– 2018 marked by strengthening of executive
team, expansion of commercial organization, bolstering of clinical
and health economic data, and achievement of important regulatory
milestones –
– REDUCE study per protocol planned interim
analysis showed statistical significance in the first 45 patients
on the primary endpoint of improvement in bowel cleanliness from
baseline –
– Market development activities associated with
salesforce expansion is driving a robust pipeline of potential
customers in support of full commercial launch of the Pure-Vu®
System in the U.S. 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,
today reported its financial results for the full year ended
December 31, 2018 and provided its 2019 business outlook.
“I am pleased with our 2018 accomplishments which reflect
significant and sustained progress in several key areas. Since we
successfully completed our IPO and began trading on NASDAQ in
February 2018, we have attracted key talent in both our executive
and commercial leadership roles, bolstered our rapidly expanding
compendium of clinical and health economic data, and began
execution of our market development program to drive momentum into
the full commercial launch of the Pure-Vu® System,” commented, Tim
Moran, Chief Executive Officer of Motus GI. “The statistically
significant interim data from the REDUCE study conducted in
real-world settings and generating clinical experience with
important thought leaders in our field, solidifies our belief that
our revolutionary Pure-Vu® System technology will not only allow
physicians to improve the time associated with completing a high
quality, successful colonoscopy, but will also provide hospitals
with a potential solution for improving the total cost of
care.”
“From a technology perspective, we are preparing to file a
special 510(k) for the second generation of our Pure-Vu® System,
which has the same cleansing power of the first generation with a
more user-friendly, compact and mobile design. We believe these
enhancements will be important to drive market adoption. We also
believe that the methodical approach we have taken to
commercialization has positioned us for a successful inpatient
market launch of the Pure-Vu® System in 2019. We believe 2019 will
be a landmark year for Motus GI, and I am excited to lead Motus
into our next phase of growth for the Company.”
Recent Corporate Highlights
- Strengthened intellectual property
portfolio with issuance of additional patents related to the
Pure-Vu® System to expand global patent estate to support strategic
pathway for the Pure-Vu® System to become standard of care.
- Announced that its manuscript titled,
“An intra-procedural endoscopic cleansing device for achieving
adequate colon preparation in poorly prepped patients,” was
published in the peer-reviewed Journal of Clinical Gastroenterology
and its manuscript titled, “A novel device for intra-colonoscopy
cleansing of inadequately prepared colonoscopy patients – a
feasibility study,” was published in the peer-reviewed journal,
Endoscopy.
- Successfully closed a follow-on public
offering of 5,750,000 shares of its common stock to help fund
commercialization activities, research and development activities,
including clinical and regulatory development and the continued
development and enhancement of the Pure-Vu® System, and for working
capital and other general corporate purposes. Gross proceeds from
the offering were approximately $15.5 million.
- Received special 510(k) clearance from
the U.S. Food and Drug Administration (FDA) and announced the first
successful clinical cases were completed in late October with the
Company’s Pure-Vu® Slim Sleeve, a compatible extension to the
Pure-Vu® System for slim colonoscopes. The Pure-Vu® Slim Sleeve
further improves ease of use and enables access to the full
colonoscopy market where Motus GI estimates, through consultation
with colonoscope manufacturing companies, approximately 30% of U.S.
procedures are performed with a slim colonoscope and growing. The
Pure-Vu® Slim Sleeve has been designed to be compatible with
smaller diameter and more flexible slim colonoscopes with
additional enhancements to the Company’s low friction lubricious
coating technology to aid in navigation through the colon and has
the same cleansing performance as the standard Pure-Vu® Sleeve and
both versions work with the same Pure-Vu® workstation control
system.
- Presented positive clinical data from a
U.S. prospective invesitagor-initiated clinical study at the
American College of Gastroenterology (ACG) 2018 Annual Meeting
demonstrating safety and effectiveness of the Pure-Vu® System in
patients who had minimal preparation regimens and who were allowed
to consume solid food the day before the procedure. Patients in the
study had an average baseline Boston Bowel Preparation Scale
(BBPS), a validated and widely used measure with a 0 to 9 point
scale, of 3.67±2.86 which was improved to an average of 8.91±0.35
(p value <0.0001) following use of the Pure-Vu® System. The
results were statistically significant and the post-cleansing BBPS
score is meaningfully higher than results generally seen with
standard liquid diet plus purgative-based bowel prep regimens.
Further, the use of the Pure-Vu® System enabled intraprocedural
cleansing of the colon and enabled 100% successful completion of
all colonoscopies performed. This data gives insight into potential
label expansion in the future.
Pure-Vu® System Update
Motus GI plans to submit a Special 510(k) Notice to FDA for the
Second-Generation (“Gen 2”) of the Pure-Vu® System in the first
half of 2019. The Gen 2 Pure-Vu® System has been designed to
improve the mobility and setup logistics of the system and will
retain all the same functionality as the current generation of the
Pure-Vu® System in terms of colon cleansing.
The Company is currently focused on post-approval clinical
trials and market 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. during 2019.
The initial launch will focus on the inpatient colonoscopy market
where challenges with insufficient bowel prep slow diagnosis,
diminish the quality of care, and add significant costs to hospital
systems. 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
Motus GI expects to present data from all patients enrolled in
the REDUCE (Reliable Endoscopic Diagnosis
Utilizing Cleansing Enhancement) study at upcoming GI conferences in
2019. The REDUCE study is a multi-center inpatient prospective
trial designed to evaluate the Pure-Vu® System’s ability to
consistently and reliably cleanse the colon to facilitate a
successful colonoscopy a timely manner in patients who are
indicated for a diagnostic colonoscopy. The primary endpoint of the
study is to determine the Pure-Vu® System’s rate of improved bowel
cleansing level using the BBPS index for all segments examined.
