http://www.medgenics.com/about_us.htm

Medgenics is developing a unique sustained-action therapeutic protein delivery technology for the treatment of a range of chronic diseases. The technology – called a “Biopump” – is made from the patient’s own skin and is implanted in a simple procedure to work inside the patient’s body, to produce and deliver the active protein steadily over a sustained period to treat the targeted disease. Medgenics believes that this biological approach can replace a major portion of the regular and costly injections of therapeutic proteins patients currently receive.

The Company has demonstrated proof-of-principle of its treatment procedure in a clinical trial using EPODURE in anemic patients. A long-acting version of EPODURE designed to produce and deliver a therapeutic dose of EPO steadily for six months or more began Phase I/II efficacy trials in Israel in mid-2008. Clinical trials with INFRADURE are intended follow in due course.

Beyond this, the Company plans to develop a pipeline of products based on its Biopump technology targeting the large and rapidly growing global $50+ billion protein therapy market, which is expected to grow to some $132 billion per year in 2013.

Medgenics is managed by a highly experienced team of biotechnology and biomedical device experts, and its Board of Directors and Scientific Advisory Board include highly experienced figures in the healthcare industry, in healthcare finance, as well as influential figures from the medical community and academia.

Share Price
Medgenics, Inc. commenced trading on the London Stock Exchange Alternative Investment Market (AIM), on Tuesday, 04 December 2007. The stock trades under two symbols: MEDG for Reg S shares and MEDU for unrestricted shares.

Medgenics reports on significant period of change as advances trials
13th Aug 2012, 3:51 pm by Jamie Ashcroft

http://www.proactiveinvestors.co.uk/companies/news/46758/medgenics-reports-on-significant-period-of-change-as-advances-trials-46758.html

Another good riser up10.69%

http://www.moneyam.com/action/news/showArticle?id=4434006

And another +6.90%

Medgenics receives approval for hepatitis trial plans

http://www.proactiveinvestors.co.uk/companies/news/47456/medgenics-receives-approval-for-hepatitis-trial-plans-47456.html

Medgenics to present EPODURE at Kidney Week 2012
2:55 pm by Jamie Nimmo Kidney Week 2012 is the world’s premier nephrology meeting Medgenics (LON:MEDG, NYSE:MDGN) has revealed it will present its EPODURE Biopump in a poster session at the American Society of Nephrology's Kidney Week 2012.

Its poster titled “Novel Sustained Delivery of Erythropoietin in Hemodialysis Patients for Safer Anemia Control using EPODURE™ Biopumps - Autologous Dermal Tissue Samples Secreting Erythropoietin” will be displayed at the San Diego event on Friday November 2.

The poster will present preliminary data from a Phase IIa clinical trial of EPODURE to treat anaemia patients with end-stage renal disease.

EPODURE is one of three long-acting protein therapy products Medgenics has in development. The other two are INFRADURE for the treatment of hepatitis and HEMODURE for haemophilia.

Kidney Week 2012 is the world’s premier nephrology meeting with more than 13,000 kidney experts attending from around the globe.

Medgenics’ shares fell 4.5% to 590 pence each today.

Phase IIa EPODURE Data Presentation at Kidney Week
RNS
RNS Number : 2169Q
Medgenics Inc
05 November 2012







Press Release
5 November 2012




Medgenics, Inc.

("Medgenics" or "the Company")



Medgenics Presents Preliminary Data from Phase IIa Study with EPODURE to Treat Anemia in Dialysis Patients at Kidney Week 2012

Medgenics, Inc. (NYSE Amex: MDGN and AIM: MEDU, MEDG), the developer of Biopump™, a novel technology for the sustained production and delivery of therapeutic proteins in patients using their own tissue, announced the presentation of preliminary data from its ongoing Phase IIa clinical trial in Israel with EPODURE™ Biopumps to treat anemia in patients on dialysis with end-stage renal disease ("ESRD"), by sustained delivery of erythropoietin ("EPO"). Data from the first three patients were highlighted in a poster presentation today at the American Society of Nephrology's Kidney Week 2012, which is being held from October 30 through November 4 in San Diego. The poster is titled "Novel Sustained Delivery of Erythropoietin in Hemodialysis Patients for Safer Anemia Control using EPODURE™ Biopumps - Autologous Dermal Tissue Samples Secreting Erythropoietin."

As the first study with EPODURE Biopumps in ESRD patients, the Phase IIa study is testing administration techniques and dosing to determine if EPODURE can replace most or all of the injections of EPO or other erythropoietic stimulating agents ("ESAs") currently used in the standard care of such patients, while maintaining blood hemoglobin levels within the desired range. The current standard of care involves frequent EPO or ESA injections, which require patient compliance for reliable administration. Each injection is short-lived, typically causing an extreme transient elevation of EPO in the patient's blood, 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").



Consistent with the earlier Phase I/II study with EPODURE in pre-dialysis patients, the EPODURE procedure went well in these first dialysis patients. These patients will continue to be monitored and enrollment in the study is continuing.



Medgenics' EPODURE Biopumps aim to provide a cost-effective way to maintain hemoglobin within a target physiological range for anemic patients through the sustained delivery of EPO, while avoiding the extreme elevations seen with injections. Medgenics believes that this steady delivery could improve the safety and efficacy of anemia treatments while enhancing patient quality of life by providing a more reliable treatment that reduces or eliminates the need for frequent EPO or ESA injections, and also provides significant cost benefits to payers.



