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The company plans to submit its AI module in September for a launch next year. They believe no additional physician education will be needed as the AI detects recognizable abnormalities. The primary advantage of in-house AI is controlling their own development destiny, priorities, and resources, which is a significant advantage over competitors who may outsource this function.

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CEO Kang-Huai Wang confirmed the company plans to submit its AI module to the FDA in late September or early October for a launch next year. He stated that no special physician education would be required, as the AI identifies abnormalities that doctors are already trained to recognize. Wang emphasized that in-house AI development provides a 'tremendous' advantage, giving CapsoVision control over its own destiny, development timelines, and resource allocation without reliance on third-party priorities.

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CFO Fred Leffler explained that gross margins are expected to increase substantially, estimating a 12-13% improvement as the cost structure shifts from a transfer price to a royalty model. He also stated that the spike in Q2 legal costs was an anomaly and that SG&A should normalize in Q3 and Q4. CEO Hermann Luebbert added that the FDA submission for sBCC is being prepared and is planned for the second half of 2025.

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CFO Eugene Leffler stated that all inventory is now at the lower 25% transfer price, which should positively impact gross margins for the rest of the year, though lower-margin lamp sales could cause fluctuations. Executive Hermann Lubbert added that the company is not aware of any reimbursement denials for the 3-tube usage, indicating the issue appears resolved with payers.

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CFO Eugene Leffler stated that the lower 25% transfer price will be in effect for nearly all of 2025, which should positively impact gross margins. He also confirmed a 5% price increase in Q4, which led to some customer buy-ins in Q3. Both Leffler and executive Hermann Lubbert indicated that SG&A and R&D expenses are expected to remain stable in 2025.

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Executive Hermann Lubbert estimated that the rebound effect accounted for at most half of the Q2 sales strength, with May and June reflecting more typical organic growth. CFO Eugene Leffler projected R&D spending of approximately $2.4 million for the remainder of the year, or about $1 million per quarter, contingent on trial recruitment. Hermann Lubbert confirmed that clinical data from the BCC trial is expected by year-end, with follow-up data in H1 2025.

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Chairman & CEO Tom Lin confirmed a route for accelerated approval existed, but the FDA recommended completing the 24-month study for a potential single-study approval. Regarding data releases, Tom Lin noted the FDA prefers they keep efficacy data confidential until the submission. CFO Hao-Yuan Chuang added that the final 24-month data will be announced once available, prior to the formal filing.

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CFO Hao-Yuan Chuang explained that future stock compensation expense is difficult to predict as it's tied to both time and development milestones, but he does not expect it to remain as high as it was in Q1. Chairman and CEO Dr. Tom Lin addressed manufacturing, stating that Tinlarebant is produced in the U.S. and other geographies, mitigating any potential tariff risks.

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Chairman and CEO Dr. Tom Lin confirmed that the warrants from the February capital raise have not yet been exercised. Regarding the regulatory process, Dr. Lin stated that the company is using multiple CROs for different jurisdictions and that they are 'basically submitting as we speak,' indicating the process is actively underway.

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President & CEO John Duke confirmed that an NIH focus on neuroscience would benefit their MeSH MEA organoid platform and pointed to the Society of Neuroscience show in November for new data. Interim CFO Mark Frost identified European tariffs as another key macro factor being watched, noting the company has operational flexibility in Europe to potentially mitigate impacts.

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The company stated that a neuroscience focus in the 2026 NIH budget would enhance their product portfolio. They are also monitoring European tariffs but have operational flexibility to mitigate impacts. New information and academic results for the MeSH MEA platform will be presented at the Society of Neuroscience show in November.

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James Green, President and CEO, confirmed the CAR-T customer is a domestic biotech that used Harvard Bioscience's BTX AgilePulse system during development and is now adopting it for bioproduction. Regarding MeshMEA, Green acknowledged that academic purchasing has slowed due to NIH staffing issues but noted the overall interest and sales funnel are growing. He emphasized that the government's push for NAMs is driving significant new interest from biopharma companies and CROs, positioning it as a strong long-term growth driver.

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The new ERP system is expected to drive operational efficiencies and gross margin improvements in 2025 after an initial learning curve. The CAR-T business is a long-term opportunity tied to the drug development pipeline. MeshMEA projects are expanding from academia to pharma and CROs for applications like tox screening. The product will be included in expanded North American distribution agreements, which is expected to generate significant leads.

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The executive stated that while uncertainty remains, their team in China sees stabilization, with the academic segment already recovering and the CRO/pharma segments expected to level off. For Mesh MEA, supply is currently limited during the beta phase, but production is being ramped up for Q2 2025, with the potential for $1-2 million in new quarterly growth plus significant recurring revenue. The focus is on scaling up the production of the consumable biochips.

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President and CEO James Green explained that the outlook for China is based on stabilizing academic budgets and improving capital availability for CROs and pharma, leading to an expectation of stable to modest growth from a low base. Regarding the Mesh MEA platform, Green noted that after a controlled beta phase, the company is ramping up production of consumable biochips, with a tenfold increase planned by Q2 2025, positioning it as a major future growth driver.

