STRATA Skin Sciences Receives Continued Validation for its Personalized Approach with New Published Study Highlighting XTRAC® Excimer Laser Treatment Combined with a Topical Drug in Psoriasis

Rhea-AI Summary

STRATA Skin Sciences (NASDAQ: SSKN) has announced positive results from a new peer-reviewed study published in Lasers in Medical Science, demonstrating the enhanced efficacy of its XTRAC® 308nm Excimer Laser when combined with tacrolimus ointment for treating plaque-type psoriasis.

The study of 100 patients showed that the combination therapy group achieved superior results compared to topical treatment alone. The combination therapy group's mean PASI score decreased from 18.36 to 3.30, significantly outperforming the control group's reduction from 18.62 to 5.23 (p < 0.01). The treatment demonstrated a strong safety profile with no serious adverse events.

This research validates STRATA's personalized medicine approach, potentially strengthening their case for expanded CMS reimbursement and positioning their XTRAC system as a viable non-biologic treatment option.

Positive

• Significant clinical improvement with combination therapy showing superior PASI score reduction
• Strong safety profile with no serious adverse events reported
• Study adds to over 400 clinical publications supporting Excimer therapy
• Results support potential CMS reimbursement expansion
• Validates combination therapy strategy with multiple treatment options

Negative

• None.

Insights

Medical Device Analyst

SSKN's XTRAC laser shows superior efficacy in combination therapy, strengthening clinical evidence for reimbursement expansion and personalized treatment approach.

The newly published study in Lasers in Medical Science provides significant clinical validation for STRATA's XTRAC 308nm Excimer Laser system. The retrospective study involving 100 patients demonstrates measurably superior outcomes when combining XTRAC treatments with tacrolimus ointment compared to the topical therapy alone. Specifically, the combination therapy reduced mean PASI scores from 18.36 to 3.30, versus 18.62 to 5.23 in the control group (43% better improvement).

This evidence is particularly valuable as it addresses two key market dynamics: First, it validates STRATA's combination therapy strategy, positioning XTRAC as a complementary rather than competing treatment alongside topicals, biologics, and JAK inhibitors. This expands XTRAC's potential patient population and clinical applications. Second, the personalized dosing approach (using Minimum Erythema Dose) aligns with the growing precision medicine movement in dermatology.

The strategic timing of this publication is noteworthy as it builds clinical evidence for expanded reimbursement from CMS, with CEO Dr. Rafaeli explicitly connecting this study to ongoing reimbursement discussions. The emphasis on XTRAC's non-biologic, targeted nature addresses market demand for localized treatments with favorable safety profiles compared to systemic immunosuppressants. With 400+ clinical publications now supporting Excimer therapy, STRATA is strengthening its position with both providers and payers through evidence-based differentiation in the competitive dermatology market.

HORSHAM, Pa., Sept. 30, 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 the publication of a new peer-reviewed study in Lasers in Medical Science that reinforces the Company’s commitment to personalized medicine. The study demonstrates that treatment using the Company’s XTRAC 308nm Excimer Laser in combination with 0.1% tacrolimus ointment significantly improves outcomes in patients with plaque-type psoriasis compared to topical monotherapy.

The study, titled “Clinical efficacy of 308 nm excimer laser irradiation combined with 0.1% tacrolimus ointment in the treatment of plaque-type psoriasis,” was authored by Xiaobin Gao, Shuhua Du, Jun Zeng, Yan Li, and Dan Shen and published in Lasers in Medical Science (2025, Vol. 40:342). DOI: https://doi.org/10.1007/s10103-025-04599-1.

Clinical Study Design Highlights Personalized Medicine in Action
The retrospective observational study involved 100 adult patients with plaque-type psoriasis treated between January 2023 and January 2024. Patients were divided into two equal groups:
- Control group (n=50), which received 0.1% tacrolimus ointment twice daily for 8 weeks
- Observation group (n=50), which received the same topical regimen plus phototherapy using the 308 nm Excimer Laser (XTRAC) twice weekly, using patient-specific dosing determined by their individual Minimum Erythema Dose (MED)

Key Findings: Personalized, Targeted Laser Therapy Enhances Efficacy

• PASI Reduction:
  • Control group: Mean PASI dropped from 18.62 to 5.23
  • Observation group: Mean PASI dropped from 18.36 to 3.30
  • The difference was statistically significant (p < 0.01), showing the combination therapy was markedly superior
• Safety Profile:
  • No serious adverse events in either group
  • Mild and self-resolving irritation or eczema reported in a small number of patients
• Personalization in Practice:
  • Individualized excimer laser dosing based on MED and plaque characteristics enabled targeted lesion treatment, maximizing benefit while minimizing exposure to healthy tissue—a fundamental principle of precision dermatology
• Mechanistic Synergy:
  • The combination works through complementary immunomodulatory pathways: the excimer laser induces apoptosis in pathogenic T-cells and suppresses keratinocyte hyperproliferation, while tacrolimus locally inhibits cytokine release through calcineurin inhibition. This resulted in faster resolution of plaques and enhanced patient outcomes
    

Dr. Dolev Rafaeli, STRATA’s President and CEO, commented, “This important new study highlights the relevance and scientific rigor behind our Excimer laser technology. As clinicians increasingly seek personalized, flexible, and safe treatment options, our XTRAC system continues to meet the moment by integrating seamlessly with topical and systemic therapies."

“With more than 400 clinical publications backing Excimer therapy and a strong safety track record, this newest publication adds further weight to our case with CMS to expand reimbursement, especially as demand for non-biologic, in-office treatment options continues to grow,” he added.

Broader Implications and Strategic Importance
This study reinforces STRATA’s strategic leadership in personalized, clinic-based dermatologic care as it:

• Supports Excimer laser’s use not only as monotherapy but also in conjunction with topical agents, biologics, and JAK inhibitors
• Validates STRATA’s combination therapy strategy
• Adds peer-reviewed evidence that strengthens provider and payer confidence
• Offers a cost-effective, targeted alternative to systemic immunosuppressants in selected patient populations

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

FAQ

What were the key findings of STRATA Skin Sciences' (SSKN) new XTRAC study in 2025?

The study showed that XTRAC laser combined with tacrolimus ointment significantly reduced mean PASI scores from 18.36 to 3.30, compared to topical treatment alone (18.62 to 5.23), with p < 0.01 statistical significance.

How many patients were included in STRATA's XTRAC clinical study?

The study included 100 adult patients with plaque-type psoriasis, divided into two equal groups of 50 patients each, conducted between January 2023 and January 2024.

What is the safety profile of STRATA's XTRAC treatment combined with tacrolimus?

The study reported no serious adverse events, with only mild and self-resolving irritation or eczema in a small number of patients.

How does STRATA's XTRAC laser treatment work for psoriasis?

XTRAC laser works through immunomodulatory pathways, inducing apoptosis in pathogenic T-cells and suppressing keratinocyte hyperproliferation, while the combination with tacrolimus provides additional local cytokine release inhibition.

What are the implications of the XTRAC study for STRATA Skin Sciences' business?

The study strengthens STRATA's case for expanded CMS reimbursement, validates their combination therapy strategy, and positions XTRAC as a cost-effective alternative to systemic immunosuppressants.