STRATA Skin Sciences Files Complaint Against LaserOptek, Monarch Laser Services, and The Pinnacle Health Group
26 Agosto 2024 - 7:00AM
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, has 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 referred to as the
“Defendants” citing unfair competition under federal and state laws
regarding the marketing and sales of competitive laser devices.
LaserOptek, a Korean company publicly traded on
the KOSDAQ exchange, is the manufacturer of the Pallas line of
solid-state laser medical devices (“Pallas lasers”), MLS is the
exclusive distributor of the Pallas lasers in the U.S., and
Pinnacle was engaged by LaserOptek to provide advisory services
regarding marketing of the Pallas lasers and reimbursement of
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 with regard to the marketing and sale of the Pallas
lasers in the U.S. by the Defendants. Specifically, STRATA claims
that:
- The Defendants have intentionally
misrepresented the nature, characteristics, and qualities of the
solid-state Pallas lasers by falsely stating to current and
potential dermatology practice customers that treatments for
psoriasis performed with Pallas lasers are reimbursable using
specific medical codes reserved only for psoriasis treatments
performed with excimer lasers, such as STRATA’s XTRAC® devices
- LaserOptek and MLS have also made
knowingly false and misleading statements regarding the
technological, functional, and clinical equivalence and/or
superiority of the solid-state Pallas lasers over STRATA’s excimer
lasers without any scientific or technical evidence to support
those claims
- LaserOptek and MLS have relied on
LaserOptek’s clearance from the Food and Drug Administration (FDA)
to make inherently misleading and false statements regarding the
technological, functional, or clinical equivalence of the
solid-state Pallas lasers as compared to STRATA’s excimer
lasers
- The Defendants’ conduct is causing
ongoing harm to the public interest by encouraging the fraudulent
use of reimbursement codes, causing purchasers and users of the
Pallas lasers to experience probable denials of insurance
reimbursement, and causing patients to be treated for psoriasis
using Pallas lasers that have not been determined to have clinical
efficacy by the Centers for Medicare and Medicaid Services (CMS)
and the American Academy of Dermatology (AAD) and for which
clinical efficacy has not been established in the peer-reviewed
scientific literature
STRATA is seeking injunctive relief, actual
damages, treble damages, disgorgement of profits, and reimbursement
of legal costs 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 U.S. that
have enjoyed the benefit of psoriasis treatment from our devices
that offer a cheaper and faster treatment option with minimal side
effects,” commented STRATA’s President and CEO Dr. Dolev Rafaeli.
“Additionally, we have observed LaserOptek’s efforts to sell its
Pallas lasers to dermatology practices in international markets,
only to see such customers convert back to our XTRAC® devices after
finding the Pallas lasers to be unstable and lacking in
efficacy.”
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, 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
IR516-222-2560IR@strataskin.com
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