GALWAY, Ireland and CHICAGO, March 30, 2025 /PRNewswire/ -- Medtronic plc (NYSE: MDT), a global leader in healthcare technology, today announced late-breaking data on five-year outcomes from the Evolut Low Risk Trial. Data shows, versus surgery, the Evolut™ transcatheter aortic valve replacement (TAVR) system delivers a numerically lower rate of all-cause mortality or disabling stroke at five years, strong valve performance and durable clinical outcomes. The findings were presented as late-breaking clinical ...

Core Insights - Daxor Corporation is expanding its ezBVA Lab service into three regional healthcare facilities across the U.S., enhancing blood volume analysis capabilities and improving patient outcomes while reducing costs [2][3] - The ezBVA Lab provides comprehensive blood volume analysis results within 24 hours for both inpatient and outpatient settings, showcasing the efficiency and effectiveness of Daxor's technology [2][3] - Daxor's BVA technology has been integrated into various healthcare settings, including a prominent Midwest academic medical center and a leading cardiovascular institute in New Jersey, indicating its growing significance in modern healthcare [3][6] Company Overview - Daxor Corporation is recognized as the global leader in blood volume measurement technology, with its BVA-100® being the only FDA-cleared diagnostic blood test for quantifying blood volume status [4] - Over 65,000 tests have been performed at leading hospital centers across the U.S., significantly reducing mortality and readmissions in heart failure and critical care [4] - Daxor is involved in ongoing trials for heart failure treatment supported by the NIH and is developing analyzers for combat casualty care in collaboration with the U.S. Department of Defense [4]

Financial Data and Key Metrics Changes - In Q4 2024, total GAAP costs and expenses increased by $7.7 million to $20.3 million compared to $12.5 million in the prior year period, primarily driven by an increase in non-cash stock-based compensation [55] - GAAP net loss in Q4 2024 was $19.4 million compared to $11.9 million in the prior year period, while non-GAAP net loss was $10.4 million compared to $8.3 million in the prior year period [56] - Cash and cash equivalents totaled $118 million as of December 31, 2024, compared to $44.4 million as of December 31, 2023 [57] Business Line Data and Key Metrics Changes - The company is advancing commercialization of its soft tissue ablation device, the Percutaneous Electrode, which has broad market clearance for the ablation of soft tissue, particularly for benign thyroid disease [23][27] - The surgical cardiac clamp for treating atrial fibrillation is undergoing a feasibility study in Europe, with 30 patients treated so far [36] - The 360 Catheter system for AF ablation is designed to deliver nanosecond PFA technology, targeting a $3 billion annual U.S. market for ablation catheters [40] Market Data and Key Metrics Changes - The U.S. sees approximately 250,000 patients diagnosed with benign thyroid nodules annually, with about 150,000 opting for thyroidectomy [25] - The market for atrial fibrillation treatment is significant, with over 1.9 million patients diagnosed annually in the U.S. [40] - The company expects nanosecond PFA to capture a significant share of the AF treatment market, expanding from 20% in 2024 to 40%-50% in 2025 [41] Company Strategy and Development Direction - The company aims to advance commercialization of its soft tissue ablation device and initiate pivotal studies for its cardiac catheter and surgical clamp [22] - A hybrid business model will be implemented to efficiently enter markets, either through direct sales or partnerships with established companies [48][49] - The focus is on leveraging its differentiated technology across multiple clinical programs while maintaining operational excellence [53][50] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the unique nanosecond PFA technology's potential to disrupt multiple clinical applications and improve patient outcomes [11][12] - The company is optimistic about its growth trajectory, with a strong balance sheet and a commitment to advancing its clinical programs [10][21] - Management highlighted the importance of robust clinical evidence to drive adoption and validate the technology's effectiveness [45] Other Important Information - The company has received seven FDA clearances and has treated 6,000 patients, indicating a mature platform for future growth [17] - The company has a portfolio of over 180 issued patents covering various systems and methods for nanosecond pulse therapies [18] - The new CFO, Jon Skinner, has joined the company and is expected to contribute significantly to its growth and operational strategies [50][53] Q&A Session Summary Question: What are the company's expectations for the commercialization of its products? - The company is focused on advancing the commercialization of its soft tissue ablation device and initiating pivotal studies for its cardiac catheter and surgical clamp [22] Question: How does the company plan to address the competitive landscape? - The company will implement a hybrid business model to efficiently enter markets, either through direct sales or partnerships with established companies [48][49] Question: What is the outlook for the nanosecond PFA technology? - Management expressed confidence in the technology's potential to disrupt multiple clinical applications and improve patient outcomes [11][12]

