Medical Device Daily Contributing Writer
And MDDs

Scotland is investing 9.5 million ($18.8 million) to attract stem cell specialist Cellartis (Gothenburg, Sweden) to set up a research and development facility in Dundee.

Cellartis is focused on developing repeatable processes for differentiating different cell types from human embryonic stem cell precursors, and an automated process for manufacturing them in volume. These techniques have been described as the missing elements in Scotland’s attempts to build a laboratory-to-patient competence in stem cells.

The money was awarded to Cellartis by the public investment agency ITI Life Sciences, following a survey of the gaps in Scotland’s stem cell infrastructure, and a search to find the company best equipped to fill them.

One obvious candidate for the funding might have been Stem Cell Sciences Group (Edinburgh), but Fergus McKenzie, ITI program manager, said Cellartis has produced the largest range of differentiated cell lines from human embryonic stem cell lines.

“Based on market surveys, we choose the subject [of the research], and then we study companies to see what they have to offer,” McKenzie said. Citing ITI’s “somewhat unusual business model” as a public body funding commercially driven research, he said, “we have to own all the intellectual property and some companies may decide they can’t adhere to our requirements.”

Unlike the more hands-off approach that is typical when a company is given a grant, the progress of research is closely monitored. “For example, lab notebooks belong to ITI,” he said.

The aim is that at the end of the project ITI Life Sciences will have rights to end-to-end processes for differentiating cell lines, and for manufacturing them in volume, including quality control protocols that will guarantee the cell lines are consistent.

McKenzie said that to do this, it may be necessary to in-license some elements of the technology. “We would then want to out-license [our process] and would think Cellartis will probably be one of the first to want to [take a license].”

Under the terms of the deal, Cellartis will collaborate with scientists in the faculties of medicine and life sciences at Glasgow University.

Matts Lundwall, CEO of Cellartis, said the collaboration “is in line with our strategic goal of scaling-up our human embryonic stem cell technology.” The company’s immediate objective in its own research is to develop cardiomyocytes and hepatocyes for use in drug discovery. It has developed 30 defined cell lines, two of which are listed on the U.S. National Institutes of Health registry and 20 in the UK Stem Cell Bank.

Cellartis claims to be the first to have characterized a stem cell-derived line with no use of animal components, a necessity if such cells are to be used in humans.

Initially, the high volumes of cells produced as a result of the project will be used in drug discovery. According to ITI’s analysis the market for cell-based tools was worth $1.4 billion in 2001 and has been growing strongly since. But the cell lines developed will also be of suitable quality for therapeutic applications, and will be applied to further Scotland’s ambitions to become an international center for regenerative medicine.

Earlier in January the Center for Regenerative Medicine was launched in Edinburgh, pulling together academic research and clinical groups. Last October the development agency Scottish Enterprise gave a pounds 2 million grant for the formation of the Roslin Stem Cell Center, which is developing GMP-grade, stem cell-derived lines with no intellectual property attached. These are to be made available to both companies and academics.

F&S cites blood gas analyzer growth

A new report by global consulting firm Frost & Sullivan (F&S; London) said that the European blood gas analyzers and monitors market had revenues of about $360.5 million in 2006 and estimates it will reach $470 million by 2013. F&S said the use of blood gas analyzers and monitors in European hospitals is increasing, driven by the ability to deliver vital parameters instantaneously. It said the market is creating lucrative growth opportunities.

“The growing need for immediate bedside results, coupled with the rising patient population, has led to the enhanced penetration of blood gas monitors and analyzers,” says Frost & Sullivan Research Analyst C.R.Hema Varshika. “Laboratory tests that used to take around 30 minutes for the result to be obtained are now a thing of the past; [with] point-of-care devices yielding immediate answers.”

The main challenges in the market are regulatory problems and competition from local participants. Each country’s distinct system of purchasing equipment, she said, leads to a disparity that can only be overcome once countries adopt uniform laws. “At the same time, high levels of brand consciousness among hospitals and intense competition from local participants will deter prospective market entrants.”

Varshika said increased penetration in what is a mature market “can be achieved only through innovative products and effective marketing strategies. Proactive marketing of technologically advanced and user-friendly products will lead to a rise in market share.”

S&N to distribute burn dressing

Smith & Nephew ’s (Hull, UK) Advanced Wound Management division has signed a sales, marketing and distribution agreement with UDL Laboratories (Rockford, Illinois) to exclusively distribute UDL’s Biobrane Biosynthetic Wound Dressing outside the U.S.

S&N said the exclusive agreement will enable it to provide a full line of burns products to its customers, enhancing its current portfolio of the Versjet Hydrosurgery system and Acticoat antimicrobial dressings.

Biobrane is a biosynthetic wound dressing constructed of a silicone film bonded to a cross-linked nylon fabric, which acts as a temporary dermal substitute. Its use leads to faster wound-healing times and a reduction in treatment costs as a whole, S&N said.

Joe Woody, president of Smith & Nephew Advanced Wound Management, said the agreement “underlines our commitment to . . . helping patients to recover from burn injuries more quickly. Biobrane is a natural fit with our surgical and burn portfolio.”

UDL is a subsidiary of Mylan Laboratories (Canonsburg, Pennsylvania).