Updated with more information, stock reaction.
EXTON, Penn. (
) --U.S. regulators approved Wednesday
Laviv, a personalized cell-based dermal filler, according to an FDA spokeswoman.
Fibrocell will market LaViv for the treatment (smoothing out) of nasolabial fold wrinkles -- those are the skin folds that run from each side of the nose to the corners of the mouth.
FDA spokeswoman Shelley Burgess confirmed LaViv's approval in an email to
Fibrocell later confirmed the approval in a statement.
Fibrocell shares were up 13 cents, or 11%, to $1.29 in early Wednesday trading. The muted response to LaViv's approval reflects the commercial and financial challenges facing the company as it tries to sell the new dermal filler. Fibrocell shares have also more than doubled in value this year already, likely leading many investors and traders to take profits.
What makes LaViv different from Botox and the myriad of dermal fillers used commonly in cosmetic skin procedures today is its active ingredient -- a patient's own fibroblasts. These are a form of stem cell that matures into connective tissue fibers and help give skin strength and elasticity.
Fibrocell makes LaViv by first removing a small tissue sample from behind a patient's ear. The tissue sample is then sent to Fibrocell's manufacturing facility, where fibroblasts are isolated and grown in a lab to form a personalized cellular therapy. Once prepared and shipped back to the doctor, the fibroblast-containing cell therapy, now known as LaViv, is re-injected into the patient's face to fill in and smooth out wrinkle lines.
LaViv is the first personalized cell therapy approved by FDA for aesthetic uses.
Fibrocell has no marketing partner for LaViv and suffers from a lack of cash. At the beginning of May, Fibrocell had $2.2 million in the bank and $1 million in debt, burning through $1 million a month. The company raised a bit less than $2 million in a private stock offering last week. With LaViv now approved, Fibrocell will need to raise a lot of money or find a partner to get this cell therapy onto the market.
--Written by Adam Feuerstein in Boston.
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