Ross Osborn

Ross Osborn asked about the number of Nanox.ARC systems deployed and actively scanning that contributed to the reported $175,000 revenue in Q3 2025, and inquired about the expected mix of lease versus capital sales agreements for the 100 units targeted for deployment by year-end 2025.

Answer

CEO Erez Meltzer stated that a few dozen systems were in the field, with more being installed, and the $175,000 revenue was a combination of scans and OEM services. CFO Ran Daniel clarified that the majority of agreements are MSES (Managed Service Agreements), but Erez Meltzer noted an increasing activity in CapEx sales.

Ross Osborn inquired about the number of Nano-X ARC systems deployed and actively scanning that contributed to the $175,000 revenue in Q3 2025, and the expected mix of lease versus capital sales agreements for the 100 units targeted for deployment by year-end 2025.

Answer

CEO Erez Meltzer stated that a few dozen systems were active, with more being installed or awaiting approvals, and the revenue came from a combination of scans and OEM services. CFO Ran Daniel clarified that the majority of agreements are MSES (Managed Service Enterprise Solutions), but CEO Meltzer noted increasing activity and expectations for capital sales.

Ross Osborn of Cantor Fitzgerald inquired about the number of operating systems that generated the reported imaging revenue, the expected sales model for the 100-system target, and the number of U.S. states where Nanox systems are approved for operation.

Answer

Erez Meltzer, CEO & Director, responded that over 20 systems are currently operating and scanning patients, contributing to the revenue. He confirmed that the target of 100 installed or deployed systems by year-end is on track, with each lead identified. Meltzer also stated that a portion of these 100 systems are expected to be capital sales (CapEx), not just MSAS model placements, and that the company is approved to operate in eight U.S. states.

Ross Osborn asked for the number of Nanox.ARC units currently operating in the U.S. out of the 60 in deployment and questioned the lack of a corresponding revenue inflection. He also sought clarity on the path to gross margin breakeven for the company's three business segments.

Answer

CEO Erez Meltzer confirmed over 20 units are in various stages of installation in the U.S. CFO Ran Daniel explained that revenue recognition lags deployment due to necessary state registrations, permits, and the process of securing reimbursement approvals (EOBs). Daniel also noted that the teleradiology segment is already profitable on a non-GAAP basis, and ARC margins are expected to improve significantly with the transition to the lower-cost ARC-X system.

Ross Osborn from Cantor Fitzgerald questioned the number of deployed U.S. systems that generated the $136,000 in Q4 system revenue and asked about the pricing strategy for the Nanox.ARC in Europe and its potential impact on gross margins.

Answer

CEO Erez Meltzer declined to provide a specific number of deployed systems, stating they are in various stages of installation and emphasizing the robust pipeline. For Europe, he explained that the commercial team is expanding, new distributors have been signed in Romania and Greece, and the primary sales model will be CapEx, supplemented by service contracts and a smaller number of MSaaS deals.

Ross Osborn of Cantor Fitzgerald inquired about the number of Nanox.ARC systems deployed in the U.S. during the quarter, the types of imaging centers adopting the technology, and the average utilization trends. He also asked for an update on the status of conversations with the FDA regarding the ARC-X and the label extension for full-body imaging.

Answer

CEO Erez Meltzer stated that 47 units are in various stages of shipment and deployment across the U.S., primarily in small-to-medium imaging centers, medical imaging chains, and some hospitals. He confirmed that utilization in active sites is approximately 7 scans per day, consistent with previous reports. Regarding the FDA, Meltzer conveyed that the company has provided all necessary information and views the indications as positive, anticipating clearance in the near future. He added that the ARC-X submission is planned for early 2025, with deployment expected in the second half of the year.

Speaking for Ross Osborne, Matt Park of Cantor Fitzgerald asked about the outlook for gross margin expansion and the clinical evidence strategy required for the FDA approval of the NXT 41X platform.

