Company: BLLN
Filing Date: 2025-09-17
Form Type: DRS/A
Source: 0001193125-25-206347
Chunk: 103

Company: BillionToOne, Inc.
Filing Date: 2025-09-17
Form: DRS/A
Chunk 103
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 comply with other post-approval requirements could result in withdrawal of approval of the PMA, which would harm our business and revenue.

The FDA and FTC also regulate the advertising and promotion of medical devices to ensure that their promotional claims made are consistent with the applicable marketing
authorizations, that there are adequate

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and reasonable data to substantiate the claims, and that the promotional labeling and advertising is neither false nor misleading in any respect. If the FDA or FTC determines that any of our promotional claims are false, misleading, not substantiated or not permissible, we may be subject to enforcement actions and we may be required to revise our promotional claims and make other corrections or restitutions. Similar requirements apply in foreign jurisdictions. The FDA, state and foreign authorities have broad enforcement powers. Our failure to comply with applicable regulatory requirements could result in enforcement action by the FDA, state or foreign regulatory agencies, which may include any of the following sanctions:

| • |     | adverse publicity, warning letters, untitled letters, fines, injunctions, consent decrees and civil penalties; |

| • |     | repair, replacement, refunds, recalls, termination of distribution, administrative detention or seizures of our products; |

| • |     | operating restrictions, partial suspension or total shutdown of production; |

| • |     | customer notifications or repair, replacement or refunds; |

| • |     | refusing our requests for clearances or approvals of new products, new intended uses or modifications to existing products; |

| • |     | withdrawals of current clearances, approvals or certifications, resulting in prohibitions on sales of our products; |

| • |     | refusal to issue certificates needed to export products for sale in other countries; and |

| • |     | criminal prosecution. |

Any of these sanctions could also result in higher than anticipated costs or lower than anticipated sales of our products and have a material adverse effect on our reputation, business, results of operations and financial condition. In addition, the FDA may change its clearance and approval policies, adopt additional regulations or revise existing regulations, or take other actions which may prevent or delay approval or clearance of our current or future products under development. For example, on February 23, 2022, the FDA issued a proposed rule to amend the Quality System Regulation (QSR), which establishes current good manufacturing practice requirements for medical device manufacturers, to align more closely with the International Organization for Standardization (ISO) standards. This proposal has not yet been finalized or adopted. Accordingly, it is unclear the extent