Reported Earnings • Aug 04
Second quarter 2026 earnings released: EPS: US$0.069 (vs US$0.043 in 2Q 2025) Second quarter 2026 results: EPS: US$0.069 (up from US$0.043 in 2Q 2025). Revenue: US$30.0m (up 43% from 2Q 2025). Net income: US$2.51m (up 66% from 2Q 2025). Profit margin: 8.4% (up from 7.2% in 2Q 2025). The increase in margin was driven by higher revenue. Over the last 3 years on average, earnings per share has increased by 110% per year but the company’s share price has only increased by 48% per year, which means it is significantly lagging earnings growth. Reported Earnings • May 11
First quarter 2026 earnings released: EPS: US$0.035 (vs US$0.032 loss in 1Q 2025) First quarter 2026 results: EPS: US$0.035 (up from US$0.032 loss in 1Q 2025). Revenue: US$24.4m (up 46% from 1Q 2025). Net income: US$1.26m (up US$2.37m from 1Q 2025). Profit margin: 5.2% (up from net loss in 1Q 2025). The move to profitability was driven by higher revenue. Over the last 3 years on average, earnings per share has increased by 102% per year but the company’s share price has only increased by 73% per year, which means it is significantly lagging earnings growth. Reported Earnings • Mar 20
Full year 2025 earnings released: EPS: US$0.15 (vs US$0.13 loss in FY 2024) Full year 2025 results: EPS: US$0.15 (up from US$0.13 loss in FY 2024). Revenue: US$87.6m (up 47% from FY 2024). Net income: US$5.49m (up US$10.0m from FY 2024). Profit margin: 6.3% (up from net loss in FY 2024). The move to profitability was driven by higher revenue. Over the last 3 years on average, earnings per share has increased by 91% per year but the company’s share price has only increased by 55% per year, which means it is significantly lagging earnings growth. Announcement • Mar 19
SofWave Medical Ltd., Annual General Meeting, Apr 23, 2026 SofWave Medical Ltd., Annual General Meeting, Apr 23, 2026. Location: co. offices, Israel Announcement • Mar 10
SofWave Medical Ltd. to Report Q4, 2025 Results on Mar 17, 2026 SofWave Medical Ltd. announced that they will report Q4, 2025 results on Mar 17, 2026 New Risk • Jan 12
New minor risk - Share price stability The company's share price has been volatile over the past 3 months. It is more volatile than 75% of Israeli stocks, typically moving 5.8% a week. This is considered a minor risk. Share price volatility indicates the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. It also increases the risk of potential losses in the short term as the stock tends to have larger drops in price more frequently than other stocks. This is currently the only risk that has been identified for the company. Announcement • Jan 07
SofWave Medical Ltd. Provides Earnings Guidance for the Fourth Quarter and Full Year Ended December 31, 2025 SofWave Medical Ltd. provided earnings guidance for the fourth quarter and full year ended December 31, 2025. for the quarter, the company expects total between $28.6 million and $28.9 million, as compared to approximately $18.3 million in the same period last year, reflecting an increase of approximately 57% compared to the same period last year.