Answer

CFO Matt Ferguson stated that the company sees clear opportunities to expand gross margins through scaling Elupro production, growing the high-margin cardiovascular business, and improving efficiency in the SimpliDerm franchise. CEO Randy Mills added that the NXT 41X platform will follow the same combination device regulatory pathway as Elupro, which they are confident in navigating. He noted the staggered launch is a marketing strategy to build clinical data, not a regulatory necessity.

Inquired about the future role of the registry study data in driving adoption and the expected pace of the product mix shift from CanGaroo to EluPro.

Answer

The registry study data is a longer-term asset, primarily for supporting VAC submissions and OUS regulatory filings, with impact expected in the second half of next year. The mix shift to EluPro is happening rapidly, driven by its strong growth, and is expected to continue, though the legacy CanGaroo product will remain available for specific needs.

Ross Osborn of Cantor Fitzgerald asked about Elutia's marketing strategy for EluPro's use in neurostimulation and the primary strategic initiatives for the SimpliDerm product line for the upcoming year.

Answer

C. Mills (Executive) clarified that the initial neurostimulator use was 'pull-through' demand, not active marketing, demonstrating a clear market need. He sees it as a rapid growth opportunity, especially in hospital settings where they are already on formulary for cardiac devices, and noted it's an area with little competition. For SimpliDerm, Mills stated the key 2025 initiative is to expand proprietary commercial distribution to 'own' the breast reconstruction case, viewing it as a distinct step from the implant itself. He mentioned the development of SimpliDerm RM (a drug-eluting version) and a focus on building out their own commercial infrastructure to drive growth.

Ross Osborn from Cantor Fitzgerald asked for more details on the Hoag health system partnership, including patient profile and workflow integration, and inquired about the business model and margin contribution from such partnerships.

Answer

Chairman and CEO Lishan Aklog described the Hoag partnership as a comprehensive, multidisciplinary program to systematically identify at-risk patients across the health system, serving as a template for future collaborations. President & CFO Dennis McGrath detailed the financial model, explaining that the ~$2,000 test has a greater than 90% contribution margin, as variable costs are under $200 per test. He noted this high margin will allow the company to absorb fixed lab costs of $1.2M per quarter as volume scales, providing a clear path to profitability.

Ross Osborn of Cantor Fitzgerald inquired about the expected trajectory of PAVmed's operating expenses (OpEx) in upcoming quarters, asking if they would remain steady pending new financing.

Answer

Dennis McGrath, Chief Financial Officer, confirmed that the pro forma OpEx presented is the new baseline. He clarified that any increase in spending is contingent on securing direct financing for the Veris and PortIO subsidiaries. Without that funding, OpEx will remain at the current normalized level.

Ross Osborn from Cantor Fitzgerald asked for more details on the Hoag health system partnership, including patient profiles and workflow integration, and inquired about the business model and margin contribution per test.

Answer

Chairman & CEO Lishan Aklog described the Hoag partnership as a comprehensive, system-wide program involving gastroenterologists, 200 primary care physicians, and concierge medicine. Lucid is assisting with training, cell collection, and identifying at-risk patients via their EHR system. CFO Dennis McGrath detailed the business model, stating that the test, benchmarked at the ~$2,000 Medicare rate, has a contribution margin over 90%, with costs under $200 per test. He noted that profitability is dependent on driving volume to absorb fixed lab costs.

Ross Osborn from Cantor Fitzgerald asked for feedback from physicians on Lucid's clinical utility data and inquired about the general awareness of EsoGuard within the clinical community.

Answer

CEO Dr. Lishan Aklog highlighted the company's "full chain of evidence," including published data showing high physician compliance with testing protocols and a 2.5- to 3-fold higher diagnostic yield for endoscopies following a positive EsoGuard test. He noted that awareness is increasing, citing a strong, active presence at the recent DDW conference. He also mentioned that a large, 12,000-patient real-world evidence study is in its final stages and will be released soon to further bolster these efforts.

