STOCK TITAN

New Peer-Reviewed Publication Confirms Unprecedented Response Rates for STRATA’s Excimer Laser Combined with JAK Inhibitors in Pediatric Vitiligo

Rhea-AI Impact
(Moderate)
Rhea-AI Sentiment
(Positive)
Tags

STRATA Skin Sciences (NASDAQ:SSKN) reported peer-reviewed results from a multicenter randomized trial in pediatric progressive vitiligo showing its 308-nm XTRAC excimer laser plus oral JAK inhibitors achieved an 85.5% overall response rate vs 53.8% with tacrolimus plus XTRAC, with only mild-to-moderate, manageable adverse events.

Face/neck response reached 97.3%, and 33 lesions achieved >95% repigmentation by week 48. STRATA is building patent protection for excimer–systemic combinations and expects AMA CPT code changes effective January 1, 2027 to triple the addressable patient population for XTRAC across inflammatory and autoimmune skin diseases.

Loading...
Loading translation...

AI-generated analysis. Not financial advice.

Positive

  • JAK inhibitor + XTRAC group showed 85.5% response vs 53.8% control (P<.001)
  • Face/neck response 97.3% in Group A, with 64.9% significantly effective rate
  • 33 lesions achieved >95% repigmentation at week 48 vs 3 in control arm
  • Mixed-effects model showed 21.7% higher repigmentation rate for combination therapy
  • All adverse events mild to moderate and fully resolved; no TB or hepatitis B/C
  • Quality of life improvements significantly greater by week 48 (P<.001)
  • Expanding patent portfolio around XTRAC plus JAK inhibitors and biologic drugs
  • CPT code updates effective Jan 1, 2027 expand coverage to more conditions
  • Over 75% of non-psoriasis XTRAC patients currently covered by insurance
  • Code expansion expected to effectively triple XTRAC addressable patient population

Negative

  • None.

News Market Reaction – SSKN

%
1 alert
% News Effect

On the day this news was published, SSKN declined NaN%, reflecting a moderate negative market reaction.

Data tracked by StockTitan Argus on the day of publication.

Key Figures

Patients enrolled: 188 children Overall response rate: 85.5% Control response rate: 53.8% +5 more
8 metrics
Patients enrolled 188 children Multicenter pediatric vitiligo RCT over 48 weeks
Overall response rate 85.5% JAK inhibitor + excimer laser group
Control response rate 53.8% Tacrolimus + excimer laser control group
Face/neck response 97.3% (64.9% significantly effective) Group A facial and neck lesions
High repigmentation lesions 33 vs 3 lesions Lesions with >95% repigmentation by week 48 (combo vs control)
Repigmentation advantage β = 0.217 (95% CI: 0.204–0.230) Mixed-effects modeling repigmentation difference, P<.001
Treatment duration 48 weeks Pediatric progressive vitiligo study period
Insurance coverage More than 75% XTRAC patients treated for non-psoriasis indications in 2025

Market Reality Check

Price: $0.1313 Vol: Volume 14,017 vs 20-day a...
normal vol
$0.1313 Last Close
Volume Volume 14,017 vs 20-day average 10,370 (relative volume 1.35). normal
Technical Trading below 200-day MA of 1.15 and 96.84% below 52-week high.

Peers on Argus

SSKN is down 6.23% while peers are mixed: BMRA (-4.13%), HSCS (-7.81%), LFWD (+0...
2 Up

SSKN is down 6.23% while peers are mixed: BMRA (-4.13%), HSCS (-7.81%), LFWD (+0.15%), PAVM (+2.19%), RSLS (+29.8%). Momentum scanner shows HSCS and TNON both moving up, highlighting stock‑specific pressure on SSKN despite generally mixed sector action.

Historical Context

4 past events · Latest: Feb 19 (Negative)
Pattern 4 events
Date Event Sentiment Move Catalyst
Feb 19 Nasdaq delisting Negative +8.2% Company confirmed Nasdaq delisting and plan to terminate SEC reporting.
Feb 18 Device placement Positive -40.0% Johns Hopkins added XTRAC 308 nm excimer laser to clinical offerings.
Feb 17 Meta-analysis data Positive -8.3% Meta-analysis confirmed substantial PASI improvements with 308 nm excimer therapy.
Dec 09 Commercial update Positive +6.5% Showcased XTRAC and TheraclearX and reported early adoption in Mexico.
Pattern Detected

Recent positive commercial and clinical news has often seen negative or volatile price reactions.

