Financial Highlights - Total revenue for Q3 2025 was reported at $226,000, marking a 135% increase from $96,000 in Q3 2024 [9] - For the nine months ended September 30, 2025, total revenue reached $581,000, up 114% from $271,000 in the same period of 2024 [9] - GAAP net loss for Q3 2025 was $2,251,000, a 45% reduction compared to $4,120,000 in Q3 2024 [9] - GAAP net loss for the nine months ended September 30, 2025, was $11,405,000, compared to $11,015,000 for the same period in 2024 [9] Commercial Highlights - Sales activities for the LockeT device outside the U.S. are increasing, with CE Mark approval generating interest in countries such as Germany, France, Italy, Spain, Portugal, the UK, and South Africa [2] - In October, five accounts in South Africa placed reorders for LockeT [2] - VIVO product line is gaining traction internationally, with the first purchase order from France received in October [2] Clinical Studies and Publications - Clinical studies and publications remain a priority, with an interview in EP Lab Digest highlighting the economic benefits of the LockeT device for venous closure after electrophysiology procedures [3] Company Outlook - The CEO of Catheter Precision expressed confidence in a pivotal growth period ahead, supported by a well-established pipeline and the completion of two VIVO clinical studies in 2025 [4] - The company anticipates a major expansion of its approved product lines across U.S. and international markets [4] - VIVO is positioned as a transformative approach to treating ventricular arrhythmias, potentially capturing a significant share of an underserved market [4]

Core Insights - Nyxoah reported strong initial results following the U.S. launch of its Genio system for treating Obstructive Sleep Apnea (OSA), achieving first revenue within a month post-FDA approval [2][4][5] Financial Highlights - Revenue for Q3 2025 was €2.0 million, a 56% increase year-over-year from €1.3 million in Q3 2024 [8][9] - The company reported a gross profit of €1.2 million with a gross margin of 60.5% for Q3 2025, compared to a gross margin of 62.0% in Q3 2024 [9][11] - Operating loss for Q3 2025 was €24.4 million, up from €15.0 million in Q3 2024, primarily due to increased selling, general, and administrative expenses [13][12] Market Launch and Strategy - The company executed a two-pronged launch strategy targeting high-volume hypoglossal nerve stimulation centers and building referral networks with sleep physicians [5][6] - As of October 31, 2025, 111 surgeons were trained on the Genio system, with 9 accounts having implanted the device [6] Reimbursement Progress - Significant progress was made in securing reimbursement coverage, with updates from major payors like Health Care Service Corporation and Blue Cross Blue Shield of Michigan, impacting over 26 million members [7][8] Cash Position - As of September 30, 2025, cash, cash equivalents, and financial assets totaled €22.5 million, down from €43.0 million at the end of June 30, 2025 [14]

Core Insights - Profound Medical Corp. reported a record revenue growth of 87% year-over-year, reaching $5.3 million in Q3 2025, driven by increased demand for its TULSA-PRO technology [2][4] - The gross margin improved significantly by 1,119 basis points to 74.3% in Q3 2025, attributed to enhanced manufacturing efficiency [2][5] - The company is expanding its sales pipeline and installed base for TULSA-PRO, with expectations to reach at least 75 installations by year-end [2][3] Business Highlights - Revenue for Q3 2025 was $5.3 million, with $4.1 million from recurring non-capital revenue and $1.2 million from one-time capital equipment sales, marking an 87% increase from $2.8 million in Q3 2024 [4] - The TULSA-PRO installed base increased to 70 systems, with a growing sales pipeline of 93 new systems in various stages of the sales process [2][3] - The TULSA Procedure was utilized for a diverse range of prostate disease patients, with 79% treated for prostate cancer only [2] Financial Performance - Operating expenses for Q3 2025 totaled approximately $12.8 million, up from $10.8 million in the prior year, primarily due to increased headcount and sales force [6] - The net loss for Q3 2025 was approximately $8.0 million, or $0.26 per share, showing a 15% improvement from a net loss of $9.4 million, or $0.38 per share, in Q3 2024 [7] - As of September 30, 2025, the company had cash reserves of approximately $24.8 million [8] Strategic Developments - In September 2025, Profound launched the TULSA-PROgram in collaboration with Texas Prostate and Dallas Medical Center to enhance access to advanced prostate treatments [2] - The company regained exclusive distribution rights for TULSA-PRO in Canada and entered into a distribution agreement for its technologies in Saudi Arabia [2][3] - A strategic distribution agreement was also established with Getz Healthcare to introduce TULSA-PRO in Australia and New Zealand [3]

