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Perimeter Medical Imaging AI to Report Third Quarter 2025 Financial Results and Host Conference Call on November 12, 2025
Prnewswire· 2025-11-05 21:30
Core Insights - Perimeter Medical Imaging AI, Inc. will report its third quarter 2025 financial and operating results on November 12, 2025, followed by a webcast and conference call for discussion [1][2]. Company Overview - Perimeter Medical Imaging AI is a medical technology company based in Toronto and Dallas, focused on transforming cancer surgery through advanced imaging tools [3]. - The company offers the FDA-cleared Perimeter S-Series OCT system, which provides real-time, cross-sectional visualization of excised tissues at the cellular level [3]. - The investigational Perimeter B-Series OCT, featuring ImgAssist AI, is currently under evaluation in a pivotal clinical trial, supported by a grant of up to US$7.4 million from the Cancer Prevention and Research Institute of Texas [3]. Product Information - The Perimeter B-Series OCT is limited to investigational use in the U.S. and is not available for sale [4]. - The Perimeter S-Series OCT has received 510(k) clearance but has not been specifically evaluated for breast tissue or cancer applications [4].
BioStem Technologies Provides Comments on CMS CY 2026 Final Medicare Reimbursement Rule Changes for Skin Substitutes
Globenewswire· 2025-11-05 21:05
Core Insights - BioStem Technologies, Inc. supports the CMS's final rule on the Physician Fee Schedule for 2026, which aims to create a more transparent and sustainable reimbursement system for skin substitutes [2][4] - The new reimbursement model is expected to restore market balance and reward clinical performance, aligning with BioStem's goals for its BioREtain-processed placental allografts [2][3] Company Positioning - BioStem's BioREtain manufacturing process offers lower cost of goods sold (COGS) and scalable production, which is expected to maintain robust product margins under the new reimbursement model [3] - The company is well-positioned to thrive in the evolving reimbursement environment due to its clinically validated products and efficient cost structure [4] Clinical Validation - BioStem's commitment to scientific validation is highlighted by a Level 1 randomized controlled trial demonstrating superior patient outcomes with its products compared to standard care [2] - The company collaborates with clinical partners and policymakers to ensure that the reimbursement framework supports innovation and optimal patient care [4]
EXTENDED CLASS PERIOD: Robbins Geller Rudman & Dowd LLP Files Class Action Lawsuit Against Lantheus Holdings, Inc. and Announces Opportunity for Investors with Substantial Losses to Lead Class Action Lawsuit - LNTH
Prnewswire· 2025-11-05 20:50
Accessibility StatementSkip Navigation You can also contact attorneys J.C. Sanchez or Jennifer N. Caringal of Robbins Geller by calling 800/449- 4900 or via e-mail at [email protected]. Lead plaintiff motions for the Lantheys class action lawsuit must be filed with the court no later than Monday, November 10, 2025. CASE ALLEGATIONS: Lantheus presents itself as a sophisticated medical technology company driving innovation in radiopharmaceuticals. Lantheus's flagship product is Pylarify, a prostate-specific ...
SeaStar Medical to Report Third Quarter Financial Results on November 13, 2025
Globenewswire· 2025-11-05 15:03
Core Insights - SeaStar Medical Holding Corporation will report its third quarter financial results on November 13, 2025, after market close [1] - The company focuses on transforming treatments for critically ill patients facing organ failure [3] Company Overview - SeaStar Medical is a commercial-stage healthcare company dedicated to critically ill patients with organ failure [3] - The QUELIMMUNE (SCD-PED) therapy is the company's first commercial product, approved by the FDA in 2024 for life-threatening acute kidney injury (AKI) in pediatric patients [3] - The Selective Cytopheretic Device (SCD) therapy has received Breakthrough Device Designation for six therapeutic indications, facilitating faster approval and better reimbursement dynamics [3] - A pivotal trial is currently underway for SCD therapy in adult patients with AKI requiring continuous renal replacement therapy (CRRT), affecting over 200,000 adults annually in the U.S. [3]
LivaNova Reports Third-Quarter 2025 Results; Raises 2025 Guidance
Businesswire· 2025-11-05 11:00
Core Viewpoint - LivaNova PLC has reported strong financial results for Q3 2025, with a notable increase in revenue and has raised its full-year guidance for 2025 [1] Financial Performance - Third-quarter revenue reached $357.8 million, reflecting a 12.5% increase on a reported basis, an 11.0% increase on a constant-currency basis, and a 12.5% increase on an organic basis compared to the prior-year period [1] - The company reported U.S. GAAP diluted earnings per share of $0.49 for the third quarter [1]
“超级助手”来帮忙 AI让深圳医疗效率“起飞”
Yang Shi Wang· 2025-11-05 07:46