"We believe that this Phase IIa study will provide valuable insight into the use of EPODURE to treat anemia in patients on dialysis, which is the largest segment of the anemia market. Although the findings presented at Kidney Week 2012 are on only three patients, we are thus far encouraged by this ongoing study. Full study results can be supportive of the larger Phase II study in dialysis patients in the U.S., now slated to begin in the first half of 2013. Once completed, we believe these studies will provide data to support the use of EPODURE in the treatment of anemia from chronic kidney disease," stated Andrew L. Pearlman, Ph.D., President and Chief Executive Officer of Medgenics.




About Kidney Week 2012

Kidney Week 2012 is the world's premier nephrology meeting. More than 13,000 kidney professionals from around the globe come together to exchange knowledge, learn the latest scientific and medical advances, and listen to engaging and provocative exchanges between leading experts in the field.

Monday, November 05, 2012
Proactive news summary including Medgenics, Silence Therapeutics, Immupharma, Minera IRL and Simba Energy






In the news today was drugs company Medgenics (LON:MEDG), which gave an early, but very encouraging hint as to the progress of its potentially revolutionary EPODURE system for treating anaemia in patients on kidney dialysis.

Referring to the first three people enrolled in a phase IIa clinical study, the drugs delivery specialist said “the EPODURE procedure went well”.

The treatment uses the company’s biopump technology, which allows the sustained production of therapeutic proteins.

Shares in London were unchanged at 597.5 pence.

Medgenics reflects on a quarter of significant progress
3:06 pm by Ian LyallIts scientists are developing the BIOPUMP system that uses the body’s own tissue to deliver drugs in a sustained longer acting way.



Third quarter results from Medgenics (LON:MEDG, AMEX:MDGN) reflect a period of huge progress in which its two main treatments have passed key milestones.

Its scientists are developing the BIOPUMP system that uses the body’s own tissue to deliver drugs in a sustained longer acting way.

It is the platform INFRADURE, to treat hepatitis C, which has received the green light from the Israeli authorities to proceed into phase I/II clinical studies assessing safety and efficacy.

The group has also enrolled its first patients for a phase IIa study on EPODURE, an anemia treatment that also uses the biopump.

"We are in the process of performing a comprehensive pipeline review to assess clinical applications we believe could benefit from our versatile Biopump platform and to update our list of targeted indications that will maximise our business development prospects," said chief executive Andrew Pearlman.

Medgenics reported a US$100,000 rise in research and development expenditure in the three months to September 30, which contributed to a net loss of just over US$3 million.

More importantly for a drug developer at this stage of its evolution it is well financed with US$9 million of cash as at the period end.

Press Release
21 November 2012




Medgenics, Inc.

("Medgenics" or "the Company")

Medgenics Granted U.S. Patent for Core Technology Used in Sustained Delivery of Erythropoietin, Aimed at Multi-Billion Dollar Anemia Market
U.S. Patent and Trademark Office also allowed key claims protecting similar method for delivery of clotting Factor VIII aimed at sustained treatment of hemophilia





Medgenics, Inc. (NYSE Amex: MDGN and AIM: MEDU, MEDG), the developer of Biopump™ a novel technology for the sustained production and delivery of therapeutic proteins in patients using their own tissue, today announced a patent granted by the U.S. Patent and Trademark Office ("USPTO") protecting the use of Medgenics' EPODURE Biopump technology for delivery of erythropoietin ("EPO"). Medgenics is developing EPODURE to address the need for safer, sustained treatment of anemia. The USPTO also allowed claims covering a similar method for delivery of clotting Factor VIII, underlying Medgenics' HEMODURE™ Biopump technology for sustained prophylactic treatment of hemophilia.



Similar claims covering EPODURE and HEMODURE have also been recently allowed in Japan, China, Korea and Australia.



In total, Medgenics' global portfolio now includes 36 patents issued, with 81 more pending.



Medgenics believes its approach to protein therapy has multiple benefits compared with current treatments, which include regular and costly injections of therapeutic proteins. Medgenics' technologies target the global protein therapy market which is forecast to reach $132 billion in 2013.



"As we continue to progress in our clinical trials and move forward in our business development efforts, the protection of our intellectual property becomes critical. We believe that receiving method patents and allowance of key claims for our Biopump™ system for the production and delivery of EPO and Factor VIII proteins increases the value of our intellectual property assets and our company," stated Andrew L. Pearlman, Ph.D., President and Chief Executive Officer of Medgenics.

Medgenics shares rise on US patent news
4:20 pm by Giles GwinnettThe US Patent and Trademark Office (USPTO) gave the patent for the firm's EPODURE Biopump technology for delivery of erythropoietin for the treatment of anaemia

Biopump developer Medgenics' (LON:MEDG) shares were lifted after it won a patent from the US authorities to protect the technology associated with the device.

The US Patent and Trademark Office (USPTO) issued the patent for the firm's EPODURE Biopump technology for delivery of erythropoietin for the treatment of anaemia - a multi-billion dollar market, it said.

The pump allows the sustained production of therapeutic proteins and uses the patients' own skin biopsy.

Medgenics' chief executive and president Andrew Pearlman told investors: "As we continue to progress in our clinical trials and move forward in our business development efforts, the protection of our intellectual property becomes critical."

The USPTO also allowed claims covering a similar method for delivery for the firm's HEMODURE biopump for treating haemophilia, the company revealed in the statement.

