SUNNYVALE, Calif. and UTRECHT, Netherlands, Aug. 13, 2025 (GLOBE NEWSWIRE) -- BioCardia, Inc. [Nasdaq: BCDA], a global leader in cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, and CART-Tech, B.V., a provider of vendor independent platform technology for augmented fluoroscopy during cardiac interventions, today announce that they have entered into an exclusive development and commercialization agreement for Heart3D™ Fusion Imaging. The Heart3D system is exp ...

Financial Data and Key Metrics Changes - Total operating expenses for Q2 2025 were $13.5 million, a 24% decrease from $17.7 million in Q2 2024 [14] - GAAP net loss for Q2 2025 was $13.2 million or $2.23 per share, compared to a net loss of $15.2 million or $2.59 per share in Q2 2024 [15] - Non-GAAP adjusted net loss for Q2 2025 was $13.3 million or $2.23 per share, compared to $16.8 million or $2.86 per share in Q2 2024 [15] - Cash burn rate for Q2 2025 was approximately $13.4 million, with an expectation of full-year 2025 cash burn around $50 million [16] Business Line Data and Key Metrics Changes - Research and development expenses for Q2 2025 were $9.1 million, down from $10.9 million in Q2 2024 [14] - General and administrative expenses for Q2 2025 were $4.1 million, compared to $5.6 million in Q2 2024 [14] - Sales and marketing expenses for Q2 2025 were $300,000, down from $1.2 million in Q2 2024 [14] Company Strategy and Development Direction - The company is focusing on completing a fully integrated production equivalent system before initiating clinical trials, shifting away from near-term targets for first clinical use (FCU) [11] - The new CEO emphasizes the importance of ensuring the system is ready for commercialization before proceeding with clinical trials [10][11] - The company aims to refine its timelines and evaluate progress across development programs while engaging with the Board and investors regarding capital strategy [12] Management's Comments on Operating Environment and Future Outlook - Management acknowledges the challenges of the current market environment but expresses confidence in the company's technology and mission to transform surgical care [18] - The new CEO is optimistic about the company's potential and the need for a system that addresses real problems in the surgical field [40][44] - Management is committed to providing reliable guidance to investors once a clearer understanding of development timelines is established [36][58] Other Important Information - The company ended Q2 2025 with approximately $24 million in cash, cash equivalents, and short-term investments [15] - The leadership transition is seen as an opportunity to reassess the company's development path and strategy [5][6] Q&A Session Summary Question: Can you discuss the process of prioritizing system readiness and the impact on clinical trial timelines? - The new CEO is focused on understanding the requirements for a full production equivalent system and ensuring that resources are allocated effectively to avoid rushing into clinical trials with an incomplete system [24][25] Question: What was anticipated to be spent on clinical trials, and how does that affect cash burn guidance? - Current budgeted costs for clinical trials are not expected to materially change the overall 2025 budget, as most groundwork does not require significant spending [30] Question: What milestones should investors expect by the end of the year? - The CEO indicates that it is too early to provide specific dates for milestones, as clarity will come after a thorough assessment of the current development status [35][36] Question: How does the company view its ability to fund development with current cash on hand? - The CEO expresses confidence in the company's potential and the need for the system being developed, emphasizing that the groundwork has already been laid for future success [39][41] Question: What led to the conclusion that the system is not ready for first in human trials? - Management identified several issues that need to be addressed before proceeding, including hardware and software adjustments, which require additional time and effort [50][52] Question: Will the timeline for clinical milestones shift significantly? - The CEO cannot provide specific guidance on timeline shifts until the assessment is completed, but he is optimistic about the visibility of the goal line as the assessment progresses [58][59]

