Joshua Jennings

Josh Jennings asked about the updated U.S. peak sales estimate for EscharEx, specifically inquiring about the changes in assumptions regarding pricing, volumes, or patient opportunity from the prior $725 million projection to the new $831 million range. He also asked for details on the DFU study design updates and whether the same centers enrolling in the VLU study would be used for DFU.

Answer

Barry Wolfenson, EVP of Strategy and Corporate Development, explained that the increase in the EscharEx peak sales estimate was primarily due to a market access-focused assessment that supported a higher potential U.S. price per course of therapy, incorporating HEOR benefits. He clarified that patient numbers and adoption rates remained unchanged. Ofer Gonen, CEO, stated that different centers specializing in DFU would be used, not the VLU centers, and that the company is awaiting EMA scientific advice to finalize the DFU study design, expecting an update in the next call.

Josh Jennings inquired about the updated U.S. peak sales estimate for EscharEx, specifically asking what assumptions, such as pricing, volumes, or patient opportunity, contributed to the increase from $725 million to over $830 million. He also asked about the DFU study, including any nuanced design updates and whether the same centers as the VLU study would be used.

Answer

Barry Wolfenson, EVP of Strategy and Corporate Development, clarified that the revised EscharEx peak sales estimate of $831 million is primarily due to a market access-focused assessment that indicated a higher potential U.S. price per course of therapy, incorporating health economic benefits. He noted that patient numbers and adoption rates remained unchanged. Ofer Gonen, CEO, stated that different specialized centers would be used for the DFU study, and the company is awaiting EMA scientific advice to finalize the study design, with an update expected in the next call.

Josh Jennings of TD Cowen inquired about the pipeline for future EscharEx publications, the status of the head-to-head trial against Santyl, details of the BARDA-funded U.S. manufacturing facility, and the implications of BARDA's recent RFP for enzymatic debridement products.

Answer

CEO Ofer Gonen confirmed that more publications focusing on diabetic foot ulcers are forthcoming to build interest among key opinion leaders. He stated the head-to-head trial is on track to begin in 2025. Regarding the U.S. facility, Gonen explained that BARDA is fully funding the planning phase, with discussions on full facility funding to follow. He also noted that Vericel is leading the response to the new BARDA RFP, with MediWound providing full support.

Joshua Jennings inquired about the specific contributions of collaborators in the VLU study beyond product supply, the potential global scope and regulatory path for the DFU study, and the earliest possible timeline for regulatory inspection and approval of the new GMP manufacturing facility.

Answer

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.

Joshua Jennings of TD Cowen inquired about the EscharEx Phase III IND submission timeline, interactions with the FDA, and the expected trial start date. He also asked whether the Phase II head-to-head study against collagenase was a regulatory requirement and sought an update on the NexoBrid manufacturing capacity expansion.

Answer

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.

Joshua Jennings asked about the impact of strong supportive evidence for Symvess in vascular trauma on the VAC process and how real-world outcomes will be tracked, as well as the robustness of the BLA package for AV Access if the VO12 interim analysis aligns with VO7 results.

Answer

CEO Laura Niklason stated that the consistent publication of long-term outcomes data has significantly aided surgeon adoption. She mentioned a post-approval registry study for 100 trauma patients, expected to commence in H1 2026, with initial data anticipated 6-12 months thereafter. Dr. Niklason confirmed that if the VO12 interim analysis shows superiority, the combined data from VO12 (as the lead study) and VO7 would constitute a robust BLA package for dialysis access.

Josh Jennings asked about the impact of strong supportive evidence for Symvess in vascular trauma on the adoption process and how real-world outcomes will be tracked, specifically regarding a post-approval registry study. He also inquired if the V012 interim analysis results mirroring V007 data in females would be robust enough for FDA approval for the AV access indication.

Answer

President and CEO Laura Niklason stated that the steady stream of long-term outcome publications has been very powerful in gaining surgeon adoption. She confirmed a post-approval registry study for 100 trauma patients, with a planned kick-off in H1 2026. Regarding AV access, Dr. Niklason believes that positive interim analysis results from the V012 study, demonstrating superiority in women, combined with V007 data, would provide a robust package for FDA approval.

Josh Jennings from TD Cowen asked about the strategy for building real-world evidence, the commercial plan for military and VA hospitals following the ECAT listing, and the enrollment and analysis timelines for the V012 AV access trial.

