Item 7.01 Regulation FD Disclosure.
On January 19, 2023, Surmodics, Inc. (the “Company”) issued a press release (the
“Press Release”) disclosing communications that the Company received from the
U.S. Food and Drug Administration related to the Company’s application for
premarket approval of the SurVeil™ drug-coated balloon. A copy of the full text
of the Press Release is furnished as Exhibit 99.1 to this report.
The information in this Item 7.01, including Exhibit 99.1, shall not be deemed
to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934,
as amended (the “Exchange Act”), or otherwise subject to liabilities under
Section 18, nor shall such information be deemed incorporated by reference into
any filings of the Company under the Securities Act of 1933, as amended, or the
Exchange Act.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits. Exhibit Number Description 99.1 Press Release dated January 19, 2023 104 Cover Page Interactive Data File (embedded within the Inline XBRL document)
——————————————————————————–
© Edgar Online, source Glimpses