A BB&T

MDS (Toronto) is selling its Canadian laboratory services business, MDS Diagnostic Services, one of Canada’s major laboratory service providers, to Borealis Infrastructure Management (Toronto) in a C$1.325 billion transaction. MDS said the sale is designed to shift the company’s focus “to the life sciences market.” It said that this strategy — initiated in September of 2005 — includes streamlining its cost structure and selling non-strategic assets. The deal is projected to close by the end of January 2007.

Additionally, Stephen DeFalco, president/CEO of MDS, said that with the divestiture the company “will be able to focus exclusively on life sciences markets, where incredible advances are being made to diagnose and treat diseases.”

From the total transaction price of C$1.325 billion, MDS expects to realize about C$1.052 billion, after provision for taxes, expenses and amounts attributable to minority interests. It said that a portion of these funds may be retained for up to 18 months, contingent on specific transition obligations of MDS.

MDS claims market leadership in drug discovery instruments, molecular imaging, radiopharmaceutics and contract research services, providing products and services for development of new drugs and diagnostics. It reports $1 billion in life sciences revenues and that following the spin-off it will generate 95% of its revenue from global markets by the end of the fiscal year.

Borealis bills itself as a leader in infrastructure investing, with assets in a wide variety of industries.

Europe C-Arm market thriving, says F&S

The need to replace existing image intensifier based systems with flat panel detectors (FPD) is driving the European C-Arms market, according to a new report from Frost & Sullivan (F&S; London). This trend has been spurred by the need for complete workflow integration in a fully digital radiology environment, according to the F&S report. “FPDs provide improved, distortion-free images in comparison to image intensifiers. However, their high cost, coupled with a lack of funding for healthcare projects, will pose an important limitation to their adoption in the mobile C-Arms segment,” it says.

F&S says that the European C-Arms Market earned revenues of $375.2 million in 2005 and estimates this to reach $548.8 million in 2012. “New systems fitted with FPDs instead of conventional image intensifiers are replacing fixed C-Arm systems across Europe,” said, Karthik Arun, F&S medical imaging team leader. “This trend will be evident in mobile C-Arms too by the year 2008 and will be the single, most important factor driving this market.”

FPDs make the C-Arm system inherently digital and eliminate the need for analogue-to-digital conversion of images captured using an image intensifier. Moreover, they are lighter and more compact, enabling ease of handling during procedures using mobile C-Arm systems. FPDs also provide distortion free images. These advantages, combined with the push towards a completely digital radiology environment, will motivate the C-Arms market to completely convert to FPDs. But FPDs are not yet being widely adopted by mobile C-Arm users. Furthermore, with Europe being on a capital investment model, C-Arms tend to take a back seat when it comes to resource allocation, resulting in prolonged replacement cycles, according to F&S.

Radlink, Ado-Med partner in Europe

Radlink (Redondo Beach, California) a provider of medical imaging systems to healthcare, said that it has signed an agreement to extend its partnership with Ado-Med (Portland, Oregon), a medical services company. Ado-Med will serve as exclusive distributor for Radlink products in the European Union, Russia and the Ukraine.

Ado-Med will also establish a European service center for Radlink’s CR Pro machine, which utilizes sealed fiber-optic laser technology to deliver “high-resolution, diagnostic-quality images at a fraction of the cost of other computed radiography machines on the market,” the company said.

Kodak wins contract in Estonia

East-Tallinn Central Hospital (Tallinn, Estonia) has awarded Kodak (Rochester, New York) a contract for PACS and Enterprise Information Management Solutions for the Baltic e-Health project.

The Baltic e-Health project is partially funded by the European Regional Development Fund, and covers the Baltic Sea Regions, to encourage e-Health as a way to enhance access to healthcare in rural areas and thereby counteract rural migration. This will be achieved by creating the Baltic Health Network, a large transnational IT infrastructure for e-Health, the first cross-border health data network of its kind across the Baltic countries connecting more than 200 hospitals and 6,000 general practitioners.

