TransEnterix Announces Approval of Senhance® Surgical System in Russian Federation
17 December 2020 - 12:00AM
Business Wire
Approval allows for marketing and sale of
Senhance Surgical System for digital laparoscopy
TransEnterix, Inc. (NYSE American:TRXC), a medical device
company that is digitizing the interface between the surgeon and
the patient to improve minimally invasive surgery, today announced
that the Senhance® Surgical System has received its registration
certificate by Roszdravnadzor, the Russian medical device
regulatory agency allowing for its sale and utilization throughout
the Russian Federation.
“Russian regulatory approval is an important milestone for
TransEnterix, and this is an underserved market for robotic
surgery,” said Anthony Fernando, President and Chief Executive
Officer of TransEnterix. “Russia has rapidly developed expertise
and adoption of minimally invasive surgery over the past 10 years,
but robotic surgery remains extremely limited in the region due to
high per-procedure costs and the success of laparoscopic
approaches. Senhance helps address these adoption hurdles. We have
worked with BOWA previously to launch four Senhance programs in the
Commonwealth of Independent States (CIS) region, and look forward
to partnering to leverage this recent success in entering the
largest CIS market.”
TransEnterix has been partnering with BOWA-electronic GmbH &
Co. KG (BOWA), based in Germany, to commercialize the Senhance
Surgical System in the CIS region over the past three years. BOWA,
together with it’s wholly-owned subsidiary OOO “BOWA Eurasia”, have
an established commercial and support presence in this region .
They are well equipped to drive medical device sales and provide
aftersale support to hospitals in the CIS region, including Russia,
for the Senhance and BOWA’s own complementary surgical device
portfolio of products.
The Senhance Surgical System is the first and only digital
laparoscopic platform designed to maintain laparoscopic minimally
invasive surgery standards while providing digital benefits such as
haptic feedback, robotic precision, comfortable ergonomics,
advanced instrumentation including 3 mm microlaparoscopic
instruments, eye-sensing camera control, and reusable standard
instruments to help maintain per-procedure costs similar to
traditional laparoscopy. TransEnterix also recently launched the
first machine vision system in robotic surgery in the US. This
first-of-its-kind augmented intelligence capability is powered by
the new Intelligent Surgical Unit™ on the Senhance Surgical System.
Not all features are currently available in every market.
About TransEnterix
At TransEnterix, Inc., we are digitizing the interface between
the surgeon and the patient to improve minimally invasive surgery
(MIS) through a new category of care called Digital Laparoscopy.
Digitizing the interface enables the use of advanced capabilities
like augmented intelligence, connectivity and robotics in
laparoscopy, and allows us to address the current clinical,
cognitive and economic shortcomings in surgery. The system features
the first machine vision system for use in robotic surgery which is
powered by the new Intelligent Surgical Unit™ (ISU™) that enables
augmented intelligence in surgery. The Senhance Surgical System
brings the benefits of Digital Laparoscopy to patients around the
world while staying true to the principles of value-based
healthcare. Learn more about Digital Laparoscopy with the Senhance
Surgical System here: https://Senhance.com/. Now available for sale
in the US, the EU, Japan, Russia, and select other countries. For a
complete list of indications for use, please visit:
https://www.transenterix.com/indications-for-use/.
About BOWA Medical
BOWA develops and produces high-specification medical-technology
solutions, and since 1977 has continuously developed into a leading
technological supplier of energy-based surgical systems. With its
three cutting-edge production sites in Gomaringen, Germany, Poznan,
Poland, and Ashburton, UK, the core of the company is in the heart
of Europe. International branches and sales offices in the Middle
East, Russia, Brazil, Kazakhstan, Ukraine and additional countries
across Asia guarantee global support for their customers. To find
out more about, visit at www.bowa-medical.com.
Forward-Looking Statements
This press release includes statements relating to the Senhance
Surgical System and that TransEnterix has received its registration
certificate by the Russian medical device regulatory agency
allowing for the Senhance System’s sale and utilization throughout
the Russian Federation. These statements and other statements
regarding our future plans and goals constitute "forward looking
statements'' within the meaning of Section 27A of the Securities
Act of 1933 and Section 21E of the Securities Exchange Act of 1934,
and are intended to qualify for the safe harbor from liability
established by the Private Securities Litigation Reform Act of
1995. Such statements are subject to risks and uncertainties that
are often difficult to predict, are beyond our control and which
may cause results to differ materially from expectations and
includes whether the Senhance Surgical System will help address the
high-procedure costs of minimally invasive surgery in Russia. For a
discussion of the risks and uncertainties associated with
TransEnterix's business, please review our filings with the
Securities and Exchange Commission (SEC), including our Annual
Report on Form 10-K for the year ended December 31, 2019, filed
with the SEC on March 16, 2020 and our other filings we make with
the SEC. You are cautioned not to place undue reliance on these
forward looking statements, which are based on our expectations as
of the date of this press release and speak only as of the
origination date of this press release. We undertake no obligation
to publicly update or revise any forward-looking statement, whether
as a result of new information, future events or otherwise.
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version on businesswire.com: https://www.businesswire.com/news/home/20201216005571/en/
Investor Contact: Mark Klausner, +1 443-213-0501