Summary of TransMedics Group (TMDX) FY Conference August 12, 2025 Company Overview - **Company**: TransMedics Group (TMDX) - **Industry**: Organ transplantation technology Key Points and Arguments 1. **Vision and Impact**: TransMedics aims to increase the number of organ transplants and improve post-transplant outcomes. From 2022 to 2024, total adult transplants in the U.S. grew by 20%, but only 2% when excluding TransMedics, indicating a significant positive impact by the company [2][3][4]. 2. **Clinical Outcomes**: The OCS technology has demonstrated superior outcomes, with ischemic biliary complications at 2.1% for TransMedics compared to 11% for competitors, highlighting the effectiveness of their technology [5]. 3. **TransMedics Trident**: The company's growth strategy is based on three pillars: - OCS multi-organ platform for organ preservation - National OCS Program with 17 hubs across the U.S. - Vertically integrated logistics network, including a fleet of 21 jets for efficient organ transport [6][7][8]. 4. **Market Potential**: In the U.S., there are approximately 17,000 organ donors annually, with significant waste in organ utilization (e.g., 80% of lungs, 75% of hearts, and 40% of livers are wasted). This presents a substantial growth opportunity for TransMedics [11][12][13]. 5. **Growth Projections**: The company expects to reach over $1 billion in revenue by 2028 with 10,000 transplants, aiming for a 30% operating margin. The growth model is scalable and efficient, with expanding margins as the business grows [17][18]. 6. **International Expansion**: TransMedics sees significant growth potential not only in the U.S. but also in international markets, which are being targeted for expansion [18]. 7. **Clinical Trials**: The company is preparing to launch heart and lung trials, with expectations to enroll the first patients by the end of 2025. Revenue from these trials is not included in current guidance, indicating potential upside [24][26][51]. 8. **Market Share**: Current market shares are approximately 35% in liver, 26% in heart, and 4% in lung. The company aims to improve organ utilization and gain market share to achieve its growth targets [33][34]. 9. **Kidney Market Opportunity**: The kidney transplant market is competitive, with over 20,000 transplants annually. TransMedics plans to leverage its technology to improve outcomes and reduce the need for post-transplant dialysis [52][54]. Additional Important Content - **Logistics and Maintenance**: The logistics team is confident in managing the maintenance of their fleet, ensuring operational efficiency. The current mix of transportation is approximately 30-40% ground and the rest aviation [39][47]. - **Service Margin Guidance**: The overall gross margin for TransMedics is expected to be around 60%, with variations based on service and product margins [29]. This summary encapsulates the key insights and strategic directions discussed during the conference, highlighting TransMedics' commitment to enhancing organ transplantation outcomes and its growth potential in the market.

Financial Data and Key Metrics Changes - Revenues for Q2 2025 were $894,000, up 46% compared to $612,000 in Q2 2024, marking the fourth consecutive quarter of double-digit growth [27] - Revenue for the six months ended June 30, 2025, increased to $1,800,000, up 42% from $1,300,000 for the same period in 2024 [27] - Operating loss in 2025 was $1,700,000, a decrease of 22% compared to a $2,200,000 loss in 2024 [33] - Net loss in 2025 was $1,700,000, down 42% from $2,900,000 in 2024 [34] Business Line Data and Key Metrics Changes - Unit sales increased approximately 5853% for the three and six months ended June 30, 2025, due to volume growth from patients with health insurance coverage and the company's financial assistance program [27] - Average selling prices for patients receiving IV stem through financial assistance are about 65% below the list price [9] Market Data and Key Metrics Changes - Approximately 53 million covered lives have been reached for medical policy coverage, which is seen as a key driver for revenue growth [12] - The company expects revenue growth to accelerate as payer medical policy coverage increases and the new category one CPT code becomes effective on January 1, 2026 [22] Company Strategy and Development Direction - The company is focused on securing broad medical policy coverage and advancing disciplined commercial execution to drive utilization and scale [25] - The introduction of the category one CPT code is expected to facilitate easier billing and reimbursement, significantly impacting revenue potential [19] - The company is also advancing the RED product line, which is in the soft launch phase, with plans for a hard launch [23] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism regarding the commercialization strategies and the expected revenue growth due to recent milestones, including FDA indication expansion and published clinical practice guidelines [7][14] - The management highlighted that the guidelines published by academic societies are crucial for gaining insurance coverage and improving treatment access [16] Other Important Information - The gross margin for 2025 was 83.6%, down from 88% in 2024, primarily due to higher discounting in the financial assistance program [28] - Cash on hand as of June 30, 2025, was $6,000,000, with the company having secured $5,000,000 through an equity financing round [34] Q&A Session Summary Question: Perceptions from larger insurance plans post-guideline publishing - Management noted positive responses from insurance plans, with some agreeing to interim reviews due to the guidelines, indicating favorable perceptions [40][41] Question: Goals for coverage and prior authorization expectations - Management expects some medication requirements to be removed, allowing for earlier use of IV stem treatments, although this will be a gradual process [44][45] Question: Salesforce expansion triggers - The urgency for payer policy coverage is aligned with the urgency on the commercial side, with plans to expand the sales force as insurance coverage increases [48][49] Question: Discount rates and cash pay devices - Management clarified that 70% of patients initially face a "no auth required" response, limiting treatment options, and discussed the average selling price for patients receiving financial assistance [54][58] Question: Approval for adults to use the IV stem device - The company is in discussions with the FDA regarding adult usage and expects to have an answer by the Q4 call [65] Question: Satisfaction with RVUs and reimbursements - Management expressed satisfaction with the RVU assignment of 1.46 and noted that reimbursement values are favorable, exceeding the cost of the device [70][71] Question: General and administrative expenses and leverage - Management discussed achieving operating expense leverage while continuing to invest in growth areas such as sales and R&D [73][74] Question: Current cash balance and future outlook - The current cash position is sufficient to support operations into 2026, with expectations for improved insurance coverage positively impacting liquidity [78]