Medgenics' total global portfolio now includes 36 patents issued with a further 81 pending, it said.

Shares rose 4.40%, to change hands at 475 pence each

A little down at the moment, the news today gave the sp a small rise. One to keep my eye on, due to the fall so far. Could be rewards with news or indeed keep falling.

Experts Affirm Medgenics' INFRADURE Technology
RNS
RNS Number : 2082S
Medgenics Inc
28 November 2012









Press Release
28 November 2012




Medgenics, Inc.

("Medgenics" or "the Company")

Renowned Experts Affirm Potential of Medgenics' INFRADURE Technology for Treatment of Hepatitis B and D



Medgenics, Inc. (NYSE Amex: MDGN and AIM: MEDU, MEDG), the developer of Biopump™ a novel technology for the sustained production and delivery of therapeutic proteins in patients using their own tissue, today announced that during the recent annual conference of the American Association for the Study of Liver Disease (AASLD) in Boston, it convened an active roundtable of top liver experts and regulatory advisors from the United States, Europe, Israel and Australia to discuss INFRADURE™, which the Company is developing to provide sustained interferon therapy for the treatment of hepatitis. Fifteen key opinion leaders in hepatitis met to interactively review Medgenics' INFRADURE for its potential applications in the treatment of hepatitis B and hepatitis D. The session provided key input reflecting the latest clinical developments in hepatitis to optimize the clinical development strategy and regulatory approach for INFRADURE.



INFRADURE is designed to provide sustained interferon therapy using the patient's own dermis tissue processed to produce and deliver interferon alpha continuously in the patient for months from a single treatment. Hepatitis B affects more than 350 million people worldwide and approximately 1.3 million in the U.S. Hepatitis D, an aggressive form of hepatitis, affects some 15 million people worldwide, and is estimated to afflict tens of thousands in the U.S. Hepatitis C affects an estimated 180 million people worldwide and 3 to 4 million in the U.S.



Nezam H. Afdhal, M.D., Chief of Hepatology, Director of Liver Center, Beth Israel Deaconess Medical Center and Professor of Medicine, Harvard School of Medicine, and a member of the Company's Strategic Advisory Board who helped organize the meeting, commented, "This group of top leaders in the field of hepatitis concurred that INFRADURE holds much promise in addressing the unmet need in the treatment of hepatitis B, namely to eliminate the hepatitis B virus (HBV), not just contain it. Years of expensive oral antiviral treatments have not eliminated the HBV. Instead these treatments have acted to contain the disease as long as the patient takes them, with mounting costs and health risks. The group agreed that the gold standard of treating HBV is to eliminate the hepatitis B surface antigen (HBsAg) by activating the immune system to fight it, known as sero-conversion - which is attained in only a small percentage of patients using oral antiviral agents and only after long-term use. Sero-conversion against HBV and surface antigen elimination has been reported to be improved by one-to-two years of interferon alpha therapy. However, today this requires the patient to endure weekly injections of pegylated interferon alpha with its associated side effects, creating a significant challenge in patient compliance to complete treatment. INFRADURE has the potential to provide a much more practical and patient-compliant way to attain sero-conversion or surface antigen loss in a large proportion of patients by having the patient's own tissue produce and deliver the protein instead of using injections, whether supplemental to oral treatments, or on its own."



Bruce R. Bacon, M.D., Saint Louis University and past President of the American Association for the Study of Liver Disease, a recognized global expert in hepatitis and a member of the Company's Strategic Advisory Board, reacted to the meeting, saying, "Colleagues who participated in the meeting and I were particularly excited about INFRADURE use as a supplement to oral drugs to address their unmet need to improve HBV surface antigen clearance. We also concurred that INFRADURE could fulfill an unmet need for reliable interferon therapy for hepatitis D, a particularly aggressive form of hepatitis for which years of interferon therapy is the only effective treatment. Though an orphan disease in the U.S., our European colleagues pointed out that hepatitis D is becoming a significant cause of death in Europe. This has now captured the attention of hepatologists in the U.S., where the AASLD held its first special session dedicated to hepatitis D this year. My colleagues agreed that if the upcoming INFRADURE trial in hepatitis C shows signs of effectiveness, it will also be promising for its use in hepatitis D as well as hepatitis B."


Andrew L. Pearlman, Ph.D., President and Chief Executive Officer of Medgenics, added, "Confirmation by this group of esteemed experts on the potential application of INFRADURE in hepatitis B and D represents an important milestone for the hepatitis program using our Biopump™ platform. We are extremely appreciative of their valuable input on our proposed development plans for INFRADURE."

Up 7.5% on my screen without a share bought or sold.

Key Patent Claims Allowed in Japan
RNS
RNS Number : 9373S
Medgenics Inc
06 December 2012







Medgenics Key Patent Claims Allowed in Japan Protecting Core Technology to be Used in Hepatitis Treatment
Expands global patent protection for Medgenics' proprietary Biopump platform





Medgenics, Inc. (NYSE MKT: MDGN and AIM: MEDU, MEDG) (the "Company"), the developer of a novel technology for the sustained production and delivery of therapeutic proteins in patients using their own tissue, today announced it has received a Notice of Allowance from the Japanese Patent and Trademark Office for key claims protecting the use of Medgenics' INFRADURE Biopump™ technology for the delivery of interferon alpha (IFNa). Medgenics is developing INFRADURE™ as a new approach to provide sustained and patient compliant interferon therapy to address unmet needs in the treatment of hepatitis B, C, and D.