for the year, revenue is expected to total between $87.3 million and $87.6 million, as compared to approximately $59.7 million in the same period last year, reflecting an increase of approximately 46% compared to the same period last year. Reported Earnings • Nov 06
Third quarter 2025 earnings released: EPS: US$0.028 (vs US$0.039 loss in 3Q 2024) Third quarter 2025 results: EPS: US$0.028 (up from US$0.039 loss in 3Q 2024). Revenue: US$21.1m (up 56% from 3Q 2024). Net income: US$982.0k (up US$2.31m from 3Q 2024). Profit margin: 4.7% (up from net loss in 3Q 2024). The move to profitability was driven by higher revenue. Over the last 3 years on average, earnings per share has increased by 78% per year but the company’s share price has only increased by 45% per year, which means it is significantly lagging earnings growth. Announcement • Oct 20
SofWave Medical Ltd. to Report Q3, 2025 Results on Nov 04, 2025 SofWave Medical Ltd. announced that they will report Q3, 2025 results on Nov 04, 2025 Buy Or Sell Opportunity • Sep 17
Now 21% undervalued Over the last 90 days, the stock has risen 22% to ₪24.66. The fair value is estimated to be ₪31.24, however this is not to be taken as a buy recommendation but rather should be used as a guide only. Revenue has grown by 28% over the last 3 years. Earnings per share has grown by 66%. Announcement • Sep 04
Sofwave Medical Ltd. Receives FDA, Pre-market Clearance for Pure Impact VIP Standalone EMS Device for Comprehensive Multi-Body Area Muscle Strengthening and Firming Sofwave Medical Ltd. announced that the Company has received 510(k) premarket notification clearance from the U.S. Food and Drug Administration (FDA). This clearance expands the Pure Impact™? product line further via the launch of a standalone EMS Device branded Pure Impact VIP™?. The Pure Impact VIP™? is designed as a standalone system that can be delegated and administered by staff using a simple and intuitive procedure. Announcement • Aug 12
Migdal Insurance and Financial Holdings Ltd. (TASE:MGDL) acquired 3.96% stake in SofWave Medical Ltd. (TASE:SOFW) for ILS 37.6 million. Migdal Insurance and Financial Holdings Ltd. (TASE:MGDL) acquired 3.96% stake in SofWave Medical Ltd. (TASE:SOFW) for ILS 37.6 million on August 7, 2025. A cash consideration valued at ILS 27.12 per share will be paid by Migdal Insurance.
Migdal Insurance and Financial Holdings Ltd. (TASE:MGDL) completed the acquisition of 3.96% stake in SofWave Medical Ltd. (TASE:SOFW) on August 7, 2025. New Risk • Aug 05
New minor risk - Share price stability The company's share price has been volatile over the past 3 months. It is more volatile than 75% of Israeli stocks, typically moving 7.0% a week. This is considered a minor risk. Share price volatility indicates the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. It also increases the risk of potential losses in the short term as the stock tends to have larger drops in price more frequently than other stocks. This is currently the only risk that has been identified for the company. Announcement • Jul 16
SofWave Medical Ltd. to Report Q2, 2025 Results on Aug 05, 2025 SofWave Medical Ltd. announced that they will report Q2, 2025 results on Aug 05, 2025 Reported Earnings • May 10
First quarter 2025 earnings released: US$0.032 loss per share (vs US$0.029 loss in 1Q 2024) First quarter 2025 results: US$0.032 loss per share (further deteriorated from US$0.029 loss in 1Q 2024). Revenue: US$16.7m (up 26% from 1Q 2024). Net loss: US$1.11m (loss widened 13% from 1Q 2024). Over the last 3 years on average, earnings per share has increased by 53% per year but the company’s share price has only increased by 1% per year, which means it is significantly lagging earnings growth. Announcement • Apr 25
Sofwave’S Lifthd Body Contouring Applicator to Debut At the 44Th Annual Meeting of the American Society for Laser Medicine and Surgery (Aslms) 2025 SofWave Medical Ltd. announced activities around the official launch of the liftHD high density body contouring handpiece at the 44th Annual Meeting of the American Society for Laser Medicine and Surgery (ASLMS) 2025 on energy-based medicine and science being held at the Orange County convention Center in Orlando, Florida, from April 24- 26, 2025. Sofwave’s onsite exhibition booth will be active throughout the event, showcasing the liftHD non-invasive aesthetic body contouring applicator as well as the Sofwave family of SUPERB™ and Pure Impact™ product lines. The new body contouring applicator benefits patients by utilizing the same precise SUPERB™ pulse technology as with the SUPERB™ line of treatments but with broader, higher density controlled thermal zones resulting in less pulses per treatment, thereby reducing treatment time by ~40%. The liftHD