Net Loss

66% deterioration (increased from –10,137k USD in Q1 2024 to –16,795k USD in Q1 2025)

The widening net loss is driven by higher operating expenditures and increased stock‐based compensation expenses, which exacerbated the loss compared to Q1 2024, thereby indicating rising cost pressures carried over from the previous period. " "

Operating Expenses

Total expenses up 70% (R&D increased from 6,741k USD to 10,313k USD and G&A nearly doubled)

Operating expenses surged as a result of intensified investments in R&D and a substantial increase in General & Administrative costs. These higher operational outlays suggest a strategic focus on growth and innovation, though they significantly impacted overall profitability relative to Q1 2024. " "

Stock‑Based Compensation

Increased by approximately 223% (from 1,759k USD in Q1 2024 to 5,681k USD in Q1 2025)

The sharp rise in stock-based compensation reflects the issuance of new stock options with blended market‐based and performance‐based vesting conditions, along with modifications to vesting criteria, in contrast to the lower expense recorded in the previous period. " "

Operating Cash Flow

38% deterioration (net cash used increased from –9,780k USD in Q1 2024 to –13,521k USD in Q1 2025)

The decline in operating cash flow is largely due to increased operating expenses—including higher R&D and administrative costs—and elevated stock‐based compensation expenses, leading to greater cash outflows compared to Q1 2024. " "

Financing Activities

Increased from 305k USD in Q1 2024 to 14,807k USD in Q1 2025

Financing activities surged because of significant new inflows in Q1 2025 likely driven by robust capital markets activity and additional financing measures, which stand in stark contrast to the minimal proceeds observed in Q1 2024. " "

Clinical Outcomes and Validation

In Q2 2024, Q3 2024, and Q4 2024, the company consistently discussed clinical outcomes and validation across multiple devices – detailing feasibility studies, data on nodule reduction, acute conduction block for AF ablation, and robust validation strategies to support regulatory approval. " " " " "

In Q1 2025, the discussion expanded with detailed clinical outcomes and follow‑up data for the soft tissue ablation product, surgical ablation clamp, and 360 cardiac catheter, emphasizing precise metrics and larger sample sizes to further validate clinical efficacy. " " "

Continued and enhanced focus – the topic remains central with increased specificity and broader study metrics, reinforcing the company’s clinical data narrative.

Regulatory Strategy and PMA Pathway

Q2 2024 and Q3 2024 earnings calls provided detailed insights into pursuing specific regulatory pathways, including PMA applications for the cardiac surgical system and the use of FDA programs (Breakthrough Device Designation and TAP) to speed approval. " " " " "

No discussion on regulatory strategy or the PMA pathway was provided in Q1 2025 earnings call.

Reduced emphasis – previously a key strategic focus, the regulatory narrative has been removed from Q1 2025 discussions, suggesting a shift in immediate priorities or messaging.

Financial Health and Expense Management

Q2 2024 and Q3 2024 earnings calls discussed the company’s cash position, cost management through GAAP and non‑GAAP metrics, increased stock‑based compensation, and net losses while noting balance sheet improvements (e.g., rights offering and cash balances). " "

Q1 2025 presented detailed GAAP and non‑GAAP cost increases, higher net losses, yet a strong cash position bolstered by warrant exercises, reflecting continued investments to support clinical trials and commercialization. "

Consistent focus with evolving metrics – the narrative remains on cost increases and investments; the sentiment is cautionary regarding expenses yet optimistic about cash resources.

Commercialization Execution and Market Adoption

In Q2 2024, the pilot commercialization program was launched with FDA 510(k) clearances and initial U.S. site evaluations, while Q3 2024 emphasized building clinical data to drive market awareness and adoption, including plans for targeted indications. " "

Q1 2025 updates focused on ramping up commercialization of the soft tissue ablation product in the U.S. and using positive clinical data (including presentations at major specialty meetings) to support broader market adoption. "

Steady and positive momentum – the commercialization narrative builds on previous efforts, evolving from early pilot programs to active market execution and adoption support.

Investor Engagement and Q&A Transparency

Earlier periods (Q2 2024, Q3 2024, and Q4 2024) did not provide much detail on investor engagement or Q&A sessions, with only minimal mentions during introductions or concluding remarks.

Q1 2025 included references to a question-and-answer session with senior leadership (e.g., Bob Duggan), indicating a modest increase in direct investor engagement and transparency efforts. " "

Emerging focus – while historically minimal, there is a slight uptick in engagement and Q&A transparency, suggesting an effort to improve communication with investors.

Pipeline Diversification and Execution Risks

None of the previous earnings calls mentioned pipeline diversification or execution risks.

There is no discussion of pipeline diversification or execution risks in Q1 2025 earnings call either.

Not a focus – this topic has consistently been absent across all periods, indicating it is not currently a priority in the company’s narrative.