Initially, Kodak will deliver PACS, remote reporting and archiving solutions to the East-Tallinn Central Hospital to facilitate participation in two pilot projects, in radiology and ultrasound. The eRadiology pilot will link the East-Tallinn Central Hospital, the Funen Hospital (Odense, Denmark) and the Vilnius University Hospital (Vilnius, Lithuania). During the pilot phase, radiologists from Estonia and Lithuania will test e-communication and the network infrastructure by remotely reporting on studies from the Funen Hospital. The eUltrasound pilot will test communication between East-Tallinn, Norrlands University Hospital (Umea, Sweden), and the St. Olav’s Hospital (Trondheim, Norway).

Kodak will work with Danish company Medical Insight (Hedehusene Denmark), specializing in systems for managing and distributing patient images and healthcare data, across disparate technology environments.

Kodak reports that, to date, more than 250 European sites handling over 10 million annual studies are managed by Kodak Carestream Solutions that enhance communication of patient data across the continuum of care, enabling the right information to be available wherever needed and regardless of where it is stored or generated.

Roslin Institute forms stem cell facility

The Roslin Institute (Midlothian, Scotland) is setting up a facility to provide clinical-grade embryonic stem cell lines with no intellectual property rights attached. The not-for-profit center aims to speed the process of translating stem cell research into treatments, and the cell lines will be available to both companies and academic researchers. Roslin Cell Center (RCC) is expected to be a key element of Scotland’s attempt to build a stem cell hub in the country. It is focused around a 600 million ($1.1 billion) translational research institute currently under construction in Edinburgh. RCC will be the first link in the supply chain, producing GMP-grade cells for clinical use.

Initial funding for the RCC of 2 million has come from the development agency Scottish Enterprise. The Roslin Institute, birthplace of Dolly the sheep, has set up Roslin Cells to run the RCC and consolidate its expertise in stem cell research.

Opportunities to spin technologies are expected out of the RCC, and a seed fund, the Genomia Fund, has partnered with Roslin to provide initial finance for technology commercialization. The RCC — to be run by Paul De Sousa, one of the leading stem cell researchers in the country — will create stem cell lines from donated eggs and embryos. De Sousa has established several new embryonic stem cell lines previously as well as being involved in setting up a program in which women having elective sterilization procedures are asked to donate eggs.

“The RCC will make clinically usable stem cell lines available under a range of negotiated terms,” De Sousa said. This approach will provide huge benefits to academics and companies already working in the field or seeking to enter it.”

University of Twente gains SCI license

Stem Cell Innovations (SCI; Houston) reported that it has launched a collaboration with the University of Twente (Enschede, the Netherlands) to explore the bone forming properties of PluriCells.

Dr. James Kelly, CEO of SCI, said, “This former IsoTis in-house orthobiology research group has developed a comprehensive set of robust in vitro and in vivo models in which the PluriCells will be tested. SCI is impressed that their science is very application driven ... .“

Under the agreement, the university gains access to SCI’s proprietary human pluripotent stem cell technology and know-how. In return SCI will receive a non-exclusive license to intellectual property generated with the PluriCells.

Stem Cell Innovations recently disclosed it has produced multiple lines of human pluripotent stem cells. These PluriCell lines can be efficiently cultured in tissue culture plates without the use of feeder layers and can be efficiently differentiated into multiple cell-types, having the potential to aid in drug discovery and development.

PluriCells are a type of pluripotent stem cell isolated from fetal tissue that has the ability to become all cell types of the body. Because they are developed from fetal germ cells, not viable embryos, they are eligible to be used in any National Institutes of Health-funded laboratory. Stem cells derived from fetal germ cells were explicitly excluded from the presidential ban by the Department of Health and Human Services guidance document that laid out what type of stem cells could and could not be used in federally funded research.

Hologic tech positive in double-read study

Hologic (Bedford, Massachusetts), a developer of digital imaging systems for women’s health, reported on a study titled “Single reading with computer-aided detection and double reading of screening mammograms in the United Kingdom National Breast Screening Program.” The study, published in the October issue of Radiology, the performance of a radiologist using computer-aided detection (CAD) was superior to that of screening mammograms, which were double-read.

