Medgenics, Inc. (NYSE MKT: MDGN)(AIM: MEDU)(AIM: MEDG) (the "Company"), developer of the novel Biopump™ technology for the sustained production and delivery of therapeutic proteins in patients using their own tissue, today announced receipt of clearance from the U.S. Food and Drug Administration ("FDA" or the "Agency") to proceed with a Phase IIb clinical trial of EPODURE™ for the treatment of anemia in patients undergoing renal dialysis. EPODURE is intended to produce and deliver erythropoietin ("EPO") on a sustained basis. This multi-center, randomized clinical trial will be the first study in the U.S. using the Company's proprietary Biopump™ technology, and will evaluate the safety and efficacy of sustained EPO therapy delivered via Medgenics' EPODURE Biopump. Treatment of anemia in dialysis patients with EPODURE is intended to replace frequent injections of EPO or other erythropoietic stimulating agents ("ESAs").    

"This timely acceptance of our first Investigational New Drug ("IND") to the FDA marks a significant milestone for our Biopump protein platform. We are very pleased with our U.S. regulatory progress and with the interactions with the FDA, allowing us to proceed with the launch of our first U.S. trial," stated Andrew L. Pearlman, Ph.D., Chief Executive Officer of Medgenics. "This trial is significant for Medgenics as a company as well as for patients with anemia, as we anticipate EPODURE could provide a better treatment for anemia in the future."

"We are hopeful that the positive interaction with the FDA for EPODURE bodes well for the Agency's approach to other future indications for our Biopump protein delivery platform technology," added Dr. Pearlman.

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