Core Insights - Aurora Spine Corporation will participate in the 2025 North American Spine Society Annual Meeting, showcasing its innovative medical devices for spinal surgery [2][3] Company Innovations - The company will feature the newly launched Hydra ANATOMIC. ELEVATED. RIGID. OSTEOFIXATION Facet Fusion System and DEXA-L, a stand-alone device for anterior lumbar interbody fusion (ALIF) procedures, as part of its patented DEXA™ Technology Platform [4] - DEXA-L is noted as the first bone-mimicking™ structural implant designed to align with individual patient bone density and T-Score, representing a significant advancement in personalized spinal care [5] Event Participation - The North American Spine Society Annual Meeting will take place from November 14-16, 2025, at the Colorado Convention Center in Denver, Colorado, providing a platform for Aurora Spine to connect with industry professionals [2][3] - Live demonstrations of the new products will be available at Booth 1622, allowing attendees to engage with the company's team [5]

Core Viewpoint - The lawsuit against Inspire Medical Systems, Inc. alleges that the company made false statements regarding the demand and launch of its implantable medical device for obstructive sleep apnea, leading to significant investor losses [3][4]. Group 1: Lawsuit Details - The class action lawsuit is on behalf of investors who purchased Inspire securities from August 6, 2024, to August 4, 2025, alleging misleading statements and failure to disclose poor demand and inventory issues [3]. - The lawsuit claims that Inspire Medical failed to complete essential tasks for a successful product launch, contrary to the company's assurances to investors [3]. Group 2: Impact of Company Disclosure - On August 4, 2025, Inspire disclosed that the launch of Inspire V was delayed due to incomplete training and onboarding at treatment centers, which affected the ability to bill for procedures [4]. - The company admitted to poor demand for Inspire V, resulting in a reduction of its 2025 earnings guidance by over 80%, causing a significant drop in share price from $129.95 to $87.91, a decline of approximately 32.35% [4].

Core Viewpoint - Rosen Law Firm has initiated a class action lawsuit on behalf of investors who purchased common stock of Inspire Medical Systems, Inc. during the specified Class Period, highlighting potential misrepresentation regarding the market demand for the Inspire V sleep apnea device [2][6]. Group 1: Class Action Details - The class action lawsuit pertains to purchases made between August 6, 2024, and August 4, 2025, and aims to address alleged misleading statements made by the defendants regarding the demand and launch of the Inspire V device [2][6]. - Investors who purchased Inspire Medical common stock during the Class Period may be eligible for compensation without incurring out-of-pocket fees through a contingency fee arrangement [3]. Group 2: Legal Process and Participation - Interested investors can join the class action by submitting a form or contacting the law firm directly, with a deadline to serve as lead plaintiff set for January 5, 2026 [4][7]. - It is noted that no class has been certified yet, meaning investors are not represented by counsel unless they choose to retain one [8]. Group 3: Rosen Law Firm's Credentials - Rosen Law Firm is recognized for its success in securities class actions, having achieved significant settlements, including the largest securities class action settlement against a Chinese company [5]. - The firm has consistently ranked highly in securities class action settlements, recovering hundreds of millions of dollars for investors, with over $438 million secured in 2019 alone [5].

Core Insights - Anteris Technologies Global Corp. reported financial results for Q3 2025 and highlighted significant progress in regulatory approvals for the PARADIGM Trial in both Europe and the U.S. [1][3] Business & Operations - The company engaged positively with the FDA to advance the Investigational Device Exemption (IDE) for the PARADIGM Trial, with U.S. patient recruitment approval announced in November 2025 [4][8] - European regulatory activities progressed, with the first approval for the PARADIGM Trial secured in Denmark in October 2025, and the first patients treated in Denmark following this approval [5][8] - Operational infrastructure was strengthened, including advancements in quality management systems and manufacturing scale-up to support clinical activities and ISO 13485 certification for DurAVR THV production [6][8] Financial Performance - For the nine months ended September 30, 2025, the company's net operating cash outflows were $59.3 million, reflecting increased clinical, regulatory, and manufacturing requirements [9] - Research and Development (R&D) expenses for Q3 2025 were $16.8 million, primarily for preparatory activities related to the PARADIGM Trial and manufacturing capability upscaling [9] - The company held $9.1 million in cash and cash equivalents as of September 30, 2025 [9] PARADIGM Trial Overview - The PARADIGM Trial is a prospective randomized controlled trial designed to evaluate the safety and effectiveness of the DurAVR THV compared to commercially available transcatheter aortic valve replacements (TAVRs) [11][12] - Approximately 1,000 patients will be enrolled across the U.S., Europe, and Canada, with a primary endpoint assessing non-inferiority on all-cause mortality, stroke, and cardiovascular hospitalization at one year post-procedure [12][13] - The trial aims to provide robust clinical evidence to support an application for Premarket Approval (PMA) in the U.S. and CE Mark approval in Europe [13]

We also encourage you to contact Brian Schall of the Schall Law Firm, 2049 Century Park East, Suite 2460, Los Angeles, CA 90067, at 310-301-3335, to discuss your rights free of charge. You can also reach us through the firm's website at www.schallfirm.com, or by email at bschall@schallfirm.com. The class, in this case, has not yet been certified, and until certification occurs, you are not represented by an attorney. If you choose to take no action, you can remain an absent class member. According to the Co ...

