Core Insights - STRATA Skin Sciences, Inc. has received regulatory clearance from COFEPRIS in Mexico for its TheraClearX® acne treatment system, valid through November 2029 [1][3] - This certification marks a significant step in STRATA's international expansion strategy, allowing for the commercialization and clinical use of TheraClearX® in Mexico [2] Regulatory Clearance and Initial Launch - The COFEPRIS registration process typically takes 6 to 12 months and confirms that STRATA's technologies meet Mexico's regulatory standards for dermatologic devices [3] - STRATA has partnered with MINO Labs for the commercial rollout, with the first system placed with Dr. Melissa Lomelí Canedo in Mexico City [4] Market Potential in Mexico - The acne treatment market in Mexico is rapidly growing, with a projected CAGR of approximately 10.2% for the professional acne medication segment by 2030 [9] - An average acne treatment session costs around MXN 3,200 (approximately USD 174), positioning TheraClearX® competitively in the premium in-office care segment [9] Strategic Partnership with MINO Labs - MINO Labs has a nationwide network of over 3,000 dermatologists and aesthetic practitioners, providing STRATA with immediate access to a robust professional base [7] - The partnership aims to enhance the standard of dermatologic care in Mexico by bridging the gap in access to advanced treatment technologies [8] Usage-Based Model - TheraClearX® will be offered under a usage-based partnership model in Mexico, allowing physicians to operate the device without upfront capital investment, thus minimizing financial barriers [10] Forward Outlook - STRATA plans to expand device deployment to major metropolitan areas in Mexico, including Guadalajara, Monterey, Puebla, and Tijuana [11] - The company aims to launch clinical education programs with MINO Labs and gather real-world clinical data to support broader adoption [16]