STRATA Skin Sciences Reinforces Market Leadership Following Key Litigation Milestones Against LaserOptek

Rhea-AI Summary

STRATA Skin Sciences (NASDAQ: SSKN) said a U.S. District Court partially granted a preliminary injunction on Nov 8, 2024, barring LaserOptek and related parties from U.S. sales/marketing that imply reimbursement under CPT codes 96920–96922 and from making false or misleading statements about STRATA products. The Court also added LaserOptek Korea as a defendant for obscuring involvement. STRATA reports >20 former Pallas buyers have switched to XTRAC, representing $1M+ in annualized capital and recurring revenue. As of June 30, 2025, STRATA’s partnership program covers 844 of ~1,200 U.S. excimer-using clinics. The AMA CPT Board reaffirmed exclusive excimer use under these codes through Jan 1, 2027, with codes broadened in May 2025 to include up to 30 conditions, potentially expanding treated patient population.

Positive

• Over 20 former Pallas buyers converted to XTRAC
• $1M+ in annualized capital and recurring revenue from conversions
• 844 clinics enrolled in STRATA partnership as of June 30, 2025
• AMA CPT codes 96920–96922 reaffirmed through Jan 1, 2027

Negative

• Litigation outcome remains partial; preliminary injunction issued Nov 8, 2024
• CPT reaffirmation is time-limited through Jan 1, 2027

Insights

Legal and Commercial Strategy Expert

Court rulings and CPT reaffirmation strengthen STRATA’s legal position and commercial reach, with measurable near-term revenue gains.

The court’s injunctions and addition of LaserOptek Korea increase STRATA’s ability to stop misleading marketing and to seek remedies. The company reports conversion of over 20 former Pallas buyers, representing over $1 million in annualized capital and recurring revenue, which validates recent business recovery efforts.

Key dependencies remain the durability of the injunctions and successful enforcement against all named defendants. The May, 2025 American Medical Association CPT Board reaffirmation through January 1, 2027 preserves exclusive billing rules that support pricing and reimbursement for excimer therapy. Monitor court enforcement actions and any appeals over the next 6-18 months and watch adoption metrics versus the stated June 30, 2025 baseline of 844 partner clinics and the cited ~1,200 clinic addressable base for evidence of sustained revenue expansion.

HORSHAM, Penn., Oct. 20, 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, today provided an update on its competitive positioning and ongoing litigation against LaserOptek America Corp., LaserOptek Co. Ltd. (“LaserOptek Korea”), and affiliated entities including The Pinnacle Health Group and C. Dalton International.

Court Recognizes STRATA’s Position and Expands Accountability

As previously disclosed, on November 8, 2024, the U.S. District Court for the Eastern District of Pennsylvania issued an order partially granting STRATA’s motion for preliminary injunction. The Court ruled in STRATA’s favor, ordering that:

• LaserOptek and The Pinnacle Health Group — along with their employees, agents, distributors, and affiliates — are enjoined from any sales or marketing of Pallas laser systems in the United States that imply treatments are reimbursable under CPT Codes 96920–96922
• The defendants are also barred from making false or misleading statements regarding STRATA’s excimer laser systems or their own competing products

In a subsequent decision, the Court also agreed with STRATA’s position that LaserOptek Korea should be added as a defendant, citing efforts by the defendants to obscure their involvement. This ruling strengthens STRATA’s ability to hold all responsible parties accountable for false advertising and unfair trade practices under the Lanham Act.

“The Court’s decision affirms our commitment to protect both our clinical partners and patients from misleading claims,” said Dr. Dolev Rafaeli, STRATA’s President and CEO. “By exposing the deceptive tactics used to promote non-excimer lasers under CPT codes reserved for excimer technology, and offering a technology that has no known independent, peer-reviewed clinical validation for the treatment of Psoriasis, or (for that matter) any other inflammatory and autoimmune skin condition whether in or outside the U.S., we are defending not only our business but the ethical and medical standards of the dermatology community. We are happy to report that many dermatology accounts that were deceived with these false advertising claims are now XTRAC excimer laser users leading to our ability to retain and enhance our market share.”

STRATA Regains Market Share and Strengthens Partner Network

Over the past few months, STRATA has successfully engaged multiple dermatology clinics that were previously misled by false claims about the Pallas solid-state laser’s capabilities and reimbursement eligibility.

To date, over 20 such LaserOptek Pallas buyers have partnered with STRATA on XTRAC excimer laser technology under XTRAC partnership program or purchased XTRAC excimer lasers. These accounts represent over $1 million in annualized capital and recurring revenue, underscoring the resilience and trust in the XTRAC^® Excimer Laser, recognized as the gold standard in targeted UVB therapy.

Expanding Leadership Ahead of New Indications

There are currently around 1,200 U.S. dermatology clinics that use excimer laser therapy for the treatment and subsequent ethical insurance billing of dermatologic autoimmune conditions such as psoriasis and vitiligo subject to CPT codes 96920 - 96922. All of these clinics are using either the XTRAC or Pharos devices – both are STRATA products. As of June 30, 2025, 844 of these clinics are using excimer laser technology under STRATA’s partnership program.

The STRATA partnership program is suitable for individual dermatology clinic owners, as well as over 358 clinics that are owned by 43 unique private equity backed national accounts, presenting a potential expansion of over 2,000 additional clinics.

With the recent (May, 2025) American Medical Association CPT Board reaffirming the exclusive use of excimer lasers under codes 96920–96922 through January 1, 2027, STRATA is positioned to expand its leadership as these codes are broadened to include up to 30 dermatologic conditions expanding the available patient population four-fold to all 1,200 users of Excimer laser, allowing them to treat and ethically bill insurance under these codes.

“The CPT expansion marks a major growth inflection point for STRATA and our 844 partner clinics, as well as all other users of the excimer lasers,” added Dr. Rafaeli. “We intend to aggressively defend our market share and ensure that the upcoming inclusion of 30 new indications translates into expanded access for patients and sustainable revenue for our partners, as we will be working with CMS and private payers alike to update their coverage policies.”

Commitment to Integrity and Market Protection

STRATA continues to take proactive measures to protect the integrity of its intellectual property, technology, and reimbursement framework. The Company remains vigilant against false efficacy or reimbursement claims that risk patient safety and provider compliance.

“The defendants’ actions caused both monetary and reputational damage to STRATA,” continued Dr. Rafaeli. “We will pursue every avenue to hold them accountable while continuing to strengthen our network and safeguard the ethical use of clinically backed excimer laser technology and based on our vast clinical foundation and valuable suite of service we offer our partners, are confident in our ability to bring back any provider that was misled.”

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 did STRATA (SSKN) win in the Nov 8, 2024 court order against LaserOptek?

The Court partially granted a preliminary injunction barring U.S. sales/marketing that imply reimbursement under CPT 96920–96922 and barred false or misleading statements about STRATA products.

How many clinics does STRATA (SSKN) have in its partnership program as of June 30, 2025?

STRATA reported 844 clinics in its partnership program as of June 30, 2025.

How much annualized revenue did conversions from LaserOptek buyers bring to STRATA (SSKN)?

STRATA said conversions from over 20 LaserOptek Pallas buyers represent over $1 million in annualized capital and recurring revenue.

What is the significance of the AMA CPT Board action for STRATA (SSKN)?

In May 2025 the AMA CPT Board reaffirmed exclusive excimer use under codes 96920–96922 through Jan 1, 2027 and broadened codes to include up to 30 dermatologic conditions.

Does the court ruling add international defendants in STRATA’s (SSKN) case?

Yes; the Court agreed LaserOptek Korea should be added as a defendant for efforts to obscure involvement.