Inogen Inc filed SEC Form 8-K: Regulation FD Disclosure, Other Events, Financial Statements and Exhibits
UNITED STATES
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FORM
CURRENT REPORT
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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).
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Item 7.01 Regulation FD Disclosure.
On December 30, 2024, Inogen, Inc. (the “Company”) issued a press release announcing U.S. Food and Drug Administration (“FDA”) 510(k) clearance of its Simeox 200 device intended to promote airway clearance and to improve bronchial drainage. A copy of the press release is furnished herewith as Exhibit 99.1 to this Current Report on Form 8-K.
The information set forth under this Item 7.01, including Exhibit 99.1, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or incorporated by reference in any filing under the Securities Act of 1933, as amended (the “Securities Act”), or the Exchange Act, except as shall be expressly set forth by specific reference in such a filing.
Item 8.01 Other Events.
On December 30, 2024, the Company announced FDA 510(k) clearance of its Simeox 200 device intended to promote airway clearance and to improve bronchial drainage. Upon FDA 510(k) clearance of the Simeox 200 device, the Company became obligated to make a $13 million cash earnout milestone payment (the “Physio-Assist Milestone Payment”) pursuant to the Share Purchase Agreement, dated July 10, 2023, by and among the Company and Mr. Adrien Mithalal, Mr. Jean-Sébastien Lantz, Mrs. Anne Reiser, CAAP Creation, Societe De Capital Risque Provencale Et Corse, Region Sud Investissement, Mérieux Participations 2, Relyens Innovation Santé and certain holders of exercisable securities identified therein (collectively, the “Sellers”). The Physio-Assist Milestone Payment must be made to the Sellers no later than ten business days following the date of the FDA 510(k) clearance.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
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Description |
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99.1 |
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104 |
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The cover page of this Current Report on Form 8-K, formatted in Inline XBRL. |
SIGNATURES
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 thereunto duly authorized.
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INOGEN, INC. |
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Date: |
December 30, 2024 |
By: |
/s/ Michael Bourque |
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Michael Bourque |