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MOUNTAIN VIEW, Calif., Aug. 11, 2025 (GLOBE NEWSWIRE) -- Heartflow, Inc. (Heartflow) (Nasdaq: HTFL), a leader in AI technology for coronary artery disease (CAD), today announced the closing of its upsized initial public offering of 19,166,667 shares of its common stock at a public offering price of $19 per share, which includes 2,500,000 shares of common stock issued upon the exercise in full by the underwriters of their option to purchase additional shares. All of the shares of common stock were offered by ...

Forward Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements other than statements of historical facts are forward-looking statements, including, without limitation, statements regarding our growth prospects, and our expectations regarding the launch of our Inspire V neurostimulation system. In some cases, you can identify forward-looking statements by terms such as ''may,'' ''will,'' ''should,'' ...

Summary of Key Takeaways from the Conference Call Industry Overview - The conference call focused on the global healthcare sector, specifically the medical technology industry, with insights from GE Healthcare, Philips NV, and Siemens Healthineers [1][4]. Company-Specific Insights GE Healthcare (GEHC) - **U.S. Market Dynamics**: Strong procedure volumes and ongoing strength in hospital capital expenditure (CapEx) spending, with increased allocation towards imaging equipment. The aged installed base supports a continued replacement cycle [4][5]. - **China Market**: Year-over-year revenue growth of -3% in Q2 2025, indicating a deceleration from -1% in Q1 2025. Market recovery is slower than expected, with extended tender cycles at the provincial level [4][5]. - **Europe**: Secured a 5-year collaboration worth $250 million, with good growth noted in Europe, particularly in response to government changes in the UK and France [4][5]. - **Overall Performance**: Reported a 3% order growth in Q2 2025 and an organic revenue growth of 2%, with an increased outlook for FY25 to approximately 3% [5]. Philips NV (PHG.AS) - **U.S. Market Dynamics**: Experienced double-digit order growth in the U.S. for the second consecutive quarter, with solid trends in patient monitoring [4][5]. - **China Market**: Noted increasing tender activity, although from a low base, with reported order intake growth in Q2. However, there are no indications of a sustained market recovery [4][5]. - **Europe**: Flat growth year-over-year in Q2, but increasing hospital capital expenditure demand is observed [4][5]. - **Overall Performance**: Achieved a 6% order growth in Q2 and expects 1-3% organic revenue growth for the year, with improved margin guidance [5]. Siemens Healthineers (SHLG.DE) - **U.S. Market Dynamics**: Reported a 14% revenue growth in Q3 in the U.S., driven by strong demand for PETNET and photon-counting portfolio [4][5]. - **China Market**: Revenue growth of 6% year-over-year in Q3, but this is attributed to soft comparisons from the previous year. The book-to-bill ratio is around 1, indicating steady but cautious momentum [4][5]. - **Europe**: Noted stable market conditions with a 1% revenue growth in the EMEA region for Q3 [4][5]. - **Overall Performance**: Group revenue grew by 7.6% in Q3, with significant growth in imaging and Varian segments. The FY25 outlook was narrowed to a top-end range of 5.5-6% organic revenue growth [5]. Key Product Launches - **GE Healthcare**: Major product launches in MR, Ultrasound, and PET are expected to accelerate in future quarters [5]. - **Philips NV**: New product introductions generated over 50% of sales, including the Azurion Neuro Biplane R3 and BlueSeal MR system [5]. - **Siemens Healthineers**: Rollout of Photon Counting CT systems and new pricing tiers for the Atellica core lab platform [5]. Additional Insights - **Emerging Markets**: Positive activity noted in emerging markets such as Indonesia and Latin America, with significant partnerships established [4][5]. - **Market Outlook**: Overall, the companies maintain a cautious but optimistic outlook for the healthcare technology sector, with varying performance across different regions [4][5]. This summary encapsulates the key points discussed during the conference call, highlighting the performance and outlook of the major players in the medical technology industry.

