Item 7.01 Regulation FD Disclosure.
On July 13, 2022, Apollo Endosurgery, Inc. (the "Company") issued a press
release announcing the marketing authorization of the Apollo ESGTM, Apollo ESG
SxTM, Apollo REVISETM and Apollo REVISE SxTM Systems through the U.S. Food and
Drug Administration's ("FDA") De Novo Classification process, which press
release is attached as Exhibit 99.1 to this report.
The press release attached to this report as Exhibit 99.1 is furnished and shall
not be deemed "filed" for purposes of Section 18 of the Securities Exchange Act
of 1934, as amended, or subject to the liabilities of that section. The
information contained in the press release attached to this report as Exhibit
99.1 shall not be deemed incorporated by reference into any other filing with
the Securities and Exchange Commission (the "SEC") made by the Company, whether
made before or after the date hereof, regardless of any general incorporation
language in such filing.
Item 8.01 Other Events.
On July 13, 2022, the Company announced the marketing authorization of the
Apollo ESGTM, Apollo ESG SxTM, Apollo REVISETM and Apollo REVISE SxTM Systems
through the FDA's De Novo Classification process. In a randomized controlled
trial, the ESG procedure demonstrated safety and effectiveness with durability
out to two years. The Apollo ESG and Apollo ESG Sx Systems are intended to be
used by trained gastroenterologists or surgeons to facilitate weight loss in
adults with obesity with Body Mass Index (BMI) between 30-50 kg/m2 who have not
been able to lose weight or maintain weight loss through more conservative
measures. The Apollo REVISE and Apollo REVISE Sx Systems are intended to be used
by trained gastroenterologists or surgeons that perform bariatric procedures to
facilitate weight loss in adult patients with obesity with BMI between 30-50
kg/m2 by enabling transoral outlet reduction (TORe) as a revision to a previous
bariatric procedure.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
Exhibit No. Description of Document
Press release, issued by Apollo Endosurgery, Inc., dated July 13 ,
99.1 2022.
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