applicator by Sofwave is the Company’s newest applicator and provides the opportunity to deliver next generation non-invasive aesthetic body treatments which improve cellulite and skin laxity appearance to achieve SUPERB results beyond the face. This body applicator’s user-friendly, ergonomic design was specifically made to deliver fast, efficient, comfortable treatments. SUPERB™ Treatment Technology is Not Only Different But Better than the Competition.Precise depth control – The thermal treatment zone is precisely placed between 0.5mm and 1.8 mm to stimulate natural healing and collagen, elastin, and hyaluronic acid production. Optimized Energy Delivery - Optimal dermal timulation is achieved by parallel heating the dermis to a temperature of 149-158°F for a controlled, predictable, and dermally selective treatment outcome.Unique Broad Tissue Coverage - Seven parallel beam transducers simultaneously create large, controlled 3D cylindrical thermal zones with each pulse, resulting in optimal treatment coverage in just one 30–45-minute treatment. In addition, clinicians continue to expand the body of clinical evidence and case studies which strongly supporting the benefits of the Sofwave™ family of products and treatments. Announcement • Apr 21
Sofwave Medical Ltd.'s SUPERB™ Non-Invasive Skin Treatment Technology Receives Regulatory Clearance in Japan Significantly Expanding its Coverage of the APAC Region Sofwave Medical Ltd. announced that Japan's Pharmaceuticals and Medical Devices Agency (PMDA) has granted the Company approval to commercially market Sofwave's SUPERB™? Technology. Market approval in Japan further extends Sofwave's sales reach in the APAC territories, which now comprises major regional medical aesthetic device markets, including Japan, Australia, Taiwan, and South Korea. Announcement • Mar 10
SofWave Medical Ltd., Annual General Meeting, Apr 15, 2025 SofWave Medical Ltd., Annual General Meeting, Apr 15, 2025. Location: cpc buileding, yokneaml, Israel Reported Earnings • Mar 06
Full year 2024 earnings released: US$0.13 loss per share (vs US$0.24 loss in FY 2023) Full year 2024 results: US$0.13 loss per share (improved from US$0.24 loss in FY 2023). Revenue: US$59.7m (up 19% from FY 2023). Net loss: US$4.55m (loss narrowed 45% from FY 2023). Over the last 3 years on average, earnings per share has increased by 41% per year but the company’s share price has fallen by 8% per year, which means it is significantly lagging earnings. Announcement • Jan 14
Sofwave Medical Provides Earnings Guidance for Fourth Quarter and Full Year 2024 Sofwave Medical Provided Earnings Guidance for fourth quarter and full year 2024. For the quarter, the company expects revenue to total between $18.2 million and $18.4 million, as compared to approximately $15.3 million in the same period last year, reflecting an increase of approximately 20% compared to the same period last year.
For the full year 2024, the company expects revenue to total between $59.5 million and $59.7 million, as compared to approximately $50.3 million in the same period last year, reflecting an increase of approximately 19% compared to the same period last year. Reported Earnings • Nov 18
Third quarter 2024 earnings released: US$0.039 loss per share (vs US$0.036 loss in 3Q 2023) Third quarter 2024 results: US$0.039 loss per share (further deteriorated from US$0.036 loss in 3Q 2023). Revenue: US$13.5m (up 11% from 3Q 2023). Net loss: US$1.33m (loss widened 7.7% from 3Q 2023). Over the last 3 years on average, earnings per share has increased by 25% per year but the company’s share price has fallen by 20% per year, which means it is significantly lagging earnings. New Risk • Nov 15
New minor risk - Share price stability The company's share price has been volatile over the past 3 months. It is more volatile than 75% of Israeli stocks, typically moving 5.1% a week. This is considered a minor risk. Share price volatility indicates the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. It also increases the risk of potential losses in the short term as the stock tends to have larger drops in price more frequently than other stocks. Currently, the following risks have been identified for the company: Major Risk Earnings have declined by 7.4% per year over the past 5 years. Minor Risk Share price has been volatile over the past 3 months (5.1% average weekly change). Announcement • Nov 13
