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STRATA Skin Sciences Announces Approval of XTRAC Momentum™ 1.0 Device in Japan

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STRATA Skin Sciences (NASDAQ: SSKN) has received approval for its XTRAC Momentum™ 1.0 device from Japan's Ministry of Health, Labor and Welfare. The device, initially launched in the U.S. in early 2022, will be commercially rolled out in Japan through JMEC Co., , STRATA's strategic partner and distributor. STRATA's excimer devices are currently used in over 300 Japanese hospitals and dermatology clinics.

The XTRAC Momentum™ 1.0 is STRATA's most advanced excimer laser, offering higher power and faster repetition rates than current models. It features a new user interface and slim design to enhance the treatment experience. The technology allows for precise delivery of targeted UVB light therapy for treating inflammatory skin conditions like psoriasis, eczema, and vitiligo in both adult and pediatric patients.

STRATA Skin Sciences (NASDAQ: SSKN) ha ricevuto l'approvazione per il suo dispositivo XTRAC Momentum™ 1.0 dal Ministero della Salute, del Lavoro e del Benessere del Giappone. Il dispositivo, lanciato inizialmente negli Stati Uniti all'inizio del 2022, sarà commercialmente distribuito in Giappone tramite JMEC Co., partner strategico e distributore di STRATA. Gli eccimeri di STRATA sono attualmente utilizzati in oltre 300 ospedali e cliniche dermatologiche giapponesi.

L'XTRAC Momentum™ 1.0 è il laser eccimerico più avanzato di STRATA, che offre maggiore potenza e tassi di ripetizione più rapidi rispetto ai modelli attuali. Presenta una nuova interfaccia utente e un design snello per migliorare l'esperienza di trattamento. Grazie alla tecnologia, è possibile fornire una terapia mirata con luce UVB per il trattamento di condizioni infiammatorie della pelle come psoriasi, eczema e vitiligine sia in pazienti adulti che pediatrici.

STRATA Skin Sciences (NASDAQ: SSKN) ha recibido la aprobación de su dispositivo XTRAC Momentum™ 1.0 por parte del Ministerio de Salud, Trabajo y Bienestar de Japón. El dispositivo, lanzado inicialmente en EE. UU. a principios de 2022, se implementará comercialmente en Japón a través de JMEC Co., socio estratégico y distribuidor de STRATA. Los dispositivos excimer de STRATA se utilizan actualmente en más de 300 hospitales y clínicas dermatológicas en Japón.

El XTRAC Momentum™ 1.0 es el láser excimer más avanzado de STRATA, que ofrece mayor potencia y tasas de repetición más rápidas que los modelos actuales. Cuenta con una nueva interfaz de usuario y un diseño delgado para mejorar la experiencia de tratamiento. La tecnología permite una entrega precisa de terapia con luz UVB dirigida para tratar condiciones inflamatorias de la piel como psoriasis, eczema y vitiligo en pacientes tanto adultos como pediátricos.

STRATA Skin Sciences (NASDAQ: SSKN)는 일본 보건 노동 복지부로부터 XTRAC Momentum™ 1.0 장치 승인을 받았습니다. 이 장치는 2022년 초 미국에서 처음 출시되었으며, STRATA의 전략적 파트너이자 유통업체인 JMEC Co.,을 통해 일본에서 상업적으로 출시될 예정입니다. STRATA의 엑시머 장치는 현재 일본의 300개 이상의 병원과 피부과 클리닉에서 사용되고 있습니다.

XTRAC Momentum™ 1.0은 STRATA의 가장 진보된 엑시머 레이저로, 현재 모델보다 더 높은 출력과 빠른 반복 속도를 제공합니다. 새로운 사용자 인터페이스와 슬림한 디자인을 특징으로 하여 치료 경험을 향상시키는 장점이 있습니다. 이 기술은 건선, 습진 및 백반증과 같은 염증성 피부 질환을 성인과 소아 환자 모두에게 치료하는 데 필요한 정밀한 UVB 광선 치료를 가능하게 합니다.

STRATA Skin Sciences (NASDAQ: SSKN) a reçu l'approbation de son appareil XTRAC Momentum™ 1.0 par le ministère de la Santé, du Travail et du Bien-être du Japon. L'appareil, lancé initialement aux États-Unis au début de 2022, sera commercialisé au Japon par JMEC Co., partenaire stratégique et distributeur de STRATA. Les appareils excimères de STRATA sont actuellement utilisés dans plus de 300 hôpitaux et cliniques dermatologiques au Japon.

Le XTRAC Momentum™ 1.0 est le laser excimère le plus avancé de STRATA, offrant une puissance supérieure et des taux de répétition plus rapides que les modèles actuels. Il dispose d'une nouvelle interface utilisateur et d'un design mince pour améliorer l'expérience de traitement. La technologie permet une délivrance précise d'une thérapie par lumière UVB ciblée pour traiter les affections cutanées inflammatoires telles que le psoriasis, l'eczéma et le vitiligo chez les patients adultes et pédiatriques.

STRATA Skin Sciences (NASDAQ: SSKN) hat die Zulassung für ihr Gerät XTRAC Momentum™ 1.0 vom japanischen Ministerium für Gesundheit, Arbeit und Soziales erhalten. Das Gerät, das Anfang 2022 in den USA auf den Markt kam, wird in Japan kommerziell über JMEC Co., STRATAs strategischen Partner und Distributor, eingeführt. Die Excimergeräte von STRATA werden derzeit in über 300 japanischen Krankenhäusern und dermatologischen Kliniken eingesetzt.

