Legal & controls
Item 3 and Item 9A as filed · every verdict is the registrant’s own sentence, printed below it · a filing that fails an extraction gate reads “not extracted”
| Fiscal year | Filed | Item 3 | ICFR | disclosure controls | material weakness | Filing |
|---|---|---|---|---|---|---|
| 2025-12-31 | 2026-04-15 | described here | NOT effective | NOT effective | disclosed | EDGAR |
Item 3 · From time to time, we may be involved in certain claims and litigation arising out of the ordinary course and conduct of business. Management assesses such claims and, if it considers that it is probable that an asset had been impaired or a liability had been incurred and the amount of loss can be reasonably estimated, provisions for loss are made based on management’s assessment of the most likely outcome. Protrade Proceeding On February 26, 2021, Protrade Systems, Inc. (“Protrade”) filed a Request for Arbitration (the “Request”) with the International Court of Arbitration (the “ICA”) of the International Chamber of Commerce alleging the Company is in breach of an Exclusive Distribution Agreement dated March 7, 2019 (the “Agreement”) between Protrade and the Company. Protrade alleges, in part, that the Company has breached the Agreement by discontinuing the manufacture of the DV0057 Painshield MD device in favor of an updated 10-100-001 Painshield MD device. Protrade claims damages estimated at $3 million. The Company vigorously defended the claims asserted by Protrade. On March 15, 2022, the arbitrator issued a final award, which, determined that (i) the Company had the right to… Item 9A · ICFR · Based on this evaluation, our management, including the Chief Executive Officer and Chief Financial Officer, has concluded that our internal control over financial reporting was ineffective as of December 31, 2025, as a result of the material weakness described below. Item 9A · disclosure controls · Our management including the Chief Executive Officer and Chief Financial Officer has determined that, as of December 31, 2025, the Company’s disclosure controls and procedures are ineffective and has concluded the consolidated financial statements for the periods covered by and included in this Annual Report fairly present, in all material respects, our financial position, results of operations and cash flows for the periods presented in conformity with U.S. Item 9A · material weakness · A significant deficiency is a deficiency, or a combination of deficiencies, in internal control over financial reporting that is less severe than a material weakness, yet important enough to merit the attention by those responsible for oversight of the company’s financial reporting. | ||||||
| 2024-12-31 | 2025-03-31 | described here | not extracted | not extracted | disclosed | EDGAR |
Item 3 · From time to time, we may be involved in certain claims and litigation arising out of the ordinary course and conduct of business. Management assesses such claims and, if it considers that it is probable that an asset had been impaired or a liability had been incurred and the amount of loss can be reasonably estimated, provisions for loss are made based on management’s assessment of the most likely outcome. Protrade Proceeding On February 26, 2021, Protrade Systems, Inc. (“Protrade”) filed a Request for Arbitration (the “Request”) with the International Court of Arbitration (the “ICA”) of the International Chamber of Commerce alleging the Company is in breach of an Exclusive Distribution Agreement dated March 7, 2019 (the “Agreement”) between Protrade and the Company. Protrade alleges, in part, that the Company has breached the Agreement by discontinuing the manufacture of the DV0057 Painshield MD device in favor of an updated 10-100-001 Painshield MD device. Protrade claims damages estimated at $3 million. The Company vigorously defended the claims asserted by Protrade. On March 15, 2022, the arbitrator issued a final award, which, determined that (i) the Company had the right to… Item 9A · ICFR · Based on this evaluation, our management, including the Chief Executive Officer and Chief Financial Officer, has concluded that our internal control over financial reporting was effective as of December 31, 2024, as a result of the material weakness described below. Item 9A · disclosure controls · Our management including the Chief Executive Officer and Chief Financial Officer has determined that, as of December 31, 2024, the Company’s disclosure controls and procedures are effective and has concluded the consolidated financial statements for the periods covered by and included in this Annual Report fairly present, in all material respects, our financial position, results of operations and cash flows for the periods presented in conformity with U.S. Item 9A · material weakness · A significant deficiency is a deficiency, or a combination of deficiencies, in internal control over financial reporting that is less severe than a material weakness, yet important enough to merit the attention by those responsible for oversight of the company’s financial reporting. | ||||||
| 2023-12-31 | 2024-04-08 | described here | NOT effective | NOT effective | disclosed | EDGAR |
Item 3 · From time to time, we may be involved in certain claims and litigation arising out of the ordinary course and conduct of business. Management assesses such claims and, if it considers that it is probable that an asset had been impaired or a liability had been incurred and the amount of loss can be reasonably estimated, provisions for loss are made based on management’s assessment of the most likely outcome. Protrade Proceeding On February 26, 2021, Protrade Systems, Inc. (“Protrade”) filed a Request for Arbitration (the “Request”) with the International Court of Arbitration (the “ICA”) of the International Chamber of Commerce alleging the Company is in breach of an Exclusive Distribution Agreement dated March 7, 2019 (the “Agreement”) between Protrade and the Company. Protrade alleges, in part, that the Company has breached the Agreement by discontinuing the manufacture of the DV0057 Painshield MD device in favor of an updated 10-100-001 Painshield MD device. Protrade claims damages estimated at $3 million. The Company vigorously defended the claims asserted by Protrade. On March 15, 2022, the arbitrator issued a final award, which, determined that (i) the Company had the right to… Item 9A · ICFR · Based on this evaluation, our management, including the Chief Executive Officer and Chief Financial Officer, has concluded that our internal control over financial reporting was not effective as of December 31, 2023, as a result of the material weakness described below. Item 9A · disclosure controls · Our management including the Chief Executive Officer and Chief Financial Officer has determined that, as of December 31, 2023, the Company’s disclosure controls and procedures are not effective due to the material weaknesses described below and has concluded that, notwithstanding the material weaknesses in our internal control over financial reporting, the consolidated financial statements for the periods covered by and included in this Annual Report fairly present, in all material respects, our financial position, results of operations and cash flows for the periods presented in conformity with U.S. Item 9A · material weakness · A significant deficiency is a deficiency, or a combination of deficiencies, in internal control over financial reporting that is less severe than a material weakness, yet important enough to merit the attention by those responsible for oversight of the company’s financial reporting. | ||||||
