FORT MILL, S.C., Nov. 20, 2025 (GLOBE NEWSWIRE) -- Catheter Precision, Inc. (VTAK - NYSE/American), a US based medical device company focused on developing technologically advanced products for the cardiac electrophysiology market, today announces the rapid commercial uptake of its LockeT closure device in South Africa. With the assistance of local distributor, HLC Medical and Dr. Heather Henry-Lines, LockeT was successfully implemented in five hospitals within two months. Three of these hospitals are using ...

Core Insights - Johnson & Johnson's (JNJ) MedTech segment, which includes products in orthopedics, surgery, cardiovascular, and vision markets, represents approximately 36% of the company's total revenues [1][11] - In Q3, MedTech sales reached $8.43 billion, reflecting a 5.6% increase on an operational basis [1][11] Sales Performance - The MedTech unit has shown improvement over the last two quarters, primarily due to the acquisitions of cardiovascular businesses, Abiomed and Shockwave, along with advancements in Surgical Vision and wound closure in Surgery [2] - Cardiovascular sales surged by 17.4% in the first nine months of 2025, driven by the strategic acquisitions [3] Strategic Developments - J&J plans to spin off its Orthopaedics franchise into a standalone company named DePuy Synthes, led by industry veteran Namal Nawana [4] - This separation aligns with J&J's strategy to focus on high-growth markets, enhancing growth and margins in the MedTech unit, which has historically been slow-growing [5] Future Outlook - J&J anticipates better growth in the MedTech business in 2026 compared to 2025, fueled by the adoption of new products and a focus on high-growth markets [6] - New product launches, including the Shockwave C2 Aero catheter and Tecnis intraocular lens, are expected to contribute to growth in 2026 [6] Market Challenges - The company faces challenges in China due to the volume-based procurement (VBP) program, which is impacting sales as the program expands [7] Competitive Landscape - J&J's MedTech unit competes with major players like Medtronic, Abbott, Stryker, and Boston Scientific, each with strong positions in various medical device sectors [8][9] Financial Performance - J&J's stock has outperformed the industry, rising 34.1% year-to-date compared to an 8.4% increase in the industry [10] - The company's shares are trading at a price/earnings ratio of 17.02, higher than the industry average of 15.84 [13] Earnings Estimates - The Zacks Consensus Estimate for 2025 earnings remains at $10.86 per share, while the estimate for 2026 has increased from $11.38 to $11.47 [15]

Financial Performance - The company reported underlying revenue growth of 50% in Q3 2025, consistent with H1[8] - Total revenue for Q3 2025 reached $1501 million[13] - The company is raising free cash flow guidance from over $600 million to around $750 million[10, 33] - The company maintains its 2025 trading margin guidance of 190-200%[33] Business Segment Performance - Orthopaedics revenue reached $577 million, with underlying growth of 41%[14, 17] - Sports Medicine & ENT revenue was $469 million, reflecting underlying growth of 51%[14, 21] - Advanced Wound Management (AWM) achieved revenue of $455 million, with underlying growth of 60%[14, 27] Regional Performance - The US market grew by 55% with revenue of $789 million[14] - Emerging Markets grew by 54% with revenue of $265 million[14] - Other Established Markets increased by 39% with revenue of $447 million[14] Key Growth Drivers and Outlook - The company expects ongoing improvement in US Recon through the 12-Point Plan, along with continued strong performance in Sports & ENT (excluding China) and AWM[34] - The company anticipates approximately 150 bps growth headwind from China[34] - Innovation, including products like REGENETEN, CARTIHEAL, and ALLEVYN CC, is expected to drive future growth[35, 39]