Ross Osborn from Cantor Fitzgerald inquired about the development status of the next-generation RNS offering and its key areas of improvement. He also asked if therapeutic partnerships, such as those with Rapport and UCB, are expected to become a material revenue contributor in the near future.

Answer

CEO Joel Becker confirmed that development of the next-generation RNS platform is on track with previously disclosed timelines, with key component testing meeting or exceeding expectations. He also announced a new collaboration agreement with UCB, in addition to the ongoing work with Rapport, and noted a pipeline of other potential partners. CFO Patrick Williams added that while this revenue is not yet material enough to be broken out as a separate segment, it is high-margin and demonstrates the growing value of NeuroPace's unique brain data asset.

Ross Osborn from Cantor Fitzgerald asked about the ease of training community-based physicians for RNS procedures under Project CARE and if patient-driven demand for the RNS System has increased.

Answer

Executive Joel Becker explained that while training new centers requires support for contracting and infrastructure, the process is well-established. He noted that the primary increase in patient engagement is coming from targeted direct-to-patient digital marketing initiatives, which work in parallel with the Project CARE expansion, rather than from patients in the community setting directly requesting the system yet.

Ross Osborn asked for feedback on the ease or difficulty new centers in the Project CARE program are experiencing when launching their RNS programs. He also requested an update on R&D projects related to AI and data analysis software tools.

Answer

Executive Joel Becker described a spectrum of experiences, with some centers launching quickly due to prior experience, while others require more training. He emphasized the program's flexibility allows centers to start with referrals and programming before performing implants. Regarding R&D, Becker confirmed active development of AI tools and next-gen platforms to improve efficiency, and said more details would be shared at the upcoming Investor Day.

Ross Osborn of Cantor Fitzgerald asked about the feedback from the cardiac call point for RestoreFlow and what the company can do to facilitate adoption. He also inquired about potential launch hurdles in Ireland or Germany beyond supply constraints.

Answer

President & Director Dave Roberts described feedback as 'fantastic,' citing 61% unit growth and increasing traction in the U.S. market. Chairman & CEO George LeMaitre noted that while sales teams are excited for the European launch, a potential hurdle in Germany is the regulatory requirement to see paperwork from every individual recovery center, adding a layer of complexity.

Ross Osborn of Cantor Fitzgerald asked about the operational steps and clinical data requirements for a strong 2026 Artegraft launch in Europe. He also inquired about market dynamics for RestoreFlow in Germany and Ireland versus the U.S. and the sales force needed to support adoption.

Answer

CEO George LeMaitre and President Dave Roberts stated that no new clinical data is required for the Artegraft launch, as it has extensive existing data; the focus is purely on marketing and logistics, with initial inventory shipments already planned. For RestoreFlow, LeMaitre noted the existing sales force is sufficient. Roberts added that the European allograft market is more fragmented than the U.S., presenting a significant opportunity, with the main challenge being supply rather than demand.

On behalf of Ross Osborn of Cantor Fitzgerald, Matthew Park asked for a breakdown of the puts and takes for the 2025 gross margin guidance of 69.7%. He also requested details on the initial commercial rollout plan for XenoSure in China following its recent approval.

Answer

EVP, CFO & Treasurer Joseph Pellegrino listed several positive drivers for gross margin, including direct labor efficiencies, higher ASPs, controlled quality costs, and improved RestoreFlow yields. CEO George LeMaitre explained the XenoSure rollout in China requires securing reimbursement and provincial listings, with initial sales expected to begin around July 2025. He noted the China sales force is small but growing from four to five reps.

Ross Osborn of Cantor Fitzgerald asked about progress in targeting cardiac surgeons, the potential for dedicated cardiac reps, and key cross-selling opportunities for the growing sales force.

Answer

CEO George LeMaitre stated that cardiac sales are now 14% of total sales, but the company has no dedicated cardiac reps yet. He noted that while a separate cardiac channel may be inevitable, the current focus is on expanding the peripheral vascular sales force. The best cross-selling opportunity is splitting territories of high-performing U.S. reps.