Sofwave Medical Ltd. Appoints Miguel Pardos to the Role of Chief Commercial Officer SofWave Medical Ltd. appointed Mr. Miguel Pardos to the role of Chief Commercial Officer. Mr. Miguel Pardos is a seasoned C-Suite executive with over 25 years of experience in the international medical aesthetics and healthcare industry. He has a strong track record as an industry leader in addition to successfully accelerating revenue growth at companies while under his helm. Before joining Sofwave, Mr. Pardos served as the Chief Executive Officer of Sinclair, a UK-based aesthetic company with a portfolio of injectables and energy-based devices. Previously held positions include CEO of Cocoon Medical, EVP International at Cutera, VP of APAC at Syneron Candela and various leadership positions at GE Healthcare. Mr. Pardos holds a BSc in Engineering and an MBA from Instituto de Empresa (Ie). Announcement • Oct 30
SofWave Medical Ltd. to Report Q3, 2024 Results on Nov 13, 2024 SofWave Medical Ltd. announced that they will report Q3, 2024 results on Nov 13, 2024 Announcement • Oct 07
SofWave Medical Ltd. Obtains U.S. Patent for Fat Tissue Reduction Technology SofWave Medical Ltd. announced that the U.S. Patent and Trademark Office has granted patent protection for Sofwave’s technology in a new embodiment for the treatment of fat tissue. The issued patent describes a system and its components for treating fat tissue by generating unfocused ultrasound energy with parameter values suitable to heat fat tissue in the hypodermis tissue layer to a desired temperature level. The unfocused ultrasound energy is emitted by an applicator placed in contact with the skin surface. During the treatment, a proprietary cooling mechanism is applied to the skin surface that is contacted by the applicator to avoid thermal damage to the epidermis layer of the skin and provide safe and efficacies treatment results. Announcement • Sep 04
SofWave Medical Ltd. Appoints Larry Laber to the Role of Executive Vice President, North American Sales Sofwave Medical Ltd. announced the appointment of Larry Laber to the role of executive vice president, North American Sales. Mr. Laber is an aesthetic energy-based medical device sales veteran with more than 20 years of experience in the industry. Mr. Laber will be responsible for managing and continuing the buildout of the US sales team, and alignment of the go to market strategy with its partner in Canada, XCite medical. Prior to joining Sofwave, Larry served as Chief Commercial Officer at Lutronic, where he was instrumental in building one of the strongest and fastest-growing aesthetic laser companies over the last five years. His strategic vision and consistent results have earned him a reputation in the industry as a proven senior commercial leader. Larry’s career is marked by his dedication to excellence and his consistent success in increasing revenue, leading commercial teams, building brands, and expanding market share. Larry holds a B.A. in Communications from California State University, Northridge, and he is passionate about building and leading dynamic teams that succeed at the highest levels. Reported Earnings • Aug 07
Second quarter 2024 earnings released: US$0.045 loss per share (vs US$0.083 loss in 2Q 2023) Second quarter 2024 results: US$0.045 loss per share (improved from US$0.083 loss in 2Q 2023). Revenue: US$14.6m (up 18% from 2Q 2023). Net loss: US$1.53m (loss narrowed 46% from 2Q 2023). Over the last 3 years on average, earnings per share has increased by 7% per year but the company’s share price has fallen by 6% per year, which means it is significantly lagging earnings. Reported Earnings • May 11
First quarter 2024 earnings released: US$0.029 loss per share (vs US$0.11 loss in 1Q 2023) First quarter 2024 results: US$0.029 loss per share (improved from US$0.11 loss in 1Q 2023). Revenue: US$13.2m (up 27% from 1Q 2023). Net loss: US$983.0k (loss narrowed 74% from 1Q 2023). Reported Earnings • Mar 07
Full year 2023 earnings released: US$0.24 loss per share (vs US$0.57 loss in FY 2022) Full year 2023 results: US$0.24 loss per share (improved from US$0.57 loss in FY 2022). Revenue: US$50.3m (up 41% from FY 2022). Net loss: US$8.28m (loss narrowed 58% from FY 2022). Announcement • Feb 12
SofWave Medical Ltd. Appoints James Bartholomeusz as Chief Innovation Officer SofWave Medical Ltd. announced the appointment of James Bartholomeusz to the newly created position of Chief Innovation Officer. Mr. Bartholomeusz is a medical aesthetics expert and industry veteran with more than 20 years of experience. He will lead global product innovation, development, and go-to market strategies for new product launches. Mr. Bartholomeusz joins Sofwave after his previous role as chief technology officer (CTO) at Lutronic, where he was responsible for developing and executing an ambitious 5-year product roadmap and growth strategy that included various industry defining products like DermaV before Lutronic was acquired by private equity in August of 2023. Prior to Lutronic Mr. Bartholomeusz served Syneron-Candela as Global Vice President of Product Development. Announcement • Dec 26
