Motus GI Announces Publication of Pure-Vu® System Clinical Study Data in Peer-Reviewed Journal of Clinical Gastroenterology
– Pure-Vu® System found to be simple, safe and effective in cleansing
inadequately prepared colons during a colonoscopy achieving a 98%
success rate in patients that had minimal bowel preparation –
– Data supports potential of Pure-Vu® System to improve clinical
outcomes while reducing costs and complications associated with
conventional purgative-based bowel preps in a market encompassing over
30 million annual procedures worldwide –
FORT LAUDERDALE, Fla.–(BUSINESS WIRE)–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 that its
manuscript titled, “An
intra-procedural endoscopic cleansing device for achieving adequate
colon preparation in poorly prepped patients,” has been
published in the peer-reviewed Journal
of Clinical Gastroenterology.
The Company’s flagship product, the
Pure-Vu® System, is 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
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. and select international markets in 2019.
Feasibility Study Data Highlights
-
The Pure-Vu® System significantly increased the number of subjects
with an adequate cleansing level (BBPS >= 2 for all 3 colon segments)
from 31% (15/49) at baseline to 98% (48/49) after use of Pure-Vu
(P
“We are very pleased with the data from this multi-center clinical study
and delighted it has been selected for publication in the prestigious Journal
of Clinical Gastroenterology. The Pure-Vu® System has consistently
shown its ability to improve clinical outcomes while reducing the
dependency on conventional purgative-based bowel preps. The data also
further supports our confidence in the Pure-Vu® System’s ability to
successfully cleanse the colon and reduce the number of failed and
repeat procedures. It will continue to be an important focus for us to
generate clinical and health economic data that we believe will help
drive adoption when we officially launch later this year,” commented Tim
Moran, Chief Executive Officer of Motus GI.
The published manuscript includes data from the Company’s multicenter
feasibility study of the Pure-Vu® System, which enrolled a total of 50
patients with poorly prepared colons undergoing colonoscopy to evaluate
the Pure-Vu® System at 2 clinical sites in Spain and Israel. Javier
Pérez-Jimenez, M.D., Medical Director of San Rafael Hospital in Cadiz,
Spain was the primary investigator in the study.
“The clinical data from this study demonstrating Pure-Vu® System’s
safety and effectiveness in cleansing poorly prepared colons combined
with the physician and patient reported outcomes were very encouraging
and we’re pleased to have it published in the Journal of Clinical
Gastroenterology,” said Dr. Pérez-Jimenez. “The Pure-Vu® System has
the potential to play a key role in enhancing the colonoscopy
procedure’s effectiveness in multiple patient populations. The ability
to improve the patient’s experience and the overall quality of the exam
is an area of great importance as inadequate preparation can lead to
increased rates of missed lesions, earlier repeat procedures, prolonged
colonoscopy duration, reduced patient satisfaction and increased costs.”
In this study, the Pure-Vu® System was used in subjects with a partially
prepared colon after a spilt dose of two tablets of 5mg Bisacodyl /
Laxadin (DulcolaxR) diet restrictions (no dried fruit, seeds
or nuts) starting 2 days before the procedure and a 24- or 18-hour clear
liquid diet prior to the colonoscopy. At Days 2 and 14 post procedure a
telephone follow-up was conducted to assess patient well-being and
capture any adverse events. The endpoints of the study were safety,
improvement of colon cleansing level as per the Boston Bowel Preparation
Scoring (“BBPS”) when comparing before and after Pure-Vu® System use,
Pure-Vu® System usability via questionnaire and patients’ satisfaction
via questionnaire.
Patients with an adequate cleansing level (BBPS ≥ 2 in each colon
segment) increased significantly from 31% (15/49) at baseline to 98%
(48/49) after use of Pure-Vu (P
The Pure-Vu® System was found to be safe, efficacious, and easy to use
in cleansing inadequately prepared colons, enabling the endoscopist to
conduct a complete examination. No serious adverse events were reported.
About the Journal
Journal of Clinical Gastroenterology gathers the world’s latest,
most relevant clinical studies and reviews, case reports, and technical
expertise in a single source. Regular features include cutting-edge,
peer-reviewed articles and clinical reviews that put the latest research
and development into the context of your practice. Also included are
biographies, focused organ reviews, practice management, and therapeutic
recommendations. The Journal of Clinical Gastroenterology is
published in the Lippincott portfolio by Wolters Kluwer.
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 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.
Contacts
Investor and Media Contact:
Jenene
Thomas
Jenene Thomas Communications, LLC
(833) 475-8247
mots@jtcir.com