Sofwave Announces Publication of Data from Randomized Controlled Study of its Pure Impact™ VIP Platform Utilizing PlyoPulse™ EMS Technology in Aesthetic Surgery Journal

A prospective randomized controlled trial of an aesthetic EMS platform to assess objective functional performance reports improvements across four standardized tests

SAN CLEMENTE, Calif., Aug. 31, 2026 (GLOBE NEWSWIRE) -- Sofwave Medical Ltd. (TASE: SOFW), a global regenerative aesthetics company advancing non-invasive technologies for skin and body, today announced the publication of data from a new randomized controlled clinical study of the Company’s proprietary PlyoPulse^™ technology, titled “Functional Performance, Subject-Body Perception, and Safety Following Multi-Muscle Electromuscular Stimulation: A Randomized Controlled Study,” in the September issue of Aesthetic Surgery Journal. The results demonstrated that PlyoPulse, delivered through the Pure Impact^™ VIP platform, produced statistically significant improvements in objective functional muscle performance, sustained through the four-week follow-up.

The prospective, open-label, blank-controlled trial (NCT07094971) enrolled 38 healthy adults, randomized equally to a treatment group and an untreated control group. Treated subjects underwent six weekly PlyoPulse sessions targeting the abdomen, quadriceps, hamstrings and glutes. Functional performance was assessed by blinded evaluators using objective testing (prone hip extension, paced curl-up, side plank endurance and seated quadriceps extension) at baseline, week 5 and week 9 (four weeks after the final treatment). Subject-reported outcomes were captured using the validated Body-Q^® questionnaire.

Key Findings

• At week 5, the treatment group improved significantly over baseline across every functional test: prone hip extension repetitions rose 68% (P<0.001), paced curl-up performance rose 42% (P=0.0025), seated quadriceps extension rose 53% (P<0.001), and side plank endurance rose 73% (P=0.0018).
• At week 5, all four functional measures showed statistically significant between-group differences favoring the treatment group (P<0.01 for three of four comparisons, and P=0.0146 for paced curl-up). Gains were largely sustained four weeks after the final treatment (week 9), when three of the four between-group comparisons remained statistically significant, while the untreated control group showed minimal to no change over the same period.
• Body-Q scores showed significant improvement in body image, abdomen, buttocks and inner-thigh satisfaction domains, and 68% of treated subjects reported that their muscles felt stronger and firmer.
• The treatment was well tolerated, with low mean discomfort (1.2 out of 10); 82% of sessions rated as none-to-minimal discomfort, and no adverse events reported.
  
  

“This publication adds an important layer of clinical evidence to our Pure Impact^™ VIP platform by demonstrating that PlyoPulse’s synchronized, multi-muscle activation can produce measurable gains in objective functional performance, sustained through the four-week follow-up, not just aesthetic improvement,” said Louis Scafuri, Chief Executive Officer of Sofwave Medical. “As more patients look for non-invasive ways to support functional performance, particularly those concerned about muscle loss, data like these reinforce why physicians around the world are turning to Sofwave’s highly innovative and effective technology platforms.”

Unlike conventional electromuscular stimulation (EMS) devices, which typically drive repetitive contractions in a single, isolated muscle group, PlyoPulse uses rotating polarity and programmable ON/OFF duty cycling to synchronize activation across anatomically linked muscle groups, including the abdomen, glutes, quadriceps and hamstrings. The design is intended to mimic the coordinated, multi-joint recruitment patterns seen in plyometric movements, such as squats and lunges, rather than the single-direction contractions produced by traditional EMS systems.

“Most EMS research to date has focused on morphological change, such as muscle thickness, firmness and contour. This trial specifically measured objective functional performance using standardized repetition- and endurance-based testing,” said Kiya Movassaghi, MD, DMD, FACS, Clinical Assistant Professor of Plastic Surgery at Oregon Health & Science University’s School of Medicine and lead author of the manuscript. “Subjects improved across all four functional tests at week 5, and most of those gains were sustained at week 9, four weeks after the final treatment. The improvements in functional performance combined with high tolerability suggest that a multidirectional electro muscular stimulation technology incorporating synchronized muscle recruitment and programmable contraction timing may promote neuromuscular adaptations.”

About Sofwave Medical Ltd.

Sofwave Medical Ltd. (TASE: SOFW) is a global regenerative aesthetics company advancing non-invasive technologies for skin and body. Its proprietary SUPERB^™ (Synchronous Ultrasound Parallel Beam) technology delivers controlled ultrasound energy to the mid-dermis to stimulate the body’s natural regenerative response and is FDA-cleared for the treatment of facial lines and wrinkles, lifting the eyebrow and lax submental and neck tissue, improving the appearance of skin laxity on the upper arms, short-term improvement in the appearance of cellulite, and treatment of acne scars.

Sofwave’s portfolio also includes Pure Impact^™, which utilizes electrical muscle stimulation (EMS) technology for muscle strengthening, toning and firming. Together, Sofwave’s technologies provide physicians with clinically supported, non-invasive solutions for the evolving needs of aesthetic patients worldwide.

Forward-Looking Statements

This press release contains “forward-looking statements” as defined in the Israeli Securities Law 5728-1968. These forward-looking statements are based on the Company's current expectations, estimates, forecasts and projections about future events and are not guarantees of future performance. Words such as “expect,” “anticipate,” “intend,” “plan,” “believe,” “seek,” “estimate,” “will,” “should,” “would,” “could,” “may,” and similar expressions are intended to identify such forward-looking statements. These forward-looking statements involve risks and uncertainties, and actual results may differ materially from those expressed or implied in such statements due to various factors, including but not limited to: risks inherent to the Company's activities; third-party decisions, including by regulatory authorities; changes in economic conditions; and other external factors beyond the Company's control. The Company undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.

Media Contact:

Christina Monteleone
CMB Media
sofwave@cmbpublicity.com

Investor Contact:

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