Financial Data and Key Metrics Changes - In Q4 2024, total GAAP costs and expenses increased by $7.7 million to $20.3 million compared to $12.5 million in the prior year period, primarily driven by an increase in non-cash stock-based compensation [55] - GAAP net loss in Q4 2024 was $19.4 million compared to $11.9 million in the prior year period, while non-GAAP net loss was $10.4 million compared to $8.3 million in the prior year period [56] - Cash and cash equivalents totaled $118 million as of December 31, 2024, compared to $44.4 million as of December 31, 2023 [57] Business Line Data and Key Metrics Changes - The company is advancing commercialization of its soft tissue ablation device, the Percutaneous Electrode, which has broad market clearance for the ablation of soft tissue, particularly for benign thyroid disease [23][27] - The surgical cardiac clamp for treating atrial fibrillation is undergoing a feasibility study in Europe, with 30 patients treated so far [36] - The 360 Catheter system for atrial fibrillation ablation is designed to deliver nanosecond PFA technology, with an estimated $3 billion annual U.S. market for ablation catheters [40] Market Data and Key Metrics Changes - The U.S. market sees approximately 250,000 patients diagnosed with benign thyroid nodules annually, with about 150,000 opting for thyroidectomy [25] - The company estimates a prevalence of approximately 2 million patients in the watchful waiting category for benign thyroid disease, indicating a significant market opportunity [26] - The annual U.S. market for atrial fibrillation ablation is estimated at $3 billion, with PFA expected to be used in 20% of global AF cases in 2024, expanding to 40% to 50% in 2025 [40][41] Company Strategy and Development Direction - The company aims to advance commercialization of its soft tissue ablation device and initiate pivotal studies for its cardiac catheter and surgical clamp [22] - A hybrid business model will be implemented to efficiently enter markets, either through direct sales or partnerships with established companies [48][49] - The focus is on leveraging differentiated technologies backed by strong clinical evidence to disrupt existing treatment paradigms [47] Management's Comments on Operating Environment and Future Outlook - The CEO expressed confidence in the company's unique nanosecond PFA technology and its potential to improve patient outcomes across various medical conditions [11][15] - Management highlighted the importance of clinical data in validating the technology and driving adoption [45] - The company is optimistic about its growth prospects in 2025, with several important milestones set to be achieved [19][22] Other Important Information - The company has received seven FDA clearances and has treated 6,000 patients, indicating a mature platform for its technologies [17] - The company has a portfolio of over 180 issued patents covering various systems and methods for nanosecond pulse therapies [18] - The new CFO, Jon Skinner, has joined the company and is expected to contribute significantly to its growth and operational excellence [50][53] Q&A Session Summary - No questions were raised during the Q&A session, and the call concluded with closing remarks from the CEO [58][60]

