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- **Revenue Milestone**: Generated $86,000 in Q3, marking first commercial sales for Vybrance system.
- **Clinical Momentum**: Over 200 patients treated across thyroid programs; nPulse surgical clamp IDE trial enrolling first patient.
- **Cardiac Device Expansion**: nPulse 360 Catheter IDE submission progressing; European feasibility study shows promising 1-year follow-up data.
- **Financial Position**: $95.2 million cash balance, with Q3 net loss of $19.4 million driven by R&D and commercialization efforts.
- **Strategic Focus**: Scaling Vybrance adoption in select markets while advancing cardiac device trials.

**【CEO Summary Section】**
- **Revenue Generation**: Achieved initial revenue of $86,000 in Q3 2025, driven by Vybrance disposable sales and nPulse capital system placements.
- **Thyroid Ablation Progress**: Over 200 patients treated across pilot programs and PRECISE-BTN study, with physicians reporting high satisfaction and procedural ease. Enrollment in PRECISE-BTN study is 40% complete, targeting 50 patients.
- **Cardiac Device Developments**: 
  - FDA IDE approval for nPulse surgical clamp (NANOCLIP AF) with first patient enrolled; feasibility study in Europe shows ablation times as low as 50 seconds.
  - nPulse 360 Catheter IDE submission progressing; anticipate Q1 2026 trial start. European feasibility study enrolling 150 patients with 1-year follow-up data expected in Q1.
- **Strategic Focus**: Limited market release for Vybrance in select geographies, prioritizing procedure volume and outcome consistency before scaling commercial teams.

**【CFO Financial Commentary】**
- **Financial Performance**: GAAP net loss of $19.4 million (vs. $12.7 million YoY), driven by R&D and commercial expansion. Non-GAAP net loss $13.5 million (vs. $9.4 million YoY). Cash balance $95.2 million, down $11.1 million from Q2 due to operating expenses.
- **Expense Management**: Q3 cash use $13 million, aligned with clinical trial and commercialization investments. Anticipate increased cash use in Q4 with IDE trial enrollment.

**【Q&A Highlights】**
- **nPulse 360 Catheter Trial Funding**: Company plans to self-fund pivotal trial, though open to partnerships for commercialization support.
- **PRECISE-BTN Study Design**: Focuses on composite endpoints including quality of life, symptom reduction, and nodule volume decrease, rather than sole reliance on size reduction.
- **Surgical Clamp Lesion Set**: Surgeon discretion in lesion set based on AF severity; no LAA closure included in trial protocol.


Pulse Biosciences, Inc. (PLSE) Q3 2025 Earnings Call Transcript

Revenue

Sales and Services Revenue

Financing Services Revenue

Other Revenue

Cost of Revenue

Cost of Goods and Services

Cost of Financing Services

Other Cost

Gross Profit

Other Operating Income

Operating Expenses

Selling, General and Administrative Expenses

Selling and Marketing Expenses

General and Administrative Expenses

Research and Development Expenses

Loss on Bad Debts

Loss on Impairment of Other Assets

Loss on Disposal of Assets

Other Operating Expenses

Operating Income

Non-Operating Income (Loss)

Income (Loss) from Affiliates

Income (Loss) from Associates

Income (Loss) from Joint ventures

Gain (Loss) on Other Investment

Gain (Loss) on Change in Fair Value

Gain (Loss) on Foreign Currency Exchange

Other Non-Operating Income (Loss)

Net Interest Expense

Interest Expense

Interest Income

Pretax Income From Continuing Operations

Income Tax Expense

Current Income Tax

Deferred Income Tax

Income Tax Adjustments

Net Income from Continuing Operations

Income from Discontinued Operations

Other Items Before Net Income

Net Income

Net Income Attributable to Minority Interests

Net Income Attributable to Owners of the Company

Preferred Stock Dividends

Other Adjustments

Net Income Attributable to Common Stockholders

Other Comprehensive Income

Total Comprehensive Income

Total Comprehensive Income Attributable to Minority Interests

Total Comprehensive Income Attributable to Owners of the Company

Basic EPS

Basic EPS from Continuing Operations

Basic EPS from Discontinued Operations

Diluted EPS

Diluted EPS from Continuing Operations

Diluted EPS from Discontinued Operations

PLSE

PLSE fundamentals

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