Strata Skin Sciences (NSDQ:SSKN) said this week it received a response letter from the FDA concerning possible 510(k) clearance paths for its Optimal Dosing Technology initially designed for treating psoriasis, vitiligo and other skin conditions.
The Horsham, Penn.-based said the federal watchdog proposed 2 alternative paths, the 1st of which would require a clinical trial to substantiate its potential claims for the device and the 2nd would seek clearance “with no new claims regarding treatment or efficacy.”
Strata said that should the company pursue the 2nd option, it would “likely consider initiatives to develop potential proprietary features” for the tech, according to an SEC filing.
“The company is assessing the alternatives for proceeding and is considering related costs and the availability of cash resources,” Strata wrote in an SEC filing. The company said that it would have cash to pursue either option, or a combination of the 2, from a proposed conversion of outstanding convertible debentures due 2021.
Last January, Strat Skin Sciences said it entered into a $12 million debt restructuring agreement, led by MidCap Financial Trust.