Answer

CEO Laura Niklason and CCO BJ Scheessele addressed the questions. Niklason confirmed a post-approval patient registry is being developed with the FDA. Scheessele added that published data and positive real-world use will counter detractor noise. Regarding the military channel, he described a near-term strategy of penetrating individual target hospitals via ECAT, with a longer-term goal of securing bulk procurement contracts. Niklason detailed the V012 trial timeline, targeting full enrollment by year-end, with a key interim analysis of 80 patients scheduled for April 2026, which could support a supplemental BLA filing later that year.

Joshua Jennings asked for an update on the company's confidence in existing Street estimates for 2025 revenue, inquired about clinical learnings being applied to the V012 dialysis access study, and questioned the current status of the partnership with Fresenius Medical Care.

Answer

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.

Joshua Jennings of TD Cowen inquired about the U.S. launch of Symvess, asking for details on the first three hospitals to grant approval, expectations for future VAC processes, 2025 launch goals, and surgeon feedback regarding a recent controversial article.

Answer

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.

Joshua Jennings asked if the V007 trial data is sufficient to fulfill the Fresenius partnership agreement for AV access, questioned the market opportunity for ATEV in revision procedures, and inquired about the development timeline and investment required for the PAD indication.

Answer

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.

Josh Jennings asked for updates on the GA platform, whether ketone sensing has moved up the priority list, and timelines for learning more or commercialization.

Answer

Jake Leach, President and Interim CEO, emphasized GA as an incredibly important multi-analytic future innovation, focused on meeting broad unmet user needs across Type 1 and higher-growth segments like basal insulin (e.g., Smart Basal). He did not provide specific timelines for GA but announced an investor event in the first half of next year at their Mesa manufacturing facility to discuss LRP and product portfolio.

Josh Jennings sought updates on the GA platform, whether ketone sensing has gained priority, and any timelines for learning more or for GA's commercialization.

Answer

Jake Leach, President and Interim CEO, emphasized that the GA platform is a crucial part of future innovation, focusing on broad unmet user needs across Type 1 and high-growth segments like basal insulin (e.g., Smart Basal). He stated that multi-analytic capabilities are important for the future platform but did not provide specific timelines for GA commercialization or ketone sensing. He announced an investor event in the first half of next year at their Mesa manufacturing facility to discuss the long-range plan and product portfolio.

Joshua Jennings of TD Cowen asked for an update on the recovery and stabilization of the DME channel following the disruptions experienced in the previous year.

Answer

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.

Joshua Jennings asked about the risk of a persistent channel shift from DME to pharmacy, particularly as pump competitors also increase their presence in the pharmacy channel.

Answer

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.

Joshua Thomas Jennings asked for details on the drivers of double-digit ablation catheter growth in the EP franchise, the expected performance of the mapping franchise in 2026 given competitive evolution, and projected CPFA penetration rates in the U.S. and OUS by the time Volt launches globally in 2026.

Answer

Chairman and CEO Robert Ford attributed double-digit ablation catheter growth primarily to international markets and a full portfolio including diagnostics and new products like the 13 French Agilisheath and ICE. He affirmed Abbott's leadership in mapping cases despite new competitors. He agreed that CPFA penetration could reach over 80% in the U.S. by 2026, with international markets potentially mimicking this high rate due to Volt.

Josh Jennings asked for granular details on the EP franchise, specifically the drivers of double-digit ablation catheter growth, the mapping franchise's expected performance in 2026 given evolving competition, and projected PFA penetration rates in the U.S. and internationally by 2026.

Answer

Robert Ford, Chairman and CEO, attributed double-digit ablation catheter growth primarily to international markets. He affirmed Abbott's continued leadership in U.S. mapping cases despite new competitors, emphasizing the importance of a full portfolio including products like the 13 French Agilisheath and ICE, which are increasing revenue per case. Ford agreed that PFA penetration could reach over 80% in the U.S. by 2026, with international rates potentially accelerating due to Volt, and highlighted Abbott's comprehensive PFA and LAA tools.

Joshua Jennings from TD Cowen asked for an outlook on the TAVR franchise, including expectations for Navitor's commercial efforts, market growth, and potential share gains, particularly in Europe after a competitor's exit.

