STRATA Skin Sciences’ TheraClear®X Acne Therapy System Found Safe and Effective in Study Published in Peer Reviewed Journal
STRATA Skin Sciences (NASDAQ: SSKN) announces the publication of a clinical study on their TheraClear®X Acne Therapy System in the Journal of Cosmetic and Laser Therapy. The study, titled "Advancing precision acne therapy using a photopneumatic device," demonstrates the system's effectiveness in treating mild-moderate acne.
Key findings include:
- ≥50% clearance of acne lesions after three treatments
- Improvements in skin texture, redness, pore size, and oiliness
- Mild and transient side effects
- Comfortable treatment experience for patients
The FDA-cleared TheraClearX combines vacuum and pulsed broadband light to treat acne, offering a non-invasive, in-office alternative to traditional therapies. The study supports its use as both monotherapy and adjuvant treatment for acne patients.
- TheraClear®X achieved ≥50% clearance of acne lesions after three treatments
- Study published in peer-reviewed Journal of Cosmetic and Laser Therapy
- TheraClear®X demonstrated effectiveness as both monotherapy and adjuvant treatment
- Patients experienced overall improvements in skin texture and acne-related issues
- Treatment was reported as comfortable by all patients
- Side effects included mild erythema, bruising, superficial erosions, and temporary pigmentation changes
The publication of a clinical study showing the effectiveness and safety of STRATA Skin Sciences' TheraClear®X Acne Therapy System in the Journal of Cosmetic and Laser Therapy presents significant implications. From a medical standpoint, the results are promising. This study demonstrated that patients had a
One of the standout features is the device's ability to tailor treatment settings to individual patient needs. This aligns well with current trends in personalized medicine, enhancing both effectiveness and patient satisfaction. Additionally, the non-invasive nature of the treatment, which avoids the use of pre-medication or anesthesia, makes it an attractive option for those who might be resistant or non-compliant with topical or oral treatments.
From a clinical perspective, these results could lead to increased adoption of the TheraClear®X system among dermatologists, especially considering the increasing prevalence of acne and the demand for effective treatment options. This could indeed position STRATA favorably in a competitive dermatology market.
The positive outcomes from the clinical study have strategic implications for STRATA Skin Sciences in the market. Acne is a prevalent condition affecting a broad demographic, making it a lucrative target for treatment solutions. The TheraClear®X system's ability to show significant clinical improvement, paired with minimal adverse effects, can enhance its marketability and acceptance among healthcare providers.
Given the FDA clearance and the support of credible scientific research, STRATA can leverage these findings to bolster market penetration and potentially increase sales. The company's ability to offer a unique, non-invasive solution that complements or replaces traditional acne treatments provides a competitive edge.
However, market dynamics should also be considered. While the study shows promise, the cost of the device and treatment sessions compared to other acne treatments could influence adoption rates. Thus, STRATA's challenge will be to effectively communicate the long-term benefits and cost-effectiveness of TheraClear®X to both clinicians and patients.
From a financial standpoint, the publication of positive clinical results for the TheraClear®X system could have a favorable impact on STRATA’s stock performance. The demonstrated efficacy and safety, combined with FDA clearance, should bolster investor confidence. This could translate to an uptick in stock prices as market participants anticipate increased product adoption leading to higher revenues.
However, investors should also consider the broader financial context. The introduction of new medical devices often involves high initial marketing and distribution costs. STRATA’s financial health, cash flow and profitability will play important roles in sustaining long-term growth. If the company can manage these effectively while scaling up production and distribution, the financial outlook remains positive.
Additionally, the study's publication in a peer-reviewed journal adds a layer of credibility that could attract institutional investors, further stabilizing and possibly driving up the stock value.
Study published in Journal of Cosmetic and Laser Therapy highlights the TheraClear®X photopneumatic device as an effective treatment option, either as monotherapy or in combination with topical or oral treatments, for patients with mild-moderate acne
HORSHAM, Pa., July 17, 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 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 IR
516-222-2560
IR@strataskin.com
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