Das XTRAC Momentum™ 1.0 ist STRATAs fortschrittlichster Excimerlaser, der höhere Leistung und schnellere Wiederholungsraten als die aktuellen Modelle bietet. Es verfügt über eine neue Benutzeroberfläche und ein schlankes Design, um die Behandlungserfahrung zu verbessern. Die Technologie ermöglicht eine präzise Lieferung gezielter UVB-Lichttherapie zur Behandlung von entzündlichen Hauterkrankungen wie Psoriasis, Ekzemen und Vitiligo bei Erwachsenen und pädiatrischen Patienten.

Positive
  • Approval of XTRAC Momentum™ 1.0 device in Japan expands market reach
  • Partnership with JMEC Co., for immediate commercial rollout in Japan
  • STRATA's excimer devices already used in over 300 Japanese medical facilities
  • XTRAC Momentum™ 1.0 offers higher power and faster repetition rates than current models
Negative
  • None.

Insights

STRATA Skin Sciences' recent approval of the XTRAC Momentum™ 1.0 device in Japan is a significant milestone for the company. This device is designed to treat dermatologic conditions such as psoriasis, eczema and vitiligo using advanced excimer laser technology. The approval by the Ministry of Health, Labor and Welfare (MHLW) of Japan signals both regulatory trust and market readiness for this innovative device. Offering higher power and faster repetition rates, the XTRAC Momentum™ 1.0 could potentially improve patient outcomes and treatment experiences.

From a medical perspective, this device's ability to deliver targeted UVB light therapy with precision is notable. Given the chronic nature of conditions like psoriasis and eczema, the demand for such technology is likely to be robust. Moreover, the use of this device in over 300 hospitals and clinics in Japan suggests an established trust and infrastructure for STRATA's products, which can facilitate a smoother market entry for the Momentum™ 1.0.

The Japanese dermatology market is known for its stringent regulatory standards, so the approval of STRATA's XTRAC Momentum™ 1.0 device represents a major validation of the product's quality and effectiveness. STRATA's partnership with JMEC Co., Ltd., a long-standing distributor in Japan, is also a important factor. This relationship not only ensures a well-established distribution network but also indicates a strong market presence and brand recognition within Japan.

Financially, the immediate rollout of the Momentum™ 1.0 device in Japan could lead to significant revenue growth for STRATA. Japan is the second largest medical device market in the world and its aging population with growing dermatologic needs makes it a lucrative market. Additionally, the advanced features of the Momentum™ 1.0, including its higher power and improved user interface, are likely to attract both new and existing customers, thereby increasing market share and driving sales.

The approval and subsequent launch of the XTRAC Momentum™ 1.0 device in Japan represent a key growth opportunity for STRATA Skin Sciences. As the device enters the Japanese market, it is expected to contribute positively to the company’s revenue streams. Japan's healthcare system and its focus on advanced medical treatments for chronic conditions provide a fertile ground for the adoption of STRATA’s technology.

Furthermore, the endorsement from Japan’s regulatory authorities could enhance STRATA's credibility and potentially open doors to other international markets. Investors should monitor the company’s sales performance in Japan closely, as a successful deployment could lead to increased market confidence and stock valuation. The strategic partnership with JMEC Co., Ltd. is also instrumental, ensuring that the distribution and commercial aspects are well-managed.

Overall, the approval is a promising development that underscores STRATA's strong position in the global dermatology device market. It could be a significant catalyst for both short-term revenue growth and long-term market expansion.

HORSHAM, Penn., July 22, 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 approval of its XTRAC Momentum 1.0 device by the Ministry of Health, Labor and Welfare of Japan. The Company initially launched the XTRAC Momentum in the U.S. in early 2022. The immediate commercial rollout of the device in Japan will be through JMEC Co., Ltd., the Company’s longstanding Japanese strategic partner and distributor. STRATA’s excimer devices are currently used by over 300 hospitals and private practice dermatology clinics in Japan.

“With this regulatory approval, we are now able to offer the Momentum device -- our most advanced excimer laser -- into the Japanese dermatology market. Working with JMEC, we look forward to introducing doctors and patients to the benefits of Momentum for the treatment of various dermatology conditions, such as psoriasis, eczema, and vitiligo,” commented STRATA’s President and CEO Dr. Dolev Rafaeli.

The Company’s XTRAC® excimer laser technology allows for the precise delivery of targeted UVB light therapy to specific treatment areas of the skin, for both adult and pediatric patients suffering from inflammatory skin conditions such as psoriasis, atopic dermatitis, and vitiligo. The new XTRAC Momentum 1.0 represents the latest in excimer laser technology and delivers higher power and a faster repetition rate than the current models. The Momentum also offers a new user interface and slim design, both intended to improve the treatment experience.

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


FAQ

What is the XTRAC Momentum™ 1.0 device approved for in Japan?

The XTRAC Momentum™ 1.0 device, developed by STRATA Skin Sciences (SSKN), has been approved by Japan's Ministry of Health, Labor and Welfare for treating dermatologic conditions such as psoriasis, eczema, and vitiligo using targeted UVB light therapy.

How does the XTRAC Momentum™ 1.0 differ from previous STRATA devices?

The XTRAC Momentum™ 1.0 is STRATA's most advanced excimer laser, offering higher power and faster repetition rates than current models. It also features a new user interface and slim design to improve the treatment experience.

When was the XTRAC Momentum™ 1.0 initially launched in the United States?

STRATA Skin Sciences (SSKN) initially launched the XTRAC Momentum™ 1.0 device in the United States in early 2022.

Who is STRATA's strategic partner for distributing the XTRAC Momentum™ 1.0 in Japan?

STRATA Skin Sciences (SSKN) will commercially roll out the XTRAC Momentum™ 1.0 in Japan through JMEC Co., , their longstanding Japanese strategic partner and distributor.

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