Loading...
01/11 05:00
Loading...
Access earnings results, analyst expectations, report, slides, earnings call, and transcript.
The earnings call highlights strong strategic developments, including a new partnership in cardiac ablation and compatibility with major mapping systems. Despite increased expenses and net losses, the company maintains a solid cash position, indicating disciplined financial management. The positive aspects, such as the partnership and product compatibility, outweigh the negatives, suggesting a likely positive stock reaction.
Total GAAP costs and expenses (Q2 2025) $20.3 million, an increase of $8.5 million year-over-year. The increase was primarily driven by administrative expenses related to the expanding organization to support advancement of nsPFA device clinical trials and commercialization, along with other compensation and noncash stock-based compensation.
Non-GAAP costs and expenses (Q2 2025) $14.8 million, an increase of $5.4 million year-over-year. This excludes stock-based compensation and depreciation and amortization.
GAAP net loss (Q2 2025) $19.2 million, compared to $11.4 million in the prior year period. The increase in net loss reflects higher costs and expenses.
Non-GAAP net loss (Q2 2025) $13.7 million, compared to $9 million in the prior year period. This excludes stock-based compensation and depreciation and amortization.
Cash and cash equivalents (as of June 30, 2025) $106.3 million, compared to $26.2 million as of June 30, 2024. The increase reflects disciplined expense management and planned cash usage.
Cash used in operating activities (Q2 2025) $12.8 million, compared to $8.4 million in the prior year period. The increase is aligned with planned cash usage and investments in commercial infrastructure and IDE clinical studies.
nsPFA technology: Developed a next-generation energy modality for therapeutic ablations with shorter pulse durations, reducing thermal damage.
Percutaneous Electrode System: FDA-cleared for soft tissue ablation, targeting benign thyroid nodules. Over 140 patients treated in pilot program with positive outcomes. Transitioning procedures to ambulatory surgery centers or operating rooms for better patient access and reimbursement.
Cardiac Surgical Clamp: Received FDA Breakthrough Device designation. IDE submission under review for a clinical trial involving 150 patients across 20 sites. Positive feasibility study results in Europe with 40 patients treated.
360 Catheter System: Feasibility study ongoing in Europe with over 140 patients treated. IDE submission under review for atrial fibrillation treatment. Positive outcomes reported, including reduced procedure times and improved lesion consistency.
Soft Tissue Ablation Market: Targeting a large U.S. market for benign thyroid nodules, with potential to convert thyroidectomy operations to minimally invasive procedures.
Electrophysiology Ablation Market: Exploring strategic partnerships with market leaders to expand adoption of nsPFA technology.
Clinical Data Generation: Conducting multicenter prospective clinical studies and presenting findings at major conferences to drive awareness and adoption.
Commercial Infrastructure: Investing in infrastructure to support IDE clinical studies and commercialization of nsPFA devices.
Regulatory Approvals: Advancing IDE submissions for multiple devices to achieve regulatory milestones.
Strategic Partnerships: Exploring collaborations with market leaders in electrophysiology to enhance market positioning.
Regulatory Hurdles: The company is awaiting FDA approval for its IDE submissions for the cardiac surgical clamp and 360 catheter system. Delays or rejections in these approvals could impact the timeline for clinical trials and market entry.
Financial Risks: The company reported a GAAP net loss of $19.2 million in Q2 2025, an increase from $11.4 million in the prior year. Cash use is expected to increase further due to investments in commercial infrastructure and clinical studies, which could strain financial resources.
Market Adoption Challenges: The adoption of the nsPFA technology depends on generating high-quality clinical data and convincing clinicians to transition from existing methods. The sales cycle for capital equipment is lengthy, and initial revenue generation is dependent on pilot programs and customer contracts.
Operational Risks: The company is transitioning procedures to ambulatory surgery centers (ASC) or operating rooms (OR), which may require additional logistical and operational adjustments. This shift could also impact patient access and reimbursement processes.
Competitive Pressures: The company faces competition from existing ablation technologies, including microsecond PFA and thermal ablation methods. Convincing clinicians and patients of the advantages of nsPFA over established methods is critical for market penetration.
