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Crosses Milestone of 50 Patients Randomized in Pivotal Trial
Remains on Track for Top-Line Data by Middle of 2017
“We are pleased with the progress in our Renevia pivotal trial,” commented
Mr. Mohanty continued, “While this trial will support approval for use in the treatment of HIV-related facial lipoatrophy in
Developed as an alternative for whole adipose tissue fat transfer procedures, Renevia is designed to mimic the naturally-occurring extracellular matrix and provide a 3-D scaffold that enables effective cell transplant and engraftment. In the run-in portion of this trial, the Renevia administration procedure was found to be reproducible. Encouraging signs of Renevia being able to promote new tissue generation were seen with the run-in practice patients. If the pivotal trial is successful, and consistent with the run-in patients, the company plans to file the data as the basis for CE marking in the second half of 2017.
Certain statements contained in this release are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Statements pertaining to future financial and/or operating results, future growth in research, technology, clinical development, and potential opportunities for
To receive ongoing