- FDA clearance supported by extremely urgent clinical study results that prove that 93% of the issues undergoing “improved” or “much improved” appearance after treatment using Superb ™
- American bracelet (surgical arm lifting) increased by 25% from 2019-2022.
San Clemente, California, December 26, 2023 (Globe Newswire) -The Sopwave Medical Ltd (Tase: SOFW), an emerging leader in energy non-invasive, aesthetic medical device worldwide, announced the clearance of US food management (FDA) for 510. (K) Premarket, the non -invasive to the appearance of SKEN on the Upper Officer on the Uppernance on the Uppormet Onderance on the Uppormet Onderance on the Upporn. UPPORME paves the way for Sofwave ™ to further extend to additional treatment indications.
Mr. Louis Scafuri, CEO of Sofwave, commented: “We are pleased to receive the FDA clearing to improve the appearance of skin hallucinations in the upper hands in American supported by the achievement of its superior study. Clear, objective set of clinical data and the results of patients who further promote our progress to become the leading selection provider in developing non -invasive medical aesthetic industry.
According to the US Society of Plastic Surgeons, 2022 procedural statistics, 2019-2022, bracelet procedures (surgical arm) increased by 25%. Sofwave’s Superb’s Superb’s Superb ™ platform introduces a sustainable FDA, a non -invasive alternative to improve the appearance of skin hallucinations on the upper arms without the relevant risks and the time of recovery of conventional surgery, contamination of the body with laser and other laser.
The results of the study and the design leading to the clearing of the FDA of the privilege notification:
- Design and results of study
- A total of 46 people were registered and treated in both upper weapons in 4 spaces in the United States.
- The subjects attended 2 treatment sessions (1-3 weeks away) and one attendance visit 3 months after the final treatment visit.
- 93% of healed weapons were “improved” or “much improved” in appearance, as rated by the blind reviewers using the global aesthetic improvement scale.
- Most people reported no one to mild levels of pain during treatment and no discomfort.
In the US, Sofwave’s technology is currently deleted for use as a non -invasive aesthetic treatment to improve facial and wrinkle lines, lifting the eyebrow and lifting the subcutaneous (under the chin) and throat tissue. which can also affect the appearance of relaxing tissue in the subcutaneous and throat areas for people aged 22 years and older. The Sofwave system is also cleared for short -term improvement in the appearance of cellulite and for the treatment of acne scarring.
About Sopwave Medical Ltd.
Sofwave Medical Ltd. It has applied an innovative approach to raising wrinkles and cellulite using its own technology. Superb ™, modern ultrasound parallel beam technology is cleared to improve facial lines and paintings, lifting eyebrows and lifting loose tissues (under the chin), throat tissue and arm, as well as short -term and short -term
Contact: info@sofwave.com
Investor Contact:
Brian Ricci
Lifesci advisors llc
(212) 915-2578
britchie@lifesciadvisors.com
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