Company Overview - Pulmonx Corporation is a global leader in minimally invasive treatments for chronic obstructive pulmonary disease (COPD) [2] - The company’s key products include the Zephyr Endobronchial Valve, Chartis Pulmonary Assessment System, LungTrax™ Platform, and StratX Lung Analysis Reports, which are designed for patients with severe emphysema/COPD [2] - The Zephyr Valve has received FDA pre-market approval and is recognized as a "breakthrough device," being commercially available in over 25 countries and included in global treatment guidelines [2] Upcoming Events - Pulmonx will present at the Goldman Sachs 46th Annual Global Health Care Conference in Miami on June 11, 2025, at 7:00 AM PT / 10:00 AM ET [1] - A live and archived webcast of the presentation will be accessible on the "Investors" section of the Pulmonx website [1]

CARLSBAD, Calif., May 28, 2025 (GLOBE NEWSWIRE) -- Aurora Spine Corporation (“Aurora Spine” or the “Company”) (TSXV: ASG) (OTCQB: ASAPF), a leader in spine and interventional spine technology that improves spinal surgery outcomes, today announced it will participate in a webcast presentation and host one-on-one meetings with investors at the Lytham Partners Spring 2025 Investor Conference, taking place virtually on Thursday, May 29, 2025. Company Webcast The webcast presentation will take place at 10:15 a. ...

NEW YORK, May 28, 2025 (GLOBE NEWSWIRE) -- WHY: Rosen Law Firm, a global investor rights law firm, reminds purchasers of securities of Treace Medical Concepts, Inc. (NASDAQ: TMCI) between May 8, 2023 and May 7, 2024, both dates inclusive (the “Class Period”), of the important June 10, 2025 lead plaintiff deadline. SO WHAT: If you purchased Treace Medical securities during the Class Period you may be entitled to compensation without payment of any out of pocket fees or costs through a contingency fee arrang ...

Core Insights - NeuroPace announced promising preliminary one-year results from its pivotal NAUTILUS trial, evaluating the RNS System for idiopathic generalized epilepsy (IGE), marking a significant milestone in neuromodulation therapy [1][2] - The trial's strong enrollment and retention rates position NeuroPace to expand its therapeutic reach and enhance its clinical value proposition, supporting potential FDA submission [2][4] Company Performance - Following the announcement, NeuroPace's shares fell by 28.4%, closing at $12.66, although the stock has gained 13.1% year-to-date compared to the industry's 11.2% decline [3] - The company currently has a market capitalization of $579.9 million and expects earnings to improve by 6.5% in 2025 year-over-year [5] NAUTILUS Trial Details - The NAUTILUS trial is a pivotal Phase 3 study assessing the safety and effectiveness of the RNS System in patients aged 12 and older with drug-resistant seizures, with 87 patients enrolled across 23 centers [6][8] - The trial met its primary safety endpoint, reporting a low incidence of serious adverse events, while a subgroup with lower baseline seizure frequency showed significant therapeutic benefits [9][10] Clinical Outcomes - The one-year data from the trial demonstrated consistent clinical improvements, including a robust median seizure reduction and increased responder rates, with improvements continuing into the second year [10]

