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Fibrocell Science, Inc. (FCSC)

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Last Post: 4/26/2019 4:00:37 PM - Followers: 122 - Board type: Free - Posts Today: 0

Fibrocell Science, Inc. is a biotechnology company focused on the development of regenerative cell therapy for aesthetic, medical and scientific applications.

 

 

Welcome to the new Fibrocell Science, Inc. and our new web site. I am pleased to have this opportunity to share my enthusiasm with you as Fibrocell’s Chairman of the Board of Directors.

We have been extremely busy charting the course for Fibrocell as a biotechnology company focused on the power of regenerative fibroblast cells for aesthetic, medical and scientific applications.

We have a challenging and exciting path before us as we continue to prepare for the U.S. Food & Drug Administration response to the biologics license application (BLA) we submitted in March 2009 for the use of Laviv™ (azficel-T)*, Fibrocell Science’s lead therapy, for the treatment of moderate to severe nasolabial fold wrinkles. The FDA’s Cellular, Tissue and Gene Therapies Advisory Committee, which reviewed our therapy on October 9, 2009, voted 11 yes to 3 no that the data presented demonstrated efficacy, and 6 yes to 8 no that the data demonstrated safety, both for the proposed indication.

We are pleased to begin operations under Fibrocell Science, Inc., having reorganized the former Isolagen, Inc. and significantly reduced the company’s debt from US $81M to US $6M. We now look forward to an ambitious evaluation of our clinical priorities to maximize the potential use of our therapy in additional indications such as full-face rejuvenation, acne scars, burn scars and dental applications.

We have considerable work before us at Fibrocell Science, and we welcome the challenge. I join Fibrocell with extensive commercial experience from GlaxoSmithKline, where I most recently served as senior vice president, Pharmaceuticals and Vaccines. I am proud to have a strong management team helping guide this new company, including Declan Daly, former Isolagen chief executive officer, who was instrumental in our reorganization and remains committed to the company’s success.

Thank you for your interest in the new Fibrocell Science, Inc.

Sincerely,
David Pernock
Chairman
Fibrocell Science, Inc.

 

Fibrocell Therapy is an investigational autologous cell therapy. In the Fibrocell Science patented process, a patient’s own natural fibroblasts are extracted, multiplied and re-injected as personalized therapy. Fibroblasts are cells that contribute to the formation of connective tissue fibers. These matrix fibers are critical to the strength and elasticity of the skin.

Broadly, the regenerative effects of fibroblasts include:

- The ability to synthesize the extracellular matrix components and, thus, to improve skin texture,

- The secretion of matrix fibers, including collagen, and

- Playing a critical role in wound healing and tissue repair.

The Company prepares the Fibrocell Therapy through a streamlined process that begins with removing a small sample of cells from behind a patient’s ear and sending that sample to the Fibrocell cGMP facility. The process expands fibroblasts into tens of millions of new cells, which are then formulated into an autologous cellular therapy. Cells are frozen and used for multiple treatment sessions. The therapy is reintroduced into the patient’s skin by injection, which we believe results in an increase in the local fibroblast population, collagen formation and assists the body’s own regenerative healing process. In controlled clinical studies, a significant improvement in the appearance of nasolabial fold wrinkles was observed after injecting Fibrocell Therapy.

Regenerative fibroblast cells may have potential in use for broad aesthetic, medical and scientific applications. The Fibrocell Therapy for aesthetics, azficel-T, proposed brand name Laviv™, is currently under review by the FDA for the treatment of moderate to severe nasolabial fold wrinkles. Fibrocell Science, Inc. is planning to continue studies for additional aesthetic and therapeutic indications for azficel-T.

The company manufactures its cell therapy at a cGMP manufacturing facility in Pennsylvania.


Fibroblasts are cells that contribute to the formation of connective tissue fibers. Fibrocell's future scientific focus will be on regenerative medicine that leverages the direct and indirect therapeutic benefit of fibroblasts.

Fibrocell has submitted a biologics license application to the U.S. Food & Drug Administration (FDA) based on its Phase III clinical trials evaluating the efficacy and safety of its azficel-T in treating moderate to severe nasolabial fold wrinkles in patients older than 18 year of age.

In addition to wrinkle correction, Fibrocell has obtained statistically significant results in a Phase II/III acne scar clinical trial and a Phase II open label full face rejuvenation study.  Fibrocell also has results in early burn scars and periodontal disease studies.

 

 

Fibrocell Science, Inc. (OTC Bulletin Board: FCSC) is a biotechnology company focused on developing autologous cell therapies for aesthetic, medical and scientific applications. Fibrocell Science is committed to advancing the scientific, medical and commercial potential of autologous skin and tissue, as well its innovative cellular processing technology and manufacturing excellence.

Fibrocell Therapy is an investigational autologous cell therapy. In the Fibrocell Science patented process, a patient's own natural fibroblasts are extracted, multiplied and re-injected as personalized therapy to regenerate skin. Fibroblasts are cells that contribute to the formation of connective tissue fibers. The Fibrocell Therapy for aesthetics, azficel-T, proposed brand name Laviv™ is currently under review by the FDA for the treatment of moderate to severe nasolabial fold wrinkles.

Fibrocell Science, Inc. is planning to continue studies for additional aesthetic and therapeutic indications for its Fibrocell Therapy, which is manufactured at a cGMP cell therapy manufacturing facility at its headquarters in Pennsylvania.

 


OCTOBER 09, 2009
Fibrocell Science, Inc. Reports Outcome of FDA Advisory Committee Meeting on Azfibrocel-T for Wrinkles

OCTOBER 06, 2009
Isolagen, Inc. Reorganizes as Fibrocell Science, Inc.

 

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#7050   GREEN beambe 04/26/19 04:00:37 PM
#7049   I agree with that beambe 04/26/19 10:15:17 AM
#7048   Added this to my list yesterday. Can't BooDog 04/26/19 06:26:57 AM
#7047   PATIENCE beambe 04/25/19 02:32:18 PM
#7046   Parabolic move is coming here, question is just when. Makk1 04/25/19 06:46:48 AM
#7045   https://www.nasdaq.com/symbol/fcsc/institutional-holdings beambe 04/23/19 01:40:18 PM
#7044   http://fibrocell.com/pipeline-clinical-trials/ beambe 04/18/19 01:27:59 PM
#7042   https://www.wallstreet-online.de/aktien/fibrocell-science-aktie/kurse beambe 04/18/19 01:19:41 PM
#7041   GREEN beambe 04/17/19 04:00:56 PM
#7040   FCSC easy 50%. No brainer THE GOLD STANDARD 04/17/19 09:53:54 AM
#7039   Great buy here imo THE GOLD STANDARD 04/17/19 09:32:58 AM
#7038   Everything is out now. Even Form 4's. $avvyPenny$tockInvestor™ 04/16/19 08:12:49 PM
#7037   8k and Form 4's out. $avvyPenny$tockInvestor™ 04/16/19 08:09:35 PM
#7036   I wonder who is manipulating this? $avvyPenny$tockInvestor™ 04/16/19 04:02:34 PM
#7035   ClayTraders said no beambe 04/16/19 03:44:40 PM
#7034   We will be lucky to back at 2.54 Imarket13 04/16/19 02:44:44 PM
#7033   I know..just have to stay strong against the $avvyPenny$tockInvestor™ 04/16/19 02:43:30 PM
#7032   Wow. We went from testing $3 to trying Imarket13 04/16/19 02:29:38 PM
#7031   Highly doubt it.. might close under 2 bucks Imarket13 04/16/19 01:46:53 PM
#7030   It's very possible $avvyPenny$tockInvestor™ 04/16/19 01:24:00 PM
#7029   how should it have been otherwise beambe 04/16/19 12:46:30 PM
#7028   I think - that we will close green beambe 04/16/19 12:44:17 PM
#7027   So you think the 30 plus million was Imarket13 04/16/19 12:42:43 PM
#7026   it will not be boring beambe 04/16/19 12:40:28 PM
#7025   I agree. It's quiet around here now. $avvyPenny$tockInvestor™ 04/16/19 12:34:44 PM
#7024   Let's see what happens next few days Imarket13 04/16/19 12:28:35 PM
#7023   Patience FCSC will explode beambe 04/16/19 12:23:51 PM
#7022   Right!!! It is stupid. They should just let $avvyPenny$tockInvestor™ 04/16/19 11:32:37 AM
#7021   Way less volume too Imarket13 04/16/19 11:29:40 AM
#7020   Someone is trying to keep it in this $avvyPenny$tockInvestor™ 04/16/19 11:28:10 AM
#7019   Right!!! $avvyPenny$tockInvestor™ 04/16/19 10:11:38 AM
#7018   Let's see what happens today Imarket13 04/16/19 09:56:45 AM
#7017   Right. I still think it's manipulation to load $avvyPenny$tockInvestor™ 04/16/19 09:54:33 AM
#7016   Either way we should have been over $5 minimum Imarket13 04/16/19 09:53:02 AM
#7015   O..ok gotcha. It's probably coming. $avvyPenny$tockInvestor™ 04/16/19 09:51:48 AM
#7014   News yesterday... previous pr they released an 8k Imarket13 04/16/19 09:49:01 AM
#7013   8k on what? $avvyPenny$tockInvestor™ 04/16/19 09:48:08 AM
#7012   They have yet to drop an 8k aswell Imarket13 04/16/19 09:45:53 AM
#7011   Right I agree. $avvyPenny$tockInvestor™ 04/16/19 09:39:20 AM
#7010   If the company is diluting it's a damn Imarket13 04/16/19 09:38:27 AM
#7009   Me too. It's crazy. $avvyPenny$tockInvestor™ 04/16/19 09:36:35 AM
#7008   Prob gonna ride out today and if still Imarket13 04/16/19 09:35:20 AM
#7007   reading a News is not enough-you have to beambe 04/15/19 05:13:28 PM
#7006   Perfect bullshit-you've not understood the NEWS beambe 04/15/19 05:09:07 PM
#7005   Got me some $2.50's on the dip today. naturalborninvestor 04/15/19 05:07:55 PM
#7004   this will have Consequences beambe 04/15/19 04:50:19 PM
#7003   * * $FCSC Video Chart 04-15-2019 * * ClayTrader 04/15/19 04:36:01 PM
#7002   Right. It was highly manipulated on MEGA HUGE NEWS. $avvyPenny$tockInvestor™ 04/15/19 04:35:02 PM
#7001   Hopefully this week... Imarket13 04/15/19 04:27:30 PM
#7000   it has to go over $ 5 beambe 04/15/19 04:26:25 PM
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