Company: BLLN
Filing Date: 2025-06-20
Form Type: DRS
Source: 0000950123-25-006095
Chunk: 88

Company: BillionToOne, Inc.
Filing Date: 2025-06-20
Form: DRS
Chunk 88
---
whereby the applicant conducts a follow-up study or follows certain patient groups for a number of years and makes periodic reports to the FDA on the clinical status of those patients when necessary to protect
the public health or to provide additional safety and effectiveness data for the device. The product labeling must be updated and submitted in a PMA supplement as results, including any adverse event data from the post-approval study, become
available. Failure to conduct or timely complete post-approval studies in compliance with applicable regulations, update the product labeling, or 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 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.

60

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