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CEO David Endicott projected that the IOL market would remain highly competitive for the next 18-24 months as new products launch. He explained the lengthy STAAR transaction timeline is due to international regulatory reviews, particularly in China, and highlighted the long-term potential of combining Alcon's optics with STAAR's collamer platform for a presbyopia-correcting ICL.

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Chief Executive Officer David Endicott confirmed that PRECISION7 is tracking well and addressing a need in the large reusable lens category where Alcon is under-indexed. For AR-15512, he emphasized its unique mechanism as an agonist for natural tear production, which differentiates it from existing treatments. He reiterated the $250M to $400M peak sales outlook, adding that he is now leaning toward the higher end of that range.

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CEO David Endicott indicated the sales strategy for Unity will focus on its standalone value proposition of improving OR efficiency and throughput, which inherently drives consumable use. For dry eye, he noted the market is attractive and that AR-15512 is differentiated by its fast onset of action and ability to show significant improvement in patient signs, a key clinical differentiator.

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CFO Tim Stonesifer explained that while the inventory provision was a headwind, the company is maintaining its margin guidance because it is committed to increasing investments in R&D and new product launches in the second half of the year. CEO David Endicott addressed M&A by reiterating that Alcon's priority remains technology-focused, bolt-on acquisitions in the $50-$500 million range to fill gaps in strategic areas like glaucoma, refractive, and pharmaceuticals.

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Chairman & CEO Geoff Martha expressed high confidence in RDN, stating that 'all the dominoes are falling' for it to become a massive market, supported by positive feedback to CMS and inclusion in physician guidelines. He suggested RDN has the potential to be even bigger than CAS and could be 'the biggest thing that we ever do' given the vast patient population.

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Sean Salmon, EVP & President of the Cardiovascular Portfolio, clarified that the TPT payment addresses the Medicare fee-for-service population, which is roughly half of all Medicare beneficiaries. The other half, covered by Medicare Advantage, would still require broader coverage decisions. He reiterated that the total patient population is very large and that establishing coverage and treatment centers is the key focus.

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CEO Paul LaViolette stated that the extensive European human data is included in the IDE submissions to support safety. He confirmed the company favors a modular PMA submission process, which is enhanced by the shared console between devices. CFO Jon Skinner added that R&D spending and cash burn are expected to increase in the second half of 2025 to support the commencement of two IDE clinical trials.

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CEO Devdatt Kurdikar acknowledged that the CMS proposal could theoretically be a positive tailwind but stated it is too early to quantify any impact. On China, Kurdikar noted that while tariff rates were reduced, the company expects a minimal impact in fiscal 2025 due to product exemptions. He confirmed that the company is observing a preference for local Chinese brands amid the uncertain geopolitical environment, a factor that has been incorporated into the updated financial guidance.

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CEO Devdatt Kurdikar stated that the company saw no evidence of tariff-related stockpiling in the U.S., noting that most of its products benefit from medical use exemptions and that imports from China are minimal. Regarding market dynamics, he explained that key indicators like insulin pen prescriptions show stability, and the sheer scale of the MDI market means any shifts from pump adoption will take time to materially impact their business.

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CEO Peter Caldini stated that the focus is shifting more toward increasing utilization within existing accounts, though new account acquisition continues. He believes Establishment Labs is helping grow the overall market and has not seen a consumer slowdown. CFO Raj Denhoy clarified that the company incurred higher shipping *costs* from using air freight to meet demand, but there was no material revenue *impact* from shipping delays.

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CEO Peter Caldini stated that U.S. account penetration is exceeding expectations and the company expects to be near its target number of accounts by year-end. For Mia in Europe, he confirmed progress with 75 accounts in 42 cities, noting that two accounts are already performing at a $1 million per month run-rate, validating the business model.

