Financial Data and Key Metrics Changes - Revenues for Q3 2025 were $11.6 million, representing a 57% increase year-over-year and a 3% sequential gain over Q2 2025 [5][16] - Gross margin for the quarter was 84%, down from 86% in the prior year, primarily due to lower manufacturing efficiency associated with newly launched products [17] - Operating loss for the quarter was $9 million, compared to $8.7 million in the prior year, driven by one-time charges related to clinical studies [18] - Cash used in operations was $3.7 million, a significant improvement from $11.2 million in Q3 2024 [19] - Adjusted EBITDA loss improved to $5.4 million from $7.1 million in the prior year [19] Business Line Data and Key Metrics Changes - The commercial organization increased the number of unique ordering accounts by 30% compared to Q3 2024, adding 20 new accounts [16] - The reimbursement use of TriNav technology within the radioembolization market has effectively doubled due to the introduction of a new CMS code [6][7] - The company launched the TriNav Flex infusion system and advanced new clinical applications to expand market opportunities [5][6] Market Data and Key Metrics Changes - The company is experiencing strong commercial momentum in the complex liver embolization market, supported by the new CMS HCPCS code C8004 [6][7] - Early feedback from key accounts indicates strong clinical and economic advantages from the expanded reimbursement, expected to drive adoption into 2026 [7] Company Strategy and Development Direction - The company is focused on expanding its TriNav platform and investing in long-term growth through increased commercial resources and funding for new applications [6][8] - Trisalus aims to leverage its pressure-enabled drug delivery (PEDD) technology across a wide range of solid tumors and interventional treatment approaches [8][15] - The company is also preparing to launch a clinical trial evaluating TriNav and genicular artery embolization (GAE) for knee osteoarthritis [12][43] Management's Comments on Operating Environment and Future Outlook - Management reaffirmed a 50% revenue growth guidance, reflecting confidence in growth momentum and market opportunities [7][21] - The company is excited about the current momentum, especially in Q4, and is focused on maintaining its growth trajectory [21][27] - Management highlighted the potential of GAE as a significant market opportunity, potentially rivaling the liver market [42][43] Other Important Information - The company simplified its capital structure through a successful exchange offer and consent solicitation for preferred stock [6] - Cash and cash equivalents at the end of the quarter were $22.7 million, providing ample liquidity for operations and strategic objectives [19] Q&A Session Summary Question: Insights on 2026 growth expectations - Management is confident about current momentum and maintaining guidance of 50% growth and adjusted EBITDA positivity in the first half of next year [21] Question: Growth in other indications outside liver - The company is investing in new applications, particularly in uterine artery embolization, which is expected to reduce procedural time and pain [22] Question: Gross margin outlook - Management expects an uptick in gross margins in Q4 as manufacturing efficiencies improve [33] Question: Adoption of new products - The TriNav Flex has been well received, with significant adoption in selective treatments and larger territory treatments [38] Question: Utilization trends for accounts launched at different times - Accounts launched 18 months ago continue to improve month over month, with faster ramps for those familiar with the technology [44]

Financial Data and Key Metrics Changes - For Q3 2025, RenovoRx reported revenues of approximately $266,000, contributing to a total of approximately $900,000 for the first nine months of 2025 [20][21] - Research and development expenses were $1.7 million, reflecting ongoing investment in the TIGeR-PaC trial and other studies [20] - Selling, general, and administrative expenses were also $1.7 million, indicating stable operating expenses while expanding commercial capabilities [20] Business Line Data and Key Metrics Changes - The RenovoCath device has seen a significant increase in adoption, expanding from five approved centers at the beginning of 2023 to 14 centers by Q3 2025, with five centers already using the device and making repeat orders [9][10] - The company anticipates a peak U.S. market opportunity of approximately $400 million annually for RenovoCath as a standalone device, with potential for several billion dollars as it expands into other tumor types [12] Market Data and Key Metrics Changes - The company has established a geographically diverse network of clinical institutions using and interested in TAMP, including leading academic institutions and high-volume community hospitals [10] - Physician feedback indicates benefits of targeted drug delivery with TAMP, including reduced systemic chemotherapy toxicity and improved patient quality of life [10] Company Strategy and Development Direction - RenovoRx aims to integrate its TAMP technology into the standard of care for cancer treatment, focusing on improving patient outcomes through targeted and tolerable treatment options [6][12] - The company is committed to maintaining fiscal discipline while scaling its commercial foundation and preparing for broader adoption [13] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the early signs of clinical adoption and the potential for revenue growth, emphasizing the importance of a lean operating structure [8][12] - The company is focused on strategic data-driven expansion and believes that its commercial growth strategy positions it for long-term success [12] Other Important Information - As of September 30, 2025, RenovoRx had over $10 million in cash and cash equivalents, which is expected to fund ongoing commercialization efforts and the completion of the TIGeR-PaC trial [13][21] - The company is exploring multiple financing options to strengthen its balance sheet, including debt and equity financing [14] Q&A Session Summary Question: Has the company considered international expansion given the positive reception? - Management indicated that while international expansion has been considered, the focus remains on the U.S. market due to favorable reimbursement and significant interest [23] Question: How quickly can the supply chain ramp up if demand exceeds expectations? - Management noted a strong partnership with their contract manufacturer, which has already begun ramping production and reducing costs, allowing for quick scalability [24] Question: Is the supply chain based in the U.S.? - Yes, the contract manufacturer is based outside of Chicago, and most components are sourced from the U.S., insulating the company from global supply chain issues [25] Question: What are the expected outcomes from the new Senior Director of Sales? - The new hire is expected to enhance the commercial strategy and increase market adoption, with early signs of success already being observed [29] Question: What is the typical timeline for hospitals to get approval after requesting it? - The sales cycle varies widely, but management anticipates that with local representation, the timeline can be shortened significantly [32] Question: Can you provide updates on patient enrollment and events for the TIGeR-PaC study? - As of the last update, 95 patients had been randomized, with 61 events reported, and final enrollment is expected to be completed early next year [34]