Financial Data and Key Metrics Changes - Total worldwide revenue for Q3 2025 was $21.5 million, a 5% increase from $20.4 million in Q3 2024, and a 4% increase on a constant currency basis [12] - US revenue in Q3 2025 was $14 million, a 1% increase from $13.8 million in the prior year [12] - International revenue for Q3 2025 was $7.5 million, a 15% increase compared to $6.6 million in the same period last year [12] - Gross margin for Q3 2025 was approximately 75%, up from 74% in the same period last year [12] - Net loss for Q3 2025 was $14 million, or $0.34 per share, compared to a $14.1 million net loss, or $0.36 per share, for the same period last year [15] - Adjusted EBITDA loss for Q3 2025 was $8.2 million, compared to $8.1 million in Q3 2024 [15] - Full year 2025 revenue guidance is updated to a range of $89-$90 million [16] Business Line Data and Key Metrics Changes - Research and development expenses for Q3 2025 were $4.8 million, an increase of 29% compared to $3.7 million in the prior year [13] - Sales, general, and administrative expenses for Q3 2025 were $25.6 million, up 1% from $25.4 million in Q3 2024 [14] Market Data and Key Metrics Changes - The company added nine new US centers during Q3 2025 [12] - Growth in international revenue was driven by major markets in Europe, partially offset by a reduction of revenue from China [12] Company Strategy and Development Direction - The company aims to improve execution and accelerate profitable growth while focusing on areas with the highest return on capital [9][10] - The management acknowledges the need to realign spending with growth expectations to return to a sustainable path to profitability [9] - The company plans to prioritize projects that deliver the greatest impact and align with sustainable, profitable growth [17] Management's Comments on Operating Environment and Future Outlook - Management recognizes challenges in the US market, including slowed growth and the need for improved execution [8][9] - There is optimism about the potential to enhance growth by aligning underperforming territories with those performing well [9] - The management is committed to extending the cash runway and improving operating leverage [15][44] Other Important Information - The company has a market-leading product, the Zephyr valves, which fulfill a significant unmet need in severe emphysema patients [6] - The company has established sufficient reimbursement for its products in nearly all countries where it operates [7] Q&A Session Summary Question: Exploration of alternate strategic pathways - Management is focused on ensuring profitable business operations and is not ready to speculate on alternative strategies at this early stage [20][22] Question: Reasons for US growth deceleration despite new center additions - Management acknowledges the complexity of the situation and is optimistic about improving performance in underperforming territories [23] Question: Addressing patient referral and workup process complexities - Management agrees on the complexity and emphasizes the need for efficient processes to move patients through treatment [26][27] Question: Guidance revision and confidence in achieving targets - Management provides a realistic view on guidance, acknowledging that some growth initiatives have not met expectations but sees opportunities for improvement [36][38] Question: Extending cash runway and reallocating expenses - Management confirms that extending the cash runway involves reallocating expenses to areas with better returns rather than seeking external financing [42][44] Question: Specific areas to pull back on in strategy - Management is not ready to discuss specific areas for pullback but is analyzing data to make informed decisions moving forward [46][47]