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CEO Juan Jose Quiros reported strong U.S. momentum with 650 accounts onboarded, 450 of which have ordered, and an 88% reorder rate. He confirmed the $35 million U.S. guidance for 2025 does not include any new product approvals. Regarding the macro environment, he noted stabilization in Latin America and conservative guidance for mid-single-digit growth in EMEA and APAC.

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CEO Juan Jose Quiros reiterated the rapid sales force expansion to 40 reps by year-end and highlighted the company's clear path to profitability, driven by U.S. gross margins and disciplined spending. Executive Rajbir Denhoy re-emphasized that the OUS forecast is a conservative start, with potential upside from China and a market recovery in Latin America.

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CEO Christopher Simon stated that share gains are on track and will be the primary driver of the guided 11-14% organic growth for Plasma this year, with some benefits extending into FY27. He highlighted customer diversification, with no single customer representing more than 10% of total revenue. Regarding Vascade, Simon described the current softness as executional, not structural, and reaffirmed the product's strong clinical value proposition. He outlined decisive actions being taken, including new leadership hires and a more clinically focused sales force, to regain momentum against competitors.

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CEO Christopher Simon stated that among the top 600 EP accounts where PFA is roughly 60% penetrated, Haemonetics is present in 85% of them, making utilization the key growth driver. He noted the larger French size catheter is in a clinical trial to strengthen the label, but regulatory timing is uncertain. Regarding Plasma, he explained that new contracts feature advanced technology, significantly improving the segment's margin profile to the mid-50s, which is better than original LRP targets.

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CEO Christopher Simon clarified that the CSL contract roll-off is proceeding as expected. He stated that underlying plasma collections, excluding CSL, grew in the low-single-digits, boosted by share gains and technology upgrades. Regarding VASCADE, Simon explained that strong growth in VASCADE MVP and MVP XL was moderated by competitive pressures on the base VASCADE product used in PCI, which constitutes about 15% of vascular closure revenue.

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CEO Christopher Simon detailed that the VASCADE MVP XL launch is progressing well, having been introduced in 200 of the 600 target accounts, with expectations for high 20s percent growth in the second half. He noted its premium pricing is justified by a larger collagen plug and will become margin accretive. For the Plasma business ex-CSL, Simon explained that revenue grew due to premium pricing from technology upgrades, which more than offset a mild decline in collection volumes, and highlighted ongoing market share gains with the NexSys platform.

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CEO Adam Grossman and CFO Brad Tade reiterated their conservative approach to guidance, aiming to beat expectations. They confirmed that while yield enhancement benefits are not in 2025 guidance and are risk-adjusted for 2026, they anticipate a reacceleration of growth in the second half of 2025. Grossman explained that while formal health economics data is pending, Ascentive's value proposition lies in preventing hospitalizations for high-risk patients.

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President and CEO Adam Grossman explained the company's conservative guidance approach, prioritizing the sale of existing inventory before recognizing revenue from the newly approved enhanced-yield lots. He confirmed manufacturing at the new scale is underway and expects OpEx to normalize and decrease sequentially. Grossman asserted that strong forecasted free cash flow allows ADMA to pursue all capital allocation priorities simultaneously. CFO and Treasurer Brad Tade reinforced that the combination of revenue growth, margin expansion, and OpEx normalization positions the company strongly for the second half of 2025.

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President and CEO Adam Grossman confirmed that 2025 guidance excludes the yield enhancement, while 2026 guidance includes a heavily risk-adjusted estimate, suggesting potential upside. He affirmed the yield enhancement offers a 20% increase in bulk product. CFO Brad Tade added that while inventory levels will see slight upward pressure, the company expects to generate significant cash in 2025 and will be opportunistic about its use, including potential debt reduction to improve its capital structure.