Ross Osborn from Cantor Fitzgerald requested more color on where the above-expectation growth in the extremities business is originating and asked about the typical time it takes for a newly trained doctor to reach scale.

Answer

President and CEO Michael Dale described the extremities growth as broad-based, resulting from a more tenured and focused sales force and success in establishing nerve care as a standard within high-potential institutions. Chief Marketing Officer Jens Schroeder Kemp added that it typically takes about three quarters for a surgeon to become fully productive after attending a training program.

Ross Osborn from Cantor Fitzgerald asked for the breakdown of volume versus price growth in the 2025 revenue guidance and questioned the company's confidence in the existing clinical data for its breast reconstruction business.

Answer

CFO Nir Naor stated the 2025 guidance assumes price growth in line with CPI, with the remainder from volume and mix, consistent with past years. CEO Michael Dale expressed high confidence in the benefit-risk profile of the Resensation technique, supported by existing data. He clarified that while the current data is strong, generating more high-quality studies is necessary to establish it as the standard of care.

Ross Osborn of Cantor Fitzgerald asked about the company's strategic balance between driving top-line growth and managing cash flow. He also requested more detail on initiatives in the breast neurotization market, such as the Resensation program.

Answer

CEO Michael Dale suggested that driving growth and managing cash are not mutually exclusive goals, with more details to come in early 2025. He described breast neurotization as a high-growth area with strong surgeon interest, calling AxoGen's educational programs a 'distinctive asset' and among the best he has seen.

Ross Osborn of Cantor Fitzgerald asked for more detail on the strategy of using lower-tiered centers as referral pathways into larger flagship accounts. He also inquired about the remaining headwinds and challenges that could prevent a material inflection in adoption next year, even with an improved reimbursement environment and a more tenured sales force.

Answer

President and CEO Kevin Hykes explained that the company has learned that some Tier 3/4 centers can be valuable satellite locations that provide a strategic path into larger, more bureaucratic flagship institutions. He identified the remaining primary barriers to adoption as building physician awareness and generating more clinical evidence. While reimbursement will become less of a headwind, he noted that changing clinical practice is a long-term 'war of attrition'.

Ross Osborn asked if Barostim adoption is showing stronger penetration in any specific patient segments. He also requested a review of the near-term timeline, patient enrollment targets, and number of centers for the potential new randomized controlled trial (RCT).

Answer

Executive Kevin Hykes responded that adoption is not differentiated by patient type but rather by physician practice patterns. He outlined the two-part process for the potential RCT: first, reaching an agreement with the FDA on the trial protocol in the next couple of months, and second, petitioning CMS for reimbursement coverage, with a final decision to proceed expected later in the year. He reiterated the trial would be sized for 1,000 to 2,000 patients across 100 to 150 centers.

Ross Osborn of Cantor Fitzgerald asked about the clinical criteria that determine whether a Barostim procedure is performed in an inpatient or outpatient setting. He also inquired about the growth runway available from deepening penetration within existing accounts versus needing to add new ones.

Answer

Executive Kevin Hykes explained that outpatient procedures are typically for stable, scheduled patients, while inpatient procedures often occur after a patient is admitted for heart failure decompensation and stabilized. He emphasized the significant growth runway within existing accounts, stating that on average, the company has less than 2% penetration of the annual patient population in these centers, with even the largest accounts still in the low single-digit penetration range.

Ross Osborn of Cantor Fitzgerald asked for a clarification on the clinical factors that determine whether a patient receives the Barostim device in an outpatient versus an inpatient setting. He also inquired about the company's growth runway within existing accounts before a strategic shift to new account growth is needed.

Answer

CEO Kevin Hykes explained that outpatient procedures are typically for stable patients scheduled in advance, whereas inpatient procedures often involve patients admitted for heart failure decompensation who are then implanted once stabilized. He emphasized that with penetration still in the low single-digits even at the largest centers, there is a significant, long runway for growth by deepening adoption within the current customer base.

