STRATA Skin Sciences’ TheraClear®X Acne Therapy System Found Safe and Effective in Study Published in Peer Reviewed Journal
July 17 2024 - 8:00AM
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, announces the publication of
a clinical study titled, “Advancing precision acne therapy using a
photopneumatic device,” in the July 11, 2024 issue of the Journal
of Cosmetic and Laser Therapy.
In the study, the TheraClear®X Acne Therapy
System was shown to reduce lesions and associated skin redness with
improvement in skin texture and pore size after one to three
treatments with infrequent adverse effects, providing benefit as
monotherapy and/or as an adjuvant. The ability to change pulse
structure, pulse duration, vacuum pressure, and fluence (i.e.,
energy intensity) allowed for treatment that best matched skin type
and acne therapy.
The study sought to evaluate visible
improvements in acne lesions and skin texture after a series of
tailored photopneumatic therapy applications delivered to patients
with mild-moderate acne. Seven female patients with inflammatory,
comedonal, and pustular lesions were evaluated after up to six
treatments, one to two weeks apart for 15-20 minutes per treatment
using customized energy settings. The results demonstrate:
- All patients experienced a visible
reduction in comedones, pustules, and inflammatory acne lesions and
achieved ≥ 50% clearance after three treatments
- Patients also experienced overall
improvements in skin texture with reduction in redness, pore size,
oiliness, perilesional erythema, and acne-induced
hyperpigmentation
- Side effects experienced by
patients were mild and transient and included mild erythema, mild
bruising, superficial erosions, and temporary pigmentation changes
(48–72 hours post-treatment)
- All patients stated that
TheraClear®X treatment was "comfortable"
The study was conducted by Gilly Munavalli, MD,
MHS, FACMS, the medical director and founder of Dermatology, Laser,
& Vein Specialists of the Carolinas in Charlotte, North
Carolina and Assistant Clinical Professor of Dermatology at the
Wake Forest University Department of Dermatology. Dr. Munavalli has
been in private practice for 20 years and has over 100 scientific
publications and book chapters and has served as principal
investigator in a broad range of clinical research trials and 10
FDA pivotal trials.
“I am very satisfied with the study results. The
study shows TheraClear®X as a monotherapy is well tolerated and
delivers visible improvements in facial acne lesions and skin
texture,” commented Dr. Munavalli. “Tailored vacuum and energy
settings based on individual acne severity allow for precision
therapy, aligning with skin type and personalized acne care
recommendations. This tailored, non-drug, physician-administered
intervention offers a promising alternative for acne patients
resistant to traditional therapies, overcoming compliance
challenges associated with topical and oral treatments.”
STRATA’s TheraClearX is a photopneumatic device
that is FDA-cleared as a noninvasive, in-office treatment for
mild-to-moderate acne, including comedonal, pustular, and
inflammatory acne vulgaris. TheraClearX combines gentle vacuum with
pulsed broadband light to treat acne. The vacuum pulls dermal
structures toward the skin surface and withdraws the contents of
the follicles. Broadband light activates porphyrins to destroy
Cutibacterium acnes and reduce sebum production. The vacuum is
released when the process is completed. The treatment is
administered through a handheld delivery system that is
liquid-cooled for patient comfort and has no patient downtime.
Treatment requires no pre-medication or anesthesia.
“The results of this study are consistent with
known clinical use of the TheraClear®X device and other published
studies that demonstrate the benefits of photopneumatic therapy in
the treatment of mild to moderate acne,” said STRATA’s President
and CEO Dr. Dolev Rafaeli. “Acne affects tens of millions of people
each year just in the U.S. alone, and can prove difficult to treat
witth only a topical or oral treatment. Photopneumatic therapy is
emerging as a viable treatment modality, and it is gratifying to
see proven results in a growing number of investigator-initiated
studies.”
The full study can be accessed with the
following link: https://doi.org/10.1080/14764172.2024.2376704
About STRATA Skin Sciences
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
Strata Skin Sciences (NASDAQ:SSKN)
Historical Stock Chart
From Jul 2024 to Aug 2024
Strata Skin Sciences (NASDAQ:SSKN)
Historical Stock Chart
From Aug 2023 to Aug 2024