Financial Data and Key Metrics Changes - For the three months ended 03/31/2025, revenue was $725,000 compared to $743,000 for the same period in 2024, indicating a slight decrease [12] - Gross profit for the same period was $218,000, down from $269,000 year-over-year, with gross margin decreasing from 36% to 30% [12] - Total operating expenses were $3,880,000, slightly down from $3,920,000 in the previous year [12] - Net loss was $3,590,000 or $0.06 per share, compared to a net loss of $3,610,000 or $0.08 per share for the same period last year [12] - As of 03/31/2025, cash equivalents were approximately $6,000,000, increasing to about $6,200,000 by 05/27/2025, which includes a $2,000,000 unsecured bridge loan [12][11] Business Line Data and Key Metrics Changes - The revenue increase was primarily driven by sales in North America and Europe, while sales in Asia declined significantly [12] - The company continues to expect revenue and gross profit to fluctuate quarter to quarter as it builds out its commercial infrastructure [12] Market Data and Key Metrics Changes - In North America, revenue increased by approximately 11% year-over-year, while Europe saw a 60% increase [29] - Sales in Asia experienced a decline of about 60%, with other parts of Asia declining by approximately 40% [29] Company Strategy and Development Direction - The company is focused on obtaining FDA marketing authorization for ProSense, which is expected to be a first-in-class minimally invasive option for early-stage breast cancer treatment [5][8] - Following FDA approval, the company plans to commence commercial sales while running a post-market study, which could lead to additional reimbursement opportunities [7][9] - The company is also preparing for potential regulatory filings and approvals in Japan and Israel [9] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism regarding the FDA's review of the post-market study plan, viewing it as a positive signal for future marketing authorization [6][7] - The company anticipates that the post-market study will drive further interest in ProSense and accelerate adoption in the market [44] Other Important Information - The company raised $2,650,000 in net proceeds from the sale of ordinary shares under its at-the-market offering facility between 01/13/2025 and 05/27/2025 [14] - The company maintains a supportive relationship with its largest shareholder, who provided a $2,000,000 unsecured loan [10] Q&A Session Summary Question: Is the post-market study expected to involve a minimum of 400 patients over 25 sites? - Yes, the post-market study will require 400 patients in at least 25 sites, but the FDA cannot guarantee a specific response time for the submission [18][19] Question: How long is the post-market study expected to take? - The recruitment for the study is expected to be completed within three years [21][22] Question: Can you provide more details on the potential for expanded reimbursement? - The company believes it can increase reimbursement rates after obtaining more records and claims under the CPT3 code, and plans to apply for a CPT1 code post-authorization [23][24] Question: What is the size of the breast cancer patient population in Japan? - The total number of new breast cancer cases in Japan is between 100,000 and 105,000 annually, with a significant portion being low-risk early-stage cases [25][26] Question: What was the geographic breakdown of revenue this quarter? - North America saw an 11% increase in revenue, while Europe experienced a 60% increase; however, Asia saw a decline of about 60% [29][30] Question: Is ProSense subject to any new tariffs for U.S. markets? - Yes, the company is currently affected by tariffs imposed by the U.S. Administration, but the situation is still evolving [36][37] Question: Will the sales team expand after post-market approval? - Yes, the company plans to increase its sales team following marketing authorization [38] Question: What are the pricing and sales strategies for ProSense? - The company plans a mix of placement and outright sales, requiring commitments for probe usage over a period [40]

Core Viewpoint - Abbott Laboratories has received FDA approval for its Tendyne transcatheter mitral valve replacement system, enhancing its Structural Heart portfolio and providing a minimally invasive solution for patients with severe mitral annular calcification [1][5][6]. Company Summary - Abbott's stock increased by 1.3% to $132.94 following the announcement of the Tendyne system approval [2]. - The company has a market capitalization of $231.29 billion and an earnings yield of 3.9%, significantly higher than the industry average of 0.6% [4]. - Abbott's Structural Heart division includes a diverse product range, such as MitraClip and TriClip, which positions the company favorably in the market [3]. Product Importance - The Tendyne system addresses mitral valve diseases caused by severe mitral annular calcification, offering a less invasive alternative for high-risk patients who may not be suitable for open-heart surgery [5]. - The system's innovative design allows for adaptability to various patient anatomies, with a self-expanding valve that can be repositioned during implantation [6]. Industry Prospects - The transcatheter mitral valve replacement market is expected to grow at a compound annual growth rate of 20% from 2025 to 2030, driven by the rising prevalence of mitral valve diseases and a preference for minimally invasive procedures [8]. Stock Performance - Over the past year, Abbott's shares have increased by 32%, outperforming the industry growth of 10.3% [11].

Core Insights - Nexalin Technology, Inc. is hosting a webinar on June 3, 2025, to discuss its innovative approach to mental healthcare using its proprietary Deep Intracranial Frequency Stimulation (DIFS™) technology [1][2] - The company is positioned in a $537 billion mental health market, with international regulatory approvals and U.S. expansion plans underway [2] - Nexalin's technology includes real-time AI-driven patient monitoring and aims to provide scalable, at-home treatment options [2] Company Overview - Nexalin designs and develops non-invasive neurostimulation products aimed at addressing the global mental health epidemic [4] - The company's devices are believed to penetrate deep brain structures associated with mental health disorders, enhancing patient response without adverse side effects [4] - The Nexalin Gen-2 15 milliamp neurostimulation device has received approval in China, Brazil, and Oman [4]