Ross Osborn of Cantor Fitzgerald asked where Mimetics sees the most immediate opportunities to take market share under the proposed new reimbursement rules, the company's view on the mobile wound care market opportunity, and if there has been any recent feedback from MACs regarding the delayed LCDs.

Answer

CEO Joseph Capper declined to specify tactical plans for share capture but affirmed Mimetics is well-positioned across all care settings. Regarding mobile wound care, he expressed support for providers and advocated for higher application fees to create a healthier payment model. On the LCDs, Capper noted that the CMS fee schedule action was the more critical step for regulating the market and reiterated that requiring clinical evidence for products is a positive development for healthcare.

Ross Osborn from Cantor Fitzgerald inquired about the specific efforts MIMEDX is undertaking to prepare for a more favorable market environment next year, particularly concerning sales force hiring and manufacturing initiatives to support anticipated demand.

Answer

CEO Joe Capper explained that sales force turnover has normalized since mid-2023 and that future growth will come from executing their existing plan: expanding the product portfolio, investing in clinical research for surgical applications, and exploring corporate development. CFO Doug Rice added that their commitment to generating clinical evidence is highlighted by their upcoming presence at medical conferences like DDW, showcasing efforts to expand into new surgical areas.

Ross Osborn of Cantor Fitzgerald asked for an update on the revenue opportunity for HELIOGEN, its expected contribution in 2025, and the status of sales force hiring following the attrition experienced in 2024.

Answer

CEO Joe Capper stated that HELIOGEN's revenue contribution is currently nominal as it is still in the early launch phase, focused on gaining hospital approvals, but is expected to be a more meaningful contributor in 2025. Regarding the sales force, he confirmed that turnover has returned to a normalized rate and the team is at 'near full strength' entering the new year after successfully managing the mid-2024 disruption.

Ross Osborn asked if the current level of SG&A spending represents a new baseline for the company and requested an update on the status of any ongoing manufacturing initiatives.

Answer

CFO Douglas Rice stated that SG&A spending was consistent with the prior quarter and is expected to remain in that 'ZIP code' in the near term. CEO Joseph Capper clarified that while there are no major new manufacturing initiatives to highlight, the company has successfully embedded a culture of continuous process improvement and operational cost control.

Asked about the company's market access and marketing initiatives to accelerate adoption and increase market penetration beyond simply adding more sales reps.

Answer

The company outlined a multi-faceted strategy that includes digital marketing campaigns, publishing clinical research to validate utility, extensive sales team training to enable a consultative approach, and leveraging Key Opinion Leaders (KOLs) to build trust and awareness for their novel diagnostics.

Ross Osborn from Cantor Fitzgerald asked about the company's market access initiatives to drive adoption higher than the current 10% penetration, questioning if the strategy relies solely on sales force expansion or includes broader marketing campaigns.

Answer

CEO John Aballi explained that the core strategy is consultative selling to build trust with clinicians in a field that has seen little innovation. This is supported by digital marketing campaigns, the use of clinical research publications to validate utility, extensive team training, and partnerships with Key Opinion Leaders (KOLs), which will be prominent in the upcoming PAD4 launch.

Ross Osborn inquired about the launch timeline for the second wave of RA markers and asked for an assessment of physician awareness of the newly enhanced AVISE CTD test.

Answer

President and CEO John Aballi stated that the next set of RA markers is expected to launch around year-end 2025 or early 2026, following a similar development cycle as the previous launch. Regarding physician awareness, he noted that it's still early and varies regionally, but the company is actively educating its existing physician base through multiple channels. He believes it will take the majority of the year to fully educate clinicians on the new value proposition.

Ross Osborn inquired about the sensitivity improvements from the new RA33 and T cell markers, future enhancements expected this year, and the company's current manufacturing capacity and ability to meet demand.

