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EVP & President of Diabetes Que Dallara confirmed the U.S. slowdown is a timing issue as patients await new CGMs, with production ramping significantly to meet demand. She stated the Abbott-based Instinct sensor is expected to launch 'in the coming months.' EVP & CFO Thierry Piéton added that the planned separation of the business remains on track for completion within 15 months.

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CEO Geoff Martha noted the recent U.S. National Coverage Analysis (NCA) milestone will create a global 'halo effect.' Sean Salmon, EVP & President of the Cardiovascular Portfolio, detailed the international strategy, explaining it's a country-by-country process. He cited progress with reimbursement in France and recent approval in China, with Japan being the main outstanding market. However, he emphasized the U.S. will be the dominant growth driver for RDN.

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CEO Paul LaViolette confirmed that for catheter-based EP, a partnership is the most appropriate strategy and discussions are ongoing. He noted that while the system is already compatible with leading mapping systems, integration can become tighter over time with partners. He also highlighted that nSPFA's rapid procedure times and low neuromuscular stimulation make it very well-suited for the ASC environment.

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CEO Peter Caldini clarified the U.S. strategy is to launch Preservay first in 2026, followed by Mia after its regulatory approval. He emphasized that the current early experience program for Preservay is for learning and is not expected to have a significant revenue impact in 2025, nor is it a material component of the updated guidance.

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CEO Peter Caldini attributed the strong U.S. launch to a superior product and effective marketing, stating that while performance is exceeding expectations, the company is choosing to remain conservative with its guidance. He noted that the competitive response has not been significant, with only isolated instances of price discounting after clinics had already converted to Motiva.

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Executive Rajbir Denhoy and CEO Juan Jose Quiros confirmed the strength of the Mia data, which shows a near-elimination of device and technique-related complications. They stated that the company is preparing for discussions with the FDA regarding the regulatory pathway for both Mia and the Ergonomix2 platform, with the goal of leveraging this compelling global data.

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President, CEO & Chairman Joseph Devivo clarified that the guidance revision was due to delays in closing large enterprise and medical school deals, not competitive headwinds. He explained that Butterfly is pioneering this market segment. For software, he noted a 'tale of two stories': churn in individual subscriptions is a headwind, while enterprise software revenue is growing. He positioned the upcoming Compass AI platform as a 'generational shift' that will simplify documentation and automation, making it a key catalyst for both software and overall enterprise sales.

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CEO Joseph DeVivo described the Rochester publication as a 'seminal moment' that enabled C-suite conversations by proving clinical and economic value. CFO Heather Getz added that iQ3 adoption is strong across all channels, not just hospitals, and confirmed the company has 'virtually no foreign currency risk,' with potential tariff impacts being manageable.

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Joseph DeVivo, Chairman and CEO, affirmed high confidence in the long-term target, stating the company is on track with its 5-year plan. He highlighted the significant upside from the Octiv and HomeCare initiatives, noting the HomeCare pilot is proving the model's scalability by training partners' existing staff. DeVivo explained that the wearable device development is being deliberately paced to align with the market use case currently being established through the HomeCare pilot, ensuring demand exists before the product launch.

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Joseph DeVivo, Chairman and CEO, attributed the strong U.S. launch to a desirable product and effective execution across all channels, including e-commerce, inside sales, and direct sales. On the RoHS directive, he described a productive meeting with EU officials and outlined the timeline for a potential revocation of exemptions for competitors, expecting a decision by late 2025. Regarding the iQ Station, DeVivo positioned it as a revolutionary workstation powered by the future P5 chip, designed to completely reimagine in-facility imaging workflows rather than being a simple cart.

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Chairman & CEO Pat Miles explained that while the lateral franchise is often the entry point, a significant halo effect is driving growth in areas like deformity, informed by the EOS ecosystem. He noted that market share is substantially higher where EOS systems are installed and that interest from academic institutions is at an all-time high. CFO Todd Koning added that the company is attracting a broader base of surgeons.

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CEO Dominick Colangelo outlined the MACI Ankle trial as a Phase III study enrolling approximately 300 patients with a 2-year endpoint, comparing MACI to microfracture. CFO Joe Mara reaffirmed that the company's long-term targets for high 70s% gross margin and high 30s% adjusted EBITDA margin by 2029 remain on track, supported by strong current performance.