Similar claims protecting Medgenics' INFRADURE technology have been granted or allowed in other large Asian markets including, China, Korea and Australia. In addition, these countries have allowed broad claims to Medgenics protecting the core Biopump technology for production and delivery of proteins.



Patents covering core Biopump technology for a genetically modified dermal micro-organ have already been granted to Medgenics in the U.S. and in the EU.



Medgenics believes its Biopump platform offers an approach to protein therapy with multiple benefits compared with current treatments, which include regular and costly injections of therapeutic proteins. Medgenics' technologies target the global protein therapy market which is forecast to reach $132 billion in 2013.



"Securing international protection for our core technology and its various methods of use are critically important as we continue to develop INFRADURE to address major unmet needs in various forms of hepatitis and to move towards commercial development. This allowance of key claims specifically covering the core technology underpinning INFRADURE in some significant hepatitis markets will help to enable us to advance our proprietary technology," stated Andrew L. Pearlman, Ph.D., President and Chief Executive Officer of Medgenics. "

Medgenics' key patent claims allowed in Japan
3:11 pm by Ian LyallSimilar protection has already been granted in China, Korea and Australia.



Medgenics (LON:MEDU, NYSE:MDGN) has received what’s called a notice of allowance from Japan’s Patent and Trademark Office for Infradure, its slow release treatment for hepatitis B, C and D.

Infradure is based around the company’s breakthrough Biopump technology, which uses the body’s own tissue to release therapeutic proteins in a far more regulated fashion than traditional treatments.

Similar protection has already been granted in China, Korea and Australia.

Chief executive Andrew Pearlman said: "Securing international protection for our core technology and its various methods of use are critically important as we continue to develop Infradure to address major unmet needs in various forms of hepatitis and to move towards commercial development.

“This allowance of key claims specifically covering the core technology underpinning Infradure in some significant hepatitis markets will help to enable us to advance our proprietary technology."

Medgenics kicks of clinical trial of hepatitis treatment
Wed 30 Jan 2013

MEDG - Medgenics Inc. (Reg S)

Latest Prices
Name Price %
Medgenics Inc. (Reg S) 447.50p 0.00%

FTSE AIM 100 3,272 -0.32%
Pharmaceuticals & Biotechnology 10,184 +0.12%

LONDON (SHARECAST) - Medgenics has enrolled the first patient for its clinical trial of its INFRADURE Biopump product, which is used for the treatment of hepatitis C.

INFRADURE is a subcutaneous autologous skin tissue implant for the continuous production and delivery of interferon-alpha (INFa )needed by hepatitis patients.

It was developed by Medgenics to treat hepatitis B, C and D, to replace months of weekly injections of INFa, along with the serious side effects.

The initial phase of the study is being conducted at the Tel Aviv Sourasky Medical Center in Israel.

The study is recruiting patients with hepatitis C of genotypes 2 and 3, who would normally receive weekly injections of INFa together with a daily dose of the oral antiviral drug ribavirin.

Patients will receive a single implantation of INFRADURE Biopumps in place of the weekly injections, together with daily ribavirin.

“Medgenics believes that the results of this study will assist in developing and calibrating INFRADURE for use in additional types of viral hepatitis, as well as other indications,” the company said.

Medgenics hails year of many milestones
2:20 pm by John Harrington "During 2012 we achieved a number of milestones under our strategic plan," stated Dr Andrew Pearlman, CEO of Medgenics.

Medgenics (LON:MEDG) pledged to pursue partnership and licensing opportunities this year as well as new applications for its innovative Biopump technology as it unveiled results for 2012.

“Our goals for the balance of 2013 will be to continue to advance the clinical development of EPODURE and INFRADURE in Israel and the US, to expand our leadership with experienced industry executives, to optimise our manufacturing process, to pursue potential partnership and licensing opportunities and to explore potential new indications for our Biopump autologous tissue technology,” declared Medgenics’ chief executive. Dr Andrew Pearlman, as the company issued results for 2012.

Epodure is currently being tested for the treatment of chronic renal anaemia, while Infradure is being tested on hepatitis C patients.

Both treatments are administered using Medgenics’ Biopump device, which takes the patient’s own skin and implants it in the patient’s body to produce and deliver the active protein to treat the targeted device.

The technology is still at the clinical trials stage and, as such, the company had no revenues in 2012.

As the company ramps up activity to bring its treatments to market, expenses are naturally mounting, resulting in an increase in the net loss over the year to US$15.07mln from US$8.10mn in 2011.

Net research & development (R&D) expenses rose to US$5.43mln from US$5.05mln the year before. General and administrative expenses, meanwhile, climbed to US$7.20mln from US$4.92mln a year earlir, in part because of increased legal fees and professional services.

Medgenics ended 2012 with US$6.43mln in cash and cash equivalents, up from US$5.00mln a year earlier.

Net cash used in operating activities during the year was US$8.61 million compared with US$8.02 million used in 2011.

Since the end of the reporting period Medgenics has raised US$29.4mln through a share issue.

Medgenics looks to "value creating" milestones in 2013
By Proactive Investors May 09 2013, 3:27pm The company is developing Biopump technology, which uses patients' won tissue to treat a range of chronic diseases including hepatitis and hemophiliaThe company is developing Biopump technology, which uses patients' won tissue to treat a range of chronic diseases including hepatitis and hemophilia



Medgenics (LON:MEDG) aims to achieve "value creating" milestones in the rest of 2013, it said, releasing first quarter results.

