Company’s year-end TULSA-PRO installed base stood at 78 systems; qualified sales pipeline grew to 97 new systemsTORONTO, Jan. 12, 2026 (GLOBE NEWSWIRE) -- Profound Medical Corp. (NASDAQ:PROF; TSX:PRN) (“Profound” or the “Company”), a commercial-stage medical device company that develops and markets AI-powered, MRI-guided, incision-free therapies for the ablation of diseased tissue, is pleased to announce that its TULSA-PRO® system installed base stood at 78 as of December 31, 2025 — higher than its previous ...

Core Insights - Elutia Inc. reported a 16% year-over-year increase in fourth quarter revenue, reaching approximately $3.3 million, and eliminated $26.9 million of secured debt, ending the year with total cash and escrowed proceeds of $44.3 million [1][8]. Company Developments - The company is advancing its NXT-41x antibiotic-eluting biomatrix program, which is expected to improve outcomes in breast reconstruction, a market valued at $1.5 billion with a post-operative infection rate of 15-25% [2][5]. - Elutia plans to submit an FDA filing for NXT-41 in the first half of 2026, with anticipated FDA clearance in the second half of 2026, followed by FDA clearance for NXT-41x in the first half of 2027 [3]. Financial Position - As of December 31, 2025, Elutia had approximately $36.3 million in cash, with an additional $8.0 million from the BioEnvelope divestiture held in escrow, expected to be released in 2026 [8]. - The company has a strong balance sheet, having repaid its outstanding debt, which will significantly reduce interest expenses moving forward [8].

Fourth quarter revenue expected to be $15.9 million to $16.1 million, representing growth of 4% to 5%Full year revenue expected to be $56.5 million to $56.7 million, representing growth of 10% to 11%Fiscal 2026 revenue expected to be between $63 million and $67 million, representing growth of 11% to 18%Category I CPT codes and the related favorable physician fee payment levels took effect on Jan. 1, 2026FDA approved the BENEFIT-HF trial design in November and the Company has since applied to CMS for coverag ...

CLEARWATER, Fla., Jan. 12, 2026 (GLOBE NEWSWIRE) -- Apyx Medical Corporation (Nasdaq: APYX) (the “Company” or “Apyx Medical”) the leader in surgical aesthetics marketed and sold as Renuvion® and the AYON Body Contouring System™ (AYON), today reported preliminary revenue results for the fourth quarter and full year ended December 31, 2025. Preliminary Fourth Quarter 2025 Revenue Summary: Total revenue is expected to be in the range of approximately $19.0 to $19.2 million, representing an increase of approxim ...

Core Viewpoint - NovoCure Ltd. reported higher revenues for the fourth quarter and fiscal year 2025, indicating strong financial performance and growth potential for 2026 [1][2]. Financial Performance - Total preliminary net revenues for Q4 were $174.4 million, an increase of 8% from the same period last year [2]. - For fiscal 2025, total preliminary net revenues reached $655.4 million, also reflecting an 8% increase compared to the prior year [3]. - Revenue breakdown for Q4 included $101.6 million from the U.S., $21.6 million from Germany, $20.5 million from France, and $10.2 million from Japan, with an additional $15.8 million from other markets [2][3]. Future Outlook - The CEO stated that NovoCure is positioned for exciting growth opportunities in 2026, with plans for multiple product launches and a clear path to profitability [2]. - The company will cease reporting new prescriptions for indications that have been commercially available for over one year but will continue to report active patients segmented by product and market [3].

Core Insights - BrainsWay's strategic investment in Neurolief has led to the FDA granting Premarket Approval for the Proliv™Rx system, the first at-home neuromodulation device for major depressive disorder (MDD) patients who have not responded to previous antidepressants [1][2][3] Company Overview - BrainsWay is a leader in noninvasive brain stimulation technologies, focusing on advanced treatments for mental health disorders [5] - The company utilizes its proprietary Deep Transcranial Magnetic Stimulation (Deep TMS™) platform to provide effective treatments for various mental health conditions, including MDD, obsessive-compulsive disorder, and smoking addiction [5] Neurolief Overview - Neurolief is a pioneering company in neuromodulation, known for developing the first wearable, non-invasive, multi-channel brain neuromodulation system designed for home use [4] - The Proliv™Rx device is indicated for adults with MDD who have not achieved satisfactory improvement from at least one prior antidepressant [4] Regulatory Milestone - The FDA's approval of Proliv™Rx marks a significant advancement in the treatment landscape for refractory MDD, allowing for treatment in both home and clinical settings [2][3] Strategic Positioning - BrainsWay's investment in Neurolief, which includes an option to acquire the company, aims to enhance its market value and expand its addressable market by providing access to patients who may struggle to visit clinics [3]