Answer

Chairman and CEO Robert Ford reported that Navitor sales have doubled over the past two years, driven by international performance. He sees a significant opportunity to accelerate growth in Europe due to a competitor's market exit, timed well with Navitor's upcoming CE Mark for low/intermediate risk. In the U.S., Abbott is doubling its commercial team to expand its presence from 20% of centers and drive share gains into 2026.

Joshua Jennings inquired about Abbott's efforts to seek tariff exemptions and asked for an updated perspective on the company's diversified business model versus potential value-unlocking divestitures.

Answer

Chairman and CEO Robert Ford responded that while Abbott is actively engaged with industry association AdvaMed on tariffs, "hope is not a strategy," and the company is focused on operational mitigation. He strongly defended the diversified model, stating it provides strategic advantages and stability in uncertain environments. He affirmed that the current portfolio is creating value and that Abbott remains the best owner for its businesses, seeing no current need for divestitures.

Joshua Jennings requested more detail on margin expansion opportunities within the EPD, Nutrition, and Diagnostics segments and asked about the potential for sustained 50-100 basis points of annual operating margin expansion beyond 2025.

Answer

CEO Robert Ford confirmed that a 50-100 basis point annual improvement is the company's target model. He highlighted the Nutrition business as a significant opportunity for gross margin recovery as commodity costs normalize. He also praised the EPD (pharmaceuticals) team for successfully expanding margins despite significant FX headwinds. Ford noted that while gross margin is still recovering, the 2025 operating margin guidance is already ahead of pre-pandemic levels due to spending efficiencies.

Joshua Jennings asked about the structural heart market, specifically whether Abbott is seeing or concerned about provider capacity constraints in the U.S. that could create a bottleneck for growth in TAVR, mitral, tricuspid, and LAAO procedures.

Answer

Robert Ford, Chairman and CEO, stated that he is not seeing or forecasting a capacity bottleneck and is not concerned about it becoming a rate-limiting factor. He believes that as demand grows, healthcare systems will make the necessary investments to expand capacity. He added that Abbott's focus is on investing in its own field presence to support the growth of its comprehensive structural heart portfolio.

Joshua Jennings asked about the Diabetes franchise, seeking to confirm the U.S. slowdown was due to patients awaiting new sensors, the expected ramp-up in the U.S., and the status of the Abbott-partnered Instinct sensor launch.

Answer

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.

Joshua Jennings of TD Cowen requested an update on the international opportunity for the Renal Denervation (RDN) franchise, asking about the status of reimbursement in various countries and the catalysts for an international ramp.

Answer

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.

Asked about the financial and practical implications of the company's strategic pivot to combination therapy, including cost-effectiveness internationally, future revenue guidance amidst distributor changes, and the expected timeline for FDA approval of the PMA submission.

Answer

The company stated that combination therapy is cost-effective internationally due to lower GLP-1 prices abroad. The combo approach is expected to improve patient adherence and long-term health outcomes. Guidance is currently suspended due to short-term disruption from distributor transitions. The FDA approval timeline could potentially be shorter than the standard 12 months because of the modular submission process and the strength of the submitted data.

Josh Jennings of TD Cowen inquired about the cost implications of Allurion's combination therapy strategy in international markets, the potential for generating cost-effectiveness data, the timeline for distributor transitions to stabilize, and the expected FDA approval timeline for the PMA submission.

Answer

Shantanu Gaur, CEO & Co-Founder, explained that GLP-1s are significantly cheaper internationally, minimizing the cost burden of the combo therapy. He stated the company's thesis that this approach improves adherence and health outcomes, leading to better cost-effectiveness. Gaur noted that the distributor transition will cause short-term disruption and could not provide a specific timeline. Regarding the FDA, he suggested the typical 12-month review could be accelerated due to the strength of the modular PMA submission.

Inquired about the pre-PMA meeting with the FDA, specifically the additional analyses of the AUDACITY trial's control group. Also asked about the current organic adoption of GLP-1 combination therapy by clinics and the expected revenue cadence for the rest of 2025.

Answer

The pre-PMA meeting was positive, with the FDA receptive to alternative statistical methods for analyzing the control group data, which strengthens the submission. Combination therapy with GLP-1s is already happening organically, and the company's Virtual Care Suite will track this data. Revenue is expected to increase steadily through the year as the new sales team is onboarded.

