Core Viewpoint - Rosen Law Firm is encouraging investors of DexCom, Inc. to secure legal counsel before the December 29, 2025 deadline for a class action lawsuit related to securities purchased between July 26, 2024, and September 17, 2025 [1][2]. Group 1: Class Action Details - Investors who purchased DexCom securities during the specified class period may be entitled to compensation without any out-of-pocket fees through a contingency fee arrangement [2]. - A class action lawsuit has already been filed, and interested parties must move the Court to serve as lead plaintiff by December 29, 2025 [3]. - The Rosen Law Firm emphasizes the importance of selecting qualified counsel with a successful track record in securities class actions [4]. Group 2: Allegations Against DexCom - The lawsuit alleges that DexCom made unauthorized design changes to its G6 and G7 continuous glucose monitoring systems, which rendered them less reliable and posed health risks to users [5]. - It is claimed that DexCom overstated the enhancements and reliability of the G7 devices while downplaying the severity of the issues related to the adulterated devices [5]. - The allegations suggest that these misrepresentations subjected DexCom to increased regulatory scrutiny and potential legal and financial repercussions [5].

Core Viewpoint - Rosen Law Firm is reminding investors who purchased DexCom, Inc. securities between July 26, 2024, and September 17, 2025, of the December 29, 2025, deadline to become lead plaintiffs in a class action lawsuit [1] Group 1: Class Action Details - Investors who bought DexCom securities during the specified Class Period may be entitled to compensation without any out-of-pocket fees through a contingency fee arrangement [1] - A class action lawsuit has already been filed, and interested parties must move the Court by December 29, 2025, to serve as lead plaintiff [2] - The Rosen Law Firm emphasizes the importance of selecting qualified counsel with a successful track record in securities class actions [3] Group 2: Allegations Against DexCom - The lawsuit alleges that DexCom made unauthorized material design changes to its G6 and G7 continuous glucose monitoring systems, which compromised their reliability and posed health risks to users [4] - It is claimed that DexCom overstated the enhancements and reliability of the G7 devices while downplaying the severity of the issues related to the adulterated devices [4] - The allegations suggest that these actions subjected DexCom to increased regulatory scrutiny and potential legal, reputational, and financial harm [4]

Core Points - A class action has been filed against Inspire Medical Systems, Inc. for allegedly misleading investors regarding the Inspire V device launch [1][2] - The Inspire V device is intended for treating obstructive sleep apnea and was marketed as a groundbreaking product [2] - The launch of Inspire V faced significant challenges, including poor demand and inadequate preparation by the company [3] Allegations - Inspire Medical Systems failed to complete essential tasks for the successful launch of Inspire V, such as training for treatment centers and updating IT systems [3] - The company did not ensure that Medicare reimbursement was in place at the time of the launch, which contributed to the launch's difficulties [3] Financial Impact - On August 4, 2025, Inspire revealed that the launch was facing an "elongated timeframe," leading to a drastic reduction in 2025 earnings guidance by over 80% [4] - Following this announcement, the stock price plummeted by $42.04 per share, a decline of more than 32%, resulting in a loss of $1.2 billion in market capitalization in one day [4] - From a high of $216.71 per share on September 23, 2024, the stock price dropped nearly 60%, erasing billions from the company's market capitalization [4]

Core Viewpoint - Rosen Law Firm is encouraging investors of Baxter International Inc. to secure legal counsel before the December 15, 2025 deadline for a securities class action lawsuit related to the company's stock performance during the specified class period [2][3]. Group 1: Class Action Details - Investors who purchased Baxter common stock between February 23, 2022, and July 30, 2025, may be entitled to compensation without any out-of-pocket fees through a contingency fee arrangement [3]. - A class action lawsuit has already been filed, and potential lead plaintiffs must move the court by December 15, 2025 [4]. - The lawsuit alleges that Baxter misled investors regarding the safety and efficacy of its Novum IQ Large Volume Pump, which suffered systemic defects leading to serious patient risks [6]. Group 2: Allegations Against Baxter - The lawsuit claims that Baxter failed to disclose systemic defects in the Novum LVP, which caused malfunctions such as underinfusion and overinfusion, exposing patients to serious injury or death [6]. - Baxter was reportedly aware of multiple device malfunctions and injuries but did not take adequate remedial measures, leading to continued harm [6]. - The allegations suggest that Baxter's statements about the product's safety, efficacy, and sales prospects were materially false and misleading, resulting in investor damages when the truth was revealed [6]. Group 3: Rosen Law Firm's Credentials - Rosen Law Firm has a strong track record in securities class actions, having achieved significant settlements, including the largest securities class action settlement against a Chinese company [5]. - The firm has been ranked highly for its number of securities class action settlements and has recovered hundreds of millions of dollars for investors [5]. - In 2019, the firm secured over $438 million for investors, showcasing its effectiveness in representing shareholder interests [5].