Financial Data and Key Metrics Changes - Research and development revenue for Q4 2024 was $7.6 million, up from $5.3 million in the prior year, reflecting increased work under the BARDA PBS contract [19] - Full year 2024 R&D revenue reached $29.6 million, a 63.5% increase from $18.1 million in 2023, marking the highest revenue in the company's history [21] - Gross margin for Q4 2024 declined to 44% from 46.1% in the prior year, primarily due to a smaller percentage of direct labor on the BARDA PBS contract [20] - General and administrative expenses decreased to $4.6 million in Q4 2024 from $5.4 million in the prior year [21] - Cash and cash equivalents as of December 31, 2024, totaled $5.2 million, with a current cash position exceeding $14 million following long-term debt financing [22][24] Business Line Data and Key Metrics Changes - The DeepView system demonstrated exceptional performance in a burn validation study, achieving 86.6% sensitivity compared to 40.8% from clinicians [10] - The DICE score for the AI algorithm reached 68.5%, significantly outperforming the 39.2% from burn physicians [10] - The company plans to submit results to the FDA by the end of Q2 2025, seeking de novo classification in 2026 [11] Market Data and Key Metrics Changes - The company has successfully deployed three DFU systems in Australia at leading hospitals, enhancing its presence in the UK and Australia [14] - The response to the DeepView system in the UK and Australia has been exceptional, with strong enthusiasm from medical specialists [13] Company Strategy and Development Direction - The company is focused on advancing its DeepView technology for wound and burn assessment, with a commitment to commercialization following FDA clearance [6][11] - A dedicated intellectual property subsidiary, Spectral IP, was formed to monetize IP assets, with plans to spin off into an independent publicly traded company [17][18] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the company's growth prospects and the successful execution of its strategic objectives [26] - The company anticipates a revenue forecast of approximately $21.5 million for fiscal year 2025, reflecting a step back in revenue as it prepares for FDA submission [25][43] Other Important Information - The company has reduced monthly operating losses from $4.6 million in the first half of 2024 to approximately $2 million in the second half [23] - The company has satisfied approximately $10.1 million of its short-term debt, enhancing its financial foundation [24] Q&A Session Summary Question: Plans for commercialization and staffing - The company plans to precondition the market with studies and mobilize a sales force as it anticipates FDA clearance [30] Question: Revenue guidance for 2025 - The company expects a slight revenue decrease in 2025 as it positions for FDA submission, with a ramp-up anticipated in 2026 [42][43] Question: Details on the FDA submission process - The submission will include a comprehensive package reviewed by BARDA before submission to the FDA [45][46] Question: DICE score significance and FDA perspective - The DICE score is crucial for evaluating segmentation tasks and provides a balanced view of the model's performance [50][51] Question: Future deployments in Australia and the UK - The company does not plan to expand the number of units but will focus on deeper utilization and feedback from existing sites [53] Question: Timeline for pediatric study data - The pediatric study data is merged with adult data, and preliminary processing has been completed [58][63] Question: Development milestones for DPU Snapshot M - The company is gathering feedback from military users and plans to submit further applications in 2026 [64] Question: Learnings from the UK deployment - Positive feedback has been received, and the company anticipates sharing data at upcoming scientific meetings [70]

Core Viewpoint - Urteste S.A. plans to initiate clinical trials for its pancreatic cancer diagnostic test, Panuri, in Europe in Q3 2025, with a focus on obtaining certification and advancing towards commercialization [1][3]. Group 1: Clinical Trials and Regulatory Process - The clinical trials for the Panuri test will involve 550 patients and will be conducted in Poland and selected EU countries [2]. - Urteste is preparing the trial protocol in collaboration with Avania and will announce a tender for a Contract Research Organization (CRO) in Q2 2025 [2]. - The company will hold its fourth Q-submission meeting with the FDA in mid-2025 to finalize details for U.S. trials, with previous meetings yielding positive insights into regulatory expectations [3]. Group 2: Technology and Product Development - Urteste's technology detects cancer through enzyme activity measurement in urine samples, which can indicate the presence of cancer by changing urine color intensity [5][6]. - The company has developed 12 prototype diagnostic tests for various cancers, which account for nearly 70% of global cancer-related deaths [4]. - By mid-2025, Urteste will complete the internal validation of the Panuri test, which will be utilized in both European and U.S. clinical trials [4].

