# EDGAR Filing Document

**Accession Number:** 0001051514
**File Stem:** 0001140361-25-029355
**Filing Date:** 2025-8
**Character Count:** 16869
**Document Hash:** 672d48f4ffdf24fc089db99f8e0ae16b
**Contains OCR:** False
**Source Format:** 

## Filing Content

## Filing Summary
**0001140361-25-029355.hdr.sgml**: 20250807

**ACCESSION NUMBER**: 0001140361-25-029355

**CONFORMED SUBMISSION TYPE**: 8-K

**PUBLIC DOCUMENT COUNT**: 14

**CONFORMED PERIOD OF REPORT**: 20250807

**ITEM INFORMATION**: Regulation FD Disclosure

**ITEM INFORMATION**: Financial Statements and Exhibits

**FILED AS OF DATE**: 20250807

**DATE AS OF CHANGE**: 20250807

**FILER**: 

**COMPANY DATA:**
- **COMPANY CONFORMED NAME:** STRATA Skin Sciences, Inc.
- **CENTRAL INDEX KEY:** 0001051514
- **STANDARD INDUSTRIAL CLASSIFICATION:** SURGICAL & MEDICAL INSTRUMENTS & APPARATUS [3841]
- **ORGANIZATION NAME:** 08 Industrial Applications and Services
- **EIN:** 133986004
- **STATE OF INCORPORATION:** DE
- **FISCAL YEAR END:** 1231

**FILING VALUES:**
- **FORM TYPE:** 8-K
- **SEC ACT:** 1934 Act
- **SEC FILE NUMBER:** 000-51481
- **FILM NUMBER:** 251191791

**BUSINESS ADDRESS:**
- **STREET 1:** 5 WALNUT GROVE DRIVE
- **STREET 2:** SUITE 140
- **CITY:** HORSHAM
- **STATE:** PA
- **ZIP:** 19044
- **BUSINESS PHONE:** 215-619-3200

**MAIL ADDRESS:**
- **STREET 1:** 5 WALNUT GROVE DRIVE
- **STREET 2:** SUITE 140
- **CITY:** HORSHAM
- **STATE:** PA
- **ZIP:** 19044

**FORMER COMPANY:**
- **FORMER CONFORMED NAME:** MELA SCIENCES, INC. /NY
- **DATE OF NAME CHANGE:** 20100504

**FORMER COMPANY:**
- **FORMER CONFORMED NAME:** ELECTRO OPTICAL SCIENCES INC /NY
- **DATE OF NAME CHANGE:** 19971216

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### UNITED STATES

### SECURITIES AND EXCHANGE COMMISSION

#### WASHINGTON, D.C. 20549

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### FORM 8-K

#### CURRENT REPORT

#### Pursuant to Section 13 or 15(d) of the

#### Securities Exchange Act of 1934
Date of report (Date of earliest event reported): August 7, 2025

![graphic](image0.jpg)

## STRATA SKIN SCIENCES, INC.
(Exact Name of Registrant Specified in Charter)

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| | | |
|:---|:---|:---|
| **Delaware**<br>| **000-51481**<br>| **13-3986004**<br>|
| (State or Other Jurisdiction of Incorporation) | (Commission File Number) | (I.R.S. Employer Identification No.) |

---

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| | |
|:---|:---|
| **5 Walnut Grove Drive, Suite 140, Horsham, Pennsylvania** | &nbsp;&nbsp;&nbsp; **&nbsp;&nbsp;&nbsp;&nbsp; 19044**<br>|
| (Address of Principal Executive Offices) | &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; (Zip Code) |

---

Registrant's telephone number, including area code: **215-619-3200**

(Former Name or Former Address, if Changed Since Last Report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

☐ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Securities registered pursuant to Section 12(b) of the Act:

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| | | |
|:---|:---|:---|
| Title of each class | Trading<br> Symbol(s) | Name of each exchange on which registered |
| Common Stock, $0.001 par value per share<br>| SSKN<br>| The NASDAQ Stock Market LLC<br>|

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| | |
|:---|:---|
| **Item 7.01.** | **Regulation FD Disclosure.** |

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On August 7, 2025, STRATA Skin Sciences, Inc. (the "Company") issued a press release announcing its work with the Centers for Medicare & Medicaid Services (CMS) to obtain temporary codes that would accelerate access to recently expanded reimbursement for its XTRAC® excimer laser treatment. As the Company had 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. By securing temporary CMS codes, the Company aims to make these expanded indications reimbursable as early as the 2026 rule cycle, effectively tripling the addressable patient population while improving treatment economics for both providers and the Company.

