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Medgenics reports 'positive' meeting with National Institutes of Health Recombinant Advisory Committee (MDGN) 5.20 +0.12 : Co announced that it has received formal notification of recommendations from the National Institutes of Health Recombinant DNA Advisory Committee ("RAC") reflecting the Company's successful presentation of study findings during a meeting held on March 8, 2012. Completion of the RAC process is an important step in advancing toward the Company's proposed U.S. Phase II clinical study evaluating the safety and efficacy of sustained erythropoietin therapy delivered via the Company's EPODURE Biopump for the treatment of anemia in dialysis patients with end-stage renal disease. Andrew L. Pearlman, President and CEO of Medgenics said, "We look forward to submitting our IND to the FDA in the coming months and to obtaining FDA clearance for our Phase II clinical trial, which we expect will affirm the positive results from our earlier Phase I/II study of EPODURE in pre-dialysis patients."
This was the transparency i was hoping for, should interesting to hear about details at the next conference call. (MDGN meeting FDA advisory committe)
gl
This open-label Phase IIa study will enroll up to 20 dialysis patients with anemia due to ESRD who have been receiving routine EPO injections three times per week. Each patient will receive an individually targeted initial dose of EPODURE Biopumps designed to produce levels of EPO that would replace the routine EPO injections over a period of 4-12 months
hmmmmmmm.....
will likely wait for the US drug application to be intiated!.......
gl
details of the study, and power should dictate credibility of the scientific body!
will be watching public sentiment!
gl
MDGN Cleared to initiate phase 2a anemia study of Epodure Biopump in dialysis patients in Israel!
should see formal announcement in few minutes!
gl
The attached press release was issued on march 21, 2012 at 10:00 a.m. et
MEDGENICS TO PRESENT AT THE MAXIM GROUP GROWTH CONFERENCE
gl
Its going to be interesting conference call. Hope they focus on milestones and outline the coming months.
Clarity would kickstart this company to many sideline investors.
The talent pool is impressive, but let's see how they apply it.
Cheers
Isaac Blech knows what he is doing it will be interesting to listen to the conference Thanks RD
largest shareholders are Joel Kanter and Isaac Blech. Joel has just sold Clarisonic for $600 million. Isaac has founded over 35 billion in companies
would recomend everyone log on to the conference:
http://wsw.com/webcast/roth26/mdgn/
many of things mentioned in the IR CD will be mentioned in more detail.
IR could not elaborate more....
gl
waiting for a response to a few , and figuring on how too load the IR CD to the intro-board.
as of now, not much more than whats in the companies website.
nothing new.
gl
Received a CD from investor relations with respnses to my questions(per form letter).
will update you guys when reviewed.
will call the company/IR when the cd is reviewed.
gl
co is potentiall gnormous, but there are 15 mln shares o/s
Spoke with a Doctor friend of mine and ask him about this company and the tech. He has heard of the company. As for the tech his exact words were it has the potential to be Ginormous...lol. I guess thats a southern word for huge beyond huge.
Still holding but wanting to see it fall back some more in order to pick up some more cheapies.
1
DRAFT 3
Medgenics To Present At LHA Life Sciences & Medical Technologies
Virtual Conference
MISGAV, Israel and SAN FRANCISCO (February 15, 2012) – Medgenics, Inc. (NYSE Amex:
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 that Andrew L. Pearlman, Ph.D., President and Chief Executive Officer of
Medgenics, will present to investors as part of the LHA Life Sciences & Medical Technologies
Virtual Conference on Thursday, February 16, 2012, at 11:00 a.m. Eastern time.
The webcast of the Medgenics presentation will be accessible live and for 30 days at
www.medgenics.com or at the PrecisionIR event site at
http://www.investorcalendar.com/IC/CEPage.asp?ID=167330.
This virtual conference event includes 30-minute presentations with accompanying slides from
eight industry leaders, and begins at 9:00 a.m. Eastern time.