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President and CEO Adam Grossman acknowledged that donor churn is a natural occurrence but stated the company is actively working to maximize donor retention. He confirmed that plasma safety stock is not yet at desired levels, which limits ASCENIV production. Regarding the political landscape, Grossman expressed confidence, citing historical bipartisan support for plasma-derived therapies and highlighting ADMA's unique position as a 100% U.S.-based manufacturer, which he views as a strategic advantage. CFO Brad Tade added that opportunistic spot sales of plasma are used to align inventory with production needs.

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President & CEO John Sheridan stated the opportunity is huge, citing Abbott's previous figures of 300,000-400,000 U.S. Libre 3 users who are not on pump therapy. He pointed to the success of a competitor in OUS markets that gained about 50,000 users with a Libre integration as existence proof. He confirmed the full U.S. commercial launch is planned for the fall and that market research indicates strong interest.

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CEO John Sheridan noted it was too early to measure the benefit, while CFO Leigh Vosseller added that guidance includes only a modest contribution for 2025. She mentioned that while commercial coverage is strong, more onerous Medicare access is a near-term gating factor the industry is working to improve.

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CEO Michael Castagna confirmed that positive interim data for clofazamine, combined with its Fast Track and QIDP designations, could lead to a faster review. He stated it was too early to specify the sales force size but noted it wouldn't be a huge footprint. Regarding pediatric Afrezza use, both Castagna and Dominic Marasco suggested that parents' concerns about hypoglycemia and the active lifestyle of children could lead to more consistent, full-time use compared to adults.

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Executive Michael Castagna expressed optimism for pediatric adherence, citing motivated parents and positive trial data. He confirmed the Danbury facility has significant capacity, built originally for the large diabetes market, and that most pipeline-related CapEx is already behind them, with no new plant needed in the next 5 years to support growth.

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CFO Bob Marshall specified that the LMI acquisition is expected to contribute $40-45 million in revenue and $0.04 of EPS in 2025. President Paul Blanchfield added that while Polarify volumes are expected to grow in the low single digits, the broader market is growing in the mid-to-high teens, implying further share loss. He also forecast continued net price declines in Q3 and Q4.

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President Paul Blanchfield acknowledged short-term competitive disruption for PYLARIFY among smaller, non-contracted sites due to reimbursement changes but affirmed the company's strategy to maintain market leadership. CEO Brian Markison and CFO Robert Marshall explained the spec divestiture streamlines the company to focus on core growth areas like PET and theranostics, noting it will also be accretive to gross margins. Markison stated the company is focused on the MK-6240 NDA filing before showcasing the data.

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CEO Brian Markison dismissed the threat from a competitor's Gallium-based agent. President Paul Blanchfield highlighted the new CMS payment policy as a long-term positive for the radiopharmaceutical diagnostic space. Chief Commercial Officer Amanda Morgan emphasized that most customers are secured under multi-year contracts, and Lantheus will leverage PYLARIFY's clinical and commercial differentiation, including its supply chain and payer access, to maintain market leadership.

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President Paul Blanchfield confirmed the final 2025 CMS payment rate for PYLARIFY is effectively the same as the current rate, which sustains access for Medicare fee-for-service patients. CFO Robert Marshall addressed the Q4 guidance, stating that while PYLARIFY revenue is expected to improve sequentially, the step-down in EPS is primarily due to a planned increase in R&D expenses.

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CEO Tim Herbert sees an opportunity to expand to general surgeons now that the pressure-sensing lead is eliminated. He confirmed the plan is for the great majority of sites to have SleepSync implemented, viewing it as a long-term competitive advantage. He noted that for high-BMI patients, centers proactively use tools like GLP-1s to help them lose weight and qualify for Inspire therapy, framing it as a pathway to treatment.

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CEO Tim Herbert outlined several factors that will increase capacity: the shorter Inspire V procedure time, attracting new ENTs who were previously reluctant, and training new graduates. He noted that capacity remains the key focus. Regarding Sleep Sync, he explained it is crucial for helping high-volume centers manage more patients and that the new Inspire V programmer integrates directly with it, streamlining data management.