Joshua Jennings asked for more details on the pre-PMA meeting with the FDA, particularly regarding the analysis of the AUDACITY trial's control group. He also inquired about the current clinical adoption of the Allurion program with GLP-1s and the expected revenue cadence for the rest of 2025.

Answer

Shantanu Gaur, Founder and CEO, reported that the FDA was receptive to using alternative statistical methods to analyze the AUDACITY trial's control group data, which he believes will strengthen the PMA submission. He confirmed that clinicians are already organically combining the Allurion program with GLP-1s, providing real-world validation. Gaur anticipates a steady increase in revenue through 2025, driven by the onboarding of new sales team members and the global expansion of the new B2B2C strategy.

Inquired about the continuation of procedure volume momentum into Q1, the current commercial adoption of the balloon and GLP-1 combo therapy, and the timeline for the prospective clinical studies on this combination.

Answer

The procedure volume momentum from mature GLP-1 markets is continuing in Q1, boosted by a new B2B2C commercial strategy. The combo therapy is already being adopted commercially by physicians, particularly bariatric surgeons, as it provides strong clinical results and a new revenue stream. While prospective studies are being planned to validate these results, no specific details on trial design or readout timing are available yet, but they will focus on weight loss, lean body mass, and GLP-1 adherence.

Joshua Jennings of TD Cowen inquired about the status of Allurion's PMA filing with the FDA, the revenue model for the Virtual Care Suite (VCS), and the potential financial impact from the French market recovery and VCS contributions in 2025.

Answer

Founder and CEO Shantanu Gaur confirmed that the first three PMA modules are under active FDA review with positive interactions, and the final clinical data module is expected early next year. He detailed that the VCS generates per-patient-per-month recurring revenue from providers managing patients on various weight loss therapies, including GLP-1s. Gaur stated that while the company is not providing 2025 guidance or a specific timeline for the French market's return, he believes the VCS has massive potential to accelerate top-line growth.

Joshua Jennings of TD Cowen sought clarification on the company's strategy regarding a potential partnership with a market leader for its cardiac ablation catheter. He also asked about the evolution of the nSPFA platform's compatibility with major mapping systems and its positioning for the growing Ambulatory Surgery Center (ASC) opportunity.

Answer

CEO & Co-Chairman Paul LaViolette confirmed that for the competitive and capital-intensive catheter-based EP market, the company's strategy is to pursue a partnership and that discussions are ongoing. He stated that the platform is already compatible with leading mapping systems and that integration can be deepened through collaboration. LaViolette emphasized that nSPFA's rapid procedure times and low neuromuscular stimulation make it exceptionally well-suited for the ASC setting.

Joshua Jennings from TD Cowen asked for clarification on a potential partnership with a market leader for cardiac ablation. He also questioned the evolution of the nSPFA platform's compatibility with major mapping systems and its positioning for the Ambulatory Surgery Center (ASC) opportunity.

Answer

CEO Paul LaViolette confirmed that the company's strategy for the catheter-based EP market is to pursue a partnership and that discussions are underway. Regarding mapping systems, he noted that the platform is already compatible with leading systems and that deeper, more customized integration is possible over time with partners. LaViolette highlighted that the platform's rapid procedure times and low neuromuscular stimulation make it very well-suited for the ASC setting.

In a follow-up, Joshua Jennings of TD Cowen asked about the U.S. launch strategy for Preservay and Mia, and whether Preservay would contribute meaningfully to 2025 revenue.

Answer

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.

Joshua Jennings asked about the strong U.S. launch of Motiva, questioning the strategy of maintaining conservative guidance despite performance meaningfully exceeding the initial $35 million forecast. He also inquired about the competitive response in the U.S., such as pricing pressure or new rival products.

Answer

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.

Josh Jennings asked for details on the steps required to finalize the U.S. and China regulatory pathways for the Mia and Preserve portfolios. He also inquired about the company's confidence in its previously stated long-range plan to achieve $500 million in revenue.

Answer

CEO Juan Jose Quiros outlined a 'super cycle of innovation,' explaining that the process involves registering tools for Preserve and securing approval for the Ergonomix2 platform for Mia, with launches expected in 2026-2028. He affirmed confidence in the $500 million revenue goal, emphasizing the new focus on achieving it profitably, supported by U.S. growth and rising gross margins.

