Solta Medical Inc. (SLTM) has received 510(k) clearance from the
U.S. Food and Drug Administration for its laser treatment of
actinic keratosis, a type of skin lesion caused by exposure to the
sun.
Shares were recently up 17% to $1.91. The stock has fallen 9.1%
in the past year.
The company, which focuses on aesthetic skin treatments,
received 510(k) clearance for its Fraxel re:store Dual treatment
for the lesions.
The FDA's 510(k) approval is an accelerated pathway under which
companies can get a faster decision if they can show a new product
is similar to an already approved device.
The company said that in a six-month study of 21 subjects, the
laser treatment produced an 83.5% average reduction of the lesions.
While comparable "to other topical therapies and AK treatment
options, Fraxel was overwhelmingly well-tolerated by all the
patients and offers the added benefit of improving a patient's
overall skin quality, color and texture," said Roy Geronemus,
director of the Laser & Skin Surgery Center of New York in a
Solta news release.
Last month, Solta said its profit soared on a legal settlement
as revenue increased 9.7%.
-By Nathan Becker, Dow Jones Newswires; 212-416-2855;
nathan.becker@dowjones.com;