A Medical Device Daily

Gambro (Stockholm, Sweden), which in December reported an agreement to sell off its U.S. kidney dialysis services business, said this week it plans to enter the emerging field of regenerative medicine, which involves the use of stem cells for improving and restoring the functionality of organs.

As a first step, Gambro said it would invest about SEK 100 million for research purposes over a three-year period. The company said it would focus its research on restoring the functionality of kidneys using adult stem cells and on new tools for cell handling and processing.

It noted that the research would be done in what it termed "close collaboration with external partners."

Gambro is a global medical technology and healthcare company with major positions in renal care products and services, as well as in blood component technology.

Its Gambro Healthcare unit is a provider of kidney dialysis services, while Gambro Renal Products develops and supplies hemodialysis, peritoneal dialysis and acute dialysis products, therapies and services.

Gambro BCT (Lakewood, Colorado) is the market leader in separation and handling of blood components, including blood bank technologies, automated blood collection and processing, pathogen reduction techniques, and blood and cell-based therapeutic services.

In early December,Gambro reported entering into an agreement to spin off Gambro Healthcare US (Nashville, Tennessee), its U.S. dialysis clinic business, to DaVita (Torrance, California) for about $3.05 billion (SEK 20.5 billion) in cash (Medical Device Daily, Dec. 8, 2004).

In announcing its plan to move into the regenerative medicine sector, Gambro said in regenerative medicine, no matter what organ or condition to be treated, a process involving collection, fractionation, expansion and application of stem cells is used.

"Throughout the process, products from Gambro BCT's current offering can be used," the company said. Gambro added that downstream of its investment into regenerative medicine, it expects that new tools and methods will add to Gambro BCT's current offerings.

"It's a proactive, long-term investment to explore potential opportunities in an emerging field of therapy," said S ren Mellstig, Gambro president and CEO. "It also has an excellent technology and capability fit with Gambro and is fully in line with our vision and core purpose."

The company said that, given the early stages of regenerative medicine as a field of endeavor, "it is not possible today to give estimates on when products will be launched to the market or what the value of the potential market will be."

UK sets framework for renal services

UK Health Minister Rosie Winterton last week set out plans to ensure that healthcare professionals offer what the Department of Health termed "the best possible treatment to people with kidney problems."

The National Service Framework for Renal Services provides the National Health Service (NHS) with recommendations on three main areas:

Chronic kidney disease, helping primary care staff to spot the early signs of such disease, since early intervention often can prevent the need for dialysis or transplant. Winterton said, for example, that the disease can be better managed by prescribing the right medication for high blood pressure or by controlling glucose levels in people with diabetes and by modifying diet.

Acute renal failure, encouraging the NHS to use all opportunities to reduce its incidence and cut the number of deaths by reinforcing National Institute for Clinical Excellence guidelines on pre-operative testing, early identification of people at risk and prompt treatment when people need the specialist skills available at critical-care units.

End-of-life care, extending good palliative care practice to people with established renal failure who are near the end of their lives. The National Service Framework will ensure that people who do not wish to receive dialysis will be able to die with dignity in a place of their choice, and strengthen the role of staff such as district nurses to care for people in their own homes.

Winterton said the framework "is designed to ensure that we are getting services right for kidney patients. It's estimated that there are up to 2.5 million people with chronic kidney disease, most of whom will not have any symptoms. We need to make sure, through improvements in primary care, that we identify them and ensure their condition is properly managed, in the right place at the right time and by the right people."

She added that it is "essential that people at high risk of developing chronic kidney disease are identified as soon as possible and closely monitored." It also is important, she said, that those with acute renal failure get the best treatment from the NHS.

Winterton said the National Service Framework "offers an opportunity to develop coordinated strategies to both prevent and treat this condition and, whenever clinically feasible, to avoid people from becoming reliant on dialysis."

Carol Black, president of the Royal College of Physicians (London), said, "It is right that the burden of chronic renal disease which now affects 5% of the population is recognized within a National Service Framework. As with other long-term conditions, effective management is best achieved through seamless, unified primary and secondary care, supporting independence."

Mayur Lakhani, chairman of the Royal College of General Practitioners, hailed the new guidance. "It is distressing to see patients suffer from preventable kidney disease in this day and age. GPs and primary healthcare teams are uniquely placed to detect kidney disease at an early stage and are adept at chronic disease management and in preventing complications by controlling cardiovascular risk factors."

The National Service Framework has been published in two parts. Part one was published in January 2004, describing a framework for the care of people with established renal failure, including renal replacement therapy by dialysis and renal transplantation.

Part 2 of the NSF covers all remaining aspects of the patient pathway for those with kidney disease and those at risk of kidney disease.

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