MOUNTAIN VIEW, Calif., Aug. 07, 2025 (GLOBE NEWSWIRE) -- Heartflow, Inc. (Heartflow) (Nasdaq: HTFL), a leader in AI technology for coronary artery disease (CAD), today announced the pricing of its upsized initial public offering of 16,666,667 shares of its common stock at a public offering price of $19.00 per share. All of the shares of common stock are being offered by Heartflow. The gross proceeds from the offering, before deducting underwriting discounts and commissions and other offering expenses payabl ...

Financial Data and Key Metrics Changes - Doximity reported revenue of $146 million for Q1 FY2026, representing a 15% year-on-year growth and a 4% beat from the high end of guidance [7] - Adjusted EBITDA margin was 55%, amounting to $80 million, which was 11% above the high end of guidance [7] - Free cash flow increased by 52% year-on-year, reaching $60.1 million [22] - Non-GAAP gross margin for Q1 was 91%, down from 92% in the prior year [21] Business Line Data and Key Metrics Changes - Unique active users across all metrics (quarterly, monthly, daily) reached record highs, with double-digit percentage growth year-on-year [9] - The number of unique active prescribers using workflow tools reached 630,000, marking significant engagement [9] - The AI tools experienced over 5x year-on-year growth [9] Market Data and Key Metrics Changes - Doximity's net revenue retention rate was 118% on a trailing twelve-month basis, with the top 20 customers showing a higher rate of 119% [20] - The company ended the quarter with 120 customers contributing at least $500,000 each in subscription-based revenue, a 17% increase from the previous year [21] Company Strategy and Development Direction - Doximity is focusing on AI integration, with the launch of the Doximity AI Scribe and the acquisition of Pathway, aiming to enhance physician productivity [19][23] - The company plans to integrate Scribe into telehealth tools, creating a seamless experience for physicians [13] - Doximity aims to build a comprehensive AI suite that addresses clinical questions and enhances workflow efficiency [19] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the business's strength despite ongoing policy uncertainty, noting no slowdown in customer budgets [27] - The outlook for FY2026 includes revenue guidance of $628 million to $636 million, reflecting an 11% growth at the midpoint [25] - Management highlighted the importance of AI investments for long-term growth and productivity improvements [56] Other Important Information - The Pathway acquisition was completed for $26 million in cash and up to $37 million in equity grants, with no expected revenue contribution this year [24] - The company repurchased $122.3 million worth of shares during the first quarter [23] Q&A Session Summary Question: How can you frame the opportunity for investors regarding Scribe, Pathways, and Doximity GPT? - Management sees these AI tools as a potential third act, enhancing physician engagement and addressing clinical questions in real-time [31] Question: Can you provide insights on customer budgets and the second half guidance? - Management noted strong Q1 performance but cautioned against extrapolating this into the second half due to policy uncertainties [36] Question: What are the qualitative differences in upsell cycles this year? - Management indicated broad-based strength across all customer segments, with significant growth in SMB customers [40] Question: How do you view the drivers of continued provider use of products? - Management highlighted the stickiness of workflow tools and the importance of AI in enhancing user engagement [48] Question: Will the new AI offerings become standalone revenue generators? - Management anticipates that AI products like Scribe could evolve into enterprise revenue streams similar to the Doximity Dialer [59] Question: What is the current state of the Provider Solutions business? - Management reported strong traction in the health system business, particularly in enterprise offerings [99] Question: How is the news feed performing and what developments are there? - Management noted record high engagement in the news feed, with video content becoming increasingly important [109]