Core Insights - The company reported record revenue of $1.2 million for Q3 2025, marking a 32% year-over-year increase from $0.9 million in Q3 2024 [1][1][1] - The growth is attributed to record volume in Catamaran® SI Joint Fusion System procedures and the introduction of SImmetry® SI Joint Fusion Product Sales [1][1][1] - The launch of SImmetry®+ alpha in Q4 2025 is expected to enhance the strategic portfolio [1][1][1] - The company has established a foundation for sustained growth through portfolio diversification, commercial expansion, and operational alignment [1][1][1] - Following the quarter end, the company announced a PIPE financing with supportive investors, raising total gross proceeds of $2.85 million [1][1][1]

Core Insights - Glucotrack, Inc. is advancing its continuous blood glucose monitoring (CBGM) technology and plans to submit an Investigational Device Exemption (IDE) to the FDA in Spring 2026 [1][3] - The company has strengthened its balance sheet and expanded its clinical advisory team, appointing Dr. Usman Latif as a key expert in pain management and medical technology [1][5] Financial Highlights - For Q3 2025, research and development expenses increased to $3.2 million from $2.1 million in Q3 2024, primarily due to higher product and manufacturing development costs [7] - The net loss for Q3 2025 was $4.2 million, or $4.64 per share, compared to a net loss of $5.1 million, or $1,092 per share, in Q3 2024 [9] - For the nine months ended September 30, 2025, the company reported a net loss of $15.8 million, or $30.09 per share, compared to a net loss of $12.5 million, or $2,868 per share, for the same period in 2024 [12] Cash Position - As of September 30, 2025, cash and cash equivalents were $7.9 million, up from $5.6 million at the end of 2024, with a net increase attributed to $13.7 million in financing activities [13] Corporate Developments - The company has initiated a long-term multicenter feasibility study in Australia to evaluate the CBGM product's performance and safety [10] - Glucotrack presented at industry conferences, highlighting strong interest from endocrinologists in the CBGM product, with 73% of surveyed endocrinologists willing to prescribe it [10] - The company is committed to expanding its advisory boards with experts in endocrinology and cardiology to enhance its diabetes management solutions [10]

Core Insights - STRATA Skin Sciences, Inc. reported a revenue of $6.9 million for Q3 2025, a decrease of 21% compared to Q3 2024, with global recurring revenue increasing by 3% year-over-year [4][7] - The company anticipates growth due to newly approved reimbursement codes for its XTRAC Excimer laser treatment, which is expected to enhance patient and practitioner interest [3][6] - STRATA's ongoing litigation has resulted in positive outcomes, potentially leading to increased revenue from new customers [3][6] Financial Performance - Total revenue for Q3 2025 was $6.9 million, down from $8.8 million in Q3 2024, with gross profit at $4.2 million, representing a gross margin of 60% [4][24] - Operating expenses decreased to $5.4 million in Q3 2025 from $6.9 million in the prior-year period [5][24] - The net loss for Q3 2025 was $1.6 million, or EPS of negative $0.36, an improvement from a net loss of $2.1 million, or EPS of negative $0.51, in Q3 2024 [7][24] Business Developments - STRATA is making progress in expanding CPT codes for reimbursement, effectively tripling the covered patient population in the U.S. [6] - The company received clearance for TheraClearX in Mexico, marking its first commercial placements [6] - XTRAC has been validated through multiple peer-reviewed publications for its clinical outcomes in treating autoimmune diseases [6] Market Position - The average gross billings per XTRAC device increased by 8.5% year-over-year to $5,981, the highest since Q4 2022 [6] - The U.S. install base of XTRAC devices decreased by 6 to 838, while the install base of TheraClearX stands at 161 [6] - STRATA continues to manage costs carefully while expanding its patient pool through direct-to-consumer efforts [3][6]

