– Building clinical and health economic
evidence demonstrating potential value of the Pure-Vu® System in
high need patient populations with focus on inpatient colonoscopy
market –
– Initiated enrollment in the REDUCE study,
evaluating the ability of the Pure-Vu® System to facilitate
successful, timely colonoscopy for emergent inpatients –
– Advancing market development programs to
build foundation for expected commercial launch of the Pure-Vu®
System for inpatient colonoscopy in 2019 –
Motus GI Holdings, Inc., (NASDAQ: MOTS) ("Motus GI" or the
"Company"), a medical technology company dedicated to improving
clinical outcomes and enhancing the cost-efficiency of colonoscopy,
announced today its financial results for the quarter ended June
30, 2018 and provided a business update.
“The first half of 2018 was marked with significant progress
toward our primary strategic objective of establishing the Pure-Vu®
System as a new standard of care to streamline and facilitate
inpatient colonoscopy procedures to improve clinical outcomes and
significantly reduce costs for hospitals,” stated Mark Pomeranz,
CEO of Motus GI. “We continue to amass a growing body of clinical
and health economic data while our market development programs are
enabling us to establish strong working relationships with
physician champions and their staff within leading institutions who
are providing vital, real-time clinical feedback which we believe
will help to accelerate adoption of the Pure-Vu® System.”
“We are focused on the continued successful execution and
completion of our clinical studies that can provide important
clinical and health economic evidence of how the Pure-Vu® System
may accelerate the time to colonoscopy, overcome the burden of
insufficient bowel prep, improve diagnosis, avoid repeat preps and
procedures, reduce length of stay and open up much needed hospital
beds to new patients. We are excited to be working with key experts
and clinical centers in the U.S. and Europe and are expanding our
outreach to additional centers during this pre-launch, market
development phase as we prepare for the full commercial launch of
the Pure-Vu® System in 2019. We believe we are well positioned to
achieve key catalysts for the business and create shareholder value
in both the near and long-term,” concluded Mr. Pomeranz.
Recent Corporate Highlights
- Announced the appointment of Jeff
Hutchison as VP of U.S. Sales and Commercial Operations who brings
over 25 years of executive sales leadership and new market
development experience in the medical device industry, having
previously served as Area Vice President of Sales for Medtronic GI
Solutions (NYSE: MDT) and Director of U.S. Sales for BÂRRX Medical.
Mr. Hutchison will be responsible for building Motus GI’s U.S.
sales organization and driving the Company’s pre-launch market
development programs ahead of the planned launch of the Pure-Vu®
System into the inpatient colonoscopy market in 2019.
- Commenced patient enrollment in the
REDUCE (Reliable Endoscopic Diagnosis
Utilizing Cleansing Enhancement) inpatient study designed to
facilitate bowel cleansing in approximately 100 hospitalized
patients who are indicated for a diagnostic colonoscopy procedure.
Motus GI expects to complete the study in the fourth quarter of
2018.
- Presented data from a cost-minimization
analysis simulating the average lifetime costs and incidence of new
colorectal cancer (CRC) comparing colonoscopy using Motus GI’s
Pure-Vu® System versus standard colonoscopy (SC) at Digestive
Disease Week® 2018 (“DDW”). The data presented indicates that the
Pure-Vu® System has the potential to reduce inadequate colon prep
rate for colonoscopy, leading to reduced cost of repeated
colonoscopy procedures due to inadequate prep by approximately 77%
- 82% and lower projected incidence of CRC in average and high-risk
patients.
- Strengthened Intellectual Property
portfolio with issuance of additional patents related to the
Pure-Vu® System to expand global IP portfolio to support strategic
pathway for Pure-Vu® System to become standard of care.
- Appointed Seth A. Gross, MD, FACG,
FASGE, AGAF, to its Medical Advisory Board comprised of leading
experts in the gastroenterology and endoscopy field who actively
work with the Company to advise, develop and execute the clinical
trials and development strategy. Dr. Gross also serves as the
principal investigator in the Company’s REDUCE study.
Pure-Vu® System Update
The Pure-Vu® System, Motus GI’s
flagship, FDA-cleared medical device system, enables physicians to
rapidly cleanse the colon during the colonoscopy procedure to
facilitate improved visualization and enable a quality exam. The
device integrates with standard colonoscopes to enable cleaning
during the procedure while preserving standard procedural workflow
and techniques.
