Pure Impact™ with PlyoPulse™ technology is a direct add-on Body module to the existing FDA cleared Sofwave medical aesthetic device platformThe PlyoPulse™ technology is an EMS (Electrical Muscle Stimulation) technology to deliver toning and strengthening simultaneously across diverse muscle groups in one treatment sessionAdding Pure Impact™ to Sofwave’s medical aesthetic device capabilities allows practitioners to expand revenue opportunities beyond existing in-clinic suite of client services utilizing modular add-on technology to the SUPERB™ ultrasound platform U.S.

纯粹的冲击™ 带PlyoPulse™ 该技术是现有FDA批准的Sofwave医疗美容设备平台PlyoPulse的直接附加人体模块™ 该技术是一种EMS（电肌肉刺激）技术，可在一次治疗过程中同时在不同的肌肉群中进行调理和强化，从而产生纯粹的影响™ Sofwave的医疗美容设备功能使从业者能够利用模块化附加技术将收入机会扩展到现有的诊所客户服务套件之外™ 超声波平台美国。

commercial launch expected in the near term SAN CLEMENTE, Calif., Jan. 03, 2024 (GLOBE NEWSWIRE) -- Sofwave Medical Ltd (“the Company”) (TASE: SOFW), an emerging leader in energy-based non-invasive, aesthetic medical devices for practitioners worldwide, announced clearance by the U.S. Food and Drug Administration (FDA) for the Company’s 510(k) premarket notification submission to market Pure Impact™ utilizing PlyoPulse™ EMS (“electromagnetic stimulation”) technology in the United States.

预计将于2024年1月3日在加利福尼亚州圣克莱门特（SAN CLEMENTE，California）进行商业启动（Global NEWSWIRE）--Sofwave Medical Ltd（“公司”）（TASE:SOFW），一家新兴的全球从业者无创美容医疗设备领军企业，美国食品和药物管理局（FDA）宣布批准该公司向市场提交510（k）上市前通知Pure Impact™ 利用PlyoPulse™ 美国的EMS（“电磁刺激”）技术。

The approval clears a pathway for Sofwave to expand medical aesthetic treatment beyond the Company’s existing SUPERB™ platform for eyebrow and submental neck lifting, treatment of fine lines and wrinkles, treatment of cellulite, and treatment of skin laxity to now allow practitioners to include body toning and strength conditioning across diverse muscle groups in one treatment session.

该批准为Sofwave在公司现有的SUPERB之外扩展医疗美容开辟了一条道路™ 用于眉毛和颏下颈部提升、细纹和皱纹治疗、脂肪团治疗和皮肤松弛治疗的平台，现在允许从业者在一次治疗中包括不同肌肉群的身体调理和力量调节。

“We continue to deliver on our promise of innovation within the medical aesthetic device space. The 510(k) clearance of Pure Impact™ allows Sofwave to bring to market a unique EMS device that can deliver muscle toning and strength conditioning simultaneously across diverse muscle groups in one treatment session,” noted, Louis Scafuri, CEO .

“我们继续履行我们在医疗美容设备领域的创新承诺。510（k）清除Pure Impact™ Sofwave将一种独特的EMS设备推向市场，该设备可以在一次治疗过程中同时在不同的肌肉群中提供肌肉调理和力量调节，”首席执行官路易斯·斯卡福里（LouisScafuri）指出。