Company Overview - Nexalin Technology, Inc. is focused on developing innovative neurostimulation products aimed at addressing the global mental health epidemic, utilizing non-invasive bioelectronic medical technology [4] - The company's neurostimulation devices are designed to penetrate deep brain structures associated with mental health disorders, potentially enhancing patient response without adverse side effects [4] Upcoming Event - Nexalin will host a webinar on April 3, 2025, at 4:15 p.m. ET, featuring CEO Mark White, who will discuss the company's clinical data and advancements in its Gen-3 HALO™ Clarity & Virtual Clinic model [2][3] - The webinar will include a live Q&A session, allowing investors to engage directly with the CEO [2] Market Potential - Nexalin's solutions have demonstrated clinically meaningful improvements in treating conditions such as insomnia, PTSD, and traumatic brain injuries, which affect millions and have limited effective treatments [2] - The mental health market is projected to reach $537 billion by 2030, indicating substantial growth potential for Nexalin's products [2]

YOKNEAM, Israel, March 26, 2025 /PRNewswire/ -- InMode Ltd. (Nasdaq: INMD), a leading global provider of innovative medical technologies, today announced that Moshe Mizrahy, Chief Executive Officer, and Yair Malca, Chief Financial Officer, will present at the 24th Annual Needham Virtual Healthcare Conference on April 8, 2025.The fireside chat, moderated by Michael Matson, Senior Equity Analyst, is scheduled for 2:15 pm Eastern Time on Tuesday, April 8, and a live webcast of the presentation can be accessed ...

Core Viewpoint - Creative Medical Technology Holdings, Inc. (CELZ) has been upgraded to a Zacks Rank 2 (Buy), indicating a positive trend in earnings estimates which is a significant factor influencing stock prices [1][4]. Earnings Estimates and Revisions - The Zacks rating system is based on changes in earnings estimates, tracking EPS estimates from sell-side analysts through a consensus measure known as the Zacks Consensus Estimate [2]. - The company is projected to earn -$2.03 per share for the fiscal year ending December 2025, reflecting a year-over-year change of 45.3% [9]. - Over the past three months, the Zacks Consensus Estimate for Creative Medical Technology Holdings has increased by 9.4% [9]. Impact of Institutional Investors - Changes in a company's future earnings potential, as indicated by earnings estimate revisions, are strongly correlated with near-term stock price movements, largely due to institutional investors who adjust their valuations based on these estimates [5]. - An increase in earnings estimates typically leads to higher fair value for a stock, prompting institutional investors to buy or sell, which in turn affects stock prices [5]. Zacks Rank System - The Zacks Rank stock-rating system classifies stocks into five groups based on earnings estimates, with Zacks Rank 1 (Strong Buy) stocks historically generating an average annual return of +25% since 1988 [8]. - The upgrade of Creative Medical Technology Holdings to a Zacks Rank 2 places it in the top 20% of Zacks-covered stocks, indicating a strong potential for market-beating returns in the near term [11].

Lucid Diagnostics - Lucid Diagnostics的EsoGuard在2024年第四季度的收入为120万美元[12]，测试量为4042，环比增长45%[12] - Highmark Blue Cross Blue Shield in New York 建立了EsoGuard的积极商业保险覆盖政策[12] - NCCN临床实践指南更新，包括食管癌前病变筛查，与ACG等专业协会指南保持一致[12] Veris Health - 完成了一项私募融资，总收益约为240万美元[16]，Veris普通股的定价为3500万美元的税前估值[16] - 与俄亥俄州立大学詹姆斯癌症医院的试点项目延长至2025年4月[16] Financial Performance - 截至2024年第四季度末，公司持有的现金为118.5万美元[21]，高于第三季度的76.5万美元[21]，增加了42万美元[21] - 2024年第四季度的收入为1万美元[23]，低于2023年第四季度的104.9万美元[23]，减少了103.9万美元[23] - 2024年第四季度的运营费用为519.8万美元[23]，低于2023年第四季度的1743.3万美元[23]，减少了1223.5万美元[23] - 2024年第四季度的净利润为114.2万美元[23]，而2023年第四季度的净亏损为1740.8万美元[23]，增加了1855万美元[23]