Core Insights - The article emphasizes the acceleration of health development in China, particularly through the integration of artificial intelligence (AI) and advanced technologies in the medical field, with Shenzhen as a leading example [1][30] Group 1: Technological Innovations in Healthcare - Shenzhen is leveraging its technological advantages to address medical resource imbalances, focusing on high-tech cardiovascular surgeries as a key area for development [3][30] - The collaboration between companies and research institutions, such as the establishment of a specialized lab with the Shenzhen Institute of Advanced Technology, aims to enhance robotic capabilities in surgeries by integrating force feedback mechanisms [5][7] - A surgical robot has been developed that can perform complex tasks like suturing and tumor removal, significantly improving operational efficiency by over three times [10][12] Group 2: AI Applications in Medical Processes - Over 450 intelligent applications have been integrated into various medical processes in Shenzhen, including smart triage systems that match patients with appropriate departments based on their symptoms [10][14] - AI technologies are also being utilized in traditional medicine practices, such as automated herbal medicine preparation and acupuncture, enhancing service quality and efficiency [16][18] - A city-level smart healthcare platform, "Yizhi Fangzhou," has been launched, connecting over 30 specialized models to improve diagnostic accuracy and decision-making efficiency by over 50% [23][25] Group 3: Quality Assurance and Evaluation - To ensure the safety and effectiveness of AI technologies in healthcare, Shenzhen has established expert review committees to evaluate new products before they are implemented in hospitals [19][21] - The integration of AI in healthcare is supported by a robust data management system that includes over 100,000 medical cases and guidelines, enhancing the training of AI models [25][27] Group 4: Broader Implications for Urban Life - The integration of AI extends beyond healthcare, impacting various aspects of urban life, including logistics and public services, showcasing a comprehensive approach to smart city development [28][30] - By 2024, the AI industry in Shenzhen is projected to exceed 70 billion yuan, with over 2,600 companies contributing to its growth, marking a significant shift from theoretical applications to practical implementations [30]
Masimo(MASI) - 2025 Q3 - Earnings Call Transcript
2025-11-04 22:30
Financial Data and Key Metrics Changes - The company reported an 8% revenue growth for the quarter, with adjusted earnings per share increasing by 38% year over year [4][16] - Operating margin expanded by 450 basis points, driven by higher revenue and cost efficiencies [4][19] - Gross margin was 62.2%, a decline of 70 basis points year over year due to tariff impacts [18] Business Line Data and Key Metrics Changes - Healthcare revenue reached $371 million, representing an 8% growth [16] - Consumables grew by 1% this quarter, compared to a 20% growth in the same quarter last year [16] - Capital equipment and other revenues grew by 67% this quarter, rebounding from a 33% decline last year [16] Market Data and Key Metrics Changes - Incremental value of new contracts secured in the third quarter was $124 million, marking a 48% year-over-year increase [17] - Unrecognized contract revenue expected to be realized within the next 12 months was $507 million, a 17% year-over-year increase [17] Company Strategy and Development Direction - The company is focusing on three waves of growth: elevating commercial excellence, accelerating intelligent monitoring, and innovating wearables [9][10] - A strategic partnership with Philips was expanded, aiming to increase market share within Philips' installed base [5][32] - The company is investing in AI and machine learning to enhance its monitoring technologies and develop next-gen wearables [10][11] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the technology's performance, particularly in critical care settings [9] - The company anticipates a strong finish for the year, driven by continued demand and new customer installations [15] - Adjusted EPS guidance was raised, reflecting strong operational improvements and share repurchases [20][22] Other Important Information - The sale of Sound United's assets was completed, with net proceeds of $328 million used for debt repayment and share repurchases [19] - The company plans to provide more details on its product pipeline and long-term financial outlook at the upcoming Investor Day on December 3rd [69] Q&A Session Summary Question: What can be expected for the rest of the year and potential for further outperformance? - Management highlighted strong contracting performance and expected a strong finish in Q4, which would drive consumable growth [25] Question: How does the share buyback impact profitability? - The increase in EPS guidance was partly due to share buybacks and operational improvements, contributing to margin expansion [27] Question: What is the status of enhancing commercial excellence? - The company is focusing on enhancing resources for specialty categories and expects to see momentum pick up into next year [29] Question: Can you provide details on share gains with Philips? - The company noted that it still has a low market share within Philips' installed base and sees significant growth opportunities [32] Question: What is the outlook for consumables growth? - Management indicated that unusual year-over-year comparisons affected consumables growth, but they expect normalization and acceleration in Q4 [40][41] Question: What is the impact of the distributor model shift? - The shift to a distributor model in some international markets is expected to create a $6 million revenue headwind but is seen as a long-term growth strategy [42][44] Question: What is the broader capital allocation framework post-Sound United sale? - The company plans to focus on share repurchases and tuck-in technologies to augment its portfolio [63]
Masimo(MASI) - 2025 Q3 - Earnings Call Presentation
2025-11-04 21:30