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CEO Laura Niklason provided an update, stating that a paper on the primate results for the CABG program has been accepted for publication. She confirmed that the company is on track to file the Investigational New Drug (IND) application with the FDA later in 2025. Following an anticipated review period, she expects the first human clinical trial to commence sometime in 2026, consistent with prior guidance.

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CEO Dr. Laura Niklason shared an anecdote of a new surgeon having a positive experience, noting adoption typically starts with early adopters. CCO BJ Scheessele added that initial champions are a mix of vascular and trauma surgeons. Regarding the pipeline, Dr. Niklason stated that work on the BioVascular pancreas is continuing, with plans to publish preclinical results later in the year, but had no new explicit updates.

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Executive Laura Niklason reported that ongoing primate studies have successfully demonstrated long-term islet survival and insulin production for months, even in a diabetic primate model. She stated that the company has proven the key technological hurdles of long-term engraftment and function. The current focus is on 'tweaking the design and the dosing' to optimize the therapeutic effect before moving forward.

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Executive Laura Niklason explained that the AV access filing is largely independent of the trauma BLA's trajectory. The timing for a supplemental BLA submission in mid-2025 depends on whether the FDA requires one-year or full two-year follow-up data from the V007 trial. For the CABG program, she stated the FDA requested a third animal model (sheep), and Humacyte has a meeting scheduled to confirm this plan would be sufficient to support a future IND filing.

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CEO Marla Beck announced plans to launch Backbar and a hero skincare SKU in Q4 2025, with a broader rollout in 2026. She specified an optimal booster cadence of one to two launches per year to maximize adoption. CFO Michael Monahan confirmed the debt refinancing will increase interest expense, as $250 million of notes were refinanced at a 7.95% rate with a maturity extended to 2028.

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Executive Marla Beck clarified that demand has bifurcated: the med spa, dermatology, and wellness sectors are performing strongly. In contrast, day spas and plastic surgery practices, which are more discretionary, have not grown as well. She emphasized that the core signature Hydrafacial treatment remains healthy across all channels, with some trading away from luxury add-ons in the softer segments.

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CEO Marla Beck explained the laser combination study was prompted by existing use among dermatologists and that results would be published soon. She confirmed that exploring other treatment pairings is a key part of the go-forward strategy, aided by the new CMO's clinical background. Regarding the device, she stated the team is actively working on the innovation strategy for 2025.

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CEO Jason Matuszewski explained that their sales footprint is currently strongest west of the Mississippi River. He detailed that their partner, Venture Medical, is actively expanding to the East Coast by hiring 40 direct representatives and has appointed three area sales directors for the East, Central, and West regions to drive adoption where coverage is currently less significant.

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CEO Cameron Reynolds confirmed the feline cancer test adaptation is progressing well and is on track for completion later in the year, which would trigger the $5 million milestone payment from Antech. Regarding the Lyon study, Chief Medical Officer Dr. Andrew Retter and CEO Cameron Reynolds highlighted the study's exciting results, noting its potential for disease prognostication and its role in active discussions with national screening programs in France and other countries in Asia and Europe.

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President and Group CEO Cameron Reynolds clarified that the feline milestone has not yet been achieved. He explained that the team successfully optimized the test for cats, which have lower nucleosome levels, and is now proceeding with a clinical utility study. Chief Medical Officer Dr. Andrew Retter added that two large publications on sepsis are nearing submission, and for oncology, papers related to lung cancer are drafted and in the submission process, supporting discussions around national screening programs.

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CFO Terig Hughes stated that while it's difficult to provide specific guidance on the revenue curve, they expect increases in the coming quarters due to recent launches by Antech and Fuji. President and CEO Cameron Reynolds added that revenue could be "lumpy" due to partner stocking cycles but the overall trend is positive. Regarding expenses, Hughes confirmed that costs are decreasing quarterly, with a target of a $10 million annualized reduction, and this trend will continue. Reynolds reinforced the commitment to cost control to extend the company's financial runway.

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CEO Jan Haverhals stated that Milestone is in 'advanced steps' with four additional JMACs, a process that involves educating the contractors on the technology's benefits. He confirmed they have a target list of specialized distributors for these regions but noted that these partners would likely engage formally only after reimbursement is approved. Regarding Q4 revenue, Haverhals avoided a direct forecast but said the goal is to reduce the year-to-date revenue gap compared to last year through various commercial efforts.

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CEO John Mastrototaro addressed the blood pressure program, noting a new prototype with more antennas yielded exceptionally clean signals in a recent trial, with plans for further studies and a market launch within a couple of years. For the Android app, Mastrototaro and CMO Tyla Bucher confirmed it will mirror iOS functionality and targets about 40% of the market, being their most requested feature. Executive Jeremy Cogan stated that while there will be incremental marketing spend for the holidays, the company will remain judicious with capital and focused on managing its cash burn. Finally, Mastrototaro expressed confidence in the FDA process, explaining they have responded to all questions, many related to labeling, and are in the final stages awaiting feedback.

