STRATA Skin Sciences Granted FDA 510(k) Clearance for its Multi Micro Dose Excimer Laser Tip

STRATA Skin Sciences has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its Multi-Micro Dose (MMD) tip accessory for its proprietary XTRAC 308nm excimer laser.
 
The Multi-Micro Dose Tip accessory is indicated for use in conjunction with the XTRAC laser system to filter the Narrow Band -UVB (NB-UVB) light at delivery in order to calculate and individualize the maximum non-blistering dose for a particular patient.
 
The patent-pending MMD Tip simultaneously applies multiple level doses of energy to a specific area of the patient’s psoriatic plaque, thereby identifying the maximum sub-blistering energy dose for a particular treatment zone. Utilizing the results from these test patches, the physician can design the optimal therapeutic dose treatment for each patient. The optimization of the dose levels should result in a shorter treatment regimen to achieve clearance.
 
The XTRAC excimer laser delivers a highly targeted therapeutic beam of NB-UVB light and is cleared by the FDA to treat psoriasis, vitiligo, eczema, atopic dermatitis and leukoderma—skin diseases that impact over 35 million patients in the United States alone. This technology is covered by multiple patents, including exclusive rights patents for the delivery of treatments to Vitiligo patients.
 
Dr. Dolev Rafaeli, STRATA’s CEO, stated, “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.”
 
Large insurance providers already guide physicians to consider NB-UVB treatment, such as the one offered by XTRAC, as a first line of treatment, requiring a failure to respond prior to approving and covering treatments with targeted immune modulators (Biologics treatment). 
 
Current physician protocol with NB-UVB can extend over an eight-to-10 week period. STRATA views the OTD protocol, which has shown patients reaching PASI-75 in as short as two weekly treatments using the MMD diagnostics tool, as a breakthrough to shortened treatment times; offering faster, no side-effect resolution for patients, lower cost for payers, and enhanced business for partner clinics.
 
STRATA Skin Sciences is a medical technology company in dermatology and plastic surgery that develops, commercializes and markets products for the treatment of dermatologic conditions. Its products include the XTRAC excimer laser and VTRAC lamp systems utilized in the treatment of psoriasis, vitiligo and various other skin conditions; and the STRATAPEN MicroSystem, marketed specifically for the intended use of micropigmentation.