Core Viewpoint - The U.S. District Court has denied the FTC's request for a preliminary injunction to block the proposed acquisition of Surmodics by GTCR, marking a significant step towards the completion of the merger [1][3]. Group 1: Merger Details - The consummation of the merger is still subject to a Temporary Restraining Order, which prevents the parties from finalizing the merger before 5:00 p.m. Central time on November 17 [2]. - The merger agreement includes conditions such as the absence of any legal restraints, no material adverse effect on the company, and other customary closing conditions [2]. Group 2: Company Background - Surmodics is a leading provider of medical device and in vitro diagnostic technologies, focusing on performance coating technologies for intravascular medical devices and components for diagnostic tests [4]. - The company's mission is to improve disease detection and treatment, leveraging its expertise in surface modification and drug-delivery coating technologies [4].

Financial Data and Key Metrics Changes - Revenue for Q3 2025 was $29.4 million, representing a 3% growth compared to Q3 2024 [13][21] - Non-GAAP gross margin reached nearly 40% in Q3 2025, with a 350 basis point increase year-over-year [19][21] - Non-GAAP operating loss was $10.4 million, over 35% lower than the operating loss of $16.1 million in the prior year [20][21] Business Line Data and Key Metrics Changes - Tablo console sales increased by 8% in Q3 2025, with a significant growth in the average size of sales opportunities, which increased by more than 20% [12][17] - Product revenue was $20.6 million, slightly ahead of $20.3 million in the prior year, with consumable sales at $12.2 million [17][21] - Recurring revenue from Tablo consumables and service was $21.1 million, slightly ahead of Q3 2024 [17] Market Data and Key Metrics Changes - The demand for insourcing dialysis with Outset's technology continues to grow, supported by clinical, operational, and financial benefits [11][12] - The company is approaching 1,000 acute sites using Tablo, with a run rate of a million treatments per year [23] Company Strategy and Development Direction - The company is focusing on enterprise-wide insourcing and managing large opportunities that span multiple hospitals within health systems [11][23] - The strategy includes optimizing inventory levels and gradually increasing production to mitigate gross margin impacts [19][20] - The company aims to reach a gross margin milestone of 50% in the future [12][19] Management's Comments on Operating Environment and Future Outlook - Management acknowledged that while progress has been made, there is still work to be done in transforming the sales process and improving execution [10][12] - The resignation of the Head of Sales may cause internal disruption, but the team remains committed to customer service [13][21] - Management remains optimistic about future growth, citing strong customer demand and a growing pipeline of larger deals [41][42] Other Important Information - The company revised its 2025 revenue guidance to a range of $115 million to $120 million, down from $122 million to $126 million [21][22] - Cash balances at the end of the quarter were $182 million, with a projected cash use of less than $50 million in 2025 [20][21] Q&A Session Summary Question: What factors contributed to the guidance trim? - Management indicated that a large console opportunity shifted from Q3 to Q4, and the departure of the Head of Sales was also a consideration in the revised guidance [26][27] Question: Can you elaborate on console revenues and order timing? - Console revenues showed positive growth, but management expressed frustration with execution and the ability to predict deal timing [29][30] Question: What qualities are being sought in a new sales leader? - The company is looking for someone with a background in capital equipment and enterprise sales, who can strategically lead and coach the sales team [32][34] Question: What is the growth outlook for 2026? - Management has not provided specific guidance for 2026 but remains optimistic about growth potential, emphasizing that demand continues to grow [40][42] Question: Are there any order cancellations or drops in the pipeline? - Management confirmed that no deals have fallen out of the pipeline, and the sales team is actively working to close pending opportunities [63][64]