The Company is currently focused on post-approval clinical
trials and marked development programs with leading U.S. hospitals
that are utilizing the Pure-Vu® System on a pilot basis in
preparation for a full commercial launch in the U.S. and select
international markets in 2019 focused on the inpatient colonoscopy
market where challenges with insufficient bowel prep slow
diagnosis, diminish the quality of care, and add significant costs
to the hospitals. Challenges with bowel preparation for inpatient
colonoscopy represent a significant area of unmet need that
directly affects clinical outcomes and increases the cost of care
in a market segment that comprises approximately 1.5 million annual
procedures in the U.S. and approximately 4 million annual
procedures worldwide. Published studies have found that the
inpatient population experiences rates of insufficiently prepped
colons at the time of colonoscopy as high as 55%. This has been
shown to lead directly to significantly longer hospital stays and
other additional costs due to the need for repeated preps, repeated
colonoscopies and additional diagnostic procedures. This is
exemplified in a recently published study from Northwestern
University Hospital System which showed an average hospital stay
extension of two days and cost increase of as much as $8,000 per
patient as a result of challenges associated with bowel
preparation. Motus GI believes that the Pure-Vu® System may improve
quality of care and potentially reduce healthcare costs by reliably
and predictably moving patients through the hospital system to a
successful examination.
Clinical Programs Update
Patient enrollment is underway in the REDUCE study, a
multi-center prospective trial designed to evaluate the Pure-Vu®
System’s ability to consistently and reliably cleanse the colon to
facilitate a successful colonoscopy in a timely manner in patients
who are indicated for an inpatient diagnostic colonoscopy
procedure. The primary endpoint of the study is to determine the
Pure-Vu® System’s rate of improved bowel cleansing level using the
Boston Bowel Preparation Scale (“BBPS”) index, a validated
assessment instrument. Other key data to be collected as part of
the study include the proportion of patients who receive a
successful colonoscopy for the intended indication in the first
attempt and the time to successful colonoscopy compared to current
care algorithms, both key data in evaluating speed and quality of
diagnosis as well as evaluating hospital costs and length of stay.
The Company remains on track to complete the REDUCE study in the
fourth quarter of this year.
Over the course of the remainder of the year, Motus GI plans to
initiate additional clinical studies which will include the
evaluation of inpatients with reduced preparation including lower
GI bleed patients who may benefit from accelerated diagnosis. The
clinical studies in the inpatient settings are designed to evaluate
the Pure-Vu® System’s ability to rapidly cleanse poorly prepped
patients during colonoscopy with BBPS as the measure of
cleanliness, as well as assess its ability to reduce healthcare
costs by reliably and predictably moving patients through the
hospital system to a successful examination.
Near-Term Milestones Expected to Drive Value in 2018 and
Beyond
- Launch slim-scope compatible version of
the Pure-Vu® System;
- Initiate accelerated, reduced
preparation inpatient study with a focus on lower GI bleeding;
- Continue to grow clinical and health
economic awareness through peer reviewed publications;
- Complete the REDUCE inpatient
study;
- Participate in key scientific
conferences in 2018 including United European Gastroenterology
(UEG) Week, the American College of Gastroenterology (ACG) Annual
Meeting, and the New York Society for Gastroenterology (NYSG)
Annual Meeting;
- Continue building an extensive
intellectual property portfolio to provide long-term protection for
multiple key aspects of the Pure-Vu® System;
- Continue to expand market development
programs to engage hospitals, physician champions and staff through
pilot utilization of the Pure-Vu® System;
- Continue to refine in-servicing and
training programs in preparation for the full commercial
launch;
- Finalize development, secure regulatory
approval and launch 2nd generation of the Pure-Vu® System that
offers enhanced features and superior usability ahead of full
commercial launch; and
- Full commercial launch of the Pure-Vu®
System in the U.S. and select international markets for inpatient
colonoscopy in 2019.
Financial Results for the Quarter Ended June 30, 2018
For the quarter ended June 30, 2018, Motus GI reported a net
loss of approximately $4.2 million, or a net loss per diluted share
of $0.27. For the six months ended June 30, 2018, Motus GI reported
a net loss of approximately $11.5 million, or a net loss per
diluted share of $0.80, which included a one-time non-cash warrant
expense charge of $3.2 million.
At June 30, 2018, the Company had cash and cash equivalents, and
short-term investments of approximately $14.9 million.