Financial Data and Key Metrics Changes - Total revenue for Q3 2025 was $134 million, reflecting a 16% increase year over year [4] - Adjusted EBITDA was nearly $18 million, with over $30 million in cash generated during the quarter [4] - Gross margin improved to 75.5%, an increase of 59 basis points from Q3 2024 [16] - Adjusted loss per share was $0.01, compared to $0.17 in Q3 2024 [17] Business Line Data and Key Metrics Changes - Appendage management revenue grew over 20% globally, driven by the adoption of AtriClip FLEX Mini and AtriClip PRO Mini devices [5][6] - Open ablation product sales in the U.S. were $35.6 million, up 16.3% year over year [14] - Pain management franchise grew 28% in the quarter, driven by CryoSPHERE MAX and CryoSPHERE PLUS probes [10][11] Market Data and Key Metrics Changes - U.S. revenue was $109.3 million, a 14.5% increase from Q3 2024 [13] - International revenue totaled $25 million, up 22% on a reported basis [15] - European sales contributed $15.2 million, representing 24.2% growth [16] Company Strategy and Development Direction - The company is focused on product innovation and clinical science initiatives, with recent successful product launches [4] - AtriCure is expanding its market opportunity with the initiation of the BoxX no-AF clinical trial [5] - The company aims to drive awareness and access to AtriClip devices globally, with recent approvals in Japan [8] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the long-term growth trajectory for underpenetrated markets [18] - The company raised its full-year 2025 revenue guidance to approximately $532 million to $534 million, reflecting 14% to 15% growth [19] - Management highlighted the importance of continued investment in clinical science and product development to drive future growth [19] Other Important Information - The company completed enrollment of over 6,500 patients in the LEAPS clinical trial, aimed at evaluating AtriClip devices for stroke prevention [6] - A one-time cash inflow of approximately $6 million was recognized from a sale leaseback transaction [17] Q&A Session Summary Question: Impact of CMS proposal on EpiSense business - Management indicated that the CMS proposal may not materially affect the EpiSense business, as growth will depend on non-responders to PFA seeking alternative treatments [22][23] Question: Opportunity in Japan post-approvals - Management noted that there are about 40,000 cardiac surgeries in Japan, with expectations for gradual market preparation and rollout of new technologies [24][25] Question: Sustainability of open ablation growth - Management attributed growth to increased adoption among CABG surgeons and the efficiency of the Encompass clamp, with significant room for market penetration [27][28] Question: Guidance on adjusted EBITDA and margins - Management discussed strengths in gross margin due to favorable product mix and efficiency in manufacturing, while also indicating a conservative approach to fourth-quarter guidance [32][33] Question: Appendage management business growth sustainability - Management expressed optimism about the growth potential in the appendage management segment, citing ongoing market penetration and the impact of clinical trials [35][36] Question: Competition and differentiation of AtriClip - Management acknowledged competition but emphasized the strength of AtriClip's clinical data and ongoing innovation as key differentiators [59][60]

Summary of ICU Medical Conference Call Company Overview - **Company**: ICU Medical - **Industry**: Medical Devices, specifically focusing on infusion systems and consumables Key Points Business Segments Performance - **Consumables Segment**: - Grew 4% in Q2, with expectations of mid-single digit growth for the year [4] - Historical growth rate of 5-6% annually over the past five years [4] - Drivers include strong end-market demand, demographic trends, and a national shortage of IV solutions [4][5] - Incremental innovations and FDA clearances are expected to enhance competitive advantage [6][8] - **IV Systems**: - Double-digit growth in LVP (Large Volume Pump) revenue [10] - Market growth is estimated at 3-4%, with ICU Medical outpacing this due to market refresh from competitors' device issues [12] - Focus on integrating various pumping modalities into a single software platform for improved user experience [10][11] - **Vital Care Division**: - Approximately $600 million division, now reduced to $300 million post joint venture with Otsuka Pharmaceutical [24][25] - Experienced a decline of 4% in Q2, with expectations of flat growth moving forward [29] Regulatory Landscape - Regulatory scrutiny is high, which is seen as a necessary barrier to ensure safety in drug delivery systems [15] - The company is focused on maintaining compliance and improving product standards to avoid setbacks [45] Innovation and Product Development - Recent FDA approvals for new products are expected to drive growth in both consumables and IV systems [16][17] - The company is investing in R&D to enhance product offerings and maintain competitive edge [42] Financial Guidance and Market Outlook - Updated guidance reflects a $17 million EBITDA loss from divestiture and $30 million in tariffs impacting the second half of the year [35][36] - Anticipated growth in 2026 is supported by innovation in consumables and a potential increase in average selling prices (ASP) for new pump technologies [40][46] - The company aims for mid-single digit growth while improving gross margins and generating cash flow for shareholder returns [42][57] Strategic Focus - Emphasis on home care as a growth area, leveraging existing market share and technology [22][20] - The company is cautious about pursuing new M&A opportunities unless they are compelling [57] Competitive Landscape - ICU Medical is positioned well against competitors by offering integrated solutions that enhance user experience and operational efficiency [18][19] - The company is focused on differentiating its offerings in the home care market, which is fragmented and competitive [21] Conclusion - ICU Medical is at a pivotal point with ongoing innovations and strategic initiatives aimed at sustaining growth and enhancing shareholder value. The focus remains on executing current opportunities while navigating regulatory challenges and market dynamics [61]