The press release also reported on recent peer reviewed publications supporting excimer laser therapy in combination with JAK inhibitors for treating vitiligo. The Company's intellectual property portfolio includes patents for the use of JAK inhibitors in combination with excimer laser therapy.

Also covered in the press release is an update on the lawsuit for unfair competition under the Lanham Act against LaserOptek America and other parties. Specifically, the release stated that that the Federal District Court has agreed with the Company's position that LaserOptek Co. Ltd, ('LaserOptek Korea') the South Korean parent of LaserOptek America, should be added as a defendant in the lawsuit, and that the Company was encouraged that the court recognized that the Company was justified in its assertions that the US based defendants had engaged in duplicitous actions in attempting to hide and shield the Korean entity from the lawsuit. The court also allowed the Company to add another defendant, C. Dalton, LLC, the entity that represented LaserOptek Korea's interests in the U.S.

A copy of the press release is attached as Exhibit 99.1 to this Current Report on Form 8-K.

The information set forth in this item 7.01, including Exhibit 99.1, is being furnished and shall not be deemed "filed" for the purposes of Section 18 of the Securities Exchange Act or otherwise subject to the liabilities of such section, nor shall such information be deemed incorporated by reference in any filing under the Securities Act or the Exchange Act, except as shall be expressly set forth by specific reference in any such filing.

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| | |
|:---|:---|
| **Item 9.01.** | **Financial Statements and Exhibits.** |

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&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**(d)** **Exhibits.** 

The following press release is furnished as an exhibit to this Current Report on Form 8-K and shall not be deemed to be "filed":

<u>Exhibit No.</u> <u>Exhibit Description</u> <br> [99.1](ef20053379_ex99-1.htm) Press release dated August 7, 2025, issued by Strata Skin Sciences, Inc.

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#### &nbsp;&nbsp;&nbsp;&nbsp; SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

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| | | |
|:---|:---|:---|
|  | **STRATA SKIN SCIENCES, INC.** | **STRATA SKIN SCIENCES, INC.** |
| Date: August 7, 2025 | By: | /s/ John Gillings |
|  |  | John Gillings |
|  |  | Chief Accounting Officer |

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## Exhibit 99.1

#### Exhibit 99.1

#### STRATA Skin Sciences Moves to Accelerate Medicare and Private Payer Coverage from Expanded CPT Code Expansion, Tripling Addressable Market to 30M+ Patients

*Peer-reviewed publications continue to validate Excimer Laser efficacy in vitiligo and treatment*

*Strata updates status of non-Excimer laser false advertising litigation*

**Horsham, PA – August 7, 2025** – 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, today announced it is working with the Centers for Medicare & Medicaid Services (CMS) to obtain temporary codes that would accelerate access to recently expanded reimbursement for its XTRAC<sup>®</sup> excimer laser treatment.

As <u>previously announced</u>, 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. By securing temporary CMS codes, STRATA aims to make these expanded indications reimbursable as early as the 2026 rule cycle, effectively tripling the addressable patient population while improving treatment economics for both providers and the Company.

"Expanding access to XTRAC<sup>®</sup> is about more than increasing device utilization and revenue per device - —it's about helping millions of patients who are living with chronic, inflammatory skin conditions, with limited long term safe, efficacious and accessible treatment modalities" said Dr. Dolev Rafaeli, STRATA Skin Sciences President and CEO. "By working with CMS to secure temporary reimbursement ahead of 2027, we aim to bring this safe, effective, non-drug therapy to a broader patient population—more than 30 million people—sooner, while creating more substantial economic incentives for providers to deliver this care, for which they are paid vs. prescribing expensive, less effective medication for which they are not.