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CEO Tim Herbert noted that most current patients have a BMI under 32 and reiterated that GLP-1s are a future tailwind that will help more patients become suitable candidates for Inspire, though the timing is uncertain. CFO Rick Buchholz explained the R&D spend includes investments in the SleepSync digital platform, the PREDICTOR study, and the new programmer, with the recent step-down in expense related to prior-year pre-launch inventory costs.

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CEO & Chairman Michael Farrell stated that ResMed has extensive experience with competitive bidding and believes the current environment is more benign than in the past, with Medicare and private payer rates now aligned. On strategy, he positioned PAP therapy as the 'gold standard,' with dental devices as 'silver' and other options like drugs or implants as 'bronze,' emphasizing ResMed's goal to maintain a relationship with patients across all therapies.

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CEO Michael Farrell stated that the competitive bidding impact should be manageable as Medicare and private payer rates are now more aligned. Regarding strategy, he positioned CPAP as the 'gold standard' and other treatments as secondary or tertiary, emphasizing ResMed's goal to maintain the patient relationship regardless of therapy choice.

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CEO Michael Farrell stated that ResMed is not waiting for pharmaceutical companies to drive demand. Instead, ResMed is proactively running targeted continuing medical education (CME) programs for high-volume GLP-1 prescribers. He confirmed these efforts are already having a measurable impact, leading to increased patient referrals and prescriptions, and are demonstrating a positive return on investment.

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CEO Michael Farrell stated that he expects a generally "benign pricing environment" ahead, though some targeted increases on high-cost components may occur. He also confirmed there have been no major changes in U.S. HME purchasing patterns, as ResMed partners with them to maintain efficient, but not excessive, inventory levels.

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CEO Liam Kelly stated that a spin-off would target mid-2026 but could not provide a specific timeline for a potential sale, emphasizing that significant progress has been made with preliminary buyer meetings. For BioTronic, he confirmed the guided Q3/Q4 revenue cadence ($99M/$105M) and highlighted revenue synergies from improved cath lab access and portfolio cross-selling opportunities.

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CFO John Deren stated it is too speculative to break down the tariff impact by the future entities. CEO Liam Kelly explained that Biotronik synergies are primarily channel-based, leveraging each company's sales force in their respective strongholds (Americas and EMEA) to cross-sell products, supported by continued investment in Biotronik's R&D.

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CEO Liam Kelly stated that the capital structure and ownership details will be determined later and disclosed in the Form 10, with the goal of creating two strong, independent companies. Regarding synergies, he highlighted the significant top-line opportunity from combining sales channels, enabling Teleflex to sell its peripheral-indicated products through Biotronik's established channels and creating a more comprehensive cath lab offering.

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Liam Kelly, Chairman, President and CEO, reported that the Palette integration is nearly complete and has exceeded expectations, leading to a guidance raise for the product. He noted the primary synergy has been a 'halo effect' benefiting Barrigel sales due to the larger sales force. Kelly highlighted the post-prostatectomy indication as a significant, approximately $100 million future market opportunity where Barrigel's NASHA technology offers a unique advantage.

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President & COO Joe Gilliam described the adoption as a mix of both new physicians starting to use the product and early adopters increasing their utilization and expanding into commercially covered patient populations. He emphasized a methodical, account-by-account approach to managed care, ensuring practices are set up for success with benefits verification and prior authorizations before scaling.

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President and COO Joseph Gilliam confirmed that in the Noridian region, there is a full spectrum of adoption, including customers performing 15-20 iDose procedures a month as well as others who are just beginning. He also affirmed that the company intends to implement a $0 co-pay program for commercial patients to ensure out-of-pocket costs are not a barrier to access.

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President and COO Joe Gilliam stated the new professional fee schedules were announced in mid-January. He emphasized that building physician confidence and consistent payment flow is a multi-quarter journey. Gilliam then provided detailed guidance: Corneal Health expects low single-digit growth; International Glaucoma high single-digit growth; and the non-iDose U.S. business is projected to be flat to down low-single-digits. This implies iDose revenue expectations are "well north of $100 million" for 2025.