SofWave Medical Ltd. Receives FDA Clearance of Superb™? Technology for Improvement of the Appearance of Skin Laxity on the Upper Arm Sofwave Medical Ltd. announced clearance by the U.S. Food and Drug Administration (FDA) for the Company's 510(k) premarket notification submission for the improvement of the appearance of skin laxity on the upper arms and paves the way for Sofwave to further expand into additional treatment indications. According to the American Society of Plastic Surgeons, 2022 Procedural Statistics Release, 2019-2022, brachioplasty (surgical arm lift) procedures grew 25%. Sofwave's SUPERB platform introduces a viable FDA-cleared, non-invasive alternative to improve the appearance of skin stringentity on the upper arms without the associated risks and recovery time of conventional surgery, laser-based body contouring, and other minimally invasive procedures. Study results and design leading to FDA clearance of premarket notification submission: Study Design and Results: A total of 46 subjects were enrolled and treated on both upper arms at 4 sites in the United States. Subjects attended 2 treatment sessions (1-3 weeks apart) and a follow-up visit 3 months after the final treatment visit. 93% of treated arms were "improved" or "very much improved" in appearance, as rated by the blinded review using the Global Aesthetic Improvement Scale. Most subjects reported none to mild levels of pain during treatment and no discomfort afterward. In the U.S., Sofwave's technology is currently cleared for use as a non-invasive aesthetic treatment to improve facial lines and wrinkles, lift the facial, 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 for subjects aged 22 and older. The Sofwave system is also cleared for short-term improvement in the appearance of cellulite and for the treatment of acne scars. Board Change • Dec 23
Less than half of directors are independent Following the recent departure of a director, there are only 3 independent directors on the board. The company's board is composed of: 3 independent directors. 4 non-independent directors. Independent Outside Director Orly Zilberman was the last independent director to join the board, commencing their role in 2021. The company's minority of independent directors is a risk according to the Simply Wall St Risk Model. Announcement • Dec 18
SofWave Medical Ltd., Annual General Meeting, Jan 23, 2024 SofWave Medical Ltd., Annual General Meeting, Jan 23, 2024, at 14:00 Israel Standard Time. Reported Earnings • Nov 12
Third quarter 2023 earnings released: US$0.036 loss per share (vs US$0.13 loss in 3Q 2022) Third quarter 2023 results: US$0.036 loss per share (improved from US$0.13 loss in 3Q 2022). Revenue: US$12.2m (up 11% from 3Q 2022). Net loss: US$1.24m (loss narrowed 72% from 3Q 2022). Announcement • Oct 17
SofWave Medical Ltd. to Report Q3, 2023 Results on Nov 08, 2023 SofWave Medical Ltd. announced that they will report Q3, 2023 results on Nov 08, 2023 Announcement • Aug 31
Sofwave Medical Announces FDA Clearance of SUPERB™ Technology For Treatment of Acne Scars Sofwave Medical Ltd. announced clearance by the U.S. Food and Drug Administration (FDA) for the Company’s 510(k) premarket notification submission to market SUPERB™ for the treatment of acne scars. The approval clears the way for Sofwave™ to expand treatment indication of the Company’s SUPERB™ system to be used for the treatment of acne scars. About the clinical study leading to FDA clearance of premarket notification submission: A multicenter study was conducted to evaluate the Sofwave SUPERB™ system for improvement in the appearance of acne scars. A total of 67 subjects were treated at 4 sites in the United States. Following 3 treatment sessions, 97% of treated subjects showed improvement in acne scars appearance, as assessed by at least 2 out of 3 masked evaluators. The study demonstrated a mean improvement level of 1.05±0.53 units based on the acne scar severity scale, which reflected an average improvement of 46% relative to the average baseline acne scars severity grading. Subjects in the trial were highly satisfied and 88% of the subjects reported improvement in their acne scars appearance. The clinical study also demonstrated a favorable safety profile for the Sofwave system. No serious or unanticipated adverse event were reported during the study. In the U.S., Sofwave’s technology has been cleared for use as a non-invasive dermatological aesthetic treatment 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 for subjects aged 22 and older. The Sofwave system is also cleared for short-term improvement in the appearance of cellulite. Reported Earnings • Aug 09