SHAREHOLDER ACTION REMINDER: Faruqi & Faruqi, LLP Investigates Claims on Behalf of Investors of Inspire Medical SystemsNovember 13, 2025 5:29 PM EST | Source: Faruqi & Faruqi LLPFaruqi & Faruqi, LLP Securities Litigation Partner James (Josh) Wilson Encourages Investors Who Suffered Losses In Inspire Medical To Contact Him Directly To Discuss Their OptionsIf you purchased or acquired securities in Inspire Medical between August 6, 2024 and August 4, 2025 and would like to discuss your legal rig ...

Core Viewpoint - enVVeno Medical Corporation has received an unfavorable decision from the FDA regarding its VenoValve® application, which indicates that the product does not meet the necessary safety and effectiveness standards [1] Company Summary - enVVeno Medical Corporation focuses on developing treatments for deep venous disease [1] - The company aimed to gain Premarket Approval (PMA) for its VenoValve®, a surgical replacement venous valve designed for severe deep chronic venous insufficiency (CVI) [1] Regulatory Summary - The FDA issued a not-approvable letter on August 19, 2025, which was upheld in a supervisory appeal [1] - The decision indicates that the VenoValve® failed to provide reasonable assurance of safety and effectiveness [1]

Core Viewpoint - An investigation has been announced regarding Zimmer Biomet Holdings, Inc. for potential violations of federal securities laws, which may impact investors who have suffered losses [1] Group 1 - The Law Offices of Howard G. Smith is representing investors of Zimmer Biomet Holdings, Inc. in this investigation [1] - Investors who experienced losses in Zimmer Biomet Holdings, Inc. are encouraged to contact the law firm to discuss potential claims for recovery [1]

Core Viewpoint - A class action lawsuit has been filed against Inspire Medical Systems, Inc. for securities fraud, following a significant drop in stock price due to poor performance and misleading statements regarding the launch of its new sleep apnea device, Inspire V [1][4][5]. Company Performance - On August 4, 2025, Inspire disclosed that the launch of the Inspire V device was facing delays due to issues such as incomplete training for treatment centers, software update delays, and excess inventory leading to poor demand [3]. - The company reduced its 2025 earnings guidance by over 80%, from a range of $2.20 to $2.30 per share down to $0.40 to $0.50 per share [3]. Stock Market Reaction - Following the announcement on August 5, 2025, Inspire's stock price fell by $42.04, or 32.4%, closing at $87.91 per share, which resulted in significant losses for investors [4]. Allegations in the Lawsuit - The lawsuit alleges that during the class period, the company made materially false and misleading statements and failed to disclose adverse facts about its business and operations, including poor demand for Inspire V and issues with training and IT systems [5]. - Specific failures included not completing necessary training for treatment centers, not updating critical software for claims processing, and not ensuring Medicare reimbursement was in place at launch [5].

