Profusa, Inc. Initial Public Offering Released - Here’s What You Should Know

Profusa, Inc. (Nasdaq: PFSA)
Investor Summary Report – August 29, 2025

Company Overview
Profusa, Inc. is a clinical-stage digital health and medical technology company, focused on the development of bioengineered sensors for real-time monitoring of biochemical markers in the body. The company’s core products are the Lumee™ Oxygen Platform (CE marked in the EU) and Lumee™ Glucose Platform (investigational CGM system). Profusa recently completed a business combination with NorthView Acquisition Corporation and has also implemented a Bitcoin treasury strategy.

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Key Financial Metrics

• Revenue:

  • For the year ended December 31, 2024: $100,000 (government grants)
    
  • For the six months ended June 30, 2025: $0
    
  • No commercial sales reported; revenue is currently derived solely from government grants (NIH, DARPA).

• Net Loss:

  • FY 2024: $(9.23) million
    
  • FY 2023: $(10.28) million
    
  • 6M ended June 30, 2025: $(5.06) million
    
  • 6M ended June 30, 2024: $(4.48) million
    
  • Net loss per share FY 2024: $(1.65);
    6M 2025: $(0.90)

• Operating Expenses:

  • FY 2024: $4.60 million
    
  • 6M ended June 30, 2025: $2.43 million

• R&D and G&A Breakdown (6M 2025):

  • Research & Development: $827,000
    
  • General & Administrative: $1.6 million

• Cash and Liquidity:

  • Cash as of June 30, 2025: $44,000
    
  • Cash as of December 31, 2024: $191,000
    
  • Net cash used in operations (6M 2025): $(1.13) million
    
  • Profusa expects to rely on additional capital raises to fund operations and product development.

• Debt and Liabilities (as of June 30, 2025):

  • Total current liabilities: $63.48 million
    
  • Total convertible debt outstanding: $49.97 million
    
  • Promissory notes: $940,000
    
  • PPP loan: $1.38 million (defaulted due to nonpayment of minimum required amounts)
  • Tasly convertible debt (related party): $2.54 million
    

• Equity Position:

  • Accumulated deficit as of June 30, 2025: $(130.0) million
  • Post-business combination, outstanding shares is expected to be ~69.2 million; after full impact of PIPE/ELOC/Note conversions, up to 258.3 million.

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Key Risks

1. Substantial Doubt about Going Concern

   • Auditors and management express substantial doubt about Profusa’s ability to continue as a going concern. The company is reliant on future financing to fund operations. As of June 30, 2025, available cash is minimal, and operating losses and negative cash flow persist.

2. No Commercial Product Revenues

   • All revenues to date are from government grants. Commercialization of Lumee Oxygen is at an early stage (EU only); Lumee Glucose has not received FDA or EU approval.

3. Heavy Debt Load

   • The company carries significant short-term debt, including $49.97 million in convertible notes and $27.9 million in senior notes (much due within the current period). Much of this must be repaid or converted to equity in connection with financing events or joint venture arrangements.

4. Execution and Regulatory Risks

   • No assurance of FDA 510(k) or PMA approval for U.S. commercialization.
   • Delays or failures in clinical trials and regulatory submissions could halt commercialization efforts. For example, execution of ongoing pivotal studies for Lumee Oxygen in the U.S. may be impacted by site enrollment and regulatory feedback.

5. Single-Product Concentration

   • Near-term revenues depend almost entirely on the successful commercialization of the Lumee Oxygen Platform.

6. Reliance on Clinical Partners and Suppliers

   • The company is dependent on third-party suppliers, contract manufacturers, and CROs. Supply disruptions or third-party failures could significantly impact timelines and product quality.

7. Competitive Landscape

   • Profusa faces large, established competitors in both the oxygen monitoring (e.g., Siemens Healthineers) and glucose monitoring space (Dexcom, Abbott, Medtronic). Larger competitors have greater resources, market presence, and regulatory experience.

8. Material Weaknesses in Internal Controls

   • The company has identified deficiencies in internal controls over financial reporting and has not engaged an independent auditor for these controls.

9. Significant Dilution Risk

   • Investor dilution is expected from PIPE and ELOC transactions and conversion of large tranches of debt. The registration statement covers up to 222,222,222 shares.

10. Bitcoin Treasury Strategy

    • The company's intentions to hold and buy Bitcoin expose it to significant market, regulatory, counterparty, and liquidity risk. Bitcoin is highly volatile, and reclassification as a security could lead to regulatory complications.

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Management Discussion & Analysis

• Profusa’s core strategy is to gain traction in Europe with its CE-marked Lumee Oxygen product, pursue FDA approval, and develop and eventually commercialize the Lumee Glucose CGM platform.
• The company reports no serious adverse events in clinical studies to date for either oxygen or glucose sensors.
• Management notes that COVID-19, inflationary pressures, and geopolitical instability (e.g., Russia/Ukraine crisis) continue to challenge supply chains and the company’s ability to operate efficiently.
• Ongoing expenditures are focused on R&D, regulatory compliance, and preparation for larger-scale commercialization pending regulatory approvals.
• Profusa has received significant funding via the PIPE transaction and expects to raise further funds through the committed equity facility and additional note conversions.
• The company is also exploring partnerships for "data as a service" business models alongside device launches.

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Ownership and Corporate Governance

• The board consists of five directors, split into classes, with Ben Hwang (Chairman and CEO) and Fred Knechtel (CFO) as key executives.
• Largest shareholders post-combination include NorthView Sponsor I, LLC (24%), Fred Knechtel (24.9%), Jack Stover (24%), Ascent Partners Fund LLC (9.99%), and BC hSensor Limited (5%).

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Conclusion & Investor Considerations

Investors should note that Profusa remains an early-stage, pre-revenue medtech company facing significant going concern risks, high debt, execution uncertainty, and future dilution. Success is highly dependent on regulatory milestones and execution of its commercialization plan. The innovative nature of its biosensor technology is balanced by heavy competition, and the bitcoin treasury strategy adds novel, non-traditional risk to the company’s profile. This investment is suitable only for those with high risk tolerance and a long-term horizon.

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