Item 8.01 Other Events.
As previously disclosed, in
In
The Company's independent subject matter experts believe the data summary and rationale provided in response to the FDA requests for additional information confirms that exhaustive extraction methodology used for chemical characterization was valid and therefore addresses the necessary subacute toxicity biocompatibility endpoints for prolonged use (less than 30 days). Therefore, the Company intends to file a timely appeal of this decision to a higher level within the FDA, which places the submission on hold until a decision is made. This process may take up to 60 days from date of the appeal before an FDA decision is reached.
The Company has stated previously that it expected to be commercial ready with the Evo sEEG electrode in the first calendar quarter of 2022 pending FDA clearance. The Company now expects that additional time will be required and will continue to work with the FDA in pursuit of 510(k) clearance.
In addition, the Company is also in negotiations with Zimmer Biomet in order to reach a mutually beneficial outcome regarding previously agreed upon milestone payments.
Forward Looking Statements
This current report may include forward-looking statements within the meaning of
Section 27A of the Securities Act of 1933, as amended, and Section 21E of the
Securities Exchange Act of 1934, as amended. Except for statements of historical
fact, any information contained in this presentation may be a forward-looking
statement that reflects the Company's current views about future events and are
subject to known and unknown risks, uncertainties and other factors that may
cause its actual results, levels of activity, performance or achievements to be
materially different from the information expressed or implied by these
forward-looking statements. In some cases, you can identify forward-looking
statements by the words or phrases "may," "might," "will," "could," "would,"
"should," "expect," "intend," "plan," "objective," "anticipate," "believe,"
"estimate," "predict," "project," "potential," "target," "seek," "contemplate,"
"continue, "focused on," "committed to" and "ongoing," or the negative of these
terms, or other comparable terminology intended to identify statements about the
future. Forward-looking statements may include statements regarding the
Company's appeal to the FDA regarding its recent decision on the Company's
510(k) clearance, the Company's ability to obtain 510(k) clearance, and the
potential receipt of milestone payments from Zimmer Biomet. Although the Company
believes that it has a reasonable basis for each forward-looking statement, we
caution you that these statements are based on a combination of facts and
factors currently known by it and its expectations of the future, about which
the Company cannot be certain. The Company's actual future results may be
materially different from what it expects due to factors largely outside its
control, including risks related to changes in regulatory requirements or
decisions of regulatory authorities; risks that it may not receive regulatory
clearance for prolonged (less than 30 days) use; risks that it may not reach a
mutually beneficial agreement with Zimmer Biomet regarding potential milestone
payments; risk it may not have accurately estimated the size and growth
potential of the markets for its technology; and other risks and uncertainties
related to market and other conditions, the impact of general economic, industry
or political conditions in
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