Financial Data and Key Metrics Changes - LifeWorks reported revenues of $5.7 million in Q2 2025, a decrease of $1 million or about 15% year-over-year compared to $6.7 million in Q2 2024, but an increase of approximately 14% quarter-over-quarter from $5 million in Q1 2025 [19][24] - GAAP gross profit was $2.5 million or 43.9% of revenue in Q2 2025, compared to $2.8 million or 41.1% in Q2 2024 [22] - GAAP operating loss for Q2 2025 was $6.6 million compared to $4.4 million in Q2 2024, while non-GAAP operating loss was $3.5 million compared to $3.7 million in the same period last year [24] Business Line Data and Key Metrics Changes - Revenue from traditional products and services totaled $2.5 million in Q2 2025, down from $3.1 million in Q2 2024, a decrease of about 19% [19] - Revenue from AlterG products and services was $3.2 million in Q2 2025, down from $3.6 million in Q2 2024, primarily due to the timing of deliveries to international distributors [20] - The ReWalk product line saw its highest quarterly total of units placed to Medicare beneficiaries since the schedule was established in April 2024 [19] Market Data and Key Metrics Changes - The pipeline of qualified leads for the ReWalk product line increased by 86% since Q3 2024, ending the quarter with more than one-third of leads in process in the U.S. [21] - In Germany, there were 46 leads in process at the quarter end, including 34 active rentals, which historically convert to sales within three to six months [21] Company Strategy and Development Direction - The company’s growth strategy is anchored in three core pillars: accelerating commercial adoption, portfolio diversification, and operational excellence [12][13] - The focus is on building strong momentum from recent Medicare and commercial insurer wins by reducing approval times and expanding coverage [12] - The company aims to leverage software innovation and AI integration to deepen customer engagement and ensure solutions are effective and commercially viable [13] Management's Comments on Operating Environment and Future Outlook - Management acknowledged that revenue cycles in their markets are inherently extended, particularly those dependent on payer approvals and coverage decisions [28] - The company expects gradual growth in the next few quarters, with meaningful acceleration weighted toward the back half of their strategic plan [28] - Management remains committed to developing solutions that enhance independence and quality of life for patients [30] Other Important Information - The company ended Q2 2025 with $5.1 million in cash and cash equivalents and no debt, indicating a strong liquidity position [24] - LifeWorks is considering both debt and equity opportunities to support operations and growth plans while implementing cost management strategies [26] Q&A Session Summary Question: Can you provide details on Medicare revenue for the quarter? - Management clarified that in Q2 2024, there was a one-time revenue recognition of approximately $700,000, and excluding this, Medicare-related sales grew year-over-year [33] Question: What is the current status of leads in the U.S. and Germany? - Management confirmed that Medicare leads are greater than 130, with a strong pipeline building quarter over quarter [34][36] Question: How does the current tariff situation impact the company? - Management stated that the ReWalk exoskeleton is exempt from tariffs, but there are some tariff situations with the UltraG product that are being addressed [39] Question: What are the plans for AlterG commercialization? - Management emphasized the importance of focusing on channel partners and specific markets to ensure sustainable growth for the AlterG product line [51] Question: What is the reasoning behind lowering the guidance? - Management explained that the trajectory of growth has changed, and while pipelines are growing, the timing of revenue recognition is still being understood [60]

