UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): November 1, 2024
LivaNova PLC
(Exact Name of Registrant as Specified in its Charter)
| (State or Other Jurisdiction of Incorporation) | (Commission File Number) | (IRS Employer Identification No.) | ||||||||||||
(Address of Principal Executive Offices)
+44 20 33250660
(Registrant’s Telephone Number, Including Area Code)
N/A
(Former Name or Former Address, if Changed Since Last Report)
Check the appropriate box below if the Form 8-K is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instructions A.2. below):
Securities registered pursuant to Section 12(b) of the Act:
| Title of each class | Trading Symbol(s) | Name on each exchange on which registered | ||||||
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
| Emerging growth company | ||||||||
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.
| ☐ | ||||||||
Item 7.01 Regulation FD Disclosure.
On November 1, 2024, the U.S. Centers for Medicare and Medicaid Services (CMS) announced that it is maintaining VNS Therapy™ for drug-resistant epilepsy (DRE) at the Level 5 Neurostimulator and Related Procedures Ambulatory Payment Classification (APC) under the 2025 Medicare Hospital Outpatient Prospective Payment System. While the Company is disappointed by this decision, it does not believe that this decision will impact the business. LivaNova will continue to pursue reimbursement opportunities for VNS Therapy for DRE.
Item 9.01 Financial Statements and Exhibits
(d) Exhibits.
| Exhibit | Description | |||||||
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) | |||||||
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| LivaNova PLC | |||||
| Date: November 1, 2024 | By: /s/ Michael Hutchinson | ||||
| Name: Michael Hutchinson | |||||
| Title: SVP, Company Secretary & Chief Legal Officer | |||||