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CEO Nick Colangelo reported that while formal data is pending from a patient registry, anecdotal surgeon feedback on MACI Arthro has been positive, indicating better post-operative recovery as expected from a less invasive procedure. He also noted the learning curve is not steep. Regarding the sales force expansion, Nick Colangelo stated it's a targeted effort to support growth in high-volume areas. CFO Joe Mara added that the associated costs are factored into the full-year guidance and will be incurred in the second half, not impeding the strong margin ramp driven by higher revenue.

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CFO Joe Mara stated that significant outperformance in 2024, with gross margin reaching 73% and 78% in Q4, provided the confidence to update the long-term targets. He acknowledged the path to the 2029 goals might not be perfectly linear as the new facility's costs are absorbed, but the overall trajectory of ~1 point/year for gross margin and ~3 points/year for adjusted EBITDA margin remains the expectation.

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CEO Nick Colangelo explained that reps began discussing the Arthro option for existing unconverted biopsies only after approval. He confirmed a mid-to-high single-digit price increase for MACI is planned for 2025 and that disposable Arthro instruments generate a small amount of revenue. He also stated that the company will re-evaluate its sales force size in early 2025 to effectively target the expanded surgeon base.

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CEO Waleed Hassanein stated he sees no headwinds, as the NOP's success in growing transplant volume aligns with modernization goals. He emphasized a collaborative approach with OPOs. He also clarified that TransMedics is not currently engaged with CMS for trial reimbursement, as it is not deemed necessary for these technology modifications.

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Executive Waleed Hassanein confirmed there was a 'pretty loud' buzz for both the heart and lung trials at ISHLT, with significant interest from both U.S. and international surgeons. Regarding the heart trial's superiority endpoint, he emphasized that TransMedics is unique in pursuing Level 1 evidence against the standard of care and expressed confidence in their approach, stating they will let the rigorous trial data speak for itself.

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CEO Waleed Hassanein dismissed concerns of customer attrition as "confabulation" from the short report, confirming that the centers cited remain active users. Regarding competition, he stated that NRP is not mutually exclusive with OCS, as the organ still requires preservation and assessment post-NRP, and noted that TransMedics' market share in DCD liver actually increased.

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CEO Waleed Hassanein acknowledged they had forecasted headwinds but conceded the Q3 slowdown was slightly higher than anticipated, attributing it to summer seasonality across all three organs. He explicitly confirmed that TransMedics' market share in both liver and heart, at both the center and national levels, remained unchanged in Q3.

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CEO Kevin Sayer stated that relationships with key DME partners are now 'much stronger' and that the company is focused on maintaining sufficient inventory for them. He emphasized that the new commercial team is dedicated to these partnerships, which will be critical for navigating the upcoming CMS competitive bidding process.

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CEO Kevin Sayer noted that a significant volume shift to pharmacy has already occurred for commercial pump users, and Dexcom is well-positioned to serve that channel. CFO Jereme Sylvain added a key constraint: the Medicare Fee-for-Service population is reimbursed via Part B (DME), which limits how much of the total market can shift to pharmacy.

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CFO Dale Sander stated the company remains comfortable with previous guidance, expecting a second-half weighted revenue ramp. CEO Dr. Laura Niklason explained that for the V012 trial, key learnings involve closely monitoring post-implantation handling of the conduit. She also affirmed the Fresenius partnership remains strong, with Fresenius encouraged by V007 trial results and aligned on reducing patient catheter-dependency.

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Executive Laura Niklason explained that rapid Value Analysis Committee (VAC) approvals were driven by strong surgeon champions and a commitment to patient care at a mix of trial and non-trial sites. While declining to give formal guidance, she noted the current pace could see most Level 1 trauma centers initiating the VAC process by year-end, with sales weighted to the second half. She also clarified that the AV access indication is now expected to contribute to revenue in 2027, not 2026. Regarding the article, she stated that trial surgeons were 'incensed' by what they felt was biased reporting and have drafted a rebuttal.

