Celsense

 

 

NEWS RELEASE - For Immediate Release

Celsense, Inc. Launches a Dual–Mode Imaging Reagent Enabling Cell Detection by MRI and Fluorescence

January 19, 2010 - Pittsburgh, Pennsylvania

Celsense, Inc. announced today the launch of a dual–mode version of its cellular imaging reagent, Cell Sense

Cell Sense is a fluorocarbon–based emulsion used to label cells ex vivo. Labeled cells are administered to the patient, and cell trafficking is monitored using 19F MRI or MRS in vivo or in fixed tissues.  The newly launched dual–mode reagent (CS–1000DM Green) provides investigators with a tool to accelerate preclinical validation studies of Cell Sense MRI data. The product, CS–1000DM Green, enables investigators to positively identify the fate and phenotype of labeled cells following 19F MRI or MRS, days and weeks after cell transfer, using fluorescence detection methods. Using biopsied or necropsied tissues, cell tracking results may be examined using fluorescence microscopy or flow cytomety, for example, to screen for potential phenotypic changes of the labeled cells post–transfer.

This true dual–mode agent is expected to enhance the rate of adoption of the Cell Sense platform in both preclinical and clinical studies. 

Celsense, Inc. has three reagents for MRI imaging of cells currently on the market for pre–clinical research and discovery.  The company also offers the Voxel Tracker™ workstation software for visualizing and quantifying cells in MRI data sets.  Customers include leading pharmaceutical and biotechnology companies and medical research centers worldwide. 

About Cell Sense
Cell Sense is a perfluorocarbon tracer agent used to safely and efficiently label cells ex vivo without the use of transfection agents. Labeled cells are transplanted into the patient enabling researchers and clinicians to non–invasively track the administration and migration of therapeutic and/or diagnostic cells using 19F MRI or MRS. Applications include tracking cells in immunotherapy or regenerative medicine as well as diagnosis of inflammatory sites by tracking selected populations of immune cells.  Using software developed by Celsense, investigators can quantify the number of labeled cells in a user-specified region of interest. It is expected that in vivo cellular imaging will routinely be used to provide a surrogate biomarker for certain cell therapy and drug trials.

The key advantage of the Cell Sense platform is that the positive-signal 19F images are extremely selective for the labeled cells with no background. Co–registered conventional proton (1H) MRI acquired in the same imaging session places the labeled cells into their anatomical context.  Furthermore, the absolute number of labeled cells can be measured directly from the in vivo 19F images, thus providing a quantitative biomarker.

Cell Sense has been designated a drug by the FDA to be reviewed and regulated by the Center for Biologics Evaluation and Research (CBER).  It is the subject of a Drug Master File with FDA and an Active Substance Master File (ASMF) is currently being reviewed by the European Medicines Agency (EMEA).  The company is currently participating in preparations for the first translational studies to evaluate Cell Sense for tracking theraptutic dendritic cells in human clinical trials.

About Celsense, Inc.
Celsense, Inc. offers products that enable the non–invasive imaging of cells in vivo using MRI.  The mission of the company is to be the standard for cellular imaging in human health.

Contact Information:

Charlie O’Hanlon, President and CEO
Celsense, Inc.
(412) 263-2870
charlie@celsense.com