Joshua Jennings of TD Cowen asked if the recently presented 3-year Mia data would be sufficient for a supplemental PMA submission to the FDA and requested any other key updates from the Ergonomic Symposium in Barcelona.

Answer

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.

Josh Jennings of TD Cowen asked for more detail on the penetration and go-forward opportunity within the enterprise/IDN channel. He also requested a roadmap for the home hemodialysis market and a comparison of its future growth trajectory versus the acute care channel.

Answer

Chair and CEO Leslie Trigg stated that despite recent successes, Outset is still in the "low double digits" of market penetration in the acute and subacute markets, indicating a large runway. For the home market, she outlined goals of maintaining high patient retention and deepening partnerships with MDOs. She clarified that the acute/post-acute segment is expected to remain the primary growth driver, constituting 80-85% of revenue.

Joshua Jennings asked about the potential risk from macroeconomic headwinds on hospital capital spending and how Tablo's value proposition positions the company in a challenging environment. He also inquired about sales force attrition rates and future plans for expanding the commercial team.

Answer

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.

Joshua Jennings of TD Cowen asked for an update on the progress of the commercial organization's transformation and the specific impact of TabloCart's return on the sales pipeline.

Answer

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.

An analyst on behalf of Josh Jennings of TD Cowen asked about customer reception of the new Hydros system and inquired about the current size and future expansion plans for the capital sales team.

Answer

EVP & CFO Kevin Waters described customer receptivity to Hydros as "fantastic," while President & CEO Reza Zadno reiterated its value propositions of simpler setup and AI assistance. Kevin Waters added that the company feels good about the current size of its capital sales team (around 40 quota-carrying reps) and will continue to add reps strategically heading into 2026.

Joshua Jennings asked about the company's plans for its upcoming prostate cancer trial results (PRCT-001 and 002) and whether PROCEPT would pursue a general use 'tools claim' before obtaining Level 1 evidence from the larger WATER IV trial.

Answer

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.

Joshua Jennings of TD Cowen inquired about the competitive landscape and whether competitors are responding to Aquablation's growth. He also asked if the 2025 system sales guidance includes any contribution from the potential prostate cancer indication.

Answer

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.

Joshua Jennings asked about the market opportunity for treating concomitant BPH and localized prostate cancer, reimbursement for these procedures, and any observed utilization uptick. He also requested an update on the Ambulatory Surgical Center (ASC) pilot program and its outlook.

Answer

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.

Joshua Jennings asked about the pipeline, focusing on the economic value proposition for the delirium indication and how potential cost savings might compare to the seizure solution. He also inquired about the pricing strategy and trends for headbands and the Clarity system during 2025 and into 2026.

Answer

CEO Jane Chao explained that the economic value for delirium is expected to parallel the seizure indication, primarily by reducing hospital length of stay, a key metric for DRG-reimbursed patients. CFO Scott Blumberg addressed pricing, stating that headband prices have been relatively consistent, while the average selling price for the Clarity subscription has increased over time as more recorders are added to subscriptions.

Joshua Jennings asked for quantification of the opportunity for departmental expansion within the existing customer base and about the effectiveness of the hub-and-spoke expansion model. He also inquired about the current competitive landscape.

Answer

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.

Joshua Jennings asked for quantification of the opportunity for expansion within the existing customer base, both across departments and into satellite hospitals. He also inquired about the current competitive landscape and whether Ceribell is facing any significant challengers.

Answer

CEO Xingjuan Chao reiterated that Ceribell has only penetrated about 3% of the total U.S. market, which includes a 70% opportunity for growth within existing accounts by expanding across departments. She confirmed the hub-and-spoke expansion model is a key strategy. Regarding competition, she stated that while some companies are trying to enter the point-of-care EEG category, Ceribell remains the clear leader and is not seeing a meaningful competitive impact on its business.

Joshua Jennings requested details on the FDA's requirements for the upcoming delirium indication submission. He also asked for clarification on the company's vision to make EEG a 'new vital sign' and how new indications are expected to increase utilization in ICU and ED settings.

Answer

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.

Joshua Jennings requested details on the FDA requirements for the upcoming delirium indication submission and asked for clarification on the company's long-term goal to make EEG a 'new vital sign' and how that would impact utilization.

