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Fibrocell Science, Inc. (FCSC)

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Last Post: 5/22/2018 3:56:13 PM - Followers: 125 - 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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#6881   RS vote was in a filing last month, benchman 05/22/18 03:56:13 PM
#6880   I listened to the whole call and did benchman 05/22/18 03:50:59 PM
#6879   Possible, not likely for an extended period without Full Contact Yoga 05/21/18 10:18:26 PM
#6878   Thank you for opportunity to load up b4 drczer 05/21/18 06:28:35 PM
#6877   RS vote in 2 days puts a damper Full Contact Yoga 05/21/18 02:51:29 PM
#6876   Oh I know it's good, but the stock benchman 05/21/18 09:35:20 AM
#6875   Read the news, it's good...meeting the 23rd as well Full Contact Yoga 05/21/18 09:31:48 AM
#6874   Not sure what they are saying on the benchman 05/21/18 09:02:38 AM
#6873   Hope the conf call is good benchman 05/21/18 08:40:30 AM
#6872   C.C. @ 8:30 this morning > up 20% crudeoil24 05/21/18 07:55:32 AM
#6871   Data looks better than ABEO data... Once we doncamel 05/19/18 02:04:38 PM
#6870   Data looks great, here is the link to benchman 05/19/18 06:35:03 AM
#6869   Fun right now Apparently news is out AH mjw007 05/18/18 06:10:00 PM
#6868   As do I. Suspect Monday will be fun.... doncamel 05/18/18 01:40:20 PM
#6867   These guys were mentioned in the Philly Business mjw007 05/18/18 01:38:21 PM
#6866   A lot of 6 digit trades today- looks doncamel 05/18/18 01:26:55 PM
#6865   Booooom time drczer 05/18/18 09:40:32 AM
#6864   Yes, but retreating now in pre. More benchman 05/18/18 09:22:41 AM
#6863   Yes Nice Move here. FCSC. Loading some Eagle1 05/18/18 09:20:14 AM
#6862   Lets continue this run...tomorrow zino 05/17/18 08:36:28 PM
#6861   Great close here. .96. Should see benchman 05/17/18 04:19:59 PM
#6860   * * $FCSC Video Chart 05-17-18 * * ClayTrader 05/17/18 04:19:42 PM
#6859   .9399 new HOD. Does this trade in benchman 05/17/18 03:49:09 PM
#6858   Word has FCSC lucrative partnership news coming. buypumps 05/17/18 03:35:45 PM
#6857   Record volume? .90s up!!!! stock1ace1 05/17/18 03:34:49 PM
#6856   Another new HOD. Now .91. $1+ coming benchman 05/17/18 03:13:51 PM
#6855   New HOD .88! Dollar should be coming. benchman 05/17/18 02:58:07 PM
#6854   Monday pps FCSC over 2pps.News on the way!Epic buypumps 05/17/18 11:50:49 AM
#6853   Gap to fill at a dollar. Obviously benchman 05/17/18 11:14:05 AM
#6852   FSCS Nice moves here. Any thoughts on Eagle1 05/17/18 10:48:11 AM
#6851   BOOM time drczer 04/18/18 01:57:02 PM
#6850   Only 15 million shares outstanding. More then drczer 03/23/18 11:50:23 AM
#6849   What makes you think it's that?? mike2like 03/22/18 04:38:14 PM
#6848   When this stock moves it’s gonna be a drczer 03/22/18 12:03:49 PM
#6847   Proposal 2! n3m3sis 03/20/18 04:13:58 PM
#6846   Come on explosion stock desk 03/19/18 02:58:24 PM
#6845   FCSC Gonna EXPLODE so hard!!! So much coming makingbiigdough 03/13/18 04:14:57 PM
#6844   Next week MAJOR breakout NORTHWARDS!!! BLOCKBUSTER earnings release makingbiigdough 03/10/18 09:45:01 PM
#6843   Anyone active on this board? Seems like this mehearty 02/26/18 01:35:43 PM
#6842   Major accumulation going on... bullrams 02/08/18 03:29:44 PM
#6841   https://www.otcmarkets.com/stock/FCSC/news shanak10 02/05/18 08:06:29 AM
#6840   https://finance.yahoo.com/news/fibrocell-announces-fda-allowance-initiate-130000 shanak10 01/30/18 08:23:23 AM
#6839   Gap fill coming IMO. short_slayer 01/16/18 08:01:53 PM
#6838   Looking good today. shanak10 01/16/18 10:25:10 AM
#6837   Expecting this move to continue upwards! Could hit makingbiigdough 01/16/18 08:58:32 AM
#6836   Had a nice move Friday reversal in effect. Chunky Salsa 01/15/18 12:33:01 PM
#6835   Yes... Imo.. two more catalysts are coming. short_slayer 01/12/18 12:54:38 PM
#6834   Still worth buying? drczer 01/12/18 12:48:34 PM
#6833   Kaboom short_slayer 01/12/18 12:42:11 PM
#6832   Breakout coming soon ... short_slayer 01/11/18 10:57:03 PM
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