The company is developing Biopump technology, which uses patients' won tissue to treat a range of chronic diseases including hepatitis and hemophilia.

"During the first quarter we achieved important milestones that strengthened our position in key areas and advanced our strategic and clinical goals," said chief executive and president Andrew Pearlman.

In the period to March 31, the firm raised gross proceeds of around $32 million, reported interim clinical results from its Phase IIa anemia trial in patients with end-stage renal disease and bolstered its board with Joseph J. Grano, Jr - former chairman and chief executive of UBS Financial Services.

Gross research and development (R&D) expenses for the first quarter of 2013 increased to US $2.03 million from US$1.59 million for same period in 2012.

The net loss stood at US$3.68 million compared with a net loss of $2.71 million in the comparable 2012 period.

In the quarter, it used US$2.80 million in net cash to fund operating activities, compared with US$2.36 million for the three months last year.

Medgenics Reports Second Quarter Financial Results

RNS


RNS Number : 0674L

Medgenics Inc

06 August 2013



















Press Release

6 August 2013




Medgenics Reports Second Quarter Financial Results



Medgenics, Inc. (NYSE MKT: MDGN and AIM: MEDU, MEDG) (the "Company"), the developer of a novel technology for the sustained production and delivery of therapeutic proteins in patients using their own tissue, today reported financial results for the three and six months ended June 30, 2013 and the filing with the U.S. Securities and Exchange Commission (SEC) of the Company's Quarterly Report on Form 10-Q. The Form 10-Q includes unaudited interim consolidated financial statements containing the information presented below, as well as additional information regarding the Company. The Form 10-Q is available at www.sec.gov and at www.medgenics.com.



Management Commentary

"The first half of 2013 was an active and productive period during which we made progress in a number of significant areas and positioned the Company to address important near term milestones," stated Andrew L. Pearlman, Ph.D., President and Chief Executive Officer of Medgenics. "We advanced our clinical programs, fortified our patent portfolio, were awarded a grant of approximately $2 million from the Israeli Office of the Chief Scientist (OCS) and raised substantial capital in a public offering to support the forward momentum of our programs.



"In April 2013 we reported interim data from our Israeli Phase IIa clinical study of EPODURE to treat anemia in patients with end-stage renal disease who are on dialysis, which showed sustained hemoglobin levels in patients for months without the need for injections of erythropoietin. We completed a number of key preparations and continue to be on target to initiate our U.S. Phase II study of EPODURE in similar patients. This will be our first U.S. clinical study for the Biopump technology. We reported the launch and enrollment of the first patient in our Phase I/II proof-of-concept clinical study of INFRADURE in the treatment of hepatitis C in Israel, and look forward to reporting interim data from this study before year-end. We expect to use data from this trial to support the clinical development and regulatory strategy for INFRADURE to treat hepatitis D, an indication for which we have U.S. orphan drug designation. We are exploring its role in treating hepatitis B as well.



"In addition, we continue to make advances in optimizing our Biopump platform through a number of developments that include enhancements to the protein expression technology and Biopump processing methods, as well as to improvements inpatient administration. These developments have the potential to further increase production and delivery of protein and to extend the duration of clinical effect," added Dr. Pearlman.



Second Quarter Financial Results

Gross research and development (R&D) expense for the second quarter of 2013 increased to $2.07 million from $1.64 million for same period in 2012. Net R&D expense for the 2013 second quarter was $0.86 million compared with net R&D expense of $1.18 million for the prior year's second quarter. The decrease in net R&D expense was due to the participation by the OCS of $1.22 million in the three months ended June 30, 2013, compared with $0.46 million in the same period in 2012, somewhat offset by the increase in the gross R&D expense.



General and administrative expense for the second quarter of 2013 decreased to $1.59 million compared with $2.77 million for the comparative quarter in 2012, due primarily to lower stock-based compensation expense related to options and restricted shares granted to directors and consultants.



Financial expenses for the quarter ended June 30, 2013 were $0.03 million, compared with $2.97 million for the same period in 2012. This decrease was mainly due to the change in valuation of the warrant liability.



Financial income for the quarter ended June 30, 2013 was $0.37 million, increasing from $0.02 million for the same period in 2012. This increase was primarily due to the change in valuation of the warrant liability.



For the second quarter of 2013 the Company reported a net loss of $2.10 million or $0.11 per share, compared with a net loss of $6.91 million or $0.69 per share for the second quarter of 2012.



Six Month Financial Results

Gross R&D expense for the first half of 2013 increased to $4.10 million from $3.23 million for same period in 2012 due to an increase in R&D personnel. Net R&D expense for the first half of 2013 was $2.89 million compared with net R&D expense of $1.75 million for the first half of 2012. The increase in net R&D expense was due to the participation by the OCS of $1.22 million in the six months ended June 30, 2013 compared with $1.49 million in the same period in 2012, and by the increase in the gross R&D expense as explained above.



General and administrative expense for the six months ended June 30, 2013 of $4.13 million was consistent with the prior-year period.



Financial income for the six months ended June 30, 2013 of $1.29 million was due primarily to the change in valuation of the warrant liability.



For the six months ended June 30, 2013, the Company reported a net loss of $5.78 million or $0.42 diluted loss per share, compared with a net loss of $9.66 million or $0.98 per share in the comparable 2012 period.



