Strat Skin Sciences wins FDA nod for Multi-Micro Dose excimer laser tip

Strata Skin Sciences (NSDQ:SSKN) said yesterday it won FDA 510(k) clearance for the Multi-Micro Dose tip designed for use with its Xtrac 308nm excimer laser.

The newly cleared tip is indicated for use in conjunction with the Horsham, Penn.-based company’s Xtrac laser system to filter narrow band UVB light at delivery, intended to individualize non-blistering doses during procedures.

The MMD tip is designed to apply multiple level doses of energy to the patient’s psoriatic plaque to identify maximum sub-blistering energy dose for treatment zones so that physicians can design an optimal dose for each patient, Strata said.

The associated Xtrac laser system is cleared by the FDA to treat psoriasis, vitiligo, eczema, atopic dermatitis and leukoderma, the company said.

“This is an exciting and important step for the Company and an amazing achievement after years of development.  We believe that the MMD is a significant step on the path to developing the optimal therapeutic dose protocol, which is intended to provide faster patient outcomes and higher patient satisfaction, and we expect that it will result in increased patient retention for our partner clinics.  Initial clinical data shown in previously issued peer reviewed studies is promising and we look forward to providing the results of our MMD pilot clinical study by the fourth quarter of this year.  We anticipate that the study will validate the achievement of clinical end points with a lower number of treatments,” CEO Dr. Dolev Rafaeli said in a press release.

In May, Strata Skin Sciences said that it raised $17 million in a new round of financing and announced a number of changes to its executive roster, including an incoming CEO, new board chair and new chief financial officer.

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