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Updated July 2010
Thank you for visiting the Fibrocell Science, Inc. web site. Our team has had an incredibly exciting and productive past few months, and I’m pleased to share with you some of our key accomplishments:
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We recently completed enrollment of a histology study for azficel-T, which was requested by the FDA in a Complete Response letter to our biologics license application for the therapy’s use in treatment of moderate to severe nasolabial fold wrinkles. The trial is designed to evaluate tissue treated with azficel-T as compared to tissue treated with sterile saline (placebo). We are on track to complete the study and submit data to the FDA in the fourth quarter of 2010.
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Three prominent physicians have joined our team as scientific advisors to provide input and expertise as we evaluate potential future indications for azficel-T in periodontics and reconstructive dentistry as well as in burn repair for skin.
- We filed a patent application with the U.S. Patent & Trademark office in May for dosage unit formulations for our autologous dermal fibroblast technology. We believe issuance of this patent will strengthen our intellectual property for our technology even further as we prepare for its entrance into the U.S. marketplace.
As you can see, we at Fibrocell Science are strongly committed to the future of our azficel-T therapy. We’re proud of the recent strides we’ve made on the clinical, regulatory, scientific and intellectual property fronts, and look forward to sharing additional milestones with you shortly. Please check back on our site regularly to stay on top of our accomplishments.
We appreciate your ongoing interest in Fibrocell Science, Inc.
Sincerely,
David Pernock
Chairman & CEO
Fibrocell Science, Inc.
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