Clinical Trial Risks: The success of ongoing and future clinical trials in Europe and the U.S. is crucial for regulatory approvals and market adoption. Any negative outcomes or delays in these trials could adversely affect the company's strategic objectives.
Revenue Expectations: The company expects to generate its initial revenue from the percutaneous electrode in the second half of 2025. Revenue recognition will depend on individual contracts with commercial pilot program participants and new customers, with potential deferral of revenue based on specific agreements.
Market Potential and Growth Expectations: The nsPFA percutaneous electrode system is expected to address unmet clinical needs in the treatment of benign thyroid nodules, with a market potential of several hundred thousand patients per year in the U.S. alone. The company anticipates an expansion in interventional volume for benign thyroid nodule treatment by offering nsPFA as a minimally invasive option.
Clinical Trials and Regulatory Progress: The company plans to commence a multicenter prospective clinical study for the nsPFA percutaneous electrode system in Q3 2025, with enrollment starting upon IRB approvals. For the cardiac surgical clamp, the IDE submission is under review, and the clinical trial is expected to enroll up to 150 patients across 20 sites, with enrollment anticipated to begin in the next few months. The 360 catheter system IDE study is also expected to commence in the next few months.
Strategic Partnerships: The company is exploring strategic partnerships in the electrophysiology space to enhance market adoption and create value for stakeholders.
Capital Expenditures and Cash Use: Quarterly cash use is expected to increase as the company invests in commercial infrastructure and IDE clinical studies for cardiac devices. These investments align with the company's 2025 priorities.
The selected topic was not discussed during the call.
The earnings call highlights significant challenges: a GAAP net loss of $19.4 million, high cash burn, and competitive pressures. Despite initial revenue from product launches, financial sustainability is a concern. The Q&A reveals uncertainties in strategic partnerships and trial outcomes. These factors, coupled with increased costs and competitive risks, suggest a negative sentiment. Without strong guidance or partnerships, the stock is likely to face downward pressure.
The earnings call highlights strong strategic developments, including a new partnership in cardiac ablation and compatibility with major mapping systems. Despite increased expenses and net losses, the company maintains a solid cash position, indicating disciplined financial management. The positive aspects, such as the partnership and product compatibility, outweigh the negatives, suggesting a likely positive stock reaction.
The earnings call presents a mixed picture. Strong clinical progress and FDA clearances are positive, but the financials show widening losses and increased expenses, which are concerning. The market strategy shows promise, but regulatory and competitive risks remain. The Q&A section didn't reveal additional negative sentiment. Given the balance of positive clinical developments and financial concerns, the stock price is likely to remain stable in the near term, resulting in a neutral prediction.
The earnings call presents a mixed picture. While there are positive developments such as FDA clearances, strengthened financials through warrant exercises, and strategic market initiatives, there are also significant risks. These include competitive pressures, regulatory challenges, and increased financial losses. The absence of guidance and the acknowledgment of potential supply chain and economic risks further contribute to a cautious outlook. As a result, the stock price is likely to remain stable in the short term, with movements within a neutral range of -2% to 2%.
All transcripts are sourced directly from the official live webcast or the company’s official investor relations website. We use the exact words spoken during the call with no paraphrasing of the core discussion.
Full verbatim transcripts are typically published within 4–12 hours after the call ends. Same-day availability is guaranteed for all S&P 500 and most mid-cap companies.
No material content is ever changed or summarized in the “Full Transcript” section. We only correct obvious spoken typos (e.g., “um”, “ah”, repeated 10 times”, or clear misspoken ticker symbols) and add speaker names/titles for readability. Every substantive sentence remains 100% as spoken.
When audio quality is poor or multiple speakers talk over each other, we mark the section instead of guessing. This ensures complete accuracy rather than introducing potential errors.
They are generated by a specialized financial-language model trained exclusively on 15+ years of earnings transcripts. The model extracts financial figures, guidance, and tone with 97%+ accuracy and is regularly validated against human analysts. The full raw transcript always remains available for verification.