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Executive Laura Niklason stated that discussions with Fresenius are ongoing and that while Fresenius leadership was encouraged by the data showing reduced catheter time, it's uncertain if the current results are sufficient to trigger the agreement. She confirmed ATEV's utility in revision cases for both aneurysmal fistulas and infected synthetic grafts. For the PAD indication, she noted it could be their largest market, but a Phase 3 trial is on hold pending an improved cash position, which could come from financing or a partnership.

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CEO Xingjuan Chao quantified the opportunity by stating Ceribell is only 20-30% penetrated within its existing accounts, leaving a 70% growth opportunity. She confirmed the hub-and-spoke model is a key and effective strategy. Regarding competition, she asserted that Ceribell remains the clear category leader with unmatched technology and clinical evidence, and is not seeing a meaningful impact from emerging competitors.

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CEO Jane Chao explained that based on pre-submission discussions, the FDA's key requirement for the delirium indication is demonstrating the algorithm's accuracy is comparable to the CAM-ICU nursing assessment. She elaborated that the 'new vital sign' vision involves creating synergies between indications like seizure, stroke, and delirium to help clinicians differentiate neurological conditions in the same patient population and call points, thereby expanding the market.

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Executive Xingjuan Chao confirmed that economic benefits are a major adoption driver and that different value propositions resonate with different hospitals. She noted that 100% of new accounts use their AI algorithm and that while ClarityPro offers stronger clinical benefits, the company is still in the process of driving its adoption.

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Leslie Trigg, Chair and CEO, stated that Outset has not observed any changes in the hospital capital spending climate and that Tablo's value proposition is advantaged because it offers tangible, near-term economic savings with a short payback period, which is compelling in any environment. She confirmed that sales force attrition was at a record low in Q1 and that the team is currently rightsized. She noted that future investments will be focused on incrementally growing the field service team to support the expanding installed base, rather than the capital sales team.

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CEO Leslie Trigg stated that the sales transformation is progressing well, with key changes largely complete and expected to be fully settled in early 2025, though positive impacts were already seen in Q3. She confirmed that no deals exited the pipeline, the 9-12 month sales cycle for large deals is stable, and while TabloCart's return is helpful, the core value proposition of cost savings and improved care remains the primary sales driver.

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Executive Reza Zadno responded that while they could potentially obtain a tool claim, the primary strategic goal is to expand the prostate cancer market. To achieve this and influence treatment guidelines, the company is focused on generating Level 1 data through the WATER IV randomized controlled trial against radical prostatectomy.

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CEO Reza Zadno stated that competition is mainly in the non-resective space and that PROCEPT is unique in running an FDA randomized trial against radical prostatectomy. CCO Sham Shiblaq added that their primary resective competitor is the fragmented TURP market, which is an advantage. CFO Kevin Waters confirmed the 2025 guidance does not assume any revenue related to a prostate cancer indication.

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Executive Reza Zadno explained the WATER IV trial aims to generate Level 1 data to expand the prostate cancer market by demonstrating harm reduction. Executive Sham Shiblaq noted that surgeons already felt safe treating these patients and the label change affirmed this. Regarding ASCs, Shiblaq confirmed the pilot's success and plans for a deliberate, limited expansion in 2025, while maintaining a primary focus on the large hospital greenfield market.

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President and CEO Ivan Tornos stated that over 20% of U.S. sales now come from the ASC setting, a significant increase from pre-pandemic levels. He noted that Zimmer Biomet is the #1 reconstructive company for knees and hips in the ASC space and is well-positioned to grow above market. He added that the S.E.T. business is also performing well and is expected to accelerate.

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Chief Operating Officer Vivek Jayaraman attributed the strong North American growth to underlying demand in the U.S. for both platelets and IFC, noting continued share capture opportunities. He clarified that while Canada contributed, growth was predominantly from the U.S. Senior Vice President Carol Moore detailed the regulatory process for the red blood cell system, explaining that the notified body (TUV) conducts a clinical review first before advancing the file to competent authorities, and expressed confidence in the strength of the resubmitted application.