The Company ended the second quarter with cash and cash equivalents of $28.98 million, compared with $6.43 million as of December 31, 2012. Medgenics raised gross proceeds of approximately $32 million in a public offering of common stock and warrants during the first quarter of 2013. The Company used $6.18 million in net cash to fund operating activities during the first half of 2013, compared with $4.34 million for the first half of 2012.

Medgenics on target for US phase II study of EPODURE
By Giles Gwinnett August 06 2013, 3:14pm Gross research and development (R&D) expenses for the three months to end June increased to US$2.07mln compared to $1.64mln for same period in 2012Gross research and development (R&D) expenses for the three months to end June increased to US$2.07mln compared to $1.64mln for same period in 2012

Medgenics (LON:MEDG) continues to be on target to carry out its first US clinical trial of its biopump technology, it said, releasing second quarter results.

Earlier this year, the firm reported interim data from its Israeli phase IIa clinical study of EPODURE to treat anaemia in end stage renal disease patients, and the US trial will be a phase II study of the technology in similar patients.

Andrew Pearlman, chief executive, said the first half had seen progress and Medgenics was now positioned for "important near term milestones".

"We advanced our clinical programmes, fortified our patent portfolio, were awarded a grant of approximately US$2 million from the Israeli Office of the Chief Scientist (OCS) and raised substantial capital in a public offering to support the forward momentum of our programmes".

Gross research and development (R&D) expenses for the three months to end June increased to US$2.07mln compared to US$1.64mln for the same period in 2012.

Meanwhile, the firm narrowed the net loss in the period to US$2.10mln or $0.11 per share, compared with a net loss of US$6.91 million (2012, Q2: US$0.69).

Pearlman told investors it continued to optimise its Biopump platform through a number of developments that include enhancements to the protein expression technology and processing methods.

"These developments have the potential to further increase production and delivery of protein and to extend the duration of clinical effect," said Pearlman.

In July this year, the firm received an annual grant for up to US$1.9mln from the Israeli government, its seventh consecutive award.

It will cover research & development (R&D) expenditure for the 12-months to November 2013 on the use of Medgenics’ Biopump platform technology to treat anaemia and hepatitis.

On the move

up 16% on little volume

Up another 16%

Looks fast to becoming out of the doldrums.

RNS


RNS Number : 3654P

Medgenics Inc

01 October 2013















Press Release

1 October 2013






Appointment of Nominated Adviser and Joint Broker



Medgenics, Inc. (NYSE MKT: MDGN and AIM: MEDU, MEDG) ("the Company"), developer of a novel technology for the sustained production and delivery of therapeutic proteins in patients using their own tissue, today announces that Oriel Securities Limited has been appointed as the Company's nominated adviser and joint broker with immediate effect.



About Medgenics



Medgenics is developing and commercializing Biopump™, a proprietary tissue-based platform technology for the sustained production and delivery of therapeutic proteins using the patient's own tissue for the treatment of a range of chronic diseases including anemia, hepatitis, among others. For more information, please visit www.medgenics.com.

Recovering very well.

Medgenics to present poster at ESGCT Congress

RNS


RNS Number : 2206R

Medgenics Inc

23 October 2013



















Press Release

23 October 2013






Medgenics To Present Poster at European Society of Gene and Cell Therapy Congress to Highlight Results from Second-Generation Viral Vector



Medgenics, Inc. (NYSE MKT: MDGN and AIM: MEDU, MEDG) (the "Company"), the developer of a novel technology for the sustained production and delivery of therapeutic proteins in patients using their own tissue, announces that a poster highlighting the Company's second-generation EPODURE Biopump™ will be presented at the European Society of Gene and Cell Therapy Congress, taking place in Madrid October 25-28.



Posters will be showcased in Poster Reception Halls A-C November 1-3 and will be available for viewing from 9:30 a.m. to 2:30 p.m. local time. Poster presentations will take place from 10:00 a.m. to 12:00 p.m. The following Medgenics' poster will be presented during Poster Session B on Sunday, October 27:



· "Second generation EPODURE Biopump™ markedly extends duration of EPO delivery in mice, could prolong therapeutic effect in patients," by Miari, et. al. Poster Number P146.



EPODURE is an autologous dermal Biopump capable of the sustained production of therapeutic erythropoietin ("EPO") in the body using a small tissue explant from the patient's own skin and processed to continuously produce EPO. Each EPODURE Biopump is subsequently implanted subcutaneously into the patient aiming to provide continuous delivery of EPO.




About The European Society of Gene and Cell Therapy (ESGCT)

The European Society of Gene and Cell Therapy (ESGCT) promotes basic and clinical research in gene therapy, cell therapy and genetic vaccines by facilitating education, the exchange of information and technology and by serving as a professional adviser to stakeholder communities and regulatory bodies in Europe.




About Medgenics

Medgenics is developing and commercializing Biopump™, a proprietary tissue-based platform technology for the sustained production and delivery of therapeutic proteins using the patient's own tissue for the treatment of a range of chronic diseases including anemia and hepatitis, among others. For more information, please visit www.medgenics.com.