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President and COO Joseph Gilliam explained that while some Medicare Advantage coverage exists, the company will methodically begin to support and drive this segment over the course of 2025. He clarified that patient assistance programs are for commercial patients only. For iDose, a Part B procedure, the donut hole is not a primary issue as most Medicare patients have supplemental insurance covering out-of-pocket costs.

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CFO Karleen Oberton clarified the goal is for every lab, not every Panther system, to have Fusion capability, with over a third of customers now having it. She noted Fusion assays carry a price premium. She also stated that no significant inventory build is anticipated for the new gantry launch, as many components are shared with the current system.

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COO Essex Mitchell stated that Hologic does not foresee any near-term issues with semiconductors, having expanded its network after previous challenges. CFO Karleen Oberton declined to comment on specific customer contracts but pointed to the strong low-double-digit underlying growth in the molecular business (ex-HIV headwinds) as evidence of strong customer relationships.

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CEO Stephen MacMillan stated that while the current year is experiencing a cyclical dip below the target, he is confident in returning to mid-single-digit growth. He cited strengthening surgical and diagnostics businesses, along with a future rebound in Breast Health driven by a new gantry, as key drivers. Regarding H5N1, Mr. MacMillan compared it to the Zika virus development, noting that while Hologic is prepared to support government needs, he would not assume significant revenue, and any contribution would be considered upside.

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Chairman, President and CEO Stephen MacMillan indicated that the gantry replacement cycle would be a rolling, durable process rather than a large bolus. Chief Operating Officer Essex Mitchell added that while details on Gynasonix's installed base would be shared post-closing, the acquisition is highly complementary as it targets the same customers and procedures as Hologic's current surgical team.

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CEO Joseph Capper responded that it is too early to determine the impact of the wound classifications and that more clarification is needed from CMS. On the market shakeout, he reiterated his belief that a significant portion of the current market spend will disappear due to both lower pricing and a reduction in overutilization. Capper expressed confidence that Mimetics will win in a rational market where product selection is based on clinical performance, safety, and efficacy.

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CEO Joe Capper acknowledged that the delay would likely cause shifts in ordering patterns as more providers learn of the high-reimbursement opportunities. He stated his belief that the Department of Justice is aware of the issue and that the new CMS administration, which is focused on eliminating fraud, waste, and abuse, views the situation as 'low-hanging fruit.' He emphasized that the core problem is pricing, which CMS has the authority to address, and that all key government stakeholders are aware of the escalating issue.

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Corporate VP Larry Wood clarified that what appears to be a backlog is the normal 3-6 month patient workup process, but noted a renewed clinical focus on timely referrals. On mitral, Corporate VP Daveen Chopra emphasized that the market is still in early stages, and the immediate focus is on expanding treatment for symptomatic patients with a portfolio of both repair (PASCAL) and replacement (SAPIEN M3) technologies.

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Larry Wood, Corporate VP of TAVR, clarified that the recent strength came from a renewed focus on referrals, not a reduction in the typical 3-6 month patient workup time. Daveen Chopra, Corporate VP of TMTT, noted the mitral market is in its early stages, and the immediate focus is on treating the large, underserved symptomatic population with a portfolio of both repair and replacement technologies.

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CEO Steve Farrell stated that the consignment inventory, combined with existing stock, is sufficient to meet most of China's demand through early 2026, mitigating tariff impacts. He detailed the rapid, multi-continent effort to ship this inventory. Regarding pricing, Farrell affirmed that there are no major changes to the strategy. He emphasized the high value EVO ICL provides to patients and surgeons, and while price is a potential lever, the focus remains on the product's life-changing value.

