1 unchanged sentence
Evaluation of Disclosure Controls and Procedures
−Removed: Our management, with the participation of our principal executive officer and principal financial officer, evaluated the effectiveness of our disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) as of December 31, 2021, the end of the period covered by this Annual Report on Form 10-K, and has concluded that, based on such evaluation, as of the end of the period covered by this annual report, our disclosure controls and procedures were not effective due to the material weakness described below.
−Removed: However, our management, including our principal executive officer and principal financial officer, has concluded that, notwithstanding the identified material weakness in our internal control over financial reporting, the financial statements in this annual report fairly present, in all material respects, our financial condition, results of operations and cash flows for the periods presented in conformity with U.S.
−Removed: Material Weakness in Internal Controls Over Financial Reporting
−Removed: We identified a material weakness in our internal control over financial reporting that exists as of December 31, 2021.
−Removed: A material weakness is a deficiency, or a combination of deficiencies, in internal control over financial reporting, such that there is a reasonable possibility that a material misstatement of our annual or interim financial statements will not be prevented or detected on a timely basis.
+Added: Our management, with the participation of our principal executive officer and principal financial officer, evaluated the effectiveness of our disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e), as amended) as of December 31, 2022, the end of the period covered by this Annual Report on Form 10-K.
+Added: Based on that evaluation, our principal executive officer and principal financial officer have concluded that, as of the end of the period covered by this annual report, our disclosure controls and procedures were effective at the reasonable assurance level.
+Added: Remediation of Previously Identified Material Weakness in Internal Control Over Financial Reporting
+Added: We previously disclosed a material weakness in our internal control over financial reporting that existed as of December 31, 2021.
We determined that we had a material weakness because we did not design controls to address segregation of duties over the review and approval of account reconciliations and manual journal entries.
There were no misstatements as a result of this material weakness;
−Removed: however, it could result in a misstatement of account balances or disclosures that would result in a material misstatement to the annual or interim financial statements that would not be prevented or detected.
−Removed: Management’s Plan to Remediate the Material Weakness
+Added: however, it could have resulted in a misstatement of account balances or disclosures that would result in a material misstatement to the annual or interim financial statements that would not be prevented or detected.
With the oversight of senior management and our audit committee, we implemented remediation steps in 2021 including hiring additional accounting personnel and implementing improved accounting and financial reporting procedures and controls.
−Removed: While we believe these measures will remediate the material weakness identified and strengthen our internal control over financial reporting, the implemented and enhanced controls have not operated for a sufficient period of time to demonstrate that the material weakness is remediated.
−Removed: As such, our remediation initiatives were not completed within a sufficient timeframe to remediate the material weakness in internal control over financial reporting as of December 31, 2021.
−Removed: We are committed to continuing to improve our internal control processes and will continue to diligently and vigorously review our financial reporting controls and procedures.
+Added: We completed the design, testing and evaluation of new and enhanced internal controls and determined that, as of March 31, 2022, the controls were designed and had operated effectively for a sufficient period of time for our management to conclude that the material weakness had been remediated.
Changes in Internal Control Over Financial Reporting
−Removed: During the quarter ended December 31, 2021, we implemented enhanced controls related to our journal entry and account reconciliation processes.
−Removed: There were no other changes in our internal control over financial reporting that occurred during the quarter that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
+Added: There were no changes in our internal control over financial reporting that occurred during the quarter ended December 31, 2022 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
Management’s Annual Report on Internal Control Over Financial Reporting
−Removed: This annual report does not include a report of management's assessment regarding internal control over financial reporting or an attestation report of the company's registered public accounting firm due to a transition period established by rules of the Securities and Exchange Commission for newly public companies.
+Added: Our management is responsible for establishing and maintaining adequate internal control over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) of the Exchange Act).
+Added: The rules define internal control over financial reporting as a process designed by, or under the supervision of, the Company’s Chief Executive Officer and Chief Financial Officer, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles.
+Added: Internal control over financial reporting is subject to inherent limitations .
+Added: A control system, no matter how well designed and operated, can provide only reasonable, not absolute, assurance that the objectives of the control system will be met.
+Added: Under the supervision and with the participation of our management, including our principal executive officer and principal financial officer, we conducted an assessment of the effectiveness of our internal control over financial reporting based on the framework in Internal Control—Integrated Framework (2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission.
+Added: Based on this assessment, our management concluded that our internal control over financial reporting was effective as of December 31, 2022.
Other Information.
58 unchanged sentences
March 24, 2021
+Added: 10.12 First Amendment to Term Loan Agreement, dated September 24, 2020, by among the Company, the Subsidiary Guarantors from time to time party thereto, the Lenders from time to time party thereto and CRG Servicing LLC
+Added: 10-Q 001-40337 10.1 May 12, 2022
Amendment One to the Supply Agreement, dated December 21, 2020, by and between the Company and Micro Systems Engineering, Inc.
11 unchanged sentences
S-1/A 333-254663 10.23 April 14, 2021
+Added: 10.19 Second Amendment to Office Lease, dated August 22, 2022, by and between the Company and BXP Research Park LP (f/k/a BP MV Research Park LLC).
+Added: 10-Q 001-40337 10.2 November 8, 2022
Officer Severance Benefit Plan.
2 unchanged sentences
S-1/A 333-254663 10.25 April 14, 2021
+Added: 10.22 Amended and Restated Investors’ Rights Agreement, dated August 19, 2020, by and among the Registrant and the investors listed on Exhibit A thereto.
+Added: S-1/A 333-254663 10.1 April 14, 2021
+Added: 10.23** Exclusive Distribution Agreement, dated August 9, 2022, by and between the Company and DIXI Medical USA Corp.
+Added: 10-Q 001-40337 10.3 November 8, 2022
+Added: 10.24 Sales Agreement, dated November 8, 2022, among the registrant and SVB Securities LLC
+Added: S-3 333-268243 1.2 November 8, 2022
Consent of PricewaterhouseCoopers LLP, independent registered public accounting firm.
15 unchanged sentences
Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, and shall not be deemed “filed” by the Registrant for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, and are not to be incorporated by reference into any of the Registrant’s filings under the Securities Act of 1933, as amended, irrespective of any general incorporation language contained in any such filing.
+Added: ** Portions of this exhibit (indicated by [*]) have been omitted because the registrant has determined that the information is both not material and is the type that the registrant treats as private or confidential.
Form 10–K Summary.
24 unchanged sentences
/s/ Renee Ryan Director March 2, 2023
+Added: /s/ Uri Geiger Director March 2, 2023
Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.