Forward-looking Statements

This release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and as that term is defined in the Private Securities Litigation Reform Act of 1995, which include all statements other than statements of historical fact, including (without limitation) those regarding the Company's financial position, its development and business strategy, its product candidates and the plans and objectives of management for future operations. The Company intends that such forward-looking statements be subject to the safe harbors created by such laws. Forward-looking statements are sometimes identified by their use of the terms and phrases such as "estimate," "project," "intend," "forecast," "anticipate," "plan," "planning, "expect," "believe," "will," "will likely," "should," "could," "would," "may" or the negative of such terms and other comparable terminology. All such forward-looking statements are based on current expectations and are subject to risks and uncertainties. Should any of these risks or uncertainties materialize, or should any of the Company's assumptions prove incorrect, actual results may differ materially from those included within these forward-looking statements. Accordingly, no undue reliance should be placed on these forward-looking statements, which speak only as of the date made. The Company expressly disclaims any obligation or undertaking to disseminate any updates or revisions to any forward-looking statements contained herein to reflect any change in the Company's expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based. As a result of these factors, the events described in the forward-looking statements contained in this release may not occur.

Medgenics Reports Positive Data At ESGCT Congress

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Medgenics aims to use latest technology in trials in first half of 2014
By Giles Gwinnett November 07 2013, 3:01pm Viral vectors are used to deliver genetic material into cells and the Biopump delivers therapuetic proteins into patients using their own tissue to treat several chronic diseases, including anaemiaViral vectors are used to deliver genetic material into cells and the Biopump delivers therapuetic proteins into patients using their own tissue to treat several chronic diseases, including anaemia

Medgenics (LON:MEDG, NYSE:MDGN) plans to use its next generation of viral vectors in clinical trials beginning in the first half of next year.

It came as the biopharmaceutical firm, which is developing Biopump technology and recently appointed a new executive team, reported third quarter results.

Viral vectors are used to deliver genetic material into cells and the Biopump delivers therapeutic proteins into patients using their own tissue to treat several chronic diseases, including anaemia.

New president and chief executive Michael Cola said: "We are excited to be building upon the company's strong scientific and technological foundation, and are refining new strategic initiatives to advance the clinical development programme in carefully selected specialty and orphan indications."

New, positive data on the company's second-generation viral vectors were recently highlighted in a poster presentation at the European Society of Gene and Cell Therapy Congress in Madrid.

In vitro (ie, test tube) and in vivo (ie, living beings) models showed the potential to increase the duration and levels of the protein secretion of the Biopump along with enhanced surgical techniques.

"These advances can be clinically meaningful, particularly for patients on chronic protein therapy. Based on these results, we believe that all clinical programs, including the proposed EPODURE trial in the US, could benefit from the potentially improved performance from a second-generation vector," the company said.

For the nine months to September 30, Medgenics reported a net loss of US$11.92 million compared with a net loss of US$12.69 mln in 2012.

Gross R&D (research and development) expense for the first nine months of 2013 increased to US$6.56 million from US$5.13 mln in the same period of 2012 due to an increase in R&D personnel and clinical activities.

Medgenics chairman buys $170,000 of shares
By Jamie Nimmo November 15 2013, 2:20pm Barer purchased 25,000 shares at an average price of $6.80 eachBarer purchased 25,000 shares at an average price of $6.80 each

Medgenics’ (LON:MEDG) chairman, Dr Sol Barer, has bought $170,000 worth of shares in the biopump developer.

Barer purchased 25,000 shares at an average price of $6.80 each. He now owns 72,000 shares or 0.4% of the company’s issued share capital.

The chairman also has the right to buy up to 1.3mln shares through options granted to him.

Last week, Medgenics unveiled plans to use its next generation of viral vectors in clinical trials beginning in the first half of next year.

Viral vectors are used to deliver genetic material into cells and the Biopump delivers therapeutic proteins into patients using their own tissue to treat several chronic diseases, including anaemia.

Directors reluctant to add exposure to their companies at current prices, says Deutsche
By Giles Gwinnett
November 16 2013, 10:00am

http://www.proactiveinvestors.co.uk/companies/market_reports/63301/directors-reluctant-to-add-exposure-to-their-companies-at-current-prices-says-deutsche-0000.html

Medgenics chairman buys again, Oriel keen
By Philip Whiterow December 03 2013, 2:27pm Broker Oriel Securities today issued a buy recommendation with a 600p target price.

Medgenics' (LON:MEDG) chairman has bought his second sizeable chunk of shares in the drug delivery innovator in little over two weeks.

Dr Sol Barer bought 20,000 shares at US$6.589 at a total cost of around US$132,000. In November, Barer bought US$170,000 worth of stock in the Israeli group and with this latest purchase he now owns 92,000 shares or 0.5% directly. Adding in his options potentially increases his holding to 7.6%.

Medgenics has patented a novel delivery technology called Biopump and recently unveiled plans to use its next generation of viral vectors in clinical trials beginning in the first half of next year.

Viral vectors are used to deliver genetic material into cells and the Biopump delivers therapeutic proteins into patients using their own tissue to treat several chronic diseases, including anaemia.

Broker Oriel Securities today issued a buy recommendation with a 600p target price, adding that Biopump had the potential to revolutionise the production and delivery of protein based therapies.

Clinical data is due in 2014 from phase I/IIa trials in treating anaemia and hepatitis C, which should help to validate its clinical potential said the broker in a connected initiation note.

The technology is designed to overcome many of the drawbacks of regular, bolus injections of therapeutic proteins by using strips of a patients’ tissue so that the Biopumps secrete a steady stream of therapeutic protein into the body.