Financial Data and Key Metrics Changes - As of September 30, 2025, the company had a cash balance of approximately $5.8 million [14] - Consolidated operating expenses for the three months ended September 30, 2025, were approximately $1.5 million, down by approximately $1.4 million, or 48%, from $2.9 million in the same period of 2024 [14][15] - Operating loss for the quarter decreased to $1.5 million compared to $2.8 million in the prior year period [16] Business Line Data and Key Metrics Changes - The company is conducting an Australian oncology trial of the chemopurifier, with three participants in cohort one completing treatments without complications [5] - The trial aims to monitor safety and feasibility, focusing on the incidence of adverse events and changes in blood tests following treatments [6][8] Market Data and Key Metrics Changes - The company is exploring the implications of extracellular vesicles (EVs) in various diseases, including Long COVID, which affects approximately 400 million individuals worldwide [11][12] Company Strategy and Development Direction - Aethlon Medical is focusing on the chemopurifier's application in oncology and Long COVID, with plans to submit preclinical data for publication [12][24] - The company is working to accelerate patient enrollment in clinical trials through various strategies, including digital marketing and additional investigative sites [6][35] Management's Comments on Operating Environment and Future Outlook - Management acknowledged the challenges in recruiting patients for the oncology trial, citing the complexity of the treatment and the need for thorough explanations to potential participants [34] - The company is optimistic about the potential for EV reductions to be relevant in multiple indications, while also emphasizing the need to focus resources effectively [24][26] Other Important Information - The next earnings call for the fiscal third quarter ending December 31, 2025, will coincide with the filing of the quarterly report in February 2026 [17] Q&A Session Summary Question: Understanding recruitment for cohort two - Management discussed the importance of explaining the trial's observations to investigators to aid in patient recruitment [19] Question: Follow-up on cohort one participants - Management clarified that while they are following cohort one participants clinically, there is no additional EV or T cell data expected beyond the initial eight-week follow-up [20] Question: Timeline for completion of cohort two - Management indicated a target of one patient per month for cohort two, acknowledging potential slowdowns due to holidays [35] Question: Data implications for patient outcomes - Management expressed caution regarding the small sample size but noted directional changes in EV decreases and T cell improvements [36] Question: Stability of EV levels post-treatment - Management confirmed that EV levels decrease during treatment but may rebound after a few weeks, emphasizing the need for more treatments to achieve sustained reductions [40]

Financial Data and Key Metrics Changes - Consolidated total revenue for Q3 2025 was $347.1 million, an increase of 43.3% compared to $242.2 million in the prior year period [16] - Net loss attributable to common stockholders decreased to $9.4 million, or $0.71 per fully diluted share, compared to $15.3 million, or $1.18 per fully diluted share in the prior year [16] - Total adjusted EBITDA was $19.8 million in Q3 2025, up from $16.8 million in the prior year [16] Business Line Data and Key Metrics Changes - Infrastructure segment revenue increased 45.4% to $338.4 million from $232.8 million in the prior year quarter, driven by project timing and size at DBM Global [17] - Life sciences revenue increased 3.3% to $3.1 million from $3 million in the prior year quarter, primarily due to R2's increased sales [20] - Spectrum segment revenue decreased by $800,000 to $5.6 million, with adjusted EBITDA decreasing by $700,000 to $1 million [20] Market Data and Key Metrics Changes - DBM Global's adjusted backlog increased by approximately $500 million to just over $1.6 billion since the end of 2024 [6] - R2's year-to-date revenues increased by approximately 65% over the same period from last year, with a 206% surge in demand outside of North America [11] - Spectrum faced a challenging advertising environment, with softness in ad sales persisting through Q3 [15] Company Strategy and Development Direction - The company is focused on exiting its life science businesses, although this strategy has taken longer than expected [5] - There is an ongoing sales process for DBM Global, with expectations of benefiting from a positive macro environment in the U.S. [5] - The company is exploring strategic alternatives for HC2 Broadcasting Holdings in accordance with spectrum debt requirements [5] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the momentum building for 2026, driven by a growing adjusted backlog and improving market conditions [9] - The company anticipates EBITDA to come in slightly below 2024 levels but remains encouraged by the performance of DBM Global [9] - MediBeacon's recent regulatory approval in China is expected to unlock access to a significant healthcare market [10] Other Important Information - As of September 30, 2025, the company had total principal outstanding indebtedness of $700.4 million, up $32.1 million from the end of 2024 [23] - The company had $35.5 million of cash and cash equivalents, down from $48.8 million as of December 31, 2024 [22] Q&A Session Summary - There were no questions during the Q&A session [23]

NEW YORK, Nov. 12, 2025 (GLOBE NEWSWIRE) -- Wolf Haldenstein Adler Freeman & Herz LLP reminds investors in Inspire Medical Systems, Inc. (NYSE: INSP) (“Inspire”) securities that a securities class action has been filed on behalf of all investors who purchased shares between August 6, 2024 and August 4, 2025 (the “Class Period”). Investors have until January 5, 2026 to seek appointment as lead plaintiff. PLEASE CLICK HERE TO JOIN THE CASE AND SUBMIT CONTACT INFORMATION Allegations The complaint filed allege ...

WHEAT RIDGE, CO / ACCESS Newswire / November 12, 2025 / Lifeloc Technologies, Inc. (OTC:LCTC), a global leader in the development and manufacturing of breath alcohol and drug testing devices, has announced financial results for the quarter ended September 30, 2025. Third Quarter Financial Highlights Lifeloc posted quarterly net revenue of $2.257 million in the third quarter of 2025, resulting in a quarterly net loss of $(263) thousand, or $(0.10) per diluted share. ...