Recent Company History

Over the last six months, STRATA has combined operational challenges with positive clinical and commercial milestones. A February 2026 delisting decision and plans to “go dark” contrasted with news of Johns Hopkins adding the XTRAC® 308 nm excimer laser and a psoriasis meta-analysis highlighting strong efficacy. Earlier, the company reported growing TheraclearX adoption in Mexico. Today’s vitiligo trial publication and reimbursement tailwinds fit a pattern of clinically supportive data against a stressed equity backdrop.

Market Pulse Summary

This announcement highlights robust pediatric vitiligo data for STRATA’s XTRAC® 308‑nm excimer laser...
Analysis

This announcement highlights robust pediatric vitiligo data for STRATA’s XTRAC® 308‑nm excimer laser combined with JAK inhibitors, including an 85.5% response rate and strong facial lesion outcomes. It also underscores reimbursement momentum, with more than 75% of non‑psoriasis patients covered in 2025 and CPT code changes from January 1, 2027 expected to expand eligible indications. Against prior disclosures of a $6.3 million net loss and going‑concern risks, monitoring execution, financing, and adoption trends remains important.

Key Terms

randomized controlled trial, jak inhibitors, tacrolimus, ifn-γ/jak-stat1, +4 more
8 terms
randomized controlled trial medical
"landmark multicenter, prospective, randomized controlled trial in the Journal..."
A randomized controlled trial is a research method that tests the effects of a new idea or treatment by randomly dividing participants into two groups: one that receives the treatment and one that does not. This approach helps ensure that the results are fair and unbiased, providing clear evidence about whether the treatment actually works. Investors value such trials because they offer reliable information that can influence decision-making and reduce uncertainty.
jak inhibitors medical
"oral JAK inhibitors combined with 308-nm excimer laser in pediatric..."
Drugs that block Janus kinase (JAK) enzymes, which act like dimmer switches for the immune system by controlling signals that tell immune cells to ramp up or calm down. They are used to treat inflammatory and some blood-related conditions, and matter to investors because trial results, regulatory approvals, safety concerns (such as infection or clot risks), patent status, and pricing determine market size and a company’s potential revenue and risk exposure.
tacrolimus medical
"over tacrolimus combination therapy in children aged 2–18 years..."
Tacrolimus is a prescription drug that suppresses the immune system to prevent organ transplant rejection and treat certain autoimmune conditions; imagine it as a thermostat that lowers the immune system’s “heat” so the body doesn’t attack transplanted tissue. It matters to investors because regulatory approvals, patent life, manufacturing capacity, pricing and the arrival of generic competitors or safety data directly affect sales and profitability for drugmakers and can move stock prices.
ifn-γ/jak-stat1 medical
"suppress the upstream IFN-γ/JAK-STAT1 autoimmune signaling cascade..."
A cellular signaling route where the immune messenger interferon-gamma (IFN-γ) binds to a cell’s surface and triggers a chain of proteins called JAK and STAT1 to switch specific genes on or off; think of it as a relay team flipping switches inside a cell to change how it behaves. Investors care because many drugs and diagnostics target or measure this pathway to treat or track inflammatory, infectious, and cancerous diseases, so its activity can influence clinical outcomes, regulatory decisions, and market value.
apoptosis medical
"308-nm excimer laser simultaneously induces targeted apoptosis of pathogenic T cells..."
Apoptosis is a controlled, built‑in process where cells deliberately shut down and are safely removed, like a person retiring and clearing out their belongings so the house stays orderly. Investors care because many drugs and diagnostics target or measure this process: how well a therapy triggers or avoids apoptosis can determine clinical trial success, safety profiles, regulatory approval, and ultimately a company’s valuation.
dermo epidermal junction medical
"pathogenic T cells at the dermo epidermal junction and actively promotes..."
A dermo‑epidermal junction is the thin interface where the outer skin layer meets the deeper layer, acting like the glue and shock absorber that holds the skin’s layers together. Investors should care because damage or changes at this seam are central to many skin diseases and wound‑healing problems, making it a common target for drugs, diagnostics and safety tests that can drive clinical value and regulatory decisions.
biologic drugs medical
"combination therapies involving its XTRAC excimer laser when used with JAK inhibitors, systemic agents, and biologic drugs."
Biologic drugs are medicines made from living cells or their products—such as proteins, antibodies or vaccines—rather than chemically synthesized small molecules. Because they are large, complex and produced in living systems, they behave more like handcrafted goods than factory-made widgets; that makes their development, manufacturing and regulation costlier and more sensitive to supply or quality issues, which in turn affects pricing, competitive barriers and investment risk and reward.
cpt regulatory
"AMA’s CPT Editorial Panel... approved updates to codes 96920–96922..."
CPT stands for Current Procedural Terminology, a standardized set of codes used to describe medical procedures and services for billing and insurance purposes. For investors, CPT codes determine how and whether healthcare providers get paid for treatments, affecting revenue streams and reimbursement risk; think of them like product barcodes that decide price and payment for clinical services. Changes to codes or coverage policies can directly alter a healthcare company's cash flow and profitability.

