Item 7.01. Regulation FD.
On June 3, 2021, Motus GI Holdings, Inc. (the “Company”) issued a press release
announcing the publication of data from the Company’s REDUCE (“Reliable
Endoscopic Diagnosis Utilizing Cleansing Enhancement”) study in an article
titled, “A multicenter, prospective, inpatient feasibility study to evaluate the
use of an intra-colonoscopy cleansing device to optimize colon preparation in
hospitalized patients: the REDUCE study” in the peer-reviewed journal BMC
Gastroenterology. A copy of the press release is attached hereto as Exhibit
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 June 3, 2021, the Company announced the publication of data from the
Company’s REDUCE (“Reliable Endoscopic Diagnosis Utilizing Cleansing
Enhancement”) study in an article (the “Article”) titled, “A multicenter,
prospective, inpatient feasibility study to evaluate the use of an
intra-colonoscopy cleansing device to optimize colon preparation in hospitalized
patients: the REDUCE study” in the peer-reviewed journal BMC Gastroenterology.
The Company noted evaluations of the data from its REDUCE study continue to
support the Company’s belief that the Pure-Vu System can improve bowel
preparation quality in hospitalized subjects undergoing colonoscopy. The Company
believes the Article will assist with educating the market on the potential for
the Pure-Vu System to enhance patient care while also lowering costs for
hospitals and payers.
The Article suggests clarity of last bowel movement may be a useful indicator in
predicting poor bowel preparation. However, larger studies powered to evaluate
clinical outcomes, hospital costs, and blinded BBPS assessments are required to
evaluate the significance of these findings.
The Article covers clinical data from the REDUCE study. The REDUCE study was a
multi-center inpatient prospective trial designed to evaluate Pure-Vu® System’s
ability to consistently and reliably improve bowel preparation to facilitate a
successful colonoscopy in a timely manner in patients who were indicated for a
diagnostic colonoscopy. The study enrolled 95 hospitalized patients on schedule
regardless of their level of pre-procedural bowel preparation. The primary
endpoint for the study was improvement of bowel preparation from baseline to
post procedure as assessed by the Boston Bowel Preparation Scale (“BBPS”), which
assesses the cleanliness of each of the three segments of the colon on a 0 to 3
scale and requires a minimum score of 2 or better per segment to be considered
Topline data from the REDUCE study evaluating the Pure-Vu® System was first
announced in May 2019 at Digestive Disease Week® 2019 (“DDW”).
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 June 3, 2021. 1
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