Second quarter 2023 earnings released: US$0.083 loss per share (vs US$0.16 loss in 2Q 2022) Second quarter 2023 results: US$0.083 loss per share (improved from US$0.16 loss in 2Q 2022). Revenue: US$12.4m (up 54% from 2Q 2022). Net loss: US$2.83m (loss narrowed 50% from 2Q 2022). New Risk • Aug 08
New major risk - Share price stability The company's share price has been highly volatile over the past 3 months. It is more volatile than 90% of Israeli stocks, typically moving 8.5% a week. This is considered a major risk. Share price volatility increases the risk of potential losses in the short-term as the stock tends to have larger drops in price more frequently than other stocks. It may also indicate the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (8.5% average weekly change). Earnings have declined by 42% per year over the past 5 years. Announcement • Jul 22
SofWave Medical Ltd. to Report Q2, 2023 Results on Aug 08, 2023 SofWave Medical Ltd. announced that they will report Q2, 2023 results on Aug 08, 2023 Announcement • Jul 06
Sofwave Medical Ltd. Gains Additional U.S. Patent Protection for the Company's Proprietary SUPERB™ Technology Sofwave Medical Ltd. announced the allowance of a second patent by the U.S. Patent and Trademark Office. The allowance grants additional U.S. patent protection for key feature sets of the Company's proprietary SUPERB™? ("Synchronous Ultrasound Parallel Beam") technology. This second patent allowance is in addition to Sofwave's existing issued IP in China, HK, Australia and Israel. The Company has an additional 31 patents pending globally and continues to focus on further building the IP around its transformative technology. This second patent allowance is in addition to Sofwave’s existing issued IP in China, HK, Australia and Israel. The Company has an additional 31 patents pending globally and continues to focus on further building the IP around its transformative technology. Board Change • May 21
Less than half of directors are independent Following the recent departure of a director, there are only 2 independent directors on the board. The company's board is composed of: 2 independent directors. 3 non-independent directors. Independent Outside Director Orly Zilberman was the last independent director to join the board, commencing their role in 2021. The company's minority of independent directors is a risk according to the Simply Wall St Risk Model. Reported Earnings • May 15
First quarter 2023 earnings released: US$0.11 loss per share (vs US$0.16 loss in 1Q 2022) First quarter 2023 results: US$0.11 loss per share (improved from US$0.16 loss in 1Q 2022). Revenue: US$10.4m (up 53% from 1Q 2022). Net loss: US$3.84m (loss narrowed 29% from 1Q 2022). Reported Earnings • Mar 11
Full year 2022 earnings released: US$0.57 loss per share (vs US$0.29 loss in FY 2021) Full year 2022 results: US$0.57 loss per share (further deteriorated from US$0.29 loss in FY 2021). Revenue: US$35.6m (up 63% from FY 2021). Net loss: US$19.5m (loss widened 186% from FY 2021). Announcement • Jan 24
SofWave Medical Ltd. Gains Market Approval for SUPERB(TM) Non-Invasive Wrinkle Reduction and Lifting Technology in Mexico Sofwave Medical Ltd. announced market approval for Sofwave's(TM) SUPERB Technology in Mexico. Approval was granted by Mexico'sFood and Drug Administration, the Federal Commission for the Protection from Sanitary Risks (COFEPRIS), a division of the Mexico's Ministry of Health. The company has regulatory submissions pending in other large markets including the People's Republic of China and Japan. Additionally, the company has also recently received U.S. Food and Drug Administration clearance to expand SUPERB's treatment indications to be used for the short-term improvement in the appearance of cellulite. Announcement • Dec 22
Sofwave Medical Ltd Announces Market Approvals for SUPERB(TM) Non-Invasive Wrinkle Reduction Technology Now Extend to Taiwan Sofwave Medical Ltd. announced Taiwan's Food and Drug Administration, Division of Medical Devices & Cosmetics, has given approval to market Sofwave's(TM) SUPERB Technology in Taiwan. Drivers of Asia-Pacific's Aesthetic Medicine Market Include: Ineasining adoption of minimally invasive and non-invasive cosmeti procedures -- Growing significance o of energy-based aesthetic market -- Hospital investments in aesthetic medicine solutions -- Influence of popular culture and social media particularly to patients ages 22-25 years old The Company also has regulatory submissions pending in other large markets including the People's Republic of China, Japan and Mexico. Additionally, Sofwave has also recently received U.S. Food and Drug Administration clearance to expand SUPERB's treatment indications to be used for the short-term improvement in the appearance of cellulite. Announcement • Dec 20
