Current Report Filing (8-k)
May 07 2021 - 7:37AM
Edgar (US Regulatory)
UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
8-K
CURRENT
REPORT
Pursuant
to Section 13 or 15(d) of
The
Securities Exchange Act of 1934
Date
of Report (Date of earliest event reported): May 7, 2021
MOTUS
GI HOLDINGS, INC.
(Exact
name of registrant as specified in its charter)
Delaware
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001-38389
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81-4042793
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(State or other jurisdiction
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(Commission File Number)
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(IRS Employer
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of incorporation)
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Identification No.)
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1301
East Broward Boulevard, 3rd Floor
Ft.
Lauderdale, FL
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33301
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(Address of principal
executive offices)
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(Zip Code)
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Registrant’s
telephone number, including area code: (954) 541-8000
Not Applicable
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(Former name or former
address, if changed since last report.)
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Check
the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under
any of the following provisions (see General Instruction A.2. below):
☐
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Written communication pursuant to Rule 425 under the
Securities Act (17 CFR 230.425)
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☐
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Soliciting material pursuant to Rule 14a-12 under the
Exchange Act (17 CFR 240.14a-12)
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☐
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Pre-commencement communication pursuant to Rule 14d-2(b)
under the Exchange Act (17 CFR 240.14d-2(b))
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☐
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Pre-commencement communication pursuant to Rule 13e-4(c)
under the Exchange Act (17 CFR 240.13e-4(c))
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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 (17 CFR §230.405)
or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR §240.12b-2).
Emerging
growth company ☒
If
an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying
with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☒
Securities
registered pursuant to Section 12(b) of the Act:
Title
of Each Class
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Trading
Symbol(s)
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Name
of Each Exchanged on Which Registered
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Common Stock, $0.0001 par
value per share
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MOTS
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The Nasdaq Capital Market
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Item
7.01. Regulation FD.
On
May 7, 2021, Motus GI Holdings, Inc. (the “Company”) issued a press release announcing the Publication of a Sponsored Pure-Vu
System® Cost Effectiveness Analysis in the Journal of Cost Effectiveness and Resource Allocation. 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
May 7, 2021, the Company announced the publication of a sponsored Pure-Vu System® Cost Effectiveness Analysis in the Journal of Cost
Effectiveness and Resource Allocation, which is titled, “Colonoscopy in poorly prepped colons. A cost effectiveness analysis
comparing standard of care to a new cleansing technology.” Sponsorship of analysis and development of the manuscript was provided
by the Company.
The
publication presents new data from a cost effectiveness and resource allocation analysis of the Pure-Vu System® on the outcomes of
cost, quality of life, and aversion of colorectal cancers (CRC), as compared to the current standard of care (SOC) for outpatient colonoscopy.
The publication suggests use of the Pure-Vu System has the potential to provide the U.S. healthcare system lifetime savings of approximately
$833-$992 per patient depending on the insurer compared to the current standard of care for outpatient CRC screening and surveillance
colonoscopy.
The
publication estimates approximately 3.75 million patients present as inadequately prepared for colonoscopies per year, as calculated
based on an estimated 15 million colonoscopies performed annually in the U.S. (according to the 2012 Survey of Endoscopic Capacity (SECAP)),
and an estimated 25% of patients presenting as inadequately prepared for colonoscopies (as reported in a poster presented at the 2011
British Society of Gastroenterology Annual General Meeting; March 14–17, 2011; Birmingham, UK).
The
publication also suggests that, assuming a national average compliance rate for colonoscopy in the U.S. at 60%, as reported by the American
Cancer Society in 2017, the implementation of the Pure-Vu System may generate significant savings for the U.S. healthcare system and
the estimated 3.75 million inadequately prepped patients per year, while potentially reducing the incidence of colorectal cancers as
a result of early detection and ensuring a similar or improved quality of life for patients.
The
objective of the Markov Model lifetime cost-effectiveness analysis was to evaluate the Pure-Vu System and its ability to minimize repeat
colonoscopies on the outcomes of cost, quality of life, and aversion of CRC screening. Researchers evaluated the Pure-Vu® System
using TreeAge 2019 software in patients who presented with inadequate prep in outpatient settings in the U.S. Pure-Vu was compared to
the SOC for outpatient colonoscopy. Peer reviewed literature was used to identify the CRC incidence of cancers based on missing polyps.
Costs for procedures were derived from 2019 Medicare records and from estimated private payer reimbursements. Base case costs, sensitivity
analysis and incremental cost effectiveness (ICE) were evaluated. The analysis results suggest that, assuming a national average compliance
rate of 60% for colonoscopy, as reported by the American Cancer Society in 2017, the use of the Pure-Vu System has the potential to provide
the healthcare system lifetime savings of approximately $833-$992 per patient depending upon the insurer when compared to SOC for outpatient
colonoscopy. The analysis results also suggest that, quality of life may be improved with the Pure-Vu System mainly due to a lower incidence
of CRCs due to early detection. In the sensitivity analysis, SOC becomes less expensive than Pure-Vu when compliance to screening for
CRC using colonoscopy is ≤28% or the cost of Pure-Vu exceeded $1,753. In incremental cost effectiveness analysis, the Pure-Vu System
improved over the SOC.
Item
9.01. Financial Statements and Exhibits.
(d)
The following exhibit is furnished with this report:
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 hereunto duly authorized.
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MOTUS GI HOLDINGS, INC.
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Dated: May 7, 2021
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By:
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/s/ Timothy
P. Moran
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Name:
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Timothy P. Moran
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Title:
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Chief Executive Officer
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2
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