Motus GI Receives CE Mark Approval for the Pure-Vu® System
February 27 2018 - 7:30AM
Business Wire
– Pure-Vu System has potential 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
– European regulatory approval bolsters
commercialization strategy to expand into Europe in 2019
Motus GI Holdings, Inc., (NASDAQ:
MOTS) ("Motus" or the "Company"), a medical technology company
dedicated to improving endoscopy outcomes and experiences,
announced today that it has received European CE mark approval for
its flagship product, the Pure-Vu® System. The Pure-Vu System works
with standard colonoscopes to help facilitate the cleaning of
poorly prepped colons during the colonoscopy procedure, while
preserving standard procedural workflow and techniques. The Pure-Vu
System has previously received 510(k) clearance from the U.S. Food
and Drug Administration ("FDA") and is currently being introduced
on a pilot basis in the U.S.
“Receiving CE mark approval for the Pure-Vu System is a notable
achievement as we work to expand the awareness of the benefits of
the Pure-Vu System in key European markets over the next 24 months.
CE mark approval enables us to continue to work with expert
clinical thought leaders in Europe and begin to lay the foundation
for future commercial expansion into Europe,” said Mark Pomeranz,
CEO of Motus. “We believe the Pure-Vu System has the potential to
improve clinical outcomes while significantly reducing costs,
particularly in our initial target market of difficult-to-prep
in-patient colonoscopy. While there are 30 million colonoscopy
procedures performed annually worldwide, nearly 4 million of these
procedures are performed for in-patients where reliance on
conventional purgative-based bowel preps remains a serious
challenge and leads to delayed diagnoses, extended hospital stays,
and other increased costs due to repeat procedures and
readmissions.”
Peter D. Siersema, MD, PhD, Professor of Endoscopic
Gastrointestinal Oncology at the Radboud University Medical Center,
Nijmegen, The Netherlands, and Medical Advisor of Motus, commented,
“I believe the Pure-Vu System has tremendous potential to provide
physicians with an easy-to-use device that enables a quality exam
for patients, especially those who experience difficulty with the
prep, and may minimize the possibility of a repeat procedure. The
Pure-Vu System has the potential to make a real difference for
patients undergoing a colonoscopy and may be an important tool in
addressing colorectal cancer and other serious GI disorders.”
In November 2017, Motus reported positive results from its most
recent European clinical study evaluating the performance of the
Pure-Vu® System in cleansing a poorly prepared colon at the 25th
United European Gastroenterology (“UEG”) Week conference in Fira
Gran Via, Barcelona. Results from the 47-patient study showed that
the Pure-Vu System significantly increased the number of subjects
with an adequate cleansing level (BBPS >= 2 for all 3 colon
segments) from 19.1% at baseline to 100% after using the Pure-Vu
System. Mean post-treatment BBPS score was 9 vs. 3 prior to Pure-Vu
System use. Motus expects to continue to involve select European
clinical centers in post-approval clinical trials of the Pure-Vu
System it plans to conduct during the next 12 months and
beyond.
About the Pure-Vu® System
The Pure-Vu® System is 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.
About Motus
Motus GI Holdings, Inc. is a medical technology company, with
subsidiaries in the U.S. and Israel, dedicated to improving
endoscopy outcomes, lowering costs and enhancing patient
experiences. The Company is focused on the development and
commercialization of the Pure-Vu® System to improve the colonoscopy
experience and assist in the early detection and prevention of
colorectal cancer and other diseases of the rectum and colon.
For more information, visit www.motugi.com and connect with the
Company on Twitter, LinkedIn, and Google+.
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. Prospective investors
are cautioned not to place undue reliance on such forward-looking
statements, which speak only as of the date of this presentation.
The Company undertakes no obligation to publicly update any
forward-looking statement, whether as a result of new information,
future events or otherwise. Important factors that could cause
actual results to differ materially from those in the
forward-looking statements are set forth in the Company's filings
with the Securities and Exchange Commission, including its
registration statement on Form S-1, as amended from time to time,
under the caption "Risk Factors."
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