Answer

CEO Jane Chao explained that for the delirium submission, the FDA's core metric is the algorithm's accuracy compared to the current standard of care. She elaborated on the 'new vital sign' strategy, stating that indications for seizure, delirium, and stroke are synergistic. They address the key conditions physicians must differentiate in patients with altered mental status, targeting the same call points and patient populations to provide a more complete neurological assessment.

Joshua Jennings of TD Cowen asked about the impact of CeriBell's cost-effectiveness, particularly how benefits like reduced length of stay and improved reimbursement coding resonate with hospitals. He also questioned if the ClarityPro version enhances these economic benefits and inquired about the adoption rates for Clarity and ClarityPro among new and existing customers.

Answer

CEO Xingjuan Chao confirmed that the platform's economic impact is a major sales driver, with different benefits like reduced patient transfers or improved ICU capacity management resonating with different types of hospitals. She stated that 100% of new accounts adopt the AI algorithm (Clarity or ClarityPro). While ClarityPro offers stronger clinical benefits, the company is still in the process of driving its adoption, as it involves additional fees and the NTAP program is only a year old.

Joshua Jennings asked about the marketing impact of the Ceribell platform's cost-effectiveness, including reduced length of stay and patient transfers, and followed up on whether ClarityPro enhances these benefits and what its adoption rate is among new and existing customers.

Answer

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.

Joshua Jennings of TD Cowen asked about the drivers of the revised financial guidance, questioning if competitive pressures were a factor, and inquired about trends in software subscription revenue, including the performance of enterprise versus individual subscriptions and the expected impact of the new Compass AI platform.

Answer

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.

Joshua Jennings inquired about the impact of clinical publications on the hospital channel pipeline, the market mix between the iQ3 and iQ+ probes, and any potential impact from currency fluctuations on guidance.

Answer

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.

Joshua Jennings of TD Cowen inquired about Butterfly Network's confidence in its long-range $500 million revenue target, the necessary steps and timeline to commercialize the HomeCare channel, and the development status of its wearable ultrasound prototype.

Answer

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.

Joshua Jennings inquired about the drivers of the strong U.S. iQ3 launch across different sales channels, the progress and next steps regarding the European Union's RoHS directive, and requested more details on the upcoming iQ Station.

Answer

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.

Joshua Jennings asked for a breakdown of the quarter's outperformance between the established lateral franchise (PTP/LTP) and newer products, the extent of the "halo effect" on non-lateral procedures, and the drivers of accelerating surgeon user growth.

Answer

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.

An associate for Josh Jennings asked about the conversion rate for the 200+ surgeon trainings and what the company can do to improve that rate.

Answer

Executive Patrick Miles explained that while interest is high, there isn't a single predictable conversion algorithm, as each surgeon has a different comfort level and process for adopting new techniques. He stated the company focuses on improving yield by ensuring the right surgeons are invited, sales structures are in place, and hospital access is secured, thereby aligning all necessary factors for successful adoption.

Eric on for Joshua Jennings asked for details on the MACI Ankle clinical trial design following its IND clearance and checked on the status of the company's long-term profitability targets for 2029.

Answer

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.

Joshua Jennings asked for qualitative feedback on the acute outcomes of MACI Arthro procedures, including recovery times and procedural success, as well as the surgeon learning curve. He followed up by asking about the planned MACI sales force expansion, its associated costs, and how this investment is balanced with the company's raised profitability guidance.

Answer

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.

Joshua Jennings asked for the rationale behind issuing new long-range margin targets now and questioned if the margin expansion trajectory could face turbulence in 2026 when the new manufacturing facility comes online.

Answer

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.

Joshua Jennings asked about the MACI biopsy bank and potential pent-up demand ahead of the Arthro approval. He also inquired about 2025 pricing, incremental revenue from Arthro instruments, and the commercial strategy for the 2,000 new target surgeons.

Answer

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.

Joshua Jennings asked about potential headwinds from the U.S. transplant network modernization and any progress with CMS on reimbursement for the upcoming clinical trials.

Answer

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.

Joshua Jennings asked about the clinical community's enthusiasm for the new lung trial following the ISHLT symposium and questioned the company's confidence in achieving a superiority endpoint in the head-to-head portion of the heart trial.