Company Overview - NeuroPace, Inc. is a medical device company focused on transforming the lives of people living with epilepsy by reducing or eliminating debilitating seizures through its RNS System, which is the first and only commercially available brain-responsive platform that delivers personalized, real-time treatment at the seizure source [5] Leadership Change - Patrick F. Williams has been appointed as Chief Financial Officer, effective June 20, 2025, bringing over 25 years of financial and operational management experience in public medical device companies [2][3] - Rebecca Kuhn will depart from her CFO role but will remain in an advisory capacity for twelve months, having contributed significantly to the company over her 25-year tenure [2][3] Strategic Importance - The appointment of Mr. Williams is seen as timely, as the company is at a critical point in its growth trajectory and has significant opportunities for its RNS System [3] - Mr. Williams expressed excitement about joining NeuroPace, highlighting the potential to serve approximately 1.2 million U.S. patients living with drug-resistant epilepsy and the goal of making the RNS System the standard of care [4] Market Potential - The RNS System is positioned to expand access and utilization, with a commitment to product and data development aimed at improving patient outcomes [4]

Core Insights - Milestone Scientific Inc. has appointed Shanth Thiyagalingam to its Board of Directors, effective May 14, 2025, bringing over 20 years of experience in commercial scaling and product innovation in the medical device and pharmaceutical industries [1][3]. Company Strategy - The appointment supports Milestone Scientific's strategy to enhance the adoption of its CompuFlo® Epidural System and expand access under favorable Medicare Part B payment rates for CPT code 0777T [3]. - The company aims to advance commercial initiatives through its Federal Supply Schedule (FSS) contract award [3]. Leadership Experience - Thiyagalingam has a proven track record in leading high-growth medical device companies, particularly in reimbursement strategy and securing CPT code approvals [3]. - He previously served as CEO of PainTEQ, where he transformed the company from a startup to a recognized innovator in interventional pain therapy, leading M&A initiatives and securing a Category 1 CPT code for a new therapy [4][5]. Previous Roles - Thiyagalingam held senior positions at Abbott, overseeing commercial strategy in the Asia-Pacific region, and at Nevro, where he significantly increased division revenue [5][6]. - His early career included roles at Stryker and St. Jude Medical, focusing on strategic growth and product launches across various regions [6]. Educational Background - He holds a Bachelor of Medical Science, a Master's in Marketing Management, and an MBA, and is a certified Gallup Strengths Coach [7]. Company Overview - Milestone Scientific Inc. specializes in developing innovative injection technologies for medical and dental applications, utilizing its proprietary DPS Dynamic Pressure Sensing Technology to enhance patient comfort and safety [8].

Financial Data and Key Metrics Changes - The company reported revenue of $201.3 million for Q1 2025, a 23% increase compared to $164 million in Q1 2024 [19] - Net income for the quarter was $3 million, translating to diluted net income of $0.10 per share, compared to a net loss of $10 million or $0.34 per share in the prior year [12][21] - Adjusted EBITDA totaled $33.2 million, representing a 16% adjusted EBITDA margin, compared to $11.9 million and 7% in Q1 2024 [21] - The company reiterated its full-year 2025 revenue guidance of $940 million to $955 million, indicating a growth of 17% to 19% year-over-year [12][22] Business Line Data and Key Metrics Changes - The U.S. revenue for the quarter was $193.6 million, a 24% increase from $155.8 million in the prior year [19] - Revenue outside the U.S. was $7.7 million, reflecting a 6% decrease year-over-year [19] Market Data and Key Metrics Changes - The company noted that European revenue in Q1 2024 benefited from pent-up demand due to supply shortages, which impacted year-over-year comparisons [19] Company Strategy and Development Direction - The company is focused on expanding the limited market release of the Inspire V system and is preparing for a full launch in the U.S. [10][11] - The Inspire V system incorporates advanced sensing capabilities, which are expected to enhance therapy and patient outcomes [11][90] - The company plans to increase investments in medical education and marketing to drive awareness and adoption of Inspire therapy [17][16] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the demand for Inspire therapy, noting that patient flow remains strong despite a transition period for the new system [42][41] - The second quarter is expected to be a transition quarter, with revenue growth anticipated in the mid to high single digits sequentially [14][22] - Management is optimistic about a strong second half of 2025 as the full launch of Inspire V progresses [14][22] Other Important Information - The company has appointed two new Vice Presidents and Senior Medical Directors to enhance its medical education and training efforts [8] - The transition to CPT code 64568 has been incorporated into policies covering approximately 80% of the covered lives, which is expected to facilitate reimbursement [15] Q&A Session Summary Question: What happened with the Q2 revenue guidance and the destock? - Management indicated that increased patient awareness and the transition to Inspire V led to some patient warehousing, affecting Q2 revenue guidance [28] Question: How confident is the company about Inspire IV inventories in the marketplace? - Management stated they have close knowledge of existing inventories and expect high-volume centers to work through their Inspire IV inventory quickly [36] Question: How should investors think about the balance of restocking and pent-up demand? - Management emphasized strong patient outcomes and continued growth in the number of implants, which supports confidence in the second half of the year [41] Question: What is the company's confidence in the manufacturing and reimbursement for Inspire V? - Management expressed confidence in the device's performance and the manufacturing processes, noting that the transition to the new system is well-prepared [50] Question: What is the expected timeline for the transition to Inspire V? - Management reiterated that they expect to complete the transition by the end of the year, with a focus on high-volume centers first [115] Question: How is the marketing strategy for Inspire V evolving? - The company plans to step up direct-to-consumer marketing efforts to increase awareness and educate potential patients about Inspire V [121]

