible."

OncoGenome Sciences recently raised EUR 14 million in its first financing round. The company was set up last November by a team that previously worked for Belgian firm Virco, now the Tibotec-Virco subsidiary of Johnson & Johnson (New Brunswick, New Jersey). Spolders was vice president of business development and operations at Virco.

DNA analysis, mapping patents licensed

Pyrosequencing AB (Uppsala, Sweden) has gained a broad, nonexclusive license to non-coding DNA analysis and mapping patents belonging to Genetic Technologies Ltd. (Melbourne, Australia), with application to all genes and all species, to be used in applications of Pyrosequencing's sequencing by synthesis technology.

The companies are expected to develop gene-based assays using Pyrosequencing's genotyping platform that will expand Genetic Technologies' diagnostics business and its cancer susceptibility testing facility, being established in Melbourne to service the Asia-Pacific region.