About Motus GI and the Pure-Vu® System
Motus GI Holdings, Inc. is a medical technology company, with
subsidiaries in the U.S. and Israel, dedicated to improving
clinical outcomes and enhancing the cost-efficiency of colonoscopy.
The Company’s flagship product is the Pure-Vu® System, a 510(k)
U.S. Food and Drug Administration cleared medical device indicated
to help facilitate the cleaning of a poorly prepared colon during
the colonoscopy procedure. The device integrates with standard
colonoscopes to enable cleaning during the procedure while
preserving standard procedural workflow and techniques. The
Pure-Vu® System has received CE mark approval in Europe. The
Pure-Vu® System is currently being introduced on a pilot basis in
the U.S. market, and the Company is planning to initiate a full
commercial launch focused on the inpatient colonoscopy market in
the U.S. and select international markets in 2019. Challenges with
bowel preparation for inpatient colonoscopy represent a significant
area of unmet need that directly affects clinical outcomes and
increases the cost of care in a market segment that comprises
approximately 1.5 million annual procedures in the U.S. and
approximately 4 million annual procedures worldwide. Motus GI
believes the Pure-Vu® System may improve outcomes and lower costs
for hospitals by reducing the time to successful colonoscopy,
minimizing delayed and aborted procedures, and improving the
quality of an exam. In clinical studies to date, the Pure-Vu®
System significantly increased the number of patients with an
adequate cleansing level, according to the Boston Bowel Preparation
Scale Score, a validated assessment instrument.
For more information, visit www.motusgi.com and connect with the
Company on Twitter, LinkedIn, Facebook and Google+.
Motus GI Holdings, Inc. Condensed Consolidated
Balance Sheets (In thousands, except share and per share
amounts) June 30, December
31, 2018 2017 (unaudited) (*)
ASSETS
Current
assets
Cash and cash equivalents $ 5,071 $ 6,939 Short-term investments
9,874 — Accounts receivable 31 5 Inventory 81 6 Prepaid expenses
and other current assets 862 734 Deferred financing fees —
602
Total current assets 15,919 8,286 Fixed
assets, net 825 783 Other long-term assets 86 99
Total assets $ 16,830 $ 9,168
LIABILITIES
AND SHAREHOLDERS’ EQUITY
Current
liabilities
Accounts payable and accrued expenses $ 1,403 $ 1,733 Other current
liabilities 69 250
Total current liabilities
1,472 1,983 Contingent royalty obligation 1,821 1,662 Other
long-term liabilities 66 —
Total
liabilities 3,359 3,645
Shareholders’
equity
Common Stock $0.0001 par value; 50,000,000
shares authorized; 15,645,755 and 10,493,233
shares issued and outstanding as of June 30, 2018 and
December 31, 2017, respectively
2 1
Preferred Series A stock $0.0001 par
value; 2,000,000 shares authorized; 0
and 1,581,128 shares issued and outstanding as of
June 30, 2018 and December 31, 2017,
respectively
— —
Preferred stock $0.0001 par value;
8,000,000 shares authorized; zero sharesissued and outstanding
— — Additional paid-in capital 64,110 44,643 Accumulated deficit
(50,641 ) (39,121 )
Total shareholders’ equity
13,471 5,523
Total liabilities and
shareholders’ equity $ 16,830 $ 9,168
(*) Derived from audited consolidated financial statements
Forward-Looking Statements
This press release contains certain forward-looking statements.
Forward-looking statements are based on the Company's current
expectations and assumptions. The Private Securities Litigation
Reform Act of 1995 provides a safe-harbor for forward-looking
statements. These statements may be identified by the use of
forward-looking expressions, including, but not limited to,
"expect," "anticipate," "intend," "plan," "believe," "estimate,"
"potential," "predict," "project," "should," "would" and similar
expressions and the negatives of those terms, including without
limitation, risks inherent in the development and commercialization
of potential products, uncertainty in the timing and results of
clinical trials or regulatory approvals, maintenance of
intellectual property rights or other risks discussed in the
Company’s Form 10-K filed on March 28, 2018, and its other filings
with the Securities and Exchange Commission. Prospective investors
are cautioned not to place undue reliance on such forward-looking
statements, which speak only as of the date hereof. The Company
undertakes no obligation to publicly update any forward-looking
statement, whether as a result of new information, future events or
otherwise.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20180814005135/en/
Investors and Media:Jenene
Thomas Communications, LLCJenene Thomas,
833-475-8247mots@jtcir.com
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