STRATA Skin Sciences Files Complaint Against LaserOptek, Monarch Laser Services and The Pinnacle Health Group

HORSHAM, Pa., Aug. 26, 2024 (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 dermatological conditions, filed a complaint in the U.S. District Court for the Eastern District of Pennsylvania against LaserOptek America Corp. (“LaserOptek”), Monarch Aesthetic Services, Inc. d/b/a Monarch Laser Services (“MLS”) and The Pinnacle Health Group (“Pinnacle”), collectively, the “Defendants,” alleging unfair competition under federal and state laws regarding the marketing and sale of competing laser devices.

LaserOptek, a Korean publicly traded company listed on the KOSDAQ Stock Exchange, is the manufacturer of the Pallas family of semiconductor laser medical devices (“Pallas Lasers”), MLS is the exclusive distributor of Pallas Lasers in the United States and Pinnacle has been engaged by LaserOptek to provide consulting services regarding the commercialization of Pallas Lasers and reimbursement for psoriasis treatment procedures performed with Pallas Lasers.

In its complaint, STRATA alleges false advertising and unfair competition under the Lanham Act and related state laws relating to the defendants’ marketing and sale of Pallas lasers in the United States. Specifically, STRATA claims that:

• The defendants intentionally misrepresented the nature, characteristics and qualities of the Pallas semiconductor lasers by falsely representing to current and potential clients of the dermatology practice that psoriasis treatments performed with Pallas lasers are reimbursable by using specific medical codes reserved only for psoriasis treatments performed with excimer laserslike STRATA’s XTRAC^® devices

• LaserOptek and MLS also made knowingly false and misleading statements regarding the technological, functional and clinical equivalence and/or superiority of Pallas solid-state lasers over STRATA excimer lasers without any scientific or technical evidence to support these claims.

• LaserOptek and MLS Relyed on LaserOptek’s FDA Clearance to Make Inherently Misleading and False Claims Regarding the Technological, Functional or Clinical Equivalence of Pallas Solid-State Lasers to STRATA Excimer Lasers

• Defendants’ conduct causes ongoing harm to the public interest by encouraging the fraudulent use of reimbursement codes, causing purchasers and users of Pallas lasers to experience likely denials of insurance reimbursement, and requiring patients to be treated for psoriasis with Pallas lasers whose clinical effectiveness has not been determined by the Centers for Medicare and Medicaid Services (CMS) and the American Academy of Dermatology (AAD) and for which clinical effectiveness has not been established in the peer-reviewed scientific literature.

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STRATA is seeking injunctive relief, actual damages, treble damages, disgorgement of profits and legal fees from the defendants.

“STRATA will protect the ethical billing and use of CMS reimbursable treatment codes for the benefit of our 4,000 partners providing dermatology treatments using our proven excimer devices and the hundreds of thousands of patients in the United States who have benefited from psoriasis treatment using our devices that provide a cheaper, faster treatment option with minimal side effects,” said Dr. Dolev Rafaeli, STRATA’s President and CEO. “Additionally, we have watched LaserOptek’s efforts to sell its Pallas lasers to dermatology practices in international markets, only to see those customers return to our XTRAC.”^® “We decided to develop Pallas laser detection devices after finding that they were unstable and inefficient.”

About STRATA Skin Sciences, Inc.
STRATA Skin Sciences is a medical technology company dedicated to the development, commercialization and marketing of innovative products for the in-office treatment of various dermatological conditions, such as psoriasis, vitiligo and acne. Its products include XTRAC^® excimer laser, VTRAC^® lamp systems and the TheraClear^®Acne Therapy System X.

STRATA is proud to bring these exciting technologies to the United States through its unique partner program. STRATA’s popular partner approach includes a processing cost structure for equipment purchase, device installation and operation, on-site training for practice staff, equipment maintenance and servicing, dedicated account and customer service associates, and cooperative advertising support to help raise awareness and promote the program within the practice.

Safe Harbor

This press release contains “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,” “seek,” and “expect,” which suggest future events or trends. These statements, the Company’s ability to launch and sell newly acquired products or to develop 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 dermatology and aesthetics franchise, 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 adverse financial, economic, business, competitive, market, regulatory, labor shortages or supply chain disruptions resulting from fiscal, political, international conflicts, responses or conditions affecting the Company, the medical device industry and our customers and patients generally, as well as more specific risks and uncertainties set forth in the Company’s SEC Reports on Forms 10-Q and 10-K. Given these uncertainties, any or all of these forward-looking statements may prove to be incorrect or unreliable. The statements contained in this press release are made as of the date of this press release, even if they are subsequently made available by the Company on its website or otherwise. The Company undertakes no 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 filings available at www.sec.gov and www.strataskinsciences.com.

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