Core Insights - SeaStar Medical Holding Corporation reported strong progress in the third quarter of 2025, highlighting growth in customer base and impressive survival results for its QUELIMMUNE therapy [2][3][4] Business Highlights - Three top-ranked children's medical centers adopted QUELIMMUNE therapy for pediatric Acute Kidney Injury (AKI) [3][4] - QUELIMMUNE therapy demonstrated a survival rate of 76% at 60 days and 71% at 90 days for 21 pediatric patients, indicating a potential 50% reduction in loss of life compared to historical data [4][14] - The company raised $12.4 million to strengthen its balance sheet and support future operations [5][11] Clinical Trials and Research - The NEUTRALIZE-AKI pivotal clinical trial is ongoing, with an interim analysis showing positive safety signals and no device-related safety issues [4][16] - Total enrollment for the NEUTRALIZE-AKI trial has been adjusted to approximately 339 patients, with 146 patients enrolled to date [4][16] - A new clinical trial for NEUTRALIZE-CRS therapy has been initiated, targeting patients with acute chronic systolic heart failure [4] Financial Performance - Net revenue for the third quarter of 2025 was approximately $0.2 million, compared to $0.1 million in the same period of 2024 [6] - Research and development expenses decreased to $1.9 million from $2.3 million year-over-year, while general and administrative expenses also saw a decline [8][9] - The net loss for the third quarter was approximately $3.5 million, or $0.13 per share, an improvement from a net loss of $4.5 million, or $1.10 per share, in the prior year [11][27] Market Position and Future Outlook - The QUELIMMUNE therapy is the only FDA-approved product for life-threatening pediatric AKI due to sepsis, with significant market potential in both pediatric and adult applications [19] - The company is focused on expanding its market share and generating sales in the adult AKI market, which is significantly larger than the pediatric segment [5][19]

Core Viewpoint - Merit Medical Systems, Inc. announced that the U.S. Centers for Medicare & Medicaid Services has deferred its application for Transitional Pass-Through incremental payment for the WRAPSODY Cell-Impermeable Endoprosthesis, with the earliest effective date now set for January 1, 2027 [1][2] Group 1: Company Strategy and Market Position - The company plans to withdraw its application for TPT incremental payment and will immediately begin full commercialization of the WRAPSODY CIE in the U.S. [2] - A new commercial strategy is being enacted to increase patient access and optimize the adoption and utilization of the WRAPSODY CIE, which is expected to improve patient outcomes and generate strong revenue growth [2] - The WRAPSODY CIE aims to restore vascular access for hemodialysis patients, with strong clinical evidence supporting its efficacy [2] Group 2: Financial Forecast - For the full year 2025, Merit forecasts U.S. revenue from WRAPSODY CIE sales to be in the range of $2 million to $4 million [2] Group 3: Regulatory Approvals - The WRAPSODY CIE received premarket approval from the U.S. FDA on December 19, 2024, and was approved by Health Canada on April 30, 2025 [3] - The device has also received the CE Mark for commercial use in the European Union and is available in Brazil [3] Group 4: Clinical Evaluation - Real-world clinical outcomes of the WRAPSODY CIE are being evaluated in the WRAP North America Registry, which aims to enroll up to 250 patients [5]

