Ocata Therapeutics Receives Three New U.S. Patents For Its RPE Therapy For Macular Degenerative Diseases

Patent Portfolio Expanded to Cover RPE Products from All Pluripotent Stem Cell Sources

MARLBOROUGH, Mass.--(BUSINESS WIRE)--Ocata Therapeutics, Inc. (“Ocata” or “the Company”; NASDAQ: OCAT), a leader in the field of Regenerative Ophthalmology™, today announced that the United States Patent and Trademark Office (USPTO) issued three new U.S. Patents, Nos. 9,040,770, 9,040,039 and 9,040,038, which expand the scope of protection of the four previously issued U.S. patents covering its retinal pigment epithelium (RPE) transplant technology. These three new patents extend protection to include all formats and formulations of RPE cells, including suspensions and sheets of cells, for use as therapeutic agents, and the use of these formulations for treating ophthalmic diseases such as dry age related macular degeneration (Dry AMD) and Stargardt’s macular degeneration (SMD).

“For the first time a pluripotent stem cell derived therapy is about to enter a pivotal trial for Stargardt’s Disease and phase 2 clinical trials for dry Age Related Macular Degeneration, bringing the possibility of these long awaited therapies that much closer to reality.”

“We believe that these three new patents are especially important as they extend our patent estate to include not only hESC-derived RPE, but also all products derived from iPSC sources. This broadening of the patent estate could also prove to be highly valuable in the long-term as we develop next generation therapies,” said Paul K. Wotton, President and Chief Executive Officer of Ocata Therapeutics. “Ocata continues to distinguish itself not only as the leader in Regenerative Ophthalmology, but also as a leader in manufacturing cell therapies from pluripotent stem cells and in the clinical development of such proprietary therapies.”

Ocata has a total of seven U.S. patents that specifically protect retinal pigmented epithelial (RPE) products derived from human embryonic stem cells (hESC) as well as any other pluripotent stem cell source including induced pluripotent stem cell (iPSC) sources.

“These new patents bolster an already robust patent estate. This is important as we continue to invest in the clinical development of these innovative new therapies for macular degeneration,” said Dr. Eddy Anglade, Chief Medical Officer of Ocata. “For the first time a pluripotent stem cell derived therapy is about to enter a pivotal trial for Stargardt’s Disease and phase 2 clinical trials for dry Age Related Macular Degeneration, bringing the possibility of these long awaited therapies that much closer to reality.”

About Ocata Therapeutics, Inc.

Ocata Therapeutics, Inc. is a clinical stage biotechnology company focused on the development and commercialization of Regenerative Ophthalmology therapeutics. Ocata’s most advanced products are in clinical trials for the treatment of Stargardt’s macular degeneration, dry age-related macular degeneration, and myopic macular degeneration. Ocata’s intellectual property portfolio includes pluripotent stem cell platforms – hESC and induced pluripotent stem cell (iPSC) – and other cell therapy research programs. For more information, visit www.ocata.com.

About Age-related Macular Degeneration

Age-related macular degeneration is the leading cause of vision loss in people over the age of 50. Every year in the USA there are 1.8 million patients newly diagnosed with dry AMD which occurs when light-sensitive photoreceptor cells in the macula, located in the center of the retina, slowly break down, causing vision loss as a result. Photoreceptor breakdown is a consequence of loss or damage to the RPE layer. As the disease progresses, patients may have difficulty reading and recognizing faces. There is currently no proven medical therapy for dry AMD and the projected number of people worldwide with age-related macular degeneration in 2020 is 196 million, increasing to 288 million in 2040 underscoring the urgent need for new treatments.

About Stargardt’s Disease

Stargardt’s macular degeneration is a form of juvenile macular degeneration that affects vision in children and young adults between the ages of six and 20, with a prevalence of approximately one in 10,000 people in the United States. It is an orphan disease and loss of vision is an inevitable aspect of SMD, with more than half of the patients experiencing vision loss in the range of 20/200-20/400. Like dry AMD, it occurs as a result of damage to the RPE layer and there are no treatments currently approved to prevent or slow the vision loss associated with SMD.

Forward-Looking Statements

All statements, other than historical facts, contained in this news release, including statements regarding, Ocata’s beliefs regarding the scope of protection provided by and the long-term value of its new and existing patents, the effect of such patents on the Ocata’s clinical development plans, the timing of a proposed pivotal trial for Stargardt’s Disease and phase 2 clinical trials for dry Age Related Macular Degeneration, and any other statements about Ocata’s future expectations, beliefs, goals, plans, results or prospects expressed by management constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Any statements that are not statements of historical fact (including statements containing the words “will,” “believes,” “plans,” “anticipates,” “expects,” “estimates,” and similar expressions) should also be considered to be forward-looking statements. There are a number of important factors that could cause actual results or events to differ materially from those indicated by such forward-looking statements, including: the fact that Ocata has no product revenue and no products approved for marketing; Ocata’s limited operating history; Ocata’s need for and limited sources of future capital; potential failures or delays in obtaining regulatory approval of products; risks inherent in the development and commercialization of potential products; reliance on new and unproven technology in the development of products; the need to protect Ocata’s intellectual property; the challenges associated with conducting and enrolling clinical trials; the risk that the results of clinical trials may not support Ocata’s product candidate claims; the risk that physicians and patients may not accept or use Ocata’s products, even if approved; Ocata’s reliance on third parties to conduct its clinical trials and to formulate and manufacture its product candidates; and economic conditions generally. Additional information on potential factors that could affect our results and other risks and uncertainties are detailed from time to time in Ocata’s periodic reports, including the Annual Report on Form 10-K for the fiscal year ended December 31, 2014. Forward-looking statements are based on the beliefs, opinions, and expectations of Ocata’s management at the time they are made, and Ocata does not assume any obligation to update its forward-looking statements if those beliefs, opinions, expectations, or other circumstances should change. Forward-looking statements are based on the beliefs, opinions, and expectations of Ocata’s management at the time they are made, and Ocata does not assume any obligation to update its forward-looking statements if those beliefs, opinions, expectations, or other circumstances should change. There can be no assurance that Ocata’s future clinical trials will be successful or that the results of previous clinical studies will lead to commercialization or products or therapies.