Medgenics, Inc. reported unaudited consolidated earnings results for the first quarter ended March 31, 2013. For the period, the company reported operating loss of $4,577,000 against $1,929,000 a year ago. Loss before taxes on income was $3,676,000 against $2,712,000 a year ago. Loss was $3,679,000 or $0.29 per share compared with a loss of $2,712,000 or $0.28 per share a year ago. Net cash used in operating activities was $2,800,000 against $2,362,000 a year ago. Purchase of property and equipment was $37,000 against $36,000 a year ago.

Medgenics, Inc. provided an update on results from the first four patients treated thus far in its ongoing Phase IIa clinical trial in Israel of EPODURE Biopumps to treat anemia in patients on dialysis with end-stage renal disease (‘ESRD’). Each of the four patients had been receiving routine EPO injections with each dialysis session until his or her EPODURE Biopumps were administered by subcutaneous implantation. Initial and on-going experience to date in ESRD patients is in line with observations from the Company's prior Phase I/II study in anemic pre-dialysis patients with chronic kidney disease (‘CKD’). To date, there have not been any procedure or drug related serious adverse events. Thus far in this single treatment study, each patient has received a single administration of EPODURE Biopumps, measured to produce between 19 to 51 IU EPO per kg per day, in place of the serial injections of EPO or ESA the patient had been receiving with each dialysis session. Following the administration of EPODURE Biopumps, the hemoglobin in these patients remained in the desired 9-11 g/dl range for approximately 2-4 months, without needing any EPO or other ESA injections. Notably, at no point following EPODURE treatment did the concentration of EPO in the serum of the patients exceed the typical normal range and always remained under 100 mU/ml. As the first study with EPODURE Biopumps in ESRD patients on dialysis, this Phase IIa study is testing administration techniques and dosing to determine how long a single treatment using EPODURE Biopumps can replace the periodic injections of EPO or other erythropoietic stimulating agents (‘ESAs’) currently used in the standard care of such patients, while maintaining the patient's hemoglobin within the desired range. The current standard of care for ESRD patients on dialysis involves EPO or ESA injections with each dialysis session, which is typically three times per week. Each injection is short-lived, typically causing an extreme transient elevation of EPO in the patient's blood to levels of several thousand milliUnits/ml, typically 10-100 times the normal physiological levels, followed by a decline to ineffective levels within a few days, so the patient may not have sufficient EPO or ESA until the next injection. The high transient levels of EPO in the blood are a source of potential safety concern to many medical experts as well as to the U.S. Food and Drug Administration (‘FDA’), and is in marked contrast with the normal EPO levels maintained with EPODURE.

Medgenics, Inc. announced the United States Patent and Trademark Office has issued a Notice of Allowance of claims that expand the Company's scope of patent coverage for additional therapeutic proteins. The claims in the patent are directed to a dermal Biopump expressing at least one recombinant gene product from any of the following: growth hormone, interferon beta, insulin, PDGF-BB, interleukin-1 receptor agonist (IL-1Ra), peptide YY3-36, interleukin-10 (IL-10) and G-CSF. These claims, combined with the prior grant of patents for genetically modified dermal micro-organ expression of erythropoietin and interferon alpha, broaden Medgenics' scope of intellectual property in the field of genetically modified dermal micro-organs. Upon the issuance of this patent, Medgenics' global patent portfolio will include 45 patents granted, with 79 patent applications pending. Medgenics believes its approach to protein therapy will have multiple benefits compared with current treatments, which include regular and costly injections of therapeutic proteins. Medgenics' technologies target a range of clinical indications within the global protein therapy market, which is forecast to reach $143 billion in 2015.