AI-generated analysis. Not financial advice.

See more from StockTitan in Google Search and AI answers. Adds StockTitan as a preferred source · opens Google
Add on Google

Multicenter prospective RCT published in JAAD confirms superiority of XTRAC® Excimer Laser plus oral JAK inhibitors over tacrolimus combination therapy in children aged 2–18 years with progressive vitiligo, fueling continued market growth and expanding indications

HORSHAM, Pa., May 18, 2026 (GLOBE NEWSWIRE) -- STRATA Skin Sciences, Inc. (“STRATA” or the “Company”), a global leader in excimer laser therapy dedicated to developing, commercializing, and marketing innovative products for the treatment of dermatologic conditions, today highlighted the publication of a landmark multicenter, prospective, randomized controlled trial in the Journal of the American Academy of Dermatology demonstrating that STRATA’s 308-nm excimer laser, when combined with oral JAK inhibitors, produces unprecedented repigmentation outcomes in pediatric patients with progressive vitiligo — with a favorable safety profile across all 188 children enrolled over a 48-week treatment period.

The study, conducted across five leading academic dermatology centers in China, enrolled children aged 2–18 years and compared two treatment arms: oral JAK inhibitors (baricitinib or tofacitinib) combined with 308-nm excimer laser therapy twice weekly (Group A) versus topical tacrolimus combined with the same excimer laser protocol (Group B).

KEY STUDY FINDINGS

  • Overall response rate of 85.5% in the JAK inhibitor + excimer laser group versus 53.8% in the tacrolimus + excimer laser control group (P<.001)
  • Face and neck lesions achieved a 97.3% response rate in Group A, including a 64.9% “significantly effective” rate, compared to 59.5% in controls
  • Trunk and limb response rates of 89.3% and 88.9%, respectively, versus 61.6% and 64.9% in controls
  • 33 lesions in the combination group achieved >95% repigmentation by week 48, compared to only 3 in the control arm
  • Mixed-effects modeling confirmed a statistically significant 21.7% higher repigmentation rate for the JAK inhibitor + excimer laser combination (β = 0.217, 95% CI: 0.204–0.230, P<.001)
  • All adverse events were mild to moderate in severity and fully resolved with appropriate management; no cases of tuberculosis or hepatitis B/C were observed
  • Quality of life improvements, measured by the Children’s Dermatology Life Quality Index, were significantly greater in Group A, reaching statistical significance by week 48 (P<.001)

“This publication is a powerful validation of our personalized medicine approach and confirms what we have long believed — that the XTRAC® excimer laser is not just a stand-alone therapy, but an essential, synergistic component of next-generation combination regimens. XTRAC®- 308-nm excimer laser served as the phototherapy backbone for both arms, underscoring its central and indispensable role in modern vitiligo combination therapy.said Dr. Dolev Rafaeli, President and CEO of STRATA Skin Sciences. “The unprecedented response rates seen here in children — a historically underserved and difficult-to-treat population — reinforce the growing body of peer-reviewed evidence supporting the XTRAC® platform as the cornerstone of modern vitiligo care. We are proud to see our technology driving outcomes that meaningfully improve patients’ lives.”

The mechanistic basis for these results reflects the complementary action of both therapies: JAK inhibitors suppress the upstream IFN-γ/JAK-STAT1 autoimmune signaling cascade that drives melanocyte destruction, while the 308-nm excimer laser simultaneously induces targeted apoptosis of pathogenic T cells at the dermo epidermal junction and actively promotes melanocyte migration and repopulation within lesional skin. Together, these mechanisms address both the immunological and cellular dimensions of vitiligo in a true personalized medicine approach.

Intellectual Property Portfolio

STRATA’s growing portfolio of patent applications is designed to support intellectual property protection and potential market exclusivity for combination therapies involving its XTRAC® excimer laser when used with JAK inhibitors, systemic agents, and biologic drugs. These pending or applied-for patents underpin STRATA’s strategy to expand into new clinical indications, including vitiligo and other inflammatory and autoimmune skin conditions.

“It is important that we continue to grow our market by expanding into new indications, while maximizing revenue opportunities for the Company and our partner clinics,” said Dr. Dolev Rafaeli, President and Chief Executive Officer of STRATA Skin Sciences. “Foundational to this long-term growth initiative are our proactive investments in technology development and patent filings, which are intended to provide broad intellectual property coverage around emerging combination therapy approaches.”