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Executive Vivek Jayaraman stated that the IFC market is inflecting, with momentum from AABB and recent BLA approvals unlocking demand. He emphasized that balancing supply with spiking demand and maturing clinical evidence are key to market penetration. Executive William Greenman addressed the China question, noting an expected NMPA approval this year, followed by a provincial reimbursement process of about a year. He clarified that meaningful revenue from China is not expected in 2025 but represents a significant long-term opportunity.

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COO Vivek Jayaraman confirmed more BLA applications are in process for 2025 and beyond, noting current capacity is sufficient to meet demand. CFO Kevin Green explained the LED illuminator is expected to be gross margin neutral with a higher ASP. President and CEO Obi Greenman added that the new system's IP significantly extends the company's competitive moat.

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CFO Leigh Vosseller confirmed that durable pumps are widely accepted in the pharmacy channel and that various reimbursement structures are possible. She specified that Tandem's current contracts are not subscription-based, so they do not anticipate the headwinds some competitors face with that model.

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CCO Mark Novara confirmed the FDA approval covers all insulin-using Type 2 patients, including basal-only. CFO Leigh Vosseller explained that commercial coverage is strong, but Medicare coverage still has onerous requirements. She noted Tandem is actively working with industry partners to advocate for changes to the national coverage determination with CMS.

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President and CEO John Sheridan stated that off-label use for Type 2 has remained steady at 5-10% of new starts and he doesn't expect a significant increase until after approval and active marketing. However, he revealed that recent market research indicates a higher propensity for adoption, leading them to believe market penetration could eventually exceed 25%, up from a previous estimate of 15%.

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Michael Mahoney, Chairman and CEO, stated that capacity is not currently a constraint, as the efficiency and strong reimbursement of these procedures are driving hospitals to invest in new labs. Dr. Ken Stein, CMO, added that Boston Scientific is enabling the shift to ASCs by making FARAPULSE safe, efficient, and predictable, with features that reduce the need for general anesthesia and expensive mapping catheters.

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CEO Mike Mahoney characterized the situation as a dynamic environment but stated that the company's guidance already accounts for global macro challenges, including tariffs, which he views as manageable. He expressed hope for an appropriate FTC environment and noted that historically, the medtech industry has not been a primary target of major policy changes across different administrations. Overall, he conveyed comfort in the company's ability to manage through potential policy shifts.

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CEO Michael Mahoney directly stated there are no supply issues and the team has done a great job scaling catheter and console supply. CMO Dr. Ken Stein clarified the FARAWAVE NAV is a single-use device and highlighted the Orion high-density mapping catheter. He noted future catheters like FARAPOINT and FARAFLEX will integrate mapping and ablation, further building out their portfolio to target arrhythmias.

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Barry Wolfenson, an executive, explained that collaborators like Solventum and Molnlycke provide standardized products and crucial training to minimize trial variability and optimize outcomes. He also confirmed the DFU study aims to mirror the VLU trial, with plans to approach the FDA and EMA in the second half of the year. CEO Ofer Gonen added that regulatory approvals for the new facility are anticipated in early 2026 from the EMA and mid-2026 from the FDA, contingent on required stability data.

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Ofer Gonen (Executive) clarified that the EscharEx Phase III protocol is cleared by the FDA and EMA, with an IND submission imminent and patient enrollment expected to begin 30 days after. He stated the head-to-head study is internally driven to bolster the commercial launch package, not a regulatory mandate. Regarding manufacturing, Gonen confirmed the new facility's construction is complete and is now in the pre-planned commissioning phase, with timing for full operation dependent on upcoming regulatory inspections.

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CEO Kevin Lobo described the ASC trend as being in the 'early innings,' providing a steady, long-term tailwind for multiple divisions. He stated that near-term M&A would focus on integrating Inari and adding tuck-ins within peripheral vascular, not expanding into broader cardiovascular markets.

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CEO Joaquin Duato explained that while large deals like Shockwave are outliers, the core strategy remains focused on smaller, value-creating bolt-on acquisitions, noting over 40 such deals in 2024. CFO Joseph Wolk added that the significant investments in Abiomed and Shockwave are performing well, with Abiomed growing 15% in 2024 and Shockwave delivering substantial growth, reinforcing their leadership in high-growth cardiovascular markets.

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