Core Viewpoint - Nyxoah has secured financing commitments totaling up to U.S. $77 million to support the U.S. commercialization of its Genio system, which is designed to treat Obstructive Sleep Apnea (OSA) through neuromodulation [1][2]. Financing Details - The financing includes a €22 million private placement of equity, a U.S. $5.6 million registered direct offering, and a convertible bond financing of up to €45 million [2][7]. - The private placement involves the issuance of 5,481,678 new ordinary shares at a subscription price of €4.00 per share, generating gross proceeds of approximately €25 million [3]. - The registered direct offering consists of 1,215,964 new ordinary shares priced at U.S. $4.6304 per share, totaling approximately U.S. $5.6 million [5][6]. - The convertible bonds will have a maximum principal amount of up to €45 million, with the first tranche of €22.5 million expected to close in December 2025 [7]. Use of Proceeds - The net proceeds from the financing will be allocated to support U.S. commercialization activities, gather clinical data, finance research and development, and explore collaboration opportunities in OSA monitoring and diagnostics [8]. Company Background - Nyxoah is focused on developing innovative solutions for OSA, with its lead product being the Genio system, which is a leadless and battery-free hypoglossal neurostimulation therapy [10]. - The Genio system received its European CE Mark in 2019 and FDA approval for certain adult patients in August 2025 [11][12].

Hyperfine Overview - Hyperfine's Swoop system is the first FDA-cleared, AI-powered portable MR brain imaging system, targeting a market opportunity exceeding $6 billion[4, 74] - The company's growth strategy is supported by the launch of the next-generation Swoop system and Optive AI software, which enhances image quality for ultra-low field MRI[4] - Hyperfine has secured approximately 200 patents related to its proprietary technology[9] Market and Expansion - The company is targeting expansion across multiple sites of care, including inpatient, outpatient, and community settings, with a total addressable market (TAM) potentially exceeding $16 billion[8] - Hyperfine has an installed base of over 190 Swoop systems globally[52] - The company estimates a potential US Swoop system revenue of $100 million for every 1.5% market penetration[54] Financial Performance - Q3 2025 revenue reached $3.4 million, representing a 27% sequential increase[58] - The effective average selling price (ASP) for the Swoop system in Q3 2025 was approximately $360,000[58] - Cash burn decreased to $5.9 million in Q3 2025, a 27% reduction compared to the previous quarter[59]

Owlet, Inc. (NYSE: OWLT) Q3 2025 Financial Results November 13, 2025 1 March 4, 2025 Owlet, Inc. (NYSE: OWLT) | Q3 2025 Financial Results Conference Call Speakers Webcast Contacts Confidential | 2 ● Jonathan Harris, CEO & President ● Amanda Twede Crawford, CFO ● Jay Gentzkow, VP Investor Relations and Corporate Development ● Domestic Callers: (833) 470-1428 ● International Callers: (646) 844-6383 ○ Access Code: 428622 ● Webcast Archive Available: investors.owletcare.com ● Website: investors.owletcare.com ● ...

Core Insights - Owlet, Inc. reported record financial results for Q3 2025, achieving significant growth in revenue, gross profit, operating income, and adjusted EBITDA, driven by strong sales of its Dream product line and international expansion [3][4][5]. Financial Performance - Revenue for Q3 2025 was $32.0 million, a 44.6% increase from $22.1 million in Q3 2024, primarily due to higher sales of Dream Sock and Dream Duo products [4]. - Gross profit reached $16.2 million with a gross margin of 50.6%, down from 52.2% in Q3 2024, attributed to tariff impacts [5]. - Operating income was $1.2 million, a turnaround from an operating loss of $4.8 million in Q3 2024 [8]. - Net income for Q3 2025 was $4.1 million, compared to a net loss of $5.6 million in Q3 2024 [8]. - Adjusted EBITDA improved to $1.6 million, up from $0.6 million in Q3 2024 [8]. Operational Highlights - Owlet360 subscription service surpassed 85,000 paying subscribers, with plans for international market expansion [3]. - The company experienced approximately 171% year-over-year growth in international markets, with a new regulatory clearance in India expected to support a product launch in early 2026 [3]. - Owlet is piloting its telehealth initiative, Owlet OnCall, to unlock healthcare channels [3]. Financial Outlook - For the full year 2025, Owlet expects revenue between $103 million and $106 million, representing a year-over-year growth of 32% to 36% [10]. - Gross margins are anticipated to be in the range of 48% to 50%, factoring in increased tariff costs [10]. - Adjusted EBITDA is projected to be between $1.25 million and $2 million [10]. Company Overview - Owlet, Inc. is a leading pediatric health platform, recognized for its FDA-cleared wearable pediatric monitors, providing hospital-grade technology for home use [23]. - The company aims to enhance pediatric wellness by integrating advanced medical technology with user-friendly design, having gained the trust of over 2.5 million parents since its inception [23].