Company Developments - Illumina, Inc. has received approval from Japan's Ministry of Health, Labour and Welfare for its TruSightTM Oncology (TSO) Comprehensive test, aimed at enhancing precision oncology accessibility [1] - The TSO Comprehensive is the first U.S. FDA-approved comprehensive genomic profiling in vitro diagnostics kit with pan-cancer companion diagnostics claims [5] - The test analyzes DNA and RNA variants across more than 500 genes, aiding in the identification of clinically actionable biomarkers for targeted therapy selection [6] - Illumina's oncology portfolio is set to be showcased at the ASCO Annual Meeting in Chicago from May 30 to June 3 [2] Financial Performance - Following the announcement of the TSO Comprehensive approval, Illumina's stock price increased by 2.6%, closing at $82.49 [3] - The company has a market capitalization of $12.72 billion and an earnings yield of 5.3%, significantly higher than the industry's -31.5% yield [4] - Illumina has achieved an earnings beat of 56.4% on average over the trailing four quarters [4] Industry Prospects - The global precision genomic testing market was valued at $15.49 billion in 2024 and is projected to grow at a compound annual growth rate of 14.8% through 2030 [7] - The rising demand for precision genomic testing is driven by the need for early disease detection and effective treatment planning [7] Other Developments - Illumina launched the DRAGEN version 4.4 software, which includes oncology applications for clinical research and supports new multiomics assays [8][10] - The company is collaborating with Ovation.io, Inc. to develop a large clinical multiomic dataset from 25,000 patients, aimed at advancing drug discovery [10]

Align Technology (ALGN) 2025 Conference Summary Company Overview - **Company**: Align Technology (ALGN) - **Event**: 2025 Stifel Jaws and Paws Conference - **Date**: May 28, 2025 Key Points Industry and Market Dynamics - **Overall Market Growth**: Align Technology reported double-digit growth in Asia and Europe, while North America remained relatively flat [4][20] - **Consumer Confidence**: The company noted a divergence between Google Trends and consumer confidence indices, suggesting that both metrics should be considered together for a comprehensive view of market interest [8][11] - **Geographic Performance**: - **APAC**: Strong growth due to stable economies post-COVID, with Japan and China performing well [21][22] - **EMEA**: Mixed results with strong performance in Spain, Italy, and the UAE, while Germany faced challenges [24] Financial Performance and Guidance - **Revenue Guidance**: The company raised its revenue guidance for 2025, attributing this to favorable foreign exchange rates and consistent volume growth [15][17] - **Gross Margin**: The gross margin was reported at 22.5%, with efforts to offset tariff impacts and improve productivity [17][18] - **Long-Range Plan (LRP)**: The company expressed confidence in achieving double-digit growth in APAC and EMEA, with modest growth expected in North America [42][43] Product and Innovation - **New Products**: Introduction of new products like IPE and MAOB aimed at expanding market reach, particularly in the teen segment [25][29] - **Conversion Tools**: Enhanced conversion rates through new tools that allow immediate treatment simulations during patient consultations [12][13] - **Direct Fabrication**: The company is transitioning to direct fabrication, which is expected to be dilutive in 2025 and 2026 but accretive by 2027 due to material cost savings [61][63] Competitive Landscape - **Market Competition**: Align Technology acknowledged increased competition but noted a more respectful pricing strategy among competitors as the market growth slows [75][78] - **Pricing Strategy**: The company is focused on maintaining pricing integrity while navigating the competitive landscape, particularly against lab-based players [76][79] Strategic Initiatives - **Advertising Strategy**: The company plans to increase direct-to-consumer advertising for new products once they gain traction in the market [30][31] - **Sales Force Engagement**: Strengthening relationships with partners like Heartland to drive consumer demand and leverage distribution channels [27][28] Miscellaneous Insights - **Tariff Impact**: The company is managing a monthly tariff impact of approximately $1 million, primarily affecting scanner flows from Israel to the U.S. [17] - **Technological Advancements**: The introduction of the Lumina platform is expected to set a new standard in intraoral scanning technology, enhancing operational efficiency [50][52] This summary encapsulates the key insights and strategic directions discussed during the Align Technology conference, highlighting the company's performance, market dynamics, and future growth prospects.

Boston Scientific (BSX) FY 2025 Conference May 28, 2025 08:00 AM ET Speaker0 Thanks everybody for coming. I'm Lee Hambrite, US med tech analyst at Bernstein. We are very pleased to host Boston Scientific today. We've got chairman and CEO Mike Mahoney Speaker1 and chief medical officer doctor Ken Stein. Thanks so much guys for being here. Pleasure. For those of you in the audience, if you would like to ask a question, you could submit it via the pigeonhole tool, and I will try to work in as many as I can her ...