Nano-X Imaging Ltd. current report, Q1 FY2021

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Business Context and Reporting Period

Nano-X Imaging Ltd. filed a Form 6-K for February 2021, dated February 1, 2021. The filing reports an FDA review update concerning the company’s Nanox.ARC medical imaging system and related development and commercialization plans.

Key Financial and Operating Metrics

  • The filing does not provide revenue, profit, cash flow, margins, debt, liquidity, or other financial statement metrics.
  • The company is developing the single-source and multiple-source Nanox.ARC systems and the Nanox.CLOUD platform.
  • If required regulatory clearances are obtained, the company is targeting shipment of 1,000 Nanox Systems by the end of the first quarter of 2022.
  • The company’s stated goal is to finalize deployment of an initial 15,000 Nanox Systems by the end of 2024.

Material Changes and Regulatory Update

On January 30, 2021, the FDA issued additional information requests regarding the company’s 510(k) premarket notification for the single-source Nanox.ARC. The requests include deficiencies and questions concerning the system’s intended use and its comparability to the predicate device. The company stated that it plans to respond promptly.

The company also plans to continue optimizing and developing Nanox.ARC features and expects to submit an additional 510(k) notification during 2021 for the multiple-source Nanox.ARC and Nanox.CLOUD.

Outlook, Risks, and Unusual Items

  • The shipment and deployment targets are conditional on FDA clearance and authorization by similar regulatory agencies in other jurisdictions.
  • Key risks include failure or delay in demonstrating commercial feasibility, obtaining or maintaining regulatory clearances, complying with quality and regulatory requirements, and securing third-party manufacturing and supply arrangements.
  • Additional risks include market acceptance of Nanox.ARC and the proposed pay-per-scan business model, execution of third-party collaborations, global operations, and COVID-19-related disruptions.
  • The stated shipment and deployment plans are forward-looking statements and may differ materially from actual results.

Facts Investors Should Verify

  1. Whether the company adequately addressed the FDA’s requested information and deficiencies.
  2. Whether the FDA cleared the relevant single-source or multiple-source Nanox.ARC systems and Nanox.CLOUD submissions.
  3. Whether regulatory approvals in other jurisdictions were obtained on a timeline consistent with the shipment and deployment targets.
  4. Whether the company secured manufacturing capacity, suppliers, funding, and customer commitments sufficient to support the planned deployment.
  5. The financial condition, cash runway, operating losses, and capital requirements, which are not provided in this filing.