Core Insights - CapsoVision, Inc. reported a strong third quarter for 2025, with significant growth in revenue and product uptake, particularly for its CapsoCam Plus® endoscopy capsule [3][4][8] - The company is pursuing Breakthrough Device Designation from the FDA for its endoscopy capsule aimed at early-stage pancreatic cancer detection, highlighting its commitment to addressing unmet medical needs [3][8] - CapsoVision is advancing its artificial intelligence capabilities with the development of a next-generation analytics engine for capsule endoscopy, with regulatory submissions planned for late 2025 [3][8] Financial Performance - Total revenue for Q3 2025 was $3.5 million, representing a 19% increase compared to Q3 2024, driven by higher sales of CapsoCam Plus capsules [4][8] - Gross profit reached $1.9 million, a 16% increase from the previous year, with a gross margin of 54%, slightly down from 56% in Q3 2024 [4][8] - Operating expenses increased to $9.9 million, up $2.5 million from Q3 2024, primarily due to development costs and higher general and administrative expenses [5][8] Cash Position - As of September 30, 2025, cash and cash equivalents totaled $17.8 million, an increase from $9.3 million at the end of 2024 [6][13] - The company completed an initial public offering in July 2025, generating net proceeds of $23.4 million after expenses [6][8] Product Development and Market Engagement - New accounts grew by 31% in Q3 2025 compared to the same quarter in 2024, indicating strong market engagement [8] - CapsoVision is collaborating with Canon Inc. to develop higher-resolution CMOS image sensors for future capsule endoscopes [3][8] - The company has initiated a clinical study for its new generation colon-capsule, further expanding its product pipeline [3][8] Leadership Changes - David Garcia was appointed as Senior Vice President of Finance, effective November 3, 2025, bringing extensive experience in financial oversight [3][8]

Core Insights - RenovoRx reported a year-to-date revenue of approximately $900,000 as of the end of Q3 2025, indicating strong commercial progress and increasing market demand for its RenovoCath device [2][3][14] - The company has expanded its customer base from five to 14 approved cancer centers for RenovoCath, with additional quotes requested from 10 more centers, reflecting growing physician interest and satisfaction [4][5][8] - RenovoRx's cash position as of September 30, 2025, was $10 million, which is expected to support ongoing commercialization efforts and the completion of its Phase III clinical trial [15][21] Commercialization Update - The commercialization strategy for RenovoCath has shown progress, with Q3 2025 revenues reaching approximately $266,000, driven by new customer orders and repeat purchases [14][3] - The company has engaged with numerous physicians and medical institutions, indicating a strong interest in utilizing RenovoCath for targeted drug delivery [4][5] - RenovoRx aims to integrate its TAMP™ therapy into standard care practices to improve patient outcomes [2][10] Clinical Research and Development - The Phase III TIGeR-PaC trial is on track for enrollment completion in early 2026, with final data expected in 2027 [10][12] - A new post-marketing registry study has been launched to gather real-world evidence on the use of RenovoCath, with initial patient procedures already initiated [12][10] - The company has strengthened its Scientific Advisory Board with the addition of experts in oncology, enhancing its clinical development capabilities [11] Financial Highlights - For Q3 2025, RenovoRx reported a net loss of $2.9 million, compared to a net loss of $2.5 million in Q3 2024, reflecting ongoing investments in R&D and commercialization [17][24] - Research and development expenses were $1.7 million for the quarter, consistent with the previous year, indicating continued commitment to clinical trials [16][24] - Selling, general, and administrative expenses increased to approximately $1.7 million, up from $1.2 million in the prior year, reflecting the company's growth efforts [17][24] Market Potential - The initial total addressable market (TAM) for RenovoCath is estimated at approximately $400 million in peak annual U.S. sales, with potential for several billion dollars as the platform expands into additional indications [9][26] - The company is actively exploring further revenue-generating activities to meet anticipated demand for RenovoCath [29]