Further, the importance of these patent fillings lies in their pioneering role in defining and protecting the combined use of Excimer laser therapy with systemic pharmacologic agents, a significant advancement in the treatment of inflammatory and autoimmune skin diseases such as psoriasis, atopic dermatitis, leukoderma, alopecia areata, and vitiligo. Excimer lasers, particularly at 308 nm, allow for precise, high-dose, localized UVB exposure, delivering therapeutic light energy to affected skin areas while sparing healthy tissue. When used alone, they provide rapid lesion clearance, but their effects may be short-lived in severe or systemic disease. These pending patents strategically address these limitations by combining phototherapy with systemic treatments—including biologic drugs and JAK inhibitors—to deliver a synergistic therapeutic effect, ranging from enhanced treatment response including prolonged remission, potential reduction of the dosage for these drugs, as well as improved safety by limiting the UV exposure to only the affected skin area.

XTRAC® Excimer Laser Insurance Coverage

As previously announced, the American Medical Association’s CPT Editorial Panel, in a landmark decision, approved updates to codes 96920–96922, expanding reimbursement eligibility for XTRAC® Excimer Laser treatments to include all inflammatory and autoimmune skin conditions—such as vitiligo, atopic dermatitis, and alopecia areata—in addition to psoriasis, effective January 1, 2027. Based on STRATA’s 2025 insurance reimbursement coverage data, more than 75% of XTRAC® excimer laser patients treated for non-psoriasis indications are currently covered by insurance. Upcoming code expansion will result in effectively tripling the addressable patient population while improving treatment economics for both providers and the Company.

PUBLICATION DETAILS

Chang S, Zhang L, Liu B, et al. Efficacy of oral JAK inhibitors combined with 308-nm excimer laser in pediatric progressive vitiligo: A multicenter study. Journal of the American Academy of Dermatology. Published online March 19, 2026. doi:10.1016/j.jaad.2026.02.096

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 involve known and unknown risks and uncertainties that may cause actual results to differ materially from those expressed or implied by such statements. STRATA Skin Sciences undertakes no obligation to publicly update or revise any forward-looking statements.

Investor & Media Contact
STRATA Skin Sciences, Inc.
5 Walnut Grove Drive, Suite 140, Horsham, PA 19044
(215) 619-3200 | ir@strataskinsciences.com | strataskinsciences.com


FAQ

What did STRATA (SSKN) announce about pediatric vitiligo results with XTRAC and JAK inhibitors?

STRATA reported that XTRAC excimer laser combined with oral JAK inhibitors achieved an 85.5% overall response rate in pediatric progressive vitiligo. According to STRATA, this compared with 53.8% for tacrolimus plus XTRAC, with only mild-to-moderate adverse events that fully resolved under appropriate management.

How effective was STRATA’s XTRAC plus JAK inhibitor therapy on face and neck vitiligo in children (SSKN)?

The combination achieved a 97.3% response rate for face and neck lesions in Group A pediatric patients. According to STRATA, 64.9% of these lesions were classified as significantly effective, outperforming the 59.5% response observed in the tacrolimus plus XTRAC control group.

What safety profile was reported for STRATA’s XTRAC and JAK inhibitor vitiligo regimen (SSKN)?

All adverse events were mild to moderate and resolved with management during the 48-week trial. According to STRATA, no cases of tuberculosis or hepatitis B or C occurred among the 188 pediatric participants receiving the XTRAC excimer laser plus systemic or topical treatments.

How might the new CPT code changes impact STRATA’s XTRAC laser market (SSKN)?

AMA CPT updates effective January 1, 2027 expand XTRAC reimbursement to all inflammatory and autoimmune skin conditions. According to STRATA, this code expansion is expected to effectively triple the addressable patient population and improve treatment economics for providers and the company.

What insurance coverage levels does STRATA report for non-psoriasis XTRAC treatments (SSKN)?

More than 75% of XTRAC excimer laser patients treated for non-psoriasis indications currently have insurance coverage. According to STRATA, this existing reimbursement base, combined with upcoming CPT code expansion, supports continued market growth across vitiligo and other inflammatory skin diseases.

How is STRATA (SSKN) using patents to protect XTRAC combination therapies?

STRATA is pursuing patents on combinations of its XTRAC excimer laser with JAK inhibitors, systemic agents, and biologic drugs. According to STRATA, these filings aim to secure intellectual property coverage, support market exclusivity, and enable expansion into multiple inflammatory and autoimmune skin conditions.