– Pure-Vu® System achieved primary endpoint demonstrating safety and
effectiveness, showing statistically significant improvement in bowel
cleanliness
– Adequate bowel preparation rate improved from 38% to 96% following
use of Pure-Vu® System
– Commercial launch of Pure-Vu® GEN2 in the U.S. hospital market on
track for 2019
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, today announced it will
present positive full clinical results from the Company’s REDUCE (“Reliable
Endoscopic Diagnosis
Utilizing Cleansing
Enhancement”) study evaluating the Pure-Vu®
System at Digestive
Disease Week® 2019 (“DDW”).
Vladimir Kushnir, M.D., Division of Gastroenterology, Washington
University, St. Louis, MO, will present the REDUCE study clinical
results poster titled, “Evaluation of Bowel Cleansing Efficacy in
Hospitalized Patient Population Using the Pure-Vu® System” during
the Lower GI 2 session being held today, May 20, 2019 at 12:00 p.m. PDT.
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 adequately prepped.
The analysis from the REDUCE study showed statistically significant
improvement in each colon segment after Pure-Vu® System use. The per
segment BBPS improved from an average baseline of 1.74, 1.74 and 1.5 to
2.89, 2.91 and 2.86, respectively, with a statistically significant p
value of .001 for all three segments of the colon. Inpatients that
received Pure-Vu® System, adequate bowel preparation improved from a
baseline of 38% to 96% in segments evaluated.
“Inadequate bowel preparation affects the quality of a colonoscopy exam
and often leads to canceled, delayed and aborted procedures, resulting
in prolonged hospitalizations and increased costs. The Pure-Vu® System
provides an important innovative solution to address the significant
clinical challenges and inefficiencies associated with inadequate prep
as witnessed with the positive REDUCE study results,” commented Dr.
Kushnir. “I believe the Pure-Vu® System has the potential to improve the
care for this challenging patient population.”
“We are excited about the results from the REDUCE study. The data
further validates that the Pure-Vu® System has the potential to provide
a paradigm shifting solution for patients with insufficient bowel prep,
enabling physicians and hospital administrators to improve patient care
and reduce costs,” commented Tim
Moran, Chief Executive Officer of Motus GI. “We are on track for the
commercial launch of Pure-Vu® GEN2 in 2019. We anticipate the results of
the REDUCE study will be an essential part of driving early adoption in
the market.”
Following the presentation, the poster will be available on Motus GI’s website
in the Pure-Vu®
Publications section. Motus GI also has a booth at DDW located in
the Exhibit Hall at Booth #4315.
About Digestive Disease Week®
Digestive Disease Week® (DDW) is the largest international gathering of
physicians, researchers and academics in the fields of gastroenterology,
hepatology, endoscopy and gastrointestinal surgery. Jointly sponsored by
the American Association for the Study of Liver Diseases (AASLD), the
American Gastroenterological Association (AGA) Institute, the American
Society for Gastrointestinal Endoscopy (ASGE) and the Society for
Surgery of the Alimentary Tract (SSAT), DDW takes place May 18-21, 2019,
at the San Diego Convention Center. The meeting showcases more than
5,000 abstracts and hundreds of lectures on the latest advances in GI
research, medicine and technology. More information can be found at www.ddw.org.
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 commercial
launch focused on the U.S. hospital market 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.
Contacts
Investors:
Jenene Thomas
Jenene
Thomas Communications, LLC
(833) 475-8247
mots@jtcir.com
Media:
Erich
A. Sandoval
Lazar Partners
(917) 497-2867
esandoval@lazarpartners.com
NEW YORK, July 15, 2024 /PRNewswire/ -- The global mindfulness meditation application market size is…
NextStep Arthropedix, a growing orthopedics company, announces the launch of TheRay™ Collared and Collarless Hip System.…
MILWAUKEE, WI / ACCESSWIRE / July 15, 2024 / SPS Health, a leading innovator in…
Record Gross Revenue: Generated $9.4 million in gross revenue, establishing a new company record.Strong International…
MURFREESBORO, TN / ACCESSWIRE / July 15, 2024 / National Health Investors, Inc. (NYSE:NHI) announced…
Established Canadian online pharmacy now partnering with smaller pharmaciesVICTORIA, BC / ACCESSWIRE / July 15,…