First English-language case study shows resolution of lesions with 308-nm Excimer laser in rare mycosis fungoides (MF) subtype, poikilodermatous mycosis fungiodes (pMF), underscoring the Company’s XTRAC capability to address the condition

HORSHAM, Pa., Oct. 14, 2025 (GLOBE NEWSWIRE) -- STRATA Skin Sciences, Inc. (“STRATA” or the “Company”) (NASDAQ: SSKN), a medical technology company dedicated to developing, commercializing, and marketing innovative products for the treatment of dermatologic conditions, announces a groundbreaking clinical case study published in Case Reports in Oncology. The study reports the successful use of 308-nm excimer laser to treat a rare and under-recognized form of cutaneous T-cell lymphoma, mycosis fungoides (MF) through a subtype called poikilodermatous mycosis fungiodes (pMF).

Led by dermatology researchers at Tohoku University Graduate School of Medicine, the newly published, peer reviewed study (Case Rep Oncol 2025;18:325–329) represents a first-of-its-kind English-language report validating excimer laser therapy as a safe and effective option for this difficult-to-treat condition.

Dr. Dolev Rafaeli, Strata President and CEO, commented, “The XTRAC Excimer laser continues to draw attention worldwide for its versatility in treating inflammatory skin conditions. It is that versatility, both in monotherapy and in combination with multiple medications, that has resulted in the Centers for Medicare and Medicaid Services (CMS) significantly expanding the reimbursement codes for a much wider variety of these conditions, including MF and pMF as outlined in this study, as well as every autoimmune-based skin condition. It is important to note that independent investigators continue testing the limits of XTRAC therapy, and publication after publication verifies the clinical track record of the device, whether in patients in the U.S. or worldwide. It is worth noting that Japan, where this study was conducted, is a significant market for the XTRAC Excimer laser as dermatologists there are at the cutting edge of pioneering new uses for the technology. We continue to work closely with CMS in obtaining the expanded reimbursement for XTRAC and will continue to provide updates as they develop.”

The study was conducted by Dr. Manami Watanabe, Dr. Taku Fujimura, and Dr. Yoshihide Asano, all faculty members in the Department of Dermatology at Tohoku University, one of Japan’s leading national universities. The institution is globally recognized for excellence in biomedical research and dermatologic innovation, with a robust clinical and translational research program focused on autoimmune and lymphoproliferative skin diseases.

In 2022, the International Journal of Dermatology published a detailed systematic review assessing the efficacy and safety of the 308-nm excimer laser in the treatment of mycosis fungoides (MF) (International Journal of Dermatology 2023, 62, e54–e104). The review included 14 studies encompassing 72 patients. Patients received an average of 18.7 treatment sessions (range 6–44) with a mean cumulative dose of approximately 5 J/cm². Overall, 73.6% of patients achieved a complete clinical response, 22.2% a partial response, and only 2.8% showed no clinical improvement. Among those with histologic follow-up, 75% demonstrated a complete histologic remission. Relapse was rare, occurring in just 5.7% of complete responders after a mean of 13 months. Reported adverse events were mild and transient, primarily limited to erythema, pruritus, or first-degree burns, with no serious complications. The authors concluded that the 308-nm excimer laser represents a safe, effective, and lesion-targeted modality for early-stage MF, achieving high remission rates and durable responses with minimal toxicity.

Understanding the Disease: Mycosis Fungoides and the Poikilodermatous Subtype
Mycosis fungoides (MF) is the most prevalent form of cutaneous T-cell lymphoma (CTCL), a rare malignancy that affects the skin’s immune T cells. In the United States, MF occurs at a rate of approximately 4–6 new cases per million person-years, with a prevalence of 5.2–6.6 per 100,000 persons, according to data from SEER and the National Cancer Database.¹ MF is more common in males, with a male-to-female ratio of approximately 1.4–2:1, and more frequently affects African American patients, who also tend to present at younger ages and with more advanced disease.²

Case Study Results: Excimer Laser Shows Rapid Clinical Response
The case involved a 50-year-old female with a 3-year history of progressive reticulated pigmentation and atrophic macules on the left thigh. Despite prolonged treatment with topical corticosteroids and vitamin D analogs, the lesions had steadily progressed. A biopsy and immunohistochemistry confirmed a diagnosis of poikilodermatous MF.

Treatment was initiated with a 308-nm excimer laser, delivering 1,250 mJ/cm² of energy over five sessions, in combination with topical corticosteroids. After three months, the patient exhibited marked clinical improvement, with complete resolution of erythema and only minimal pigmentation remaining.³

This is the first English-language report to document the successful treatment of pMF using 308-nm excimer laser, highlighting both its safety and efficacy in localized, patch-stage MF—a setting where traditional therapies often carry greater systemic risks.

Why Excimer Laser Therapy Matters
While narrowband UVB (NB-UVB) and psoralen plus UVA (PUVA) are standard treatments for early MF, they require whole-body exposure, carry cumulative dose concerns, and can be impractical for patients with localized disease. The excimer laser, by contrast, emits high-intensity, targeted UVB light (308 nm), allowing clinicians to treat specific lesions while sparing unaffected skin.⁴

Additionally, the energy density of the excimer laser exceeds that of conventional UV therapy, potentially enhancing therapeutic effects in lesions that are treatment-resistant or thickened.⁵

Its clinical utility has been previously demonstrated in vitiligo, alopecia areata, psoriasis, and early-stage MF, but this is the first formal application and publication in pMF.⁶

Conclusion
This case adds to the growing evidence base for the excimer laser as a front-line modality in early-stage or treatment-resistant CTCL variants, offering a targeted, safe, and efficacious alternative to systemic or full-body phototherapy. Future studies and broader clinical application could significantly impact treatment guidelines and improve patient quality of life in this rare disease population.

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.

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

¹ SEER & NCDB analysis – PMCID: PMC9128921
² Demographic disparities in MF – JAAD 2017
³ Watanabe M, Fujimura T, Asano Y. Case Rep Oncol 2025;18:325–329. DOI: 10.1159/000544164
⁴ Olsen EA et al., USCL Consortium phototherapy guidelines – JAAD 2016
⁵ Meisenheimer JL, Excimer laser in MF – Dermatol Online J 2006;12(7):11
⁶ Passeron et al., Excimer efficacy in MF – Arch Dermatol 2004;140(10):1291–3

Source: STRATA Skin Sciences, Inc.