Nexell Therapeutics Cleared to Market Isolex Cell Selection Systems

Nexell Therapeutics Inc. (Irvine, CA) has received FDA clearance to market its Isolex Magnetic Cell Selection Systems in the United States.

The semi-automated Isolex 300 and fully-automated Isolex 300i, along with the reagent kit and disposable sets used in each selection procedure, will be sold for the selection of hematopoietic stem cells and the removal of tumor cells from autologous peripheral blood as a component of aggressive cancer treatment.

They are the only stem cell selection systems commercially available in the United States.

The launch of the Isolex systems will take place over the next several months and initially focus on the conversion of existing Isolex investigational sites to commercial status and the installation of Isolex systems at sites currently operating CellPro Ceprate SC devices.

These sites have continued to use the Ceprate SC system under a limited supply agreement with Baxter Healthcare Corp. created to provide treatment for patients in need of stem cell selection in the interim between cessation of CellPro's business operations and Isolex approval.