| 2.01 | MD&A gives no reason for the [n]-point fall in gross profit margin and does not quantify how much of Product 1's growth came from price and how much from volume | Compliance gap | Medium | Regulation S-K narrative: business, risk factors and MD&A | Interpretation |
| 2.02 | The critical accounting estimates give no figures: no discount rate, no quantified change in the assumptions and no sensitivity, and the revenue estimate repeats the policy note | Compliance gap | Medium | Regulation S-K narrative: business, risk factors and MD&A | Established |
| 1.01 | The segment note no longer gives revenue by country or the location of long-lived assets | Compliance gap | Low | Financial statements, US GAAP and Regulation S-X | Established |
| 1.02 | The Level 3 royalty obligation gives no figure for its key input, projected Product 1 net revenues | Compliance gap | Low | Financial statements, US GAAP and Regulation S-X | Interpretation |
| 1.03 | The financial statements do not describe the dividend restriction in the term loan, which Item 5 says exists | Compliance gap | Low | Financial statements, US GAAP and Regulation S-X | Interpretation |
| 2.03 | Item 7A gives no prior-year market risk comparison, and its rate-decrease figure does not reflect the [n]% SOFR floor | Compliance gap | Low | Regulation S-K narrative: business, risk factors and MD&A | Interpretation |
| 4.01 | A separation agreement with a 2025 named executive officer is neither filed nor listed as an exhibit | Compliance gap | Low | Cover page, exhibits, XBRL and other disclosures | Interpretation |
| 4.02 | Neither Form 10-K lists the [date] amendment that doubled the share reserve of the inducement plan, which stockholders did not approve | Compliance gap | Low | Cover page, exhibits, XBRL and other disclosures | Established |
| 4.03 | No one signs the Form 10-K as controller or principal accounting officer | Compliance gap | Low | Cover page, exhibits, XBRL and other disclosures | Established |
| 2.04 | Item 1 gives two different dates, and a product count the notes contradict, for the European approval of the Product line 2 devices | Presentation | Low | Regulation S-K narrative: business, risk factors and MD&A | Interpretation |
| 2.05 | The tax-attribute risk factor says the carryforwards expire from 2034, but the tax note says the state losses begin to expire in 2026 | Presentation | Low | Regulation S-K narrative: business, risk factors and MD&A | Established |
| 1.04 | Goodwill sits in one reporting unit while the company has a stockholders' deficit, but the note does not say the unit's carrying amount is negative | Question | Medium | Financial statements, US GAAP and Regulation S-X | Interpretation |
| 1.05 | Shares issued under the incentive plan and ESPP in 2025 exceed the cash shown in financing activities by [n] | Question | Low | Financial statements, US GAAP and Regulation S-X | Interpretation |
| 1.06 | The 2025 restructuring charge is disclosed without the required reconciliation of the restructuring liability | Question | Low | Financial statements, US GAAP and Regulation S-X | Interpretation |
| 1.07 | Income taxes paid: state and local taxes are given as one line | Question | Low | Financial statements, US GAAP and Regulation S-X | Established |
| 1.08 | Segment expense lines were re-cut from last year: stock-based compensation and the royalty revaluation are no longer shown separately | Question | Low | Financial statements, US GAAP and Regulation S-X | Established |
| 1.09 | Research and development credit carryforwards fell sharply; the amounts appear in the rate reconciliation but the reason is not given | Question | Low | Financial statements, US GAAP and Regulation S-X | Established |
| 1.10 | First-year rate reconciliation: an aggregated foreign line above the 5% threshold, a tax-credit line that increases tax, and a valuation-allowance gap | Question | Low | Financial statements, US GAAP and Regulation S-X | Interpretation |
| 1.11 | The effect of exchange rates on cash equals the whole currency translation adjustment in 2022-2024 but not in 2025 | Question | Low | Financial statements, US GAAP and Regulation S-X | Interpretation |
| 1.12 | Revenue said to come from the opening contract-liability balance equals almost all of a balance described mainly as rebates owed to customers | Question | Low | Financial statements, US GAAP and Regulation S-X | Interpretation |
| 1.13 | The current portion of the operating lease liability equals the next year's undiscounted rent at both year-ends | Question | Low | Financial statements, US GAAP and Regulation S-X | Interpretation |
| 1.14 | No remaining performance obligation disclosure, and no statement that the one-year expedient is used | Question | Low | Financial statements, US GAAP and Regulation S-X | Interpretation |
| 1.15 | All payments of the founders' royalty are financing cash flows, although fair-value increases are charged to operating expenses | Question | Low | Financial statements, US GAAP and Regulation S-X | Interpretation |
| 2.06 | The operating cash flow discussion cites a 'higher operating loss' although loss from operations fell, and names its drivers without amounts | Question | Low | Regulation S-K narrative: business, risk factors and MD&A | Interpretation |
| 2.07 | MD&A no longer says when the [amount] term loan falls due, or how it will be met beyond the next twelve months | Question | Low | Regulation S-K narrative: business, risk factors and MD&A | Interpretation |
| 2.08 | The shareholder derivative lawsuit is called ongoing in the risk factors and liquidity discussion but has disappeared from the contingencies note and Item 3 without any statement of how it ended | Question | Low | Regulation S-K narrative: business, risk factors and MD&A | Interpretation |
| 3.01 | Year-end results release: non-GAAP operating expenses exclude a fourth item, beyond the three the company told the SEC staff it would exclude | Question | Low | Auditor's report, ICFR and the SEC filings record | Interpretation |
| 5.01 | Wording slips in the term loans and [counterparty] settlement notes | Drafting | Low | Financial statements, US GAAP and Regulation S-X | Established |
| 5.02 | Wording, acronym and label slips in Item 1 and Item 1A, most carried over from the prior-year Form 10-K | Drafting | Low | Regulation S-K narrative: business, risk factors and MD&A | Established |
| 5.03 | Two end dates for the Founders royalty: 'the quarter after' the tenth anniversary versus the anniversary quarter itself | Drafting | Low | Regulation S-K narrative: business, risk factors and MD&A | Established |
| 5.04 | Exhibit index: the European [supplier 2] agreement carries the wrong year, and the calculation linkbase is not listed | Drafting | Low | Cover page, exhibits, XBRL and other disclosures | Established |