Answer

John Aballi detailed the significant sensitivity gains for both lupus (capturing ~51% of seronegatives) and RA (~16% of seronegatives, with more to come) from the new markers. He also confirmed that the company has sufficient manufacturing capacity to meet expected demand in 2025, having made significant investments in equipment and staffing.

Asked about the company's lab capacity expansion initiatives to handle future demand and requested an update on the biopharma contract opportunity for 2025.

Answer

The lab can nearly double its current capacity by adding a night shift, and preparatory steps like hiring licensed personnel and upgrading equipment are complete. On the biopharma front, there is no material update, but it's a growing area with over $1M in contracts signed in 2024, though no specific 2025 guidance has been provided.

Ross Osborn asked for early feedback on the TriNav Large device, including the types of patients and clinicians showing initial adoption. He also inquired about the completion timeline for the clean room expansion and the expected gross margin cadence for the rest of the year.

Answer

CEO Mary Szela and Executive Dr. Richard Marshall provided details on TriNav Large, explaining it's primarily used in the liver for larger tumors and is also seeing adoption in uterine fibroid and thyroid procedures. CFO James Young addressed the gross margin question, stating the clean room expansion was completed in March. He expects gross margins to trend back up from 84% to the upper 80s, potentially hitting 90% in a strong quarter.

Asked about the outlook for gross margins for the rest of the year and the key success metrics for the upcoming Tissue Health Plus pilot program.

Answer

Gross margins are expected to remain consistent with current levels, with limited further leverage anticipated. The success of the Tissue Health Plus pilot will be measured across three categories: clinician-facing metrics (e.g., protocol adherence, time savings), operational metrics (e.g., staff productivity, billing capture), and adoption metrics (e.g., user satisfaction).

Ross Osborn of Cantor Fitzgerald inquired about the strategic rationale for the ChemoMouthpiece investment, the progress of the Tissue Health Plus (THP) pilot program, talent acquisition for THP, the outlook for operating expenses, and updates on the peptide development with Tufts University.

Answer

Executive Ronald Nixon explained that ChemoMouthpiece aligns with their wound and skin care strategy by addressing oral mucositis. An executive, identified as Sam, confirmed the THP pilot program is on track for the first half of the year with positive early feedback and noted success in attracting a skilled team. Ronald Nixon added that OpEx is carefully budgeted with no surprises anticipated, and that the radiation dermatitis peptide project is progressing well, complementing their joint venture with InfuSystem.

Ross Osborn inquired about the commercial launch progress of Genio in Dubai, the allocation of resources to the Middle East, and the current enrollment status of the ACCCESS study.

Answer

CEO Olivier Taelman reported that the launch in the Middle East is progressing well, with successful initial implants in Dubai and plans to expand into Kuwait and Saudi Arabia. He also confirmed that enrollment for the ACCCESS study remains on track for completion by the summer, consistent with prior communications.

Matthew Park, on behalf of Ross Osborn, asked about the sufficiency of Nyxoah's manufacturing and supply chain to meet U.S. demand upon launch and inquired about plans and timelines for generating post-approval real-world data.

Answer

CEO Olivier Taelman expressed high confidence in their supply chain, highlighting the strategic decision to manufacture products for the U.S. market domestically. Both CEO Olivier Taelman and CFO John Landry confirmed that collecting real-world data is a key part of their post-launch strategy and a requirement of their post-market study approval to demonstrate the technology's clinical and economic value.

Ross Osborn inquired about the progress of Nyxoah's manufacturing ramp-up ahead of the U.S. launch, the expected timing of the operating expense increase (Q3 vs. Q4), and how the commercialization plan has been shaped following the recent hiring of the Chief Commercial Officer.

