Item 7.01. Regulation FD.
On April 30, 2021, Motus GI Holdings, Inc. (the “Company”) issued a press
release announcing that the Company has received 510(k) clearance from the U.S.
Food and Drug Administration (“FDA”) for a version of the Pure-Vu System that is
compatible with gastroscopes used during upper gastrointestinal (GI) endoscopy
procedures. A copy of the press release is attached hereto as Exhibit 99.1.
The information in this Current Report on Form 8-K under Item 7.01, including
the information contained in Exhibit 99.1, is being furnished to the Securities
and Exchange Commission, and shall not be deemed to be “filed” for the purposes
of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange
Act”), or otherwise subject to the liabilities of that section, and shall not be
deemed to be incorporated by reference into any filing under the Securities Act
of 1933, as amended, or the Exchange Act, except as shall be expressly set forth
by a specific reference in such filing.
Item 8.01 Other Events.
On April 30, 2021, the Company announced that it has received 510(k) clearance
from the FDA for a version of the Pure-Vu System that is compatible with
gastroscopes used during upper gastrointestinal (GI) endoscopy procedures to
remove blood, blood clots and debris in order to provide a clear field-of-view
for the endoscopist. This proprietary technology is the latest innovation for
the Pure-Vu System platform that is specifically designed to integrate with
therapeutic gastroscopes to enable safe and rapid cleansing during the
procedure, while preserving established procedural workflow and techniques.
Upper GI bleeds occurred in the U.S. at a rate of approximately 400,000 cases
per year in 2019, according to iData Research Inc. The existence of blood and
blood clots in these patients can impair a physician’s view, making it difficult
to identify the bleed source. The Company believes removing adherent blood clots
from the field of view is a significant need in allowing a physician the ability
to identify and treat the bleed source. The mortality rate of this condition can
reach up to approximately 10%, as noted in Thad Wilkins, MD, et al., American
Family Physician (2012).
Item 9.01. Financial Statements and Exhibits.
(d) The following exhibit is furnished with this report:
Exhibit No. Description 99.1 Press Release issued by Motus GI Holdings, Inc., dated April 30, 2021. 1
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