Arteriocyte’s pharmed blood goes to the FDA: Arteriocyte of Cleveland, Ohio, sent an initial shipment of its pharmed blood product to the Food & Drug Administration for evaluation. Issues with storage, transportation and safety provided an incentive to search for alternatives to donated blood for use on the battlefield. Under a $1.95 million contract with the Pentagon’s DARPA project, the company has developed a process to produce fresh units of universal-donor (type O, Rhesus factor negative) packed red blood cells from hematopoietic stem cells. Although this has been possible on a small scale for many years, the main challenge is implementing this process on production scale. The technology, which the company calls NANEX, permits 250-fold expansion of hematopoietic stem cells that are subsequently cultured in a unique environment of nutrients and growth factor to induce differentiation into enucleated red blood cells. The company is working on improving the production process, as one unit of pharmed blood currently costs $5,000 to produce. To make economical sense to use arteriocyte instead of donated blood, a unit will have to cost less than $1,000. Human trials aren’t expected until 2013.
ReNaChip biomimetic, biohybrid brain stimulation technology: An international collaboration of researchers is working on a new deep brain stimulation technology that may address some of the shortcomings of current devices. The Rehabilitation Nano Chip (ReNaChip) will have monitoring capabilities to help regulate the electric signals applied to the brain, a capability missing in current DBS offerings. Because available DBS therapy devices are continuously applying an electric current, patients invariably receive stimulation at times when it’s unnecessary. This overstimulation can lead to long-term insensitivity to further stimulation, rendering DBS devices less effective over time.
New, robust test for extended group typing of donated blood: French scientists recently reported a new method to quickly provide extended blood group typing for donated blood, an advance that should help us better match donors with recipients. The new test, called HiFi-Blood 96, is being commercialized by AXO Science, a spin-off from the Institut de Chimie et Biochimie Moléculaires et Supramoléculaires ICBMS.
NeuroPace files for a PMA for its RNS epilepsy treatment using DBS: Mountain View, Calif.-based NeuroPace Inc. filed a pre-market approval application with the Food & Drug Administration for its RNS System. The technology is designed to decrease or eliminate epilepsy episodes through the use of an implant which monitors the patient’s brain and delivers electric signals to prevent seizures by disrupting any abnormal activity.
A weekly roundup of new developments in medical technology, by MedGadget.com.