• Aastrom Biosciences (Ann Arbor, Michigan) said that it has completed the last patient accrual and treatment in its U.S. Phase I/II multi-center long-bone fracture trial. Completion of the cell therapy phase for all 36 patients enrolled in this trial represents a key milestone that supports Aastrom's business model to use its cell-based Tissue Repair Cells (TRCs) for tissue regeneration. The Phase I/II trial is evaluating the use of TRCs – a mixture of stem, stromal and progenitor cells derived from the patient's bone marrow –in the treatment of severe fractures that have failed prior treatment interventions. It is expected that additional interim data will be disclosed by the end of September.

• FoxHollow Technologies (Redwood City, California), which has developed a minimally invasive method of removing obstructive plaque and restoring blood flow to the legs and feet, said a 65-year-old diabetic female with severe leg pain was the first patient to be enrolled in a new clinical trial. SWIFT is a non-randomized, multi-center study assessing the long-term outcomes for patients with peripheral arterial disease (PAD) treated with the SilverHawk Plaque Excision System. After treatment with plaque excision, 100 patients will be followed for a year using duplex ultrasound, and in some cases, also will be evaluated using CT angiography. The company also reported a new randomized, controlled, multicenter study set to begin later this year. The PROOF study will compare SilverHawk to open surgical bypass for patients who are at extremely high risk for limb loss due to a severe form of PAD known as critical limb ischemia. In addition, FoxHollow is supporting a number of studies related to its expanding biologics program. The largest of these studies is LEAP, a multicenter, multiarm trial involving patients who have arterial blockages in both of their legs.

• GlucoTec (Greenville, South Carolina), developing systems for the management of blood glucose levels, reported that it has received FDA 510(k) clearance to market Glucommander Plus. The Glucommander is designed to manage blood glucose levels in an acute care hospital setting.