SofWave Medical Ltd. Announces FDA Clearance of SUPERB™ Technology For Cellulite Sofwave Medical Ltd. announced the U.S. Food and Drug Administration’s (FDA) clearance of Sofwave’s SUPERB™ technology to be used for the short-term improvement in the appearance of cellulite. In the clinical trials submitted to the FDA as part of the 510(k) application in support of the cellulite FDA clearance, the Company conducted a multi-site clinical study that evaluated the safety and effectiveness of the device for the non-invasive dermatological aesthetic improvement in cellulite appearance. A total of 68 women were treated at 4 sites in the United States. Eligible patients received 2 treatments (2-4 weeks apart) using SUPERB™ technology on one side (right or left) of the lateral /posterior upper thigh or buttocks. Serial clinical photographs were collected under standardized conditions before treatment (baseline) and at the 3-month follow-up visits. Photographs were assessed by blinded independent reviewers to identify pre-treatment images when compared to post treatment images and to grade the pre-treatment and post-treatment images using the Cellulite Severity Scale (CSS). Improvement was also evaluated using the Global Aesthetic Improvement Scale (GAIS) and Laxity Scale (LS). Safety assessments included evaluation of adverse events via physician examination during and after the treatment. Post-study, the blinded reviewers correctly identified the post treatment images for 89% of the subjects. No serious or unanticipated adverse event was reported during the study. In 2021, the FDA cleared additional indications for SUPERB™ technology, for lifting the eyebrow and lifting lax submental tissue (beneath the chin) and neck tissue; which can also affect the appearance of lax tissue in the submental neck regions. In addition, the Sofwave SUPERB™ technology is also cleared by the U.S. FDA for a non-invasive dermatological aesthetic treatment to improve facial lines and wrinkles. Announcement • Nov 03
SofWave Gains Approval to Market the Superb™ Non-Invasive Wrinkle Reduction Device in Brazil SofWave Medical Ltd. announced that Brazil’s health regulatory agency, ANVISA, the equivalent of the US Food and Drug Administration, has given an approval to market Sofwave’s™ SUPERB device in Brazil. The approval is required prior to the commercialization and marketing of medical devices in Brazil. Permission to distribute Sofwave’s aesthetic devices is immediate, following public notice of the approval via Brazil’s government newspaper. The Company continues to have regulatory submissions pending in other countries including the People’s Republic of China, Japan, Taiwan and Mexico. Announcement • Oct 19
Sofwave Medical Ltd. Receives Grants U.S. Patent Covering Key Elements of Proprietary Superb™ Non-Surgical Skin and Collagen Remodeling Technology Sofwave Medical Ltd. announced the granting of a patent by the U.S. Patent and Trademark Office. The approval grants U.S. patent protection for key features of the Company’s proprietary SUPERB technology. The issued patent protects two key technology elements in particular: The transducer array, which is used to convert and transfer ultrasound pulse energy into a patient’s skin and allows for treatment to occur. The cooling module, which maintains surface temperatures of a cooling surface at a constant low temperature, significantly reducing the potential for thermal damage to the outer layer of a patient’s skin surface, allowing for safe and effective clinical results. This new approved patent is in addition to Sofwave’s existing issued IP in China and Hong Kong. The Company has an additional 29 patents pending globally and continues to focus on further building the IP around its innovative technology. Announcement • Jul 26
SofWave Medical Ltd. to Report Q2, 2022 Results on Aug 16, 2022 SofWave Medical Ltd. announced that they will report Q2, 2022 results on Aug 16, 2022 Reported Earnings • Mar 10
Full year 2021 earnings: Revenues and EPS in line with analyst expectations Full year 2021 results: US$0.29 loss per share (up from US$21.68 loss in FY 2020). Revenue: US$21.8m (up 409% from FY 2020). Net loss: US$6.83m (loss narrowed 42% from FY 2020). Revenue was in line with analyst estimates. Announcement • Feb 25
SofWave Medical Ltd. to Report Q4, 2022 Results on Mar 09, 2022 SofWave Medical Ltd. announced that they will report Q4, 2022 results on Mar 09, 2022 Executive Departure • Sep 14
Chief Financial Officer Michael Eden has left the company During their tenure, earnings grew by 238% annually compared to the industry average, which went down by 49%. As of June 2021, Michael still personally held 310.54k shares (₪7.7m worth at the time). Michael is the only executive to leave the company over the last 12 months.