The per protocol planned interim analysis showed statistical
significance in the first 45 patients on the primary endpoint of
improvement in the BBPS for segments of the colon that were
examined. Other key data being collected in the study includes the
proportion of patients who receive a successful colonoscopy for the
intended indication in the first attempt, which correlates to the
quality of the exam as well as hospital length of stay and costs
required for the episode of care.
“The positive interim data from the REDUCE study, along with my
ongoing experience using the Pure-Vu® System in the inpatient
setting gives me confidence that this product can provide an
important solution to the significant number of delayed and
incomplete procedures associated with inpatients,” commented Jason
B. Samarasena MD FACG, Associate Clinical Professor of Medicine,
Division of Gastroenterology School of Medicine, University of
California Irvine. “I truly believe the Pure-Vu® System has the
potential to quicken the time to diagnosis, reduce costs and
improve bed turnover, all of which are important with the current
reimbursement landscape and ultimately will have a transformational
positive impact on patients, physicians and the healthcare
system.”
Over the course of 2019, Motus GI plans to support additional
investigator initiated clinical studies, including EXPEDITE, which
is a planned feasibility study in hospitalized patients. The
EXPEDITE study is designed to assess the Pure-Vu® System’s ability
to minimize the use of conventional bowel preparation regimens in
order to further accelerate the time to a successful colonoscopy in
the inpatient population, as well as investigate other difficult to
prep populations. Faster diagnosis of critical emergent conditions
such as GI bleeding may improve clinical outcomes and potentially
reduce costs and complications.
Near-Term Milestones Expected to Drive Value
- Announce results from the REDUCE study
at major medical GI conferences beginning in Q2 2019;
- Commence investigator-initiated
clinical studies focused on accelerating the time to a successful
inpatient colonoscopy as well as high risk outpatient
populations;
- Secure regulatory approval and launch
Gen 2 of the Pure-Vu® System that offers enhanced features and
superior usability ahead of full commercial launch;
- Continue to expand field-based sales
and clinical resources in key U.S. locations;
- Continue to expand market development
programs to engage hospitals, physician champions and staff through
pilot utilization of the Pure-Vu® System;
- Continue to grow clinical and health
economic awareness through peer-reviewed publications;
- Continue to refine in-servicing and
training programs in preparation for the full commercial
launch;
- Full commercial launch of the Pure-Vu®
System in the U.S. for inpatient colonoscopy in the U.S. in
2019;
- Continue building an extensive
intellectual property portfolio to provide long-term protection for
multiple key aspects of the Pure-Vu® System; and
- Participate in key scientific
conferences over the course of 2019.
Financial Results for the Year Ended December 31,
2018
For the year ended December 31, 2018, Motus GI reported a net
loss of approximately $22.3 million, or a net loss per diluted
share of $1.47, which included a one-time non-cash warrant expense
charge of $3.2 million, compared to a net loss of approximately
$13.2 million or a net loss per diluted share of $1.28 for the year
ended December 31, 2017.
The Company ended the year with cash and cash equivalents, and
short-term investments of approximately $21.1 million.
Motus GI Holdings, Inc. Consolidated Balance
Sheets
(In thousands, except share and per share
amounts)
December 31, 2018 2017
ASSETS
Current
assets
Cash and cash equivalents $ 18,050 $ 6,939 Short-term investments
3,043 — Accounts receivable 5 — Inventory 23 6 Prepaid expenses and
other current assets 930 739 Deferred financing fees
— 602
Total current assets
22,051 8,286 Fixed assets, net 846 783 Other non-current
assets 57 99
Total assets $ 22,954 $ 9,168
LIABILITIES AND SHAREHOLDERS’ EQUITY
Current
liabilities
Accounts payable and accrued expenses $ 2,140 $ 1,733 Other current
liabilities 253 250
Total current liabilities 2,393 1,983 Contingent
royalty obligation 1,953 1,662 Other non-current liabilities
91 —
Total
liabilities 4,437 3,645
Shareholders’
equity
Preferred stock $0.0001 par value;
8,000,000 shares authorized; zero shares issued and outstanding
— —
Preferred Series A stock $0.0001 par
value; 2,000,000 shares authorized; zeroand 1,581,128 shares issued
and outstanding as of December 31, 2018 and December 31, 2017,
respectively
— —
Common stock $0.0001 par value; 50,000,000
shares authorized; 21,440,148 and10,493,233 shares issued and
outstanding as of December 31, 2018 and December 31, 2017,
respectively
2 1 Additional paid-in capital 79,893 44,643 Accumulated deficit
(61,378 ) (39,121 )
Total shareholders’ equity 18,517
5,523
Total liabilities and
shareholders’ equity $ 22,954 $
9,168
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 U.S. FDA
cleared medical device indicated to help facilitate the cleaning of
a poorly prepared colon during the colonoscopy procedure. The
device integrates with standard and slim colonoscopes to enable
safe and rapid cleansing during the procedure while preserving
established 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 incomplete
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 and Facebook.
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 26, 2019, 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.
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Investors and Media:Jenene
ThomasJenene Thomas Communications, LLC(833)
475-8247mots@jtcir.com
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