| 2022-12-31 | 2023-04-17 | in the notes | NOT effective | NOT effective | disclosed | EDGAR |
Item 3 · From time to time, we may be involved in certain claims and litigation arising out of the ordinary course and conduct of business. Management assesses such claims and, if it considers that it is probable that an asset had been impaired or a liability had been incurred and the amount of loss can be reasonably estimated, provisions for loss are made based on management’s assessment of the most likely outcome. See “Item 8. Financial Statements and Supplementary Data – Note 12. Commitments and Contingencies,” which information is incorporated herein by reference, for a description of pending and recent litigation. Protrade Proceeding On February 26, 2021, Protrade Systems, Inc. (“Protrade”) filed a Request for Arbitration (the “Request”) with the International Court of Arbitration (the “ICA”) of the International Chamber of Commerce alleging the Company is in breach of an Exclusive Distribution Agreement dated March 7, 2019 (the “Agreement”) between Protrade and the Company. Protrade alleges, in part, that the Company has breached the Agreement by discontinuing the manufacture of the DV0057 Painshield MD device in favor of an updated 10-100-001 Painshield MD device. Protrade claims dam… Item 9A · ICFR · Based on this evaluation, our management, including the Chief Executive Officer and Chief Financial Officer, has concluded that our internal control over financial reporting was not effective as of December 31, 2022, as the result of the material weaknesses described below. Item 9A · disclosure controls · Our management including the Chief Executive Officer and Chief Financial Officer has determined that, as of December 31, 2022, the Company’s disclosure controls and procedures are not effective due to the material weaknesses described below. Item 9A · material weakness · A significant deficiency is a deficiency, or a combination of deficiencies, in internal control over financial reporting that is less severe than a material weakness, yet important enough to merit the attention by those responsible for oversight of the company’s financial reporting. | ||||||
| 2021-12-31 | 2022-04-15 | in the notes | NOT effective | NOT effective | remediated (prior year) | EDGAR |
Item 3 · From time to time, we may be involved in certain claims and litigation arising out of the ordinary course and conduct of business. Management assesses such claims and, if it considers that it is probable that an asset had been impaired or a liability had been incurred and the amount of loss can be reasonably estimated, provisions for loss are made based on management’s assessment of the most likely outcome. See “Item 8. Financial Statements and Supplementary Data – Note 12. Commitments and Contingencies,” which information is incorporated herein by reference, for a description of pending and recent litigation. On February 26, 2021, Protrade Systems, Inc. (“Protrade”) filed a Request for Arbitration (the “Request”) with the International Court of Arbitration (the “ICA”) of the International Chamber of Commerce alleging the Company is in breach of an Exclusive Distribution Agreement dated March 7, 2019 (the “Agreement”) between Protrade and the Company. Protrade alleges, in part, that the Company has breached the Agreement by discontinuing the manufacture of the DV0057 Painshield MD device in favor of an updated 10-100-001 Painshield MD device. Protrade claims damages estimated at $3… Item 9A · ICFR · Based on this evaluation, our management, including the Chief Executive Officer and Chief Financial Officer, has concluded that our internal control over financial reporting was not effective as of December 31, 2021, as the result of the material weaknesses described above. Item 9A · disclosure controls · Our management including the Chief Executive Officer and Chief Financial Officer has determined that, as of December 31, 2021, the Company’s disclosure controls and procedures are not effective due to a lack of a full and complete testing plan of the Company’s disclosure controls and procedures. Item 9A · material weakness · In previously filed 10-K’s, we disclosed material weaknesses related to the design and effectiveness of our internal control over financial reporting. | ||||||
5 of 5 annual reports on record have their filing text cached on this host; the rest are listed with their EDGAR link and no extraction, because this surface never fetches from SEC on a page load.
- Item 3 and Item 9A are located in the filing HTML already cached on this host and read with the same line-anchored item matcher and largest-gap body disambiguation the filing-narrative pass uses for Item 1A and Item 7 — no fetch, no model, no summarization.
- A heading is accepted as a section only when it is not a table-of-contents row (a trailing page number), not a quoted reference in prose, and names its own section; the span must then clear a per-item length band and carry readable text after the heading. Anything that fails a gate is served as 'not extracted' with the reason — never as a default value.
- An effectiveness conclusion is read only from a sentence that names its own control set (disclosure controls and procedures, or internal control over financial reporting) and states an outcome. Conditional sentences — the standard limitations paragraph and forward-looking remediation language — are excluded, because they are hypotheses rather than conclusions.
- When a filing's own sentences disagree — an effective conclusion beside an unremediated material-weakness disclosure, or two conclusions of opposite sign — no verdict is asserted. A wrong 'controls were effective' reading is worse than no reading.
- Every verdict is shown beside the verbatim sentence it was read from. The excerpt is the filing's own words, capped at 1,200 characters; the filing itself is one link away.