In This Article:
– Approval by Health Canada regulatory authority immediately clears the way for Pure Impact™ with PlyoPulse™ device launch and commercialization in Canada
– Canada Represents Another Substantial Market Opportunity for Sofwave’s Pure Impact™
SAN CLEMENTE, Calif., June 11, 2024 (GLOBE NEWSWIRE) -- Sofwave Medical Ltd (“the Company”) (TASE: SOFW), an emerging leader in energy-based non-invasive, aesthetic medical devices for practitioners worldwide, today announced marketing clearance from Health Canada to commercialize Pure Impact™ utilizing PlyoPulse™ EMS (“Electric Muscle Stimulation”) technology in that region. Pure Impact™ with PlyoPulse™ technology, which is currently also approved and marketed in the U.S., was purposefully designed as a modular add-on component to the SUPERB™ system.
“The latest regulatory approval from Health Canada allows the Company to immediately initiate Sofwave’s second Pure Impact™ launch in North America. Pure Impact™ with PlyoPulse™ technology is the result of years of research and development and was developed in response to consumers’ growing demand for a cost-effective, non-invasive muscle toning treatment alternative to conventional plastic surgery,” noted Louis Scafuri, CEO of Sofwave Medical. “The U.S. Pure Impact™ product launch has been a major milestone this year for Sofwave, and we continue to seek additional approvals in other key markets for this highly innovative product. We are delighted to have this opportunity to offer a growing base of enthusiastic Canadian Sofwave practitioners an exciting, full body muscle toning solution and SUPERB™ product line extension, which we expect will further contribute to our growing base of recurring utilization revenues.”
About Pure Impact™ utilizing PlyoPulse™ EMS Technology:
Providers
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Pure Impact™ is a first-of-its-kind plyometric muscle toning and firming system designed to stimulate multiple muscle groups and body areas simultaneously.
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Our PlyoPulse™ technology encapsulates the efficacy of plyometric exercises, all within a concise 30-minute treatment. No electrode rearrangement is required, no delays in treatment time – for greater patient turnover and expedited ROI.
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The modular add-on redefines toning with up to 16 synchronized electrodes designed to emulate plyometric exercises. The device achieves unparalleled muscle strengthening and toning for patients quickly.
Clinicians
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Advanced next generation wireless connectivity untangles and uncomplicates clinicians’ ability to provide a superior treatment across multiple muscle groups without the need for gels, liquids, or belts.
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Easy digital programming allows different exercise protocols to engage diverse muscle groups without the need to manually rearrange electrodes, thus avoiding treatment interruption.