STRATA Skin Sciences Announces COFEPRIS Clearance of TheraClear® in Mexico and First Commercial Placements

Rhea-AI Summary

STRATA Skin Sciences (NASDAQ: SSKN) announced COFEPRIS clearance of its TheraClearX® acne treatment system under Device Registration No. 3187E2024SSA, valid through November 2029, authorizing importation, commercialization, and clinical use across Mexico.

STRATA initiated commercial rollout with partner MINO Labs, placing the first system with Dr. Melissa Lomelí Canedo in Mexico City. The company will offer TheraClearX® via its usage-based physician partnership model and plans expanded deployments, clinician training, real-world data collection, and further Latin America registrations in 2026.

Market context cited: professional acne medication segment CAGR ~10.2% to 2030, average session ~MXN 3,200 (≈USD 174), and approximately 3,000 licensed dermatologists in Mexico.

Positive

• COFEPRIS device registration No. 3187E2024SSA valid through November 2029
• First commercial placement completed with Dr. Melissa Lomelí Canedo in Mexico City
• Partnership with MINO Labs gives access to a network of ~3,000 dermatologists
• Usage-based model supports recurring revenue without upfront clinic investment
• Market projection: professional acne medication CAGR ~10.2% to 2030

Negative

• Device registration is time-limited, expiring in November 2029
• Commercial rollout currently limited to an initial single placement

Insights

Market Expansion Analyst

COFEPRIS clearance and a local commercialization partner enable immediate Mexico market entry with initial device placements.

STRATA gains formal authorization to import, commercialize, and clinically use TheraClearX® in Mexico under Registration No. 3187E2024SSA, valid through November 2029. The company already placed its first system with Dr. Melissa Lomelí Canedo and launched distribution with MINO Labs, giving immediate access to a network of roughly 3,000 dermatologists.

The business mechanism relies on a usage-based model that removes upfront cost barriers for clinics and creates recurring revenue tied to treatments. Key dependencies include successful physician training, clinic uptake rates, and the planned rollout into Guadalajara, Monterrey, Puebla, and Tijuana. Risks include adoption speed and the need to collect real-world data to sustain momentum.

Monitor short-term metrics such as the number of device placements and training sessions through Q4 2025 and adoption in the named metro areas over the next 12–18 months. Also watch regulatory timelines for additional Latin America registrations and results from real-world data collection that support broader clinical adoption.

HORSHAM, Pa., Oct. 28, 2025 (GLOBE NEWSWIRE) -- STRATA Skin Sciences, Inc. (NASDAQ: SSKN), a global leader in in-office dermatologic technologies for the treatment of skin conditions such as acne, psoriasis, and vitiligo, today announced that its TheraClearX® acne treatment system has received regulatory clearance from the Mexican health authority, COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios), under Device Registration No. 3187E2024SSA, valid through November 2029.

This certification represents a major milestone in STRATA’s international expansion strategy, officially authorizing the importation, commercialization, and clinical use of TheraClearX® across Mexico’s medical and aesthetic markets.

Regulatory Clearance and Initial Launch

The COFEPRIS medical device registration process, which typically spans 6 to 12 months, involves a detailed review of device safety, efficacy, and quality documentation aligned with international standards. The granting of Registration No. 3187E2024SSA confirms that STRATA technologies meet Mexico’s rigorous regulatory requirements for dermatologic medical devices.

Following certification, STRATA has initiated its commercial rollout in partnership with MINO Labs, a leading Mexican pharmaceutical and medical device commercialization firm. The first TheraClearX® system has been placed with Dr. Melissa Lomelí Canedo in Mexico City.

Dr. Canedo will be the first in Mexico to offer TheraClearX®’s photopneumatic technology — a non-drug, device-based therapy that targets acne at its source through deep cleansing and light-based treatment, producing visible results with minimal downtime. She is a graduate of Hospital General de México “Dr. Eduardo Liceaga” (Ministry of Health). She completed fellowships in Dermatologic and Mohs Surgery at Hospital Clinic Barcelona, in Trichology in São Paulo, Brazil, and in Dermatologic Oncology in Salzburg, Austria, Medical Institute (January 2024). She holds a diploma in Dermato-oncology, CILAD and completed a medical rotation at Polyclinic Hospital Di SANT ORSOLA, Bologna, Italy.

Market Potential in Mexico

The acne treatment market in Mexico represents a substantial and fast-growing opportunity:

• The professional acne medication segment is projected to nearly double by 2030 (CAGR~10.2%)
• An average acne treatment session costs around MXN 3,200 (≈ USD 174), positioning TheraClearX® competitively within the premium in-office care segment
• Mexico has approximately 3,000 licensed dermatologists, all trained to treat inflammatory skin conditions; however, most lack access to advanced phototherapeutic and device-based solutions — highlighting the strong market potential for TheraClearX® and XTRAC®
  
  

“The clearance of TheraClearX® by COFEPRIS expands STRATA’s reach into a fast-growing, innovation-driven dermatology market,” said Shmuel Gov, STRATA Skin Sciences Chief Operating Officer. “With Mino Labs as a strong local partner, and its Mino Derm & Aesthetics Dermatology Division, we are positioned to rapidly scale physician adoption and make proven, device-based dermatologic care more accessible across Mexico by taking advantage of the unique placement worry free business model we can offer.”