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CFO Patrick Williams confirmed the order was from the newer distributor, whose focus is on market expansion. He noted that while sell-through data is being refined, they observed a mid-single-digit year-over-year increase in January but cautioned against treating it as a definitive trend. CEO Tom Frinzi acknowledged they are monitoring the same stimulus news as the market. Patrick Williams added that Chinese consumers have significant savings, and a boost in confidence could unlock demand.

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Tom Frinzi, Chair, President and CEO, acknowledged that a slowdown in China's high season led to slightly more inventory in the channel but deemed the level appropriate for when the market turns. Patrick Williams, CFO, added that the updated U.S. guidance for 20% full-year growth already contemplates a continued downturn in the broader laser vision correction market, where STAAR continues to gain share.

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Executive Thomas G. Frinzi noted it's too early to tell the impact of Chinese stimulus but local intelligence is encouraging. Executive Patrick Williams confirmed a ~300 bps pricing tailwind from new distributor deals was already factored in. Regarding the U.S., Frinzi confirmed the 'Highway 93' initiative is the key driver, with those accounts growing significantly faster (29%) than other accounts (19%).

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CFO Jereme Sylvain stated that utilization is currently highest among users identifying as Type 2, followed by prediabetic, then non-diabetic. He noted the primary channel is still stelo.com as the Amazon launch is recent, but he expects Amazon to become a much larger part of the distribution mix due to its broad reach.

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CFO James Saccaro confirmed semiconductor impacts are reflected in the guidance and that the company has a pathway to a sub-$0.85 impact in 2026, though it's too early to quantify. CEO Peter Arduini added that price is a potential lever but the focus is on cost offsets. On Flyrcado, he reiterated revenue targets and said adoption rate is the key driver, not the installed base of PET/CT scanners.

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CFO Jay Saccaro explained that the Q4 margin strength was driven by volume, mix, price, and productivity, which fully offset inflation. He noted that about 100 basis points were from one-time items and cautioned against extrapolating from a seasonally strong quarter. However, he expressed increased confidence in achieving the "20%-plus" long-term target. CEO Peter Arduini added that the company is on track with its strategy, with higher-margin new products expected to launch in 2026 and beyond, supporting future margin expansion.

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CEO Al White stated that while there's always a slight risk of inventory tightening, he doesn't see it as significant for Cooper due to contractual obligations with partners. On the IVF executive order, he views any government activity supporting expanded access as a net positive for the industry, noting that Cooper's products are a small part of the overall cost of treatment, which is heavily driven by pharmaceuticals.

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CEO Al White explained that fitting toric lenses is more complex but is a growing and high-margin area, expecting it to outpace overall market growth for years. He believes all competitors will continue to highlight strength in torics. Regarding MiSight, he attributed the Q4 inventory contraction to distributors tightening their inventory levels, a dynamic he expects may cause some fluctuations in the high-growth product going forward.

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CEO Al White indicated that annual price increases of 2-3% are reasonable to offset inflation and that the mix shift to higher-value toric and multifocal lenses is accretive to operating margins long-term. Regarding PARAGARD, he expressed confidence in its market position, highlighting its 10-year indication and a newly launched single-handed inserter that improves ease of use and addresses practitioner feedback.

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Chief Innovation Officer Ahmet Tezel deferred comment on specific endpoints until the data is published in Q4. CEO Vladimir Makatsaria clarified that the commercialization decision is not endpoint-driven but will be 'purely driven by the reimbursement decision of CMS.' He reiterated that the formal CMS application will occur in Q1 2025 after all publications are released, with a review process that typically takes about a year.

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CEO Michael Mahoney clarified that the system is not 'closed'; physicians can still use FARAPULSE with competitor mapping systems. CMO Dr. Ken Stein added that the original FARAWAVE catheter (without the NAV sensor) will remain available for this purpose. However, they believe the user experience and differentiated features of the FARAWAVE NAV with the OPL system will be compelling enough for physicians to want to use it.

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