This replaces the need for frequent injections and in chronic conditions such as anaemia, diabetes, hepatitis and arthritis means lower cost, greater convenience, and fewer side effects.

Oriel said: “Although at a relatively early stage of development, Medgenics’ key risk lies in demonstrating the validity of the Biopumps’ delivery mechanism in a clinical setting.

“By using well characterised molecules, we believe the pharmaceutical risk is more in line with that of biosimilars.”

Shares rose 6% to 415p today.

Still down 10% -


Purchase of Common Stock by Chairman

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RNS Number : 6102V

Medgenics Inc

16 December 2013











Press Release

16 December 2013






Medgenics Reports Open Market Purchase of Common Stock by Chairman of the Board



Medgenics, Inc. (AIM: MEDU, MEDG and NYSE MKT: MDGN), ("the Company"), the developer of BiopumpTM, a novel technology for the sustained production and delivery of therapeutic proteins in patients using their own tissue, announces that on December 13, 2013, the Company was informed by Dr. Sol Barer, Medgenics' Chairman of the Board, that he purchased 20,000 shares of common stock on the open market on that day at an average price of $5.3711 per share.



Following this purchase, Dr. Barer now owns 112,000 shares of common stock, which represents approximately 0.6 per cent of the total issued shares of common stock. Dr. Barer, directly or through trusts for the benefit of Dr. Barer and his family, also has the right to purchase up to 1,315,000 shares of common stock pursuant to options previously granted (in aggregate Dr. Barer's shares of common stock and options represent 1,427,000 shares of common stock which represent approximately 7.7 per cent of the Company's total issued shares of common stock).



This announcement is being made pursuant to the London Stock Exchange's AIM Rules for Companies admitted to trading on the AIM market

Purchase of Common Stock by Director

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RNS Number : 8468V

Medgenics Inc

18 December 2013











Press Release

18 December 2013






Medgenics Reports Open Market Purchase of Common Stock by Director



Medgenics, Inc. (AIM: MEDU, MEDG and NYSE MKT: MDGN), ("the Company"), the developer of BiopumpTM, a novel technology for the sustained production and delivery of therapeutic proteins in patients using their own tissue, announces that the Company was informed today by Dr. Alastair Clemow, a director of the Company, that he purchased 4,500 shares of common stock on the open market on 16 December at an average price of $5.7787 per share.



Following this purchase, Dr. Clemow now owns 18,500 shares of common stock, which represents approximately 0.1 per cent of the total issued shares of common stock. Dr. Clemow also has the right to purchase up to 105,714 shares of common stock pursuant to options previously granted (in aggregate Dr. Clemow's shares of common stock and options represent 124,214 shares of common stock which represent approximately 0.7 per cent of the Company's total issued shares of common stock).



This announcement is being made pursuant to the London Stock Exchange's AIM Rules for Companies admitted to trading on the AIM market.

Up just under 16%

Medgenics looks to accelerate gene therapy platform after transition year

By Giles Gwinnett

February 20 2014, 2:59pm
The company reported a net loss of US$17.13 million for the year ended December 31 last year compared with a net loss of $15.07 million in 2013


Medgenics (LON:MEDG, NYSE:MDGN) plans to accelerate its gene therapy platform and maximise the potential of its technology assets, it told investors, unveiling 2013 financial results.

The firm is developing Biopump to treat patients and last year repositioned itself as a rare and orphan disease firm with a brand new executive management team.

Michael Cola, president and chief exexcutive, told the statement: "2013 has been an important transition year for us as we build a foundation and corporate strategy to position the company for the future.

He said that based on results to date, the firm had developed a second generation viral vector and Biopump protocol that shows more durable protein production in mice - a model historically predictive of success in human clinical trials.

"We plan to utilise this new vector and protocol as we realign our research and development focus towards the orphan and rare disease market, where we feel the Biopump's attributes of continuous autologous protein/peptide production would be highly advantageous."

Cola said the company had two aims for 2014 - firstly to begin the Phase 1/2 EPODURE trial for human proof-of-concept of the Biopump platform with the second-generation viral vector and protocol, and to replicate the mouse results in humans.

Secondly, the company wants to obtain in-vitro (test tube) and in-vivo (living) preclinical data in human tummy-tuck tissue and mice in several rare and orphan disease indications.

The company reported a net loss of US$17.13 million for the year ended December 31 last year compared with a net loss of $15.07 million in 2012.

Medgenics looks to exit AIM

By Ian Lyall

March 03 2014, 8:07am
The group which is developing a the Biopump for the sustained release of therapeutic proteins.
The group which is developing a the Biopump for the sustained release of therapeutic proteins.


The biotechnology group Medgenics (NYSE MKT:MDGN, LON:MEDG) has unveiled plans to cancel its AIM listing.

The group, which is developing a Biopump for the sustained release of therapeutic proteins, said the high cost of maintaining UK quote as well as limited trading volumes were two of the reasons for the proposed London exit.

Medgenics said it will maintain its quote on the NYSE MKT (formerly the AMEX).

A vote will be heard at the stockholder’s meeting on April 8. If the proposal is approved then the last day of trading on AIM would be April 15.

Medgenics said all stock on the UK share register will be added the US register.

It said either Capita Registrars or Corporate Stock Transfer, the company's US registrar, will send out transmittal letters to all stockholders whose shares were previously UK listed “providing them with further information regarding the transfer of their shares to the company's US share register