HORSHAM, PA — STRATA Skin Sciences, Inc. (NASDAQ: SSKN) announced that its TheraClearX acne treatment system has received regulatory clearance from Mexico’s health authority, COFEPRIS, marking a key milestone in the company’s international expansion.
The certification, valid through November 2029, authorizes the importation, commercialization, and clinical use of TheraClearX across Mexico’s dermatology and aesthetic markets. The device, which uses non-drug, photopneumatic technology to treat acne at its source, combines deep cleansing with light-based therapy for visible results and minimal downtime.
STRATA has begun commercial rollout through a strategic partnership with Mexico City–based MINO Labs, a leading pharmaceutical and medical device distributor. The first TheraClearX system has been installed in the clinic of Dr. Melissa Lomelí Canedo, who becomes the first dermatologist in Mexico to offer the treatment.
“The clearance of TheraClearX by COFEPRIS expands STRATA’s reach into a fast-growing, innovation-driven dermatology market,” said Shmuel Gov, Chief Operating Officer of STRATA Skin Sciences. “With Mino Labs as a strong local partner, we are positioned to rapidly scale physician adoption and make proven, device-based dermatologic care more accessible across Mexico.”
MINO Labs’ aesthetics division operates a network of more than 3,000 dermatologists and aesthetic professionals nationwide, providing STRATA with immediate market access. “TheraClearX bridges the gap in advanced dermatologic equipment, empowering Mexican dermatologists with the latest U.S. technology,” said Manuel Cosme, MINO Labs Owner and President.
The device will launch under STRATA’s usage-based partnership model, which enables clinics to adopt the system without upfront investment and pay per treatment performed. The company plans to expand distribution to major cities including Guadalajara, Monterrey, Puebla, and Tijuana, alongside new clinical training programs and data initiatives to support adoption throughout Latin America.
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