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 skin biopsy for the treatment of a range of chronic diseases including anemia, hepatitis C
and hemophilia. Medgenics believes this approach has multiple benefits compared with current
treatments, which include regular and costly injections of therapeutic proteins.
Medgenics has three long-acting protein therapy products in development based on this
technology:
· EPODURE (now completing a Phase I/II dose-ranging trial) to produce and deliver
erythropoietin for many months from a single administration, has demonstrated elevation
and stabilization of hemoglobin levels in anemic patients for six to more than 36 months;
· INFRADURE (planning to commence a Phase I/II trial in Israel in 1H12 in hepatitis C) to
produce a sustained therapeutic dose of interferon-alpha for use in the treatment of
hepatitis;
· HEMODURE is a sustained Factor VIII therapy for the prophylactic treatment of
hemophilia, now in development.
Medgenics intends to develop its innovative products and bring them to market via strategic
partnerships with major pharmaceutical and/or medical device companies.
News Release
2
In addition to treatments for anemia, hepatitis and hemophilia, Medgenics plans to develop
and/or out-license a pipeline of future Biopump™ products targeting the large and rapidly
growing global protein therapy market, which is forecast to reach $132 billion in 2013. Other
potential applications for Biopumps™ include multiple sclerosis, arthritis, pediatric growth
hormone deficiency, obesity and diabetes.
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.
For further information, contact:
Medgenics, Inc.
Dr. Andrew L. Pearlman
Andrew.pearlman@medgenics.com
LHA
Anne Marie Fields
afields@lhai.com
@LHA_IR_PR
Phone: +972 4 902 8900
Phone: 212-838-3777
Abchurch Communications
Adam Michael
Joanne Shears
Jamie Hooper
jamie.hooper@abchurch-group.com
Phone: +44 207 398 7719
Religare Capital Markets (NOMAD)
Emily Staples
Phone: +44 207 444 0800
SVS Securities plc (Joint Broker)
Alex Mattey
Ian Callaway
Phone: +44 207 638 5600
3
Nomura Code Securities (Joint Broker)
Jonathan Senior
Phone: +44 207 776 1219
- Ends -
look forward to it!
gl
Hey Buddy , there will be a web cast thursday bringing all and every up to date.
trading is too volatile for such minimal volume, hence my worries!
still waiting for feed back from the company, after several emails
gl
cool - thanks ..
this thing worked on 20 clinicals in Israel and what is more Isaac is resoundingly behind it; he was one of the early investors in Celegene, made a few billion. Did the IPO at $5 wit a $6 warrant.
just talked to the anne marie fields , they are having a webcast thursday, Dr Pearlman will lay out the yellow brick road.
i'm just keeping an eye on it, as i think this potentially a winner, especially with its epo alternative, etc.
but the lack of clarity is concerning.
sent several emails and will look forward to there replies.
this trading purely on speculation byt the biomedreports. therefore be careful at this juncture.
gl
hey guys - just popped up on radar couple days ago - anyone think that they may need to do a public offering? looks very promising . though the financials are alil vague at this point..
Agree, mdgn need to be more transparent with the finances and filings. Though, it has huge potential!
Revenu is still some time away!
Speculation is driving this now, which is not a bad thing!
Gl
ONLY 5 Million O/S. I have bought this each day this week and if it falls I'm loading the boat to the top. 5 million outstanding shares spells rocket with any positive news and MDGN is positioned to make some big headlines.
I can see a run to double digits in just hours of trading. We are talking a market worth billions and this company currently has a market cap of 25 million.
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About Medgenics, Inc.
Medgenics is developing TARGT™ (Transduced Autologous Restorative Gene Therapy), a proprietaryex vivo gene therapy platform for the sustained production and delivery of therapeutic proteins and peptides using a patient's own tissue, for the treatment of rare and orphan diseases. For more information, visit the Company's website at www.medgenics.com.
Our core strategy is based upon three fundamental strengths:
TECHNOLOGY:![]() Transduced Autologus Restorative Gene Theraphy |
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