Third Quarter 2025 Performance - Non-GAAP revenue grew by 8% on a constant currency basis, reaching $371 million[5] - Non-GAAP operating profit increased by 29% year-over-year to $101 million[5] - Non-GAAP earnings per share grew by 38% year-over-year to $1.32[5] Business Highlights - The incremental value of new contracts was $124 million[5] - Unrecognized contract revenue was $1,714 million[5] - The amount of unrecognized contract revenue expected to be recognized within the next 12 months increased 17% from Q3 2024, reaching $507 million[5] Full Year 2025 Guidance (Non-GAAP) - Revenue is projected to be between $1,510 million and $1,530 million, representing 85% to 100% growth on a constant currency basis[5] - Operating profit is expected to be between $412 million and $424 million[5] - Earnings per share are projected to be between $540 and $555[5] Impact of Tariffs - Updated 2025 guidance incorporates an increase of $16 million to $17 million to cost of sales for fiscal 2025, representing a 110 basis point impact to margin and a 22 cent to 24 cent impact to EPS[30]
Shoulder Innovations to Participate in the Jefferies Global Healthcare Conference
Prnewswire· 2025-11-04 21:05
Core Insights - Shoulder Innovations, Inc. is set to present at the Jefferies Global Healthcare Conference on November 18, 2025, at 8:30 a.m. GMT / 3:30 a.m. EST [1][2] - The company focuses on transforming the shoulder surgical care market with advanced implant systems for shoulder arthroplasty [3] Company Overview - Shoulder Innovations is a commercial-stage medical technology company dedicated to improving shoulder surgical care through an ecosystem that includes preoperative planning, implant design, and procedural efficiency [3] - The company's offerings aim to address clinical and operational challenges in the shoulder surgical care market, delivering predictable outcomes and procedural simplicity [3] Upcoming Events - The live and archived version of the presentation will be available on the Investor Relations section of the Shoulder Innovations website [2]
Novanta (NOVT) - 2025 Q3 - Earnings Call Transcript
2025-11-04 14:30
Financial Data and Key Metrics Changes - Novanta reported record revenue of $248 million for Q3 2025, surpassing guidance, with a reported revenue growth of +1% and organic revenue declines of 4% [5][6] - Adjusted gross margins were 46.5%, up 30 basis points year over year, and adjusted EBITDA margins were above 23% [5][17] - Non-GAAP adjusted earnings per share was $0.87, up 2% year over year and up 14% sequentially [18] Business Line Data and Key Metrics Changes - Medical markets accounted for 53% of year-to-date revenue, intelligent subsystems contributed nearly 30%, and medical consumables represented about 15% of sales, with the latter growing at a high teens rate [8][10] - Advanced surgery business revenue grew 17% year over year, while precision medicine business sales declined 4% year over year but grew sequentially by 3% [24][25] - Robotics and automation applications saw revenue growth driven by demand for products supporting physical AI applications [12] Market Data and Key Metrics Changes - Customer bookings grew 17% year over year and 4% sequentially, indicating a stronger backlog and positive outlook [20] - Sales to China increased by 11% sequentially, with strong design win activity and new product revenue growth [25][26] - The advanced industrial markets showed continued improvement, with normalized order patterns leading to sequential growth in precision manufacturing [13] Company Strategy and Development Direction - Novanta's long-term growth strategy focuses on markets with secular tailwinds such as AI-driven robotics, advanced minimally invasive surgery, and precision medicine [6][9] - The company is investing in regionalized manufacturing and a new ERP system to build a strong foundation for growth and resilience [10] - Novanta aims to deliver sustainable mid-to-high single-digit organic revenue growth with less cyclicality [9] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in returning to positive organic growth and double-digit profit growth in Q4 2025, with expectations for mid-single-digit organic growth for the full year of 2026 [6][31] - The company noted strong momentum in growth platforms, design wins, and new product launches, positioning it well for future performance [15][31] - Management highlighted the importance of customer partnerships and proprietary technology solutions in driving growth [8][10] Other Important Information - Novanta's adjusted gross profit for Q3 2025 was $115 million, with R&D expenses at $24 million and SG&A expenses at $44 million [17] - The company ended Q3 with gross debt of $457 million and a net leverage ratio of approximately 1.7 times [19] - An additional $200 million share buyback program was authorized by the board of directors [19] Q&A Session Summary Question: Update on robotics retail customer contracts - Management confirmed ongoing excitement about a major design win with a large e-commerce player, with deployment expected to start in 2026 [32][33] Question: Potential for revenue and scaling in humanoid robotics - The combined physical AI market opportunity is estimated at $1 billion by 2030, with current deployments still in early stages [34] Question: Progress on regional manufacturing footprint - Management indicated that the transition to regional manufacturing is expected to be completed by the end of Q1 2026, with potential for 100 basis points of margin expansion [36][37] Question: Growth expectations for 2026 across business units - Advanced surgery and robotics are expected to be the higher growth categories, while precision manufacturing is anticipated to return to growth [38][40] Question: Update on tariff-related revenue dynamics - Management noted that solid growth in China and strong design win activity are contributing to the recovery of revenue previously impacted by tariffs [44][45] Question: Outlook for DNA sequencing and EUV business - The DNA sequencing business is not expected to grow, while the EUV business is anticipated to gain momentum in 2026 [46][47] Question: Recognition of the $50 million warehouse automation opportunity - Management confirmed that bookings and revenue from the warehouse automation opportunity are expected to materialize in 2026 [49][50]