Answer

CEO Olivier Taelman confirmed manufacturing capacity will be sufficient, detailing plans to launch with the Genio 3.1 generation in the U.S. and establishing manufacturing lines in both the U.S. and Europe to de-risk the supply chain. CFO Loic Moreau stated that the OpEx and cash burn inflection will begin in Q3 and continue to increase steadily through Q4 as U.S. hiring accelerates. Taelman added that key leadership roles are filled and the company is seeing a high number of spontaneous applications for sales positions.

Ross Osborn of Cantor Fitzgerald questioned the reiterated guidance, given it previously assumed an LCD-driven inflection, asked for more detail on the expected market "stabilization," and inquired if higher-priced products would be used to offset volume.

Answer

CFO David Francisco and CEO Gary Gillheeney clarified that the guidance holds because the company can now leverage its entire portfolio for all indications, including higher-margin products like PuraPly. This broader product mix offsets the previously forecasted high volume on a smaller set of LCD-covered products. Gillheeney explained that "stabilization" refers to customers returning to normal buying patterns as the company educates them and the near-term LCD uncertainty is removed. Francisco added that the plan is not to introduce new high-priced products but to utilize the existing, full portfolio's favorable mix.

Ross Osborn of Cantor Fitzgerald asked about sales force attrition levels during the quarter and requested an update on the progress of Randomized Controlled Trials (RCTs) for products not on the LCD covered list.

Answer

CFO David Francisco stated that while there was some sales force attrition, it was not significant, and the company has been successful in backfilling roles with quality talent. CEO Gary Gillheeney reported that the PuraPly study is progressing, with an interim analysis expected in Q4 2025 and a publication in Q1 2026, positioning it for MAC reconsideration.

Ross Osborn of Cantor Fitzgerald inquired about the progress of sales force expansion, specifically the number of direct reps focused on the Sports Med business, and sought details on the lower-than-expected R&D spending in Q3 and the outlook for 2025.

Answer

Chief Financial Officer David Francisco confirmed an increase in sales representative count during the quarter, noting strong productivity from wound care reps and that the direct Surgical & Sports Medicine (SSM) team is under 20 people. Regarding R&D, Francisco explained the Q3 dip was due to the lumpy timing of expenses for the ReNu BLA submission and expects Q4 spending to rebound to Q2 levels, with similar investment continuing into 2025.

Ross Osborn of Cantor Fitzgerald sought clarification on the 2025 SG&A guidance, asking if the projected modest increase is based on the full 2024 reported figure, which included a one-time Q4 item, or an adjusted number. He also asked about the commercialization timeline and necessary steps for Cerus in Brazil.

Answer

Executive Kevin Green clarified that the SG&A guidance was based on the full-year 2024 results and that the Q4 anomaly was roughly a $2 million impact. He stated that future growth would be driven by inflation, not significant new investments. Regarding Brazil, Executive Vivek Jayaraman explained that the company is currently seeking approval to access the larger public sector market, with a decision anticipated later in the calendar year, after which the focus would shift to operational rollout.

Ross Osborn of Cantor Fitzgerald inquired about the expected adoption curve for RECELL GO Mini in 2025 and questioned the company's manufacturing capacity to meet anticipated future demand.

Answer

CEO Jim Corbett anticipates quicker adoption for RECELL GO Mini because its size is better matched to the majority of full-thickness defect wounds. He also expressed high confidence in manufacturing capacity, citing the completion of 'Project Phoenix' which expanded capacity tenfold and the successful in-sourcing of RECELL GO production.

Ross Osborn inquired about adoption trends within the broad full-thickness indication, asking if certain defects are more common and how the new Dermal Matrix fits in. He also asked about international reimbursement dynamics and whether the sales force needs for expansion are factored into the cash breakeven guidance.

Answer

CEO James Corbett explained that adoption is currently stronger in acute wounds like trauma and degloving injuries over chronic wounds. The Dermal Matrix will be applicable across burns, full-thickness, and chronic wounds. Regarding international expansion, he stated they will use third-party distributors, so no additional sales force headcount is needed, and this is reflected in the guidance. He expects an average international ASP of 75-80% of the U.S. price.