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"Our confidence in this mission is reinforced by the huge support we have secured from members of the legislature, patient advocacy groups, and leading academic key opinion leaders. We are further encouraged by the growing body of peer-reviewed published clinical studies supporting Excimer Laser therapy, and pointing to new and enhanced applications, adding to the hundreds of other studies published over the years. In fact, two new studies published last month confirmed that combining 308-nm excimer-laser therapy with Janus kinase (JAK) inhibitors—an emerging class of immune-modulating drugs—is both safe and effective for vitiligo. These findings further strengthen XTRAC's standing as a leading drug-free option and highlight its role to enhance patient outcomes in the era of next-generation therapies," concluded Dr. Rafaeli.

#### Recent Peer Reviewed Publications Supporting Excimer Laser Therapy in Vitiligo

One study, published in *<u>International Journal of Dermatology</u>*, focused on a multicenter randomized controlled trial evaluated the efficacy and safety of 308nm excimer laser therapy in combination with oral JAK inhibitors (baricitinib), a novel class of immune-modulating drugs. A total of 240 adult patients were enrolled and monitored over a 52-week period. The study demonstrated superior re-pigmentation in combination therapy, with patients receiving 308 nm excimer laser combined with baricitinib reporting a 100% overall response rate and 96% pigment stability, indicating a durable response. Further, the study showed treatment was well tolerated across all groups, with no serious adverse events reported over the 52-week trial. All adverse events were mild and manageable, with no treatment discontinuations or severe complications reported.

The second study, published in *<u>Human Vaccines and Immunotherapeutics</u>,* highlights a case report for conjunctive use of excimer laser with JAK inhibitor (tofacitinib). In the report, a 22-year-old woman developed segmental vitiligo one week after her third Gardasil-9 HPV dose. Following a combined regimen of tofacitinib, 308 nm excimer laser, fractional laser, and topical tacrolimus, the patient achieved approximately 70 % re-pigmentation over 13 months.

#### Update on Ongoing Litigation

In an update to its previous announcements on the lawsuit STRATA has been prosecuting against LaserOptek America , Dr. Rafaeli stated that, "STRATA is pleased to report that the Federal District Court has agreed with Strata's position that LaserOptek Co. Ltd, ('LaserOptek Korea') the South Korean parent of LaserOptek America, should be added as a defendant in the lawsuit. It is encouraging that the court recognized what we believe to be the duplicitous actions of the defendants in attempting to hide and shield the Korean entity from the lawsuit. We are further gratified by the significant potential damages that may be awarded to STRATA. The addition of LaserOptek Korea and C. Dalton, LLC, the entity that represented LaserOptek Korea's interests in the U.S., clearly demonstrates that those parties should be held accountable for the knowingly false misrepresentations made as outlined in our unfair trade practices claim under the Lanham Act."

STRATA filed the original lawsuit in August 2024 in the U.S. District Court of the Eastern District of Pennsylvania alleging that the defendants had made false and misleading statements regarding marketing of the Pallas lasers and reimbursement of psoriasis treatment procedures performed with Pallas lasers. In that complaint, STRATA alleged false advertising and unfair competition under the Lanham Act and related state laws with regard to the marketing and sale of the Pallas lasers in the U.S., potentially exposing the Pallas physician offices and the staff to action by CMS for submitting reimbursement claims for non-reimbursable procedures.

With its intellectual property portfolio that includes issued patents covering the methods for localized treatment of any skin condition by administering a therapeutically effective amount of JAK inhibiters, systemic or biologic drugs to the patient, and a dosimeter guided Excimer Laser dose to an area of the patient's skin, Strata is well prepared to have a unique offering into these new treatment frontiers.

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#### 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<sup>®</sup> excimer laser, VTRAC<sup>®</sup> lamp systems, and the TheraClear<sup>®</sup>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 <u>www.sec.gov</u> and <u>www.strataskinsciences.com</u>.

#### Investor Contact:
CORE IR

516-222-2560

<u>IR@strataskin.com</u>

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