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CEO John Mastrototaro detailed progress on the cuffless blood pressure monitor, targeting a market launch within the next couple of years, and confirmed the Android app will have identical functionality to the iOS version. CMO Tyla Bucher added that Android users represent about 40% of the market. Executive Jeremy Cogan stated that while there will be some incremental Q4 marketing spend, the company will remain focused on managing its cash burn. Mastrototaro also expressed confidence in the final stages of the EvieMed 510(k) FDA review, noting recent questions were largely related to labeling and that the company's clinical data is exceptionally strong.

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CEO John Mastrototaro and Executive Jeremy Cogan addressed the questions. Mr. Mastrototaro confirmed the blood pressure device is on track for market entry within a few years and that the Android app will mirror the iOS version's functionality. He also expressed high confidence in the FDA submission, noting they are in the '11th hour.' Mr. Cogan stated that while there will be incremental marketing spend, the company will remain judicious with capital and focused on managing its cash burn.

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CEO John Mastrototaro explained that for the cuffless blood pressure monitor, they are analyzing data from a new prototype and expect to be on track for a market launch within a couple of years. He and CMO Tyla Bucher confirmed the upcoming Android app will have full feature parity with the iOS version, addressing a key customer request from their 40% Android user base. Regarding the FDA 510(k) process for EvieMed, Mastrototaro stated they are in the '11th hour' after responding to the FDA's final questions and feel confident in their strong clinical data. Executive Jeremy Cogan addressed financials, noting that while there will be some incremental Q4 marketing spend, the company will remain judicious with capital and focused on managing its burn rate.

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CEO John Mastrototaro, CMO Tyla Bucher, and executive Jeremy Cogan addressed the questions. Mastrototaro expressed excitement about the cuffless blood pressure program, noting a new prototype was recently tested and that the company is on track for a market launch within two years. He and Bucher confirmed the Android app will have full feature parity with the iOS version, targeting the 40% of their audience on Android, which has been the most requested feature. Regarding financials, Cogan stated that while there will be incremental marketing spend for the holidays, the company will remain highly focused on managing its cash burn. Finally, Mastrototaro described the FDA process as being in the '11th hour,' with recent questions focusing on medical device aspects like labeling, and expressed strong confidence in their submitted responses and clinical data.

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Chief Technology Officer Michael Leabman explained that the new heart rate algorithm is a deep learning-based fix for accuracy during motion, while auto activity detection is a separate feature to identify workouts automatically. Chief Commercial Officer Michael Soule stated that B2B engagements with providers, payers, and RPM channels are moving into agreement phases pending FDA clearance. CEO John Mastrototaro confirmed the FDA meeting is on schedule and expressed strong confidence in a positive outcome, citing their experienced regulatory team and the strength of the underlying clinical data for the pulse oximetry feature.

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Executive Vered Caplan clarified that the company is currently focused on validating the single UC Davis site in California before further expansion, noting that each site serves as a regional hub for multiple hospitals. She confirmed that international expansion for Koligo is still planned, supported by a Belgium grant for the European market. Regarding revenue, Caplan explained that the increase in cell process development services is due to onboarding new customers and represents a timing-related fluctuation, as process development builds the pipeline for future production.

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CEO Vered Caplan explained that while they are pushing for a formal agreement with UC Davis, academic institutions have their own processes. She clarified that OMPULs are flexible and can be adapted for various therapies. The plan is to validate one location and then expand. Regarding Koligo, the FDA audit validated their process for duplication across a network of sites. CFO Neil Reithinger confirmed the 10-K would be filed the following day.

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CEO Vered Caplan explained that capital constraints were primarily CapEx-related, limiting the setup of new point-of-care sites. The new funding will enable expansion, especially in the U.S. Caplan declined to provide a specific number of active OMPULs, stating the focus is on full utilization of existing capacity rather than the quantity of units. Regarding the therapeutic pipeline, she noted that while there were no major clinical trial completions, programs are progressing well, and she is hopeful for more news and payment benefits in the coming year.

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CEO Vered Caplan confirmed the company remains on track with its revenue commitments, noting a minor positive adjustment of about $5 million from new contracts. Regarding the subsidiary, she clarified that it holds service-related assets like the 'on fields' and associated know-how, while intellectual property for the therapies themselves is held in separate entities.

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CEO James Schutz and CFO Bob Miller responded, stating that mail-order now accounts for over 40% of unit volume, up from approximately 20% in the prior quarter. They confirmed the rebate situation has stabilized, aided by a mail-order program for cash-paying patients. Miller added that the initial shipment to Brazil was $248,000 and that they expect continued strong growth from the region as more products are launched.

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CEO James Schutz confirmed they are providing financial arguments to an insurance consultant to detail the cost-effectiveness of their products. He and CFO Robert Miller stated the Invekra agreement was extended to late fall 2020. COO Marc Umscheid added that two significant orders from their new Brazilian partner have been received, with products expected to be on the market within 60 to 90 days.

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