Summary of Merit Medical Systems (MMSI) Conference Call Company Overview - **Company**: Merit Medical Systems (MMSI) - **Event**: Rhapsody Investor Conference Call - **Date**: January 28, 2025 - **Key Participants**: Fred Lampropoulos (CEO), Brian Lloyd (CLO), John Hall (EVP R&D), Daniel Patel (Medical Director), Caleb Konstanski (VP Sales & Marketing), Raul Parra (CFO) Core Industry and Product Insights - **Industry**: Medical Device Industry, specifically focusing on dialysis access solutions - **Product**: Rhapsody Cell and Permeable Endoprosthesis (CIE) - **FDA Approval**: Received pre-market approval from the FDA in December 2024, with commercial launch initiated in January 2025 [9][10] Key Points Discussed 1. **Strategic Initiative**: The Rhapsody CIE is part of a long-term strategic initiative that began in 2010, aimed at transitioning Merit towards higher-value therapeutic medical devices [11][12][13] 2. **Market Opportunity**: - Over 660,000 people in the U.S. live with end-stage renal disease, with approximately 560,000 undergoing in-center hemodialysis [38] - The addressable market for Rhapsody CIE includes over 420,000 U.S. patients using AV fistulas or AV grafts [39][40] - In 2023, there were 665,000 dialysis access maintenance procedures, with 95,000 stent units implanted [41][42] 3. **Clinical Validation**: - Rhapsody CIE demonstrated 84.6% target lesion primary patency at 12 months and 65.9% access circuit primary patency at 12 months in clinical trials [22][25] - A total of 423 patients were studied in the U.S. and international markets, with plans to enroll up to 500 patients in a post-market study [25][26] 4. **Innovative Features**: - The Rhapsody CIE includes a cell impermeable membrane to prevent tissue growth, a modified biocompatible PTFE to reduce thrombosis, optimized compression resistance, and a user-friendly catheter delivery system [20][21][22] 5. **Commercial Strategy**: - The U.S. commercialization strategy includes intensive training for sales teams, marketing plans, and engagement with physician advocates [44][46][48] - Targeted average selling price (ASP) for Rhapsody CIE is set at $5,800, positioned as a premium product [84][86] Financial Expectations - **Revenue Forecast**: Projected U.S. revenue from Rhapsody CIE in 2025 is estimated to be between $7 million and $9 million [63] - **Reimbursement Strategy**: Applications for new technology add-on payments (NTAP) and transitional pass-through payments (TPT) are underway, with decisions expected in June 2025 [55][57] Additional Considerations - **Challenges**: Pricing sensitivity in outpatient settings and the need for larger diameter sheets for Rhapsody CIE may impact adoption [35][36] - **Future Outlook**: The Rhapsody CIE is expected to be featured in multiple medical meetings and publications throughout 2025, enhancing awareness and credibility [58][61] Conclusion - Merit Medical Systems is positioned to leverage the Rhapsody CIE as a significant advancement in dialysis access technology, with a comprehensive strategy for market entry and growth, supported by clinical validation and a focus on improving patient outcomes.