Answer

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.

Joshua Jennings from TD Cowen asked for assurance regarding the retention of high-volume customers following a recent short report and questioned the competitive threat posed by the Normothermic Regional Perfusion (NRP) approach in the DCD organ market.

Answer

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.

Joshua Jennings from TD Cowen asked if the Q3 performance, despite being a miss for the Street, was in line with management's internal expectations given their prior warnings about headwinds. He also requested reassurance on market share stability for liver.

Answer

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.

Joshua Jennings of TD Cowen questioned how the cardiac ablation case mix might evolve with Stereotaxis's expanding catheter portfolio and asked about the expected adoption pathway for the EMAGIN neurovascular portfolio post-regulatory approvals.

Answer

David Fischel (executive) explained that he expects the case mix to continue favoring complex procedures like VTs and PVCs, where robotic navigation provides the most value. For the EMAGIN neurovascular portfolio, he outlined that initial adoption could occur in existing labs, but broader adoption will likely be predicated on the availability of GenesisX and its compatibility with various X-ray systems, with initial sites being established to demonstrate clinical value.

Inquired about the specifics of the MAGIC catheter's U.S. trial design and initial indication, the commercial ramp-up of the acquired APT catheter portfolio, and the potential timeline and revenue impact of the robotic HD mapping catheter.

Answer

The initial U.S. indication for MAGIC will focus on patients with high unmet medical needs. The APT catheter portfolio is seeing a ramp-up through sales team education and securing hospital contracts, with an expected market opportunity in the high single-digit to double-digit millions. The robotic HD mapping catheter is planned for regulatory submission in Q1 2025 and is expected to significantly increase disposable revenue per procedure, potentially doubling it on top of the ablation catheter's contribution.

Asked for updates on the MAGiC FAST clinical study data, the regulatory pathway with the FDA for MAGiC, the catheter's potential for high-power short-duration ablation, and the potential marketing impact of the upcoming magnetic VT study results.

Answer

The MAGiC study is performing well and data is being prepared for publication. The company is in collaborative discussions with the FDA to leverage European data for a US PMA submission, followed by post-approval studies. While the MAGiC catheter is capable of high-power ablation, the initial regulatory submission is for up to 50 watts. The magnetic VT study results are being prepared for presentation at an upcoming conference.

Speaking on behalf of Josh Jennings, an analyst from TD Cowen asked about the expected revenue contribution from Cohealyx within the 2025 guidance, the sales force's capacity to meet year-end targets, and the anticipated revenue cadence for the remainder of the year.

Answer

CEO James Corbett stated that Cohealyx is expected to be a material contributor, and the company will likely begin breaking out non-RECELL sales by Q3. He affirmed confidence in the newly reconfigured, selling-oriented sales force. CFO David O'Toole added that they model for sequential quarterly growth, with some weighting towards the second half of the year as more hospital approvals for Cohealyx are secured.

Joshua Jennings of Cowen followed up on Cohealyx adoption, asking about the anticipated impact of cost-effectiveness data, particularly length-of-stay reduction, and whether the Cohealyx-1 study would be sufficient for gaining approval from hospital Value Analysis Committees (VACs).

Answer

CEO Jim Corbett affirmed that the cost-effectiveness and reduced length of stay for Cohealyx will be a 'very large deal' and a key adoption driver, similar to RECELL's success. He explained that for near-term VAC approval, the combination of preclinical data, early case studies, favorable pricing, and the consignment model would be the key drivers, rather than waiting for the full study results.

Joshua Jennings questioned if management's optimism for the full-thickness skin defect launch and its total addressable market (TAM) has changed. He also asked for details on the new Regenity Dermal Matrix, including the competitive landscape, market size, and potential pricing strategy.

Answer

CEO James Corbett affirmed that they remain just as optimistic about the TAM. He noted that the launch highlighted the need for more education at new centers, resulting in a longer VAC process and prompting the development of RECELL GO Mini for smaller wounds. Regarding the Dermal Matrix, he explained that competitors price around $14-$15/sq cm, and AVITA will price competitively while building clinical data. Animal studies suggest their matrix could be graft-ready in half the time of competitors, creating significant market potential.

Joshua Jennings inquired about Zimmer Biomet's performance in the Ambulatory Surgery Center (ASC) channel versus traditional hospitals, and whether the growth dynamics were similar for its joint and S.E.T. product lines.

