• Third quarter revenue of $28.5M, +35% year-over-year growth; IFRS gross margin of 76.6%
  • Third quarter usage fee revenue of $13.3M, +60% year-over-year growth
  • First nine months revenue of $82.9M, +41% year-over-year growth; IFRS gross margin of 76.1%
  • Third quarter IFRS and non-IFRS net income of $4.1M and $4.6M, respectively, versus IFRS and non-IFRS net income of $1.0M and $1.4M, respectively, in the prior year period
  • Generated $2.6M in cash in the third quarter
  • Received approval in the third quarter from China’s National Medical Products Administration (NMPA) to market the Sofwave™ System in mainland China
  • Approximately 3,400 Sofwave systems sold to date and approximately 1.1 million Sofwave treatments administered since commercialization

SAN CLEMENTE, Calif., Nov. 03, 2026 (GLOBE NEWSWIRE) -- Sofwave Medical Ltd. (TASE: SOFW), an emerging leader in energy-based, non-invasive aesthetic medical devices for practitioners worldwide, today reported financial results for the third quarter and first nine months of fiscal year 2026, for the period ended September 30, 2026, and recent business highlights.

Third Quarter and First Nine Months Fiscal 2026 Financial Highlights

  • Third Quarter Revenue of $28.5M; representing 35% year-over-year growth
    • Recurring Usage Fee Revenue of $13.3M, a year-over-year increase of 60%, representing 47% of total revenue
    • Capital Equipment Revenue of $15.2M, a year-over-year increase of 19%
    • Gross Profit was $21.8M, a year-over-year increase of 41%
    • IFRS and Non-IFRS Gross Margin: 76.6% and 76.7%, respectively, compared to 73.7% for the third quarter of 2025
    • IFRS and Non-IFRS Operating Income: $4.4M and $4.9M, respectively, versus operating income of $1.5M and $1.9M, respectively, for the prior year period
    • IFRS and Non-IFRS Net Income: $4.1M and $4.6M, respectively, versus net income of $1.0M and $1.4M, respectively, for the prior year period
  • First Nine Months Revenue of $82.9M; representing 41% year-over-year growth
    • Recurring Usage Fee Revenue of $38.2M, a year-over-year increase of 56%, representing 46% of total revenue
    • Gross Profit was $63.1M, a year-over-year increase of 43%
    • IFRS and Non-IFRS Gross Margin: 76.1%, compared to 75.1% for the first nine months of 2025
    • IFRS Operating Income: $8.9M, compared to operating income of $2.7M for the first nine months of 2025; Non-IFRS Operating Income: $10.3M and $11.1M excluding one-time Nasdaq listing expenses
    • IFRS and Non-IFRS Net Income: $7.9M and $9.2M(**) respectively, versus net income of $1.4M and $3.2M, respectively, for the prior year period. Excluding one-time expenses as well, non-IFRS net income was $10.0M
  • Cash, Cash Equivalents and Short-Term Deposits as of September 30, 2026: $41.4M(*); generated $2.6M in cash in the third quarter of 2026

(*) including $10M short-term bank deposit and $520K restricted short-term bank deposit
(**) Non-IFRS results exclude stock-based compensation expense.

Management Commentary
Mr. Louis Scafuri, Sofwave CEO, commented, “Sofwave delivered another quarter of profitable growth, with revenue increasing 35% to $28.5 million and recurring usage fee revenue growing 60% to $13.3 million. Usage fees represented 47% of total revenue, reflecting growth in treatment activity across our expanding provider network.

“IFRS gross margin expanded to 76.6% from 73.7% a year ago, and IFRS operating income nearly tripled to $4.4 million. Non-IFRS operating income increased 161% to $4.9 million, or 17.2% of revenue. We achieved our sixth consecutive quarter of positive IFRS net income and generated $2.6 million in cash during the quarter.

“The NMPA approval adds an important growth opportunity in China. The approval covers the Sofwave™ System for improving mid-to-lower facial wrinkles in adults aged 22 and older and was supported by a 200-subject randomized, controlled study in China. Working with HTDK, which leads marketing, distribution and sales in mainland China, we are focused on physician education and adoption by premium accounts. Late in the third quarter, we began the first phase of our strategic rollout in mainland China, engaging selected physician thought leaders across major markets to establish a foundation for broader adoption across additional customer segments. We received an initial order for 70 systems, with 10 shipped in the third quarter and the remaining 60 scheduled for shipment in the fourth quarter.

“Through the first nine months, revenue grew 41% to $82.9 million. Our growing recurring revenue and improving operating profitability support continued investment in clinical development and commercial expansion. We remain focused on disciplined execution and building long-term shareholder value,” Mr. Scafuri concluded.

Dr. Shimon Eckhouse, Chairman of the Board, added, “Sofwave continues to execute its business and product development plan and our third quarter financial results clearly demonstrate its successful implementation. Our SUPERB™ skin treatment technology with 8 FDA clearances is becoming the leading global solution for patients seeking safe, effective, predictable and minimal down-time skin regeneration.

“The NMPA approval reflects the strength of our skin regeneration technology, as demonstrated by a large, multi-site, randomized clinical trial on Chinese patients performed by leading local aesthetic physicians. China is one of the fastest growing global territories in medical aesthetics, and its size and vast middle class, which is highly oriented towards non-invasive aesthetic treatments, creates a great growth opportunity for Sofwave,” Dr. Eckhouse concluded.

Recent Operational Highlights

  • Approximately 3,400 Sofwave systems sold to date and approximately 1.1 million treatments have been conducted since commercialization
  • 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
  • Announced the approval from China’s NMPA to market the Sofwave™ System for use in mainland China to improve wrinkles in the mid-to-lower face for individuals aged 22 and older
  • Announced the publication of a prospective clinical study in Lasers in Surgery and Medicine, the official journal of the American Society for Laser Medicine and Surgery (ASLMS), evaluating the use of Sofwave™ to improve skin laxity and facial wrinkles in Asian patients
  • Significant and growing brand awareness; over 1.5M social media followers to date
  • Geographically diversified revenue: North America represented 49% of third quarter revenue, APAC 37%, EMEA 12% and LATAM 2%

Financial Summary (Q3 FY’26)

IFRS Results
(U.S. dollars in thousands)
 Q3 2026Q3 2025
Revenues$28,504$21,074
Gross Profit$21,845$15,529
Gross Margin76.6%73.7%
Operating Income$4,424$1,488
Net Income$4,104$982
***Non-IFRS Results
(U.S. dollars in thousands)
 Q3 2026Q3 2025
Gross Profit$21,857$15,538
Gross Margin76.7%73.7%
Operating Income$4,910$1,878
Net Income$4,590$1,372

(***) Excluding stock-based compensation expense.

Non-IFRS Financial Measures
This press release includes information about certain financial measures that are not prepared in accordance with International Financial Reporting Standards (“IFRS”), including non-IFRS gross profit, non-IFRS gross margin, non-IFRS operating income (loss), and non-IFRS net income (loss). These non-IFRS measures adjust for non-cash share-based compensation expense. Management believes that these non-IFRS measures provide useful supplemental information to investors by excluding items that are not directly attributable to the Company’s core operating performance. Non-IFRS measures should be considered in addition to, not as a substitute for, financial measures prepared in accordance with IFRS. A reconciliation of IFRS to non-IFRS measures is provided in the table included in this press release above.

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.

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