Core Insights - EDAP TMS SA reported record fourth quarter and full-year 2025 HIFU revenue, driven by strong system placements and increasing procedure growth [1][2] - The company anticipates 36% to 38% annual year-over-year growth in HIFU revenue for 2026, with initial revenue guidance set between $50.0 million and $54.0 million [1][5] Financial Performance - For Q4 2025, worldwide HIFU revenue is projected to be between $12.9 million and $13.3 million, marking the highest quarterly revenue in the company's history [2] - Annual 2025 HIFU revenue is expected to range from $36.7 million to $37.2 million, also the highest annual revenue recorded [2] - Non-core revenue for Q4 2025 is estimated between $7.9 million and $8.3 million, with annual non-core revenue expected between $32.7 million and $33.1 million [3] Operational Highlights - A record 15 Focal One system placements occurred in Q4 2025, indicating strong global demand from hospitals and urology centers [2] - The number of Focal One HIFU procedures in the U.S. increased approximately 28% year-over-year in Q4, showcasing growing utilization [2] Strategic Outlook - The CEO emphasized that the growth in HIFU revenue now represents over half of the company's expected annual revenue, validating the execution strategy [4] - Increasing clinical validation and data from key trials are driving broader adoption of focal therapy for prostate cancer, with more hospital networks recognizing Focal One as a strategic investment [4] - The company is confident in its ability to deliver continued revenue growth and shareholder value creation in 2026, supported by a strong global pipeline and customer engagement [4]

BURLINGTON, Mass. and JERUSALEM, Jan. 12, 2026 (GLOBE NEWSWIRE) -- BrainsWay Ltd. (NASDAQ & TASE: BWAY) (“BrainsWay” or the “Company”), a global leader in advanced noninvasive brain stimulation technologies, today announced that the U.S. Food and Drug Administration (FDA) has granted Premarket Approval (PMA) for Neurolief's Proliv™Rx system, a Class III device, as an adjunctive treatment for adult patients suffering from major depressive disorder (MDD) who have failed to achieve satisfactory improvement fro ...

Core Insights - OrthoPediatrics Corp. achieved an all-time high revenue of $236.1 million for the full year 2025, reflecting a growth of 15% compared to the previous year [1][6] - The company initiated guidance for record Adjusted EBITDA in 2026, projecting revenue between $262 million and $266 million, which represents an 11% to 13% growth compared to 2025 [3][4] Recent Business and Financial Highlights - In 2025, OrthoPediatrics helped over 37,500 children in the fourth quarter alone, totaling nearly 1.3 million since inception [4][6] - The preliminary unaudited net revenue for the fourth quarter of 2025 was $61.3 million, marking a 16% increase from $52.7 million in Q4 2024 [6] - Domestic net revenue for 2025 is expected to be $186.2 million, indicating a 16% annual growth, while international net revenue is projected at $49.9 million, reflecting a 15% annual growth [6] - The company generated approximately $6.0 to $7.0 million in free cash flow for Q4 2025, resulting in total free cash flow usage for the year being over 50% lower than in 2024 [6] Strategic Initiatives - The Trauma and Deformity and Scoliosis implant businesses have effectively executed strategies to gain market share, drive revenue, and improve profitability [4] - The specialty bracing (OPSB) business is identified as a significant market opportunity and a strategic catalyst for enhancing customer relationships, proving to be a capital-efficient driver of revenue and earnings [4]

Fourth quarter and Full-Year 2025 revenue are expected to be approximately $9.2 million and $37.0 million, respectively, with expected Q4 gross margins in the range of 73% to 75% DrugSorb®-ATR De Novo Pre-Submission Meeting scheduled with the FDA this month, with anticipated De Novo Application filing this quarter and regulatory decision in mid-2026 Results of the pivotal STAR-T study for DrugSorb®-ATR have recently been accepted for publication in a top cardiac surgery journal Management will host in-perso ...