Answer

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.

Joshua Jennings asked for a deeper analysis of the 22% North American product revenue growth, seeking details on the U.S. INTERCEPT platelet business and the relative contributions from the U.S. and Canada. He also inquired about the next steps and expected milestones for the INTERCEPT red blood cell system's CE Mark application in Europe.

Answer

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.

Joshua Jennings of TD Cowen inquired about the progress of Cerus's INTERCEPT Fibrinogen Complex (IFC), asking about the remaining steps for full U.S. market access and the company's confidence in capturing a significant share of the market. He also asked for an update on the China opportunity, including the timeline for NMPA approval and potential revenue contribution.

Answer

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.

Joshua Jennings of TD Cowen followed up on the INTERCEPT Fibrinogen Complex (IFC), asking about the pipeline for future BLA approvals, and also inquired about the new LED illuminator's expected ASP, gross margin impact, and intellectual property protection.

Answer

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.

Joshua Jennings followed up on the pharmacy channel, asking if Tandem has faced any payer pushback on its DME-like reimbursement model.

Answer

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.

Joshua Jennings from TD Cowen inquired about the Type 2 indication, asking if the basal-only opportunity is in play with the current label and requesting an update on the status of insurance coverage for Type 2 patients.

Answer

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.

Joshua Jennings inquired about trends in Type 2 diabetes patient prescriptions and whether they were increasing ahead of the official label expansion.

Answer

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%.

Joshua Jennings of TD Cowen asked about provider capacity in electrophysiology given the rapid growth of PFA and WATCHMAN, and inquired about the pathway for PFA procedures to move into the Ambulatory Surgery Center (ASC) setting.

Answer

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.

Joshua Jennings asked for a high-level perspective on potential risks to the medical device sector, and Boston Scientific specifically, from the new administration's policies, including those related to the FTC and taxes.

Answer

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.

Joshua Jennings from TD Cowen asked for confirmation that there are no manufacturing capacity issues for FARAPULSE and inquired about the business model for the mapping segment, including the diagnostic catheter portfolio.

Answer

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.

Joshua Jennings asked for details on the successful Cadaver Lab results, including whether ventral hernia maneuvers were performed, and inquired about the clinical trial design and the scale of the inventory build required.

Answer

CEO Adam Sachs confirmed that ventral hernia repairs, including defect closure and mesh implantation, were successfully performed in the cadaver labs. He explained that the final clinical trial design will be locked in after the initial first-in-human cases, leveraging the flexibility of the FDA's Safer Technologies Program. President Randolph A. Clark added that the inventory build requires a few capital systems and a larger quantity of instruments, noting that finished instruments are already coming off the production line.

Asked for details on the successful cadaver lab results, specifically regarding ventral hernia procedures, inquired about updates to the clinical trial design and patient count following FDA discussions, and requested quantification of the inventory build needed for the clinical trial.

Answer

Executives reported that the cadaver labs, performed by surgeons, successfully completed ventral hernia repairs including defect closure and mesh implantation. The final clinical trial design will be locked after the first-in-human cases, leveraging flexibility from the FDA's Safer Technologies Program. For inventory, they are scaling up production and will need a few capital systems and larger quantities of instruments for the technical dossier submission and initial cases.

Joshua Jennings asked about the expected time between the first clinical patient treatment and the start of the pivotal trial, the criteria for selecting OUS clinical sites, and the remaining steps for the V1.0 system integration.

Answer

Adam Sachs, Co-Founder and CEO, explained that the pivotal trial will commence as quickly as possible after the first clinical patient. He noted that the primary criteria for OUS site selection are the regulatory pathway and patient volume to ensure rapid enrollment. Regarding the V1.0 system, Sachs stated the final weeks are focused on running labs to gain confidence in system functionality and resolve any remaining issues before formal validation testing.

Joshua Jennings asked about the stage of the ASC infrastructure build-out in the U.S. and its impact on Stryker's businesses. He also questioned if the Inari deal opens the door for M&A in other cardiovascular sectors.

Answer

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.

Joshua Jennings inquired about Johnson & Johnson's future acquisition strategy for its MedTech business, specifically asking about the balance between acquiring pre-revenue companies versus more established businesses.

Answer

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.