Ocata Therapeutics Receives Regulatory Guidance from European Medicines Agency

Ocata Therapeutics, Inc. ("Ocata"; NASDAQ: OCAT), a leader in the field of regenerative ophthalmology, today announced that the company has received written formal guidance from the European Medicines Agency (EMA) related to the advancement of its Retinal Pigment Epithelium Program (RPE) into a pivotal clinical trial for Stargardt's Macular Degeneration (SMD). "We are pleased with the guidance we've received from the European Medicines Agency which means that our SMD program can be initiated as a pivotal clinical trial, potentially allowing us to apply for marketing authorization upon its completion," said Paul K. Wotton, President and Chief Executive Officer of Ocata Therapeutics who added, "As a result of these discussions we plan to enroll a total of approximately 100 patients, including an untreated control arm to more closely match guidance received from FDA. This would harmonize the development approach resulting in a more effective program." Ocata previously announced that it has been granted Advanced Therapy Medicinal Product (ATMP) designation for its RPE therapy for macular degeneration. The SMD program has orphan status both in Europe and the US.