Financial Data and Key Metrics Changes - Revenue for the fiscal second quarter increased by 128% year-over-year, reaching $1.8 million, up from $0.8 million in the same period last year [4][15] - The company reported a gross loss of $0.3 million for the fiscal second quarter, an improvement from a loss of $1.1 million for the same period last year [16] - Net loss attributed to common stockholders was $7.9 million, or a loss of $1.25 per share, compared to a net loss of $13.4 million, or a loss of $5.67 per share, for the same quarter last year [18] Business Line Data and Key Metrics Changes - The company introduced a capital purchase sales model in the U.S. and had its first hospital purchase of LungFit PH [6] - The sales pipeline remains robust, with substantial opportunities across the U.S. as awareness of LungFit PH builds [4] Market Data and Key Metrics Changes - The company added new distribution partnerships in Japan, South Korea, Mexico, Costa Rica, Guatemala, Panama, and El Salvador, expanding its international coverage to 35 countries [10][11] - The company anticipates reaching its goal of 60 countries under partnership by calendar 2026 [11] Company Strategy and Development Direction - The company is preparing for the launch of its second-generation LungFit system, expected in late calendar 2026, pending FDA approval [8] - A national group purchasing agreement for therapeutic gases with Premier has been awarded, providing access to nearly 3,000 hospitals [7] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the trajectory of growth post-launch of the second-generation LungFit PH, anticipating a steeper growth curve [23] - The company is navigating complexities in hospital sales cycles, with expectations for sequential growth to resume in upcoming quarters [4] Other Important Information - The company raised $12 million in debt and plans to file a registration statement for an additional $20 million through an equity line of credit [5] - The company reported a 37% reduction in total operating expenses year-over-year, down to just above $7.4 million from $11.7 million [16] Q&A Session Summary Question: Expected growth drivers leading into the potential approval of the second-generation LungFit PH - Management believes the trajectory post-launch will be significantly steeper, with international expansion and the introduction of a capital purchase model as key growth drivers [23][24] Question: Comments on timing for commercialization of the second-gen LungFit PH - Management indicated that FDA timing is not the limiting factor, but supply chain issues are affecting the timeline [26] Question: Comparison between the new model and prior ones - The second-generation machine will be about 60% the size of the original, with improved user interface and longer maintenance intervals [28][29] Question: Insights on international deals and pricing models - The international model involves selling to distributors who then use various models, including capital equipment purchases and disposables [33] Question: Update on the updated guidance of $8 million-$10 million - Management noted that the transition in leadership may cause some disruption, but the revenue target is achievable based on current performance [35][36]

Core Insights - QT Imaging reported strong financial results for Q3 2025, generating revenue of $4.2 million, which represents a 339% year-over-year increase and a 15% sequential increase from Q2 2025 [7][8] - The company reaffirmed its revenue forecast of $18 million for the full year 2025, with plans to ship a total of 40 scanners [1][9] - QT Imaging has significantly strengthened its financial position through an $18.2 million PIPE transaction and additional financing [1][6] Financial Performance - Revenue for Q3 2025 was $4.2 million, up from $956,000 in Q3 2024, driven by the shipment of nine QTI Breast Acoustic CT™ scanners [7][23] - Gross margin decreased to 43% in Q3 2025 from 63% in Q3 2024, attributed to variability in inventory costs [7] - Operating expenses increased to $3.5 million in Q3 2025, an 18% rise from $2.9 million in Q3 2024 [7][8] Business Developments - The company shipped nine QTI Breast Acoustic CT™ scanners in Q3 2025, aligning with its annual projections [3][7] - QT Imaging launched QTviewer™ version 2.8, enhancing clinical efficiency and diagnostic accuracy [3] - A strategic distribution agreement was established with Gulf Medical Co. for exclusive distribution of scanners in Saudi Arabia [3][4] Leadership Changes - Jay Jennings was appointed as the new Chief Financial Officer, and Satrajit Misra joined as the Chief Commercial Officer, bringing nearly 60 years of combined experience [2][6][4] Future Outlook - QT Imaging plans to increase its revenue outlook for 2026 from $27 million to $39 million, reflecting new agreements and market expansion [9] - The company submitted an application to relist on Nasdaq, following a 3:1 reverse stock split to meet listing requirements [6][9]

Core Insights - The company reported a strong performance in Q3, with sales exceeding expectations and guidance for future growth being raised [1] - New product launches have significantly contributed to the company's growth, particularly in the appendage management and pain management franchises [2][3] Group 1: Financial Performance - The third quarter demonstrated pronounced strength, particularly attributed to new product innovations [2] - The company raised its guidance for 2025, indicating confidence in continued growth [1] Group 2: Product Innovations - The FLEX-Mini device, set to launch in the second half of 2024, is expected to be a major growth driver in 2025 within the appendage management market [2] - The cryoSPHERE MAX has shown robust adoption, enhancing the performance of the pain management franchise [3]

The statements in this presentation regarding expectations of future events or results, including SI-BONE's expectations of continued revenue and procedure growth and financial outlook, are "forward-looking" statements. These forward-looking statements are based on SI-BONE's current expectations and inherently involve significant risks and uncertainties. These risks include SI-BONE's ability to introduce and commercialize new products and indications, SI-BONE's ability to maintain favorable reimbursement fo ...