Celsense, Inc Files FDA & EMEA Regulatory S...(Click( this.href ); target _blank tit...),Health

“Several customers are now planning to incorporate the use of Cell Sense in new and existing INDs,” stated O’Hanlon, “and having a DMF/ASMF for them to reference will encourage product adoption, shorten the qualification process for customers, and meet our corporate goal of having the first imaging reagent formally approved for non-invasive, human clinical in vivo tracking of therapeutic and diagnostic cells.”

In October 2007, the U.S. FDA concluded, in response to the company’s request for designation, that Cell Sense is a drug that will be reviewed and regulated by the Center for Biologics Evaluation and Research (CBER) under the new drug provisions of the Federal Food, Drug, and Cosmetic Act (the Act).

Cell Sense is a fluorocarbon ex vivo cell label that enables investigators and clinicians the ability to non-invasively track the therapeutic and diagnostic cells in vivo using Magnetic Resonance Imaging (MRI). The emulsion is a self-delivering nanoparticle that requires no exogenous transfection agent and is stable at lysosomal pH levels within the cell. Cell Sense emulsion enables investigators the ability to identify, quantify, and follow pre-labeled cells in vivo using fluorine (19F) magnetic resonance imaging (MRI) technologies.

Celsense, Inc. has three reagents for MRI imaging of cells currently on the market for pre-clinical research and discovery. The company also offers Voxel Tracker workstation software that maximizes the Cell Sense MRI data set. Customers include leading pharmaceutical and biotechnology companies and medical research centers worldwide.

About Cell Sense
Cell Sense is a fluorocarbon tracer agent used to
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