Item 7.01 Regulation FD Disclosure
On January 18, 2023, LivaNova PLC (the "Company") learned that the independent
Statistical Analysis Committee advised that trial enrollment in the Company's
RECOVER difficult-to-treat depression trial should continue on from 425 to 450
unipolar patients, in line with the protocol. As has been previously discussed,
the study was designed with frequent interim analyses, which occur every 25
patients. The interim analysis assesses if predictive probability of success has
been reached for the unipolar cohort of the study, at which point the randomized
controlled trial enrollment will cease and future patients will be enrolled into
the prospective open label longitudinal study for that cohort. After the last
patient enrolled into the RCT has completed 12 months of follow-up, a final
analysis will be conducted on the complete dataset for that respective cohort.
The trial, if successful, will be used to support a peer-reviewed article and
reconsideration of reimbursement for VNS Therapy™ by the U.S. Centers for
Medicare & Medicaid Services for the treatment of depression that is difficult
to treat.
The information furnished pursuant to this Current Report on Form 8-K shall not
be considered "filed" for purposes of Section 18 of the Securities Exchange Act
of 1934, as amended, or otherwise subject to the liabilities of that section,
nor shall it be incorporated by reference into any filing by the Company under
the Securities Act of 1933, as amended, or under the Securities Exchange Act of
1934, as amended, unless the Company expressly sets forthh by specific reference
in such filing that such information is to be considered "filed" or incorporated
by reference therein.
Item 9.01 Financial Statements and Exhibits
(d) Exhibits.
Exhibit Description
104 Cover Page Interactive Data File (embedded within the Inline XBRL document)
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