This study, by researchers from two UK breast centers, measured radiologists’ performance with the use of CAD. The study also showed a 15% increase in cancer detection rates when CAD was used. The CAD system used in the study, the ImageChecker 1000 version 5.0, was supplied by Hologic’s R2 Technology subsidiary.

CE marks granted

• TransMedics (Andover, Massachusetts) reported receiving CE-marking for its Organ Care System, which it calls “the first and only system that allows human donor organs to be maintained in their normal functioning state outside the human body.” TransMedics says that its Organ Care System maintains donor organs in “a physiologic functioning state outside the human body to optimize their health and to allow real time ex vivo clinical evaluation of donor organs for the first time.”

Warm, oxygenated blood is perfused through the organ from the time of removal until it is implanted, maintaining organs in a warm, functioning state outside the body until ready for implantation to withstand longer periods of time outside of the body and experience less damage resulting from lack of blood supply during transportation.

• Genzyme (Cambridge, Massachusetts) reported that it has received approval to expand the CE-mark labeling for Synvisc (hylan G-F 20) to include treatment of pain due to osteoarthritis (OA) of the ankle and shoulder. Approval of this new label will broaden the use of Synvisc beyond its established use in knee and hip OA patients, Genzyme said. Synvisc has been shown in European clinical trials to provide up to 12 months of pain relief in knee OA. Genzyme said it will begin marketing Synvisc immediately in the European Union with its new label.

The approval of Synvisc in the ankle and shoulder follows clinical studies conducted in Europe in these two joints. The studies were prospective, multi-center, open investigations conducted throughout Europe. Both studies found treatment with one or two injections of Synvisc to be well-tolerated, the data showing that Synvisc significantly decreases ankle and shoulder pain due to OA.

Genzyme says it is using evidence-based medicine to broaden Synvisc label claims to establish its efficacy and safety. In addition, two meta-analyses in 2004 and 2006 also affirmed the benefit of Synvisc and its class of viscosupplements, using research methodologies providing tools to evaluate new treatments using an evidence-based approach.

Synvisc is marketed in more than 60 countries and has been used to treat more than three million people, Genzyme said. Synvisc is currently approved in the U.S. for treatment of pain due to OA of the knee, and the company is pursuing a label expansion in the U.S. that would include the hip indication.

• Biofisica (Atlanta), a high-tech wound care company, reported receiving CE-marking for its POSiFECT RD Bio-Electric Stimulation Therapy, its flagship wound care product. Biofisica worked with the British Standards Institute throughout the conformity assessment process, and that it now plans to launch POSiFECT RD in the UK in the next 90 days, followed by staged rollouts in France, Germany and the Nordic region.

POSiFECT RD (RD referring to the dressing’s round shape) is the first device available that combines two technologies — moist wound-care dressing and electrical stimulation.

The CAD program scans a mammogram for abnormalities and indicates the abnormality on a screen for the radiologist to check. The CAD system used R2 EmphaSize software providing variable size marks that correlate to lesion significance. A larger mark indicates that the CAD algorithm detects more mammographic features that are indicative of cancer.

The study included a sample of more than 10,000 mammograms obtained from women aged 50 years or older who underwent routine screening. Double-read mammograms initially were randomly allocated to be re-read by eight different radiologists using a single read and CAD. The researchers found that single reading with R2 CAD detected 6.5% more cancers — a 15% increase in the cancer detection rate — than that achieved with double reading (P=0.02)

Fiona Gilbert, of Aberdeen University (Aberdeen, UK), the study leader, said: “The mammograms studied were from a sample taken in 1996 so that all cancers that developed subsequently in this group of women could be included. We have now embarked on a new study to confirm that the CAD result is still as good when used in real day-to-day decision-making about breast cancer diagnosis.”

Dr. Sue Astley of Manchester University (Manchester, UK), who worked on the study, said the new research “will involve 30,000 women in three major screening centers, most of whom will have single reading with CAD in addition to their routine double reading. This is an opportunity for women in the UK to have their mammograms read using the latest CAD technology which is already available in America and other countries.”

The R2 ImageChecker was the first CAD system approved by the FDA for use with film-based mammography in 1998 and for digital mammography in 2001.