Strategic Partnership with MINO Labs

MINO Labs, and its Aesthetics Dermatology Division headquartered in Mexico City, has built a nationwide commercialization network encompassing over 3,000 dermatologists and aesthetic practitioners. Its integrated model — combining regulatory affairs, logistics, marketing, and clinical training — provides STRATA with immediate access to a robust professional base for rapid deployment.

“We are proud to partner with STRATA in introducing advanced acne and phototherapy solutions to the Mexican market,” said Manuel Cosme, MINO Labs Owner and President. “Mexico has approximately 3,000 dermatologists, all trained to treat inflammatory skin conditions, yet most clinics lack access to the right equipment to do so effectively. TheraClearX® bridges that gap, empowering dermatologists with the latest U.S. technology. We believe this partnership will significantly elevate the standard of dermatologic care in Mexico and drive meaningful growth over the coming years.”

Usage-Based Model Mirroring U.S. Success

As in the United States, TheraClearX® will be offered in Mexico under STRATA’s usage-based partnership model, allowing physicians to acquire and operate the device with no upfront capital investment, paying only per treatment performed. This structure minimizes financial barriers for clinics, aligns incentives with patient outcomes, and supports a recurring revenue model for STRATA and its partners.

Forward Outlook
With COFEPRIS certification secured and initial placements underway, STRATA plans to:
1. Expand device deployment to major metropolitan areas including Guadalajara, Monterey, Puebla, and Tijuana.
2. Launch clinical education programs with MINO Labs for dermatologists and clinic staff.
3. Gather real-world clinical data to support broader adoption.
4. Evaluate additional device registrations and indications for Latin America in 2026.
5. Participate on the TERACILAD conference in Mexico City on November 20^th - 22^nd 2025

About STRATA Skin Sciences, Inc.

STRATA Skin Sciences is a medical technology company dedicated to developing, commercializing, and marketing innovative products for the in-office treatment of various dermatologic conditions, such as psoriasis, vitiligo, and acne. Its products include the XTRAC^® excimer laser, VTRAC^® lamp systems, and the TheraClear^®X Acne Therapy System.

STRATA is proud to offer these exciting technologies in the U.S. through its unique Partnership Program. STRATA’s popular partnership approach includes a fee per treatment cost structure versus an equipment purchase, installation and use of the device, on-site training for practice personnel, service and maintenance of the equipment, dedicated account and customer service associates, and co-op advertising support to help raise awareness and promote the program within the practice.

About MINO Labs

MINO Labs S.A. de C.V. is a Mexico-based pharmaceutical and medical technology company specializing in the representation and commercialization of innovative therapeutic and wellness products. With established relationships across 3,000 dermatologists in Mexico, MINO Labs provides a comprehensive commercialization platform encompassing research, regulatory affairs, marketing, and nationwide distribution. For more information, visit www.minolabs.com.

Safe Harbor

This press release includes "forward-looking statements" within the meaning of the Securities Litigation Reform Act of 1995. These statements include but are not limited to the Company’s plans, objectives, expectations and intentions and may contain words such as “will,” “may,” “seeks,” and “expects,” that suggest future events or trends. These statements, the Company’s ability to launch and sell products recently acquired or to be developed in the future, the Company’s ability to develop social media marketing campaigns, direct to consumer marketing campaigns, and the Company’s ability to build a leading franchise in dermatology and aesthetics, are based on the Company’s current expectations and are inherently subject to significant uncertainties and changes in circumstances. Actual results may differ materially from the Company’s expectations due to financial, economic, business, competitive, market, regulatory, adverse market conditions labor supply shortages, or supply chain interruptions resulting from fiscal, political factors, tariffs, international conflicts, responses, or conditions affecting the Company, the medical device industry and our customers and patients in general, as well as more specific risks and uncertainties set forth in the Company’s SEC reports on Forms 10-Q and 10-K. Given such uncertainties, any or all these forward-looking statements may prove to be incorrect or unreliable. The statements in this press release are made as of the date of this press release, even if subsequently made available by the Company on its website or otherwise. The Company does not undertake any obligation to update or revise these statements to reflect events or circumstances occurring after the date of this press release. The Company urges investors to carefully review its SEC disclosures available at www.sec.gov and www.strataskinsciences.com.

Investor Contact:
CORE IR
516-222-2560
IR@strataskin.com

FAQ

What did STRATA (SSKN) receive from COFEPRIS on October 28, 2025?

STRATA received COFEPRIS device registration No. 3187E2024SSA for TheraClearX®, valid through November 2029.

How is STRATA commercializing TheraClearX® in Mexico (SSKN)?

STRATA partnered with MINO Labs and will deploy TheraClearX® using its usage-based physician model (pay-per-treatment).

Where was the first TheraClearX® system placed in Mexico and who is the clinician?

The first system was placed with Dr. Melissa Lomelí Canedo in Mexico City.

What is the market opportunity cited for acne treatments in Mexico for SSKN?

The professional acne medication segment is projected to grow at ~10.2% CAGR to 2030, with average session cost ~MXN 3,200 (≈USD 174).

What near-term commercial steps will STRATA (SSKN) take in Mexico?

Plans include expansion to major metro areas, clinician education with MINO Labs, real-world data collection, and evaluating further Latin America registrations in 2026.