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Fibrocell Science, Inc. (FCSC)

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Last Post: 9/26/2017 6:11:28 PM - Followers: 113 - 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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PostSubject
#6800   Karma is a ..................... n3m3sis 09/26/17 06:11:27 PM
#6799   Shorts are having a field day on today's n3m3sis 09/26/17 10:43:40 AM
#6798   Up big today on no news and light Tlsmd 08/22/17 10:36:34 AM
#6797   Price weak lately. I thought the Tlsmd 08/12/17 02:22:48 PM
#6796   Beast Planopenny 06/27/17 11:54:10 AM
#6795   I certainly agree with that NT. All Tlsmd 06/15/17 12:46:14 AM
#6794   Another great day for us FCSC believers.Keep them coming! novicetrader 06/14/17 12:50:53 PM
#6793   Yes NT, a bit more volume and a Tlsmd 06/12/17 08:56:47 PM
#6792   today was a good volume day here,for this novicetrader 06/12/17 07:14:09 PM
#6791   Just as an observation---Technically speaking,FCSC has formed a Tlsmd 06/12/17 02:48:17 PM
#6790   WOW!!! News on FCSC. Stock hits Tlsmd 06/12/17 02:16:50 PM
#6789   It would be encouraging if it could hold Tlsmd 06/12/17 01:01:42 PM
#6788   That is true novicetrader. I bought more Tlsmd 05/29/17 09:38:24 PM
#6787   Tlsmd 05/29/17 09:26:59 PM
#6786   The dips seem to be on low volume novicetrader 05/29/17 08:47:21 PM
#6785   On Thursday there were a great amount of Tlsmd 05/26/17 04:03:00 AM
#6784   Hey NT, on Thursday I bought some Tlsmd 05/26/17 03:18:06 AM
#6783   You might have trouble with bringing up my Tlsmd 05/24/17 11:15:47 PM
#6782   This should bring you to the May 10,,2017 Tlsmd 05/24/17 10:49:15 PM
#6781   After much trying I am unable to bring Tlsmd 05/24/17 07:23:54 PM
#6780   See if you are able to get anything Tlsmd 05/24/17 07:12:00 PM
#6779   Fibrocell to Present at Inaugural Cell & Gene Tlsmd 05/24/17 06:52:03 PM
#6775   As of 5/21/17 Thompson-Reuters has raised their Tlsmd 05/22/17 10:20:40 AM
#6774   Thank you NT.. Just a bit of luck, Tlsmd 05/16/17 11:47:24 AM
#6773   what beautiful timing for you,Tlsmd!Wish I had done novicetrader 05/16/17 11:41:17 AM
#6772   Yes NT, I did a bit more buying Tlsmd 05/16/17 11:27:15 AM
#6771   WOW!What a great 2 day action in FCSC,finally! novicetrader 05/16/17 11:21:44 AM
#6770   I do not yet know the exact float Tlsmd 05/15/17 02:35:53 PM
#6769   thank you,Tlsmd. Our FCSC action looking great today,nice novicetrader 05/15/17 02:14:48 PM
#6768   Hi again novice trader. I tried again Tlsmd 05/15/17 12:21:24 AM
#6767   tried googling but couldn't come up with anything novicetrader 05/14/17 04:23:13 PM
#6766   Hi novice trader. Please disregard previous link Tlsmd 05/14/17 11:52:59 AM
#6765   Tlsmd 05/14/17 11:12:18 AM
#6764   On Apr 13,FCSC had a huge spike to novicetrader 05/06/17 10:00:39 PM
#6763   No, I have seen quite a few morons Jiminy Cricket 04/24/17 10:14:51 AM
#6762   No,n3m3sis isn't the only one.Not in all cases, novicetrader 04/24/17 07:48:26 AM
#6761   I think you are the only person in vp_007_99 04/24/17 04:34:48 AM
#6760   This split is a great thing....... n3m3sis 03/10/17 03:25:08 PM
#6759   Fibrocell Announces One-for-Three Reverse Stock Split! n3m3sis 03/10/17 09:34:47 AM
#6758   Sluggish morning at $FCSC . Whole market is 711711 01/10/17 11:35:00 AM
#6757   I'm in for the new year with 6000 shares. 711711 01/05/17 12:40:30 PM
#6756   WOOT FCSC WOOT ! dollardeadline 01/05/17 11:13:39 AM
#6755   FCSC .76 ClearlyStocks 10/05/16 11:18:47 AM
#6754   Looking primed to go higher Gcasa 10/05/16 10:53:34 AM
#6753   FCSC .70 call .74 now ClearlyStocks 10/05/16 10:25:56 AM
#6752   Hope we have found our bottom Pencher 08/29/16 01:34:08 PM
#6751   $FCSC just hit my radar. On watch. goarmy123 08/27/16 03:41:20 PM
#6750   http://www.consumereagle.com/fibrocell-science-25-00-million-financing-michael-f Pencher 08/25/16 03:36:26 AM
#6749   Who is still active here? Pencher 08/24/16 06:40:46 PM
#6748   Get ready for a run $$ Pencher 08/22/16 12:49:25 PM
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