Skip to main content

Sofwave™ Granted FDA Clearance For Latest Innovation: The “Precise” SUPERB™ Applicator

Written by Customer Service on . Posted in Public Companies.

  • “Precise” delivers the same SUPERB™ technology in a compact applicator head for more convenient and precise treatment of smaller curved areas, such as around the eyes and mouth
  • The modular, smaller applicator head and its benefits are a direct add-on feature requiring no modification to current SUPERB™ console systems

SAN CLEMENTE, Calif., March 15, 2023 (GLOBE NEWSWIRE) — Sofwave Medical Ltd (“the Company”) (TASE: SOFW), an emerging leader in energy-based non-invasive, aesthetic medical devices for practitioners worldwide, announced today receipt of U.S. Food and Drug Administration (FDA) clearance of the Company’s 510(k) notification submission for its “Precise” compact SUPERB™ applicator to improve facial lines and wrinkles, lift the eyebrow, and lift lax submental (beneath the chin) and neck tissue; which can also affect the appearance of lax tissue in the submental and neck regions. The “Precise” applicator is also FDA cleared for short-term improvement in the appearance of cellulite.

“Following the recent FDA clearance of Sofwave’s SUPERB™ technology for the short-term improvement of cellulite last December, we are delighted to introduce the new “Precise” applicator to existing and prospective customers,” said Louis Scafuri, CEO of Sofwave Medical. “The compact applicator transducer array delivers the same safe and effective Synchronous Ultrasound Parallel Beam technology of existing large size applicators, but has been further refined with a condensed transducer configuration for more precise and convenient delivery of pulses around small, curved areas, such as the eyes and mouth. We expect this enhanced feature set and applicator configuration will be well received by Sofwave customers, and intend to leverage the new Precise applicator in additional indications in the future.”

Sofwave’s SUPERB™ System consists of two main functional components: 1) the console and 2) the applicator. The console includes the power sources, cooling unit, electrical components and the user interface. The applicator is comprised of an array of ultrasonic transducers that emit continuous acoustic waves and an active cooling element that is used to cool the skin area in contact with the applicator’s transducers.

“We continue to add functional yet transformational feature sets to the initial SUPERB™ platform’s design,” said Dr. Shimon Eckhouse, Chairman & Co-Founder. “The Precise SUPERB ™ will enable treatment of hard to reach anatomical sites with the ability to accurately target the area of treatment and with a superior ergonomic design while delivering the same safe, comfortable and highly effective treatment.”

About Sofwave Medical
Sofwave Medical Ltd. has implemented an innovative approach to wrinkle reduction lifting and cellulite using proprietary breakthrough technology. SUPERB™, Synchronous Ultrasound Parallel Beam technology is FDA-cleared head to improve facial lines and wrinkles, lift the eyebrow, and lift lax submental (beneath the chin) and neck tissue; which can also affect the appearance of lax tissue in the submental and neck regions and for short-term improvement in the appearance of cellulite providing physicians with smart yet simple, effective, and safe aesthetic solutions for their patients. Contact: Info@sofwave.com

Investor Contact:
Brian Ritchie
LifeSci Advisors LLC
(212) 915-2578
britchie@lifesciadvisors.com

Disclaimer & Cookie Notice

Welcome to GOLDEA services for Professionals

Before you continue, please confirm the following:

Professional advisers only

I am a professional adviser and would like to visit the GOLDEA CAPITAL for Professionals website.

Important Notice for Investors:

The services and products offered by Goldalea Capital Ltd. are intended exclusively for professional market participants as defined by applicable laws and regulations. This typically includes institutional investors, qualified investors, and high-net-worth individuals who have sufficient knowledge, experience, resources, and independence to assess the risks of trading on their own.

No Investment Advice:

The information, analyses, and market data provided are for general information purposes only and do not constitute individual investment advice. They should not be construed as a basis for investment decisions and do not take into account the specific investment objectives, financial situation, or individual needs of any recipient.

High Risks:

Trading in financial instruments is associated with significant risks and may result in the complete loss of the invested capital. Goldalea Capital Ltd. accepts no liability for losses incurred as a result of the use of the information provided or the execution of transactions.

Sole Responsibility:

The decision to invest or not to invest is solely the responsibility of the investor. Investors should obtain comprehensive information about the risks involved before making any investment decision and, if necessary, seek independent advice.

No Guarantees:

Goldalea Capital Ltd. makes no warranties or representations as to the accuracy, completeness, or timeliness of the information provided. Markets are subject to constant change, and past performance is not a reliable indicator of future results.

Regional Restrictions:

The services offered by Goldalea Capital Ltd. may not be available to all persons or in all countries. It is the responsibility of the investor to ensure that they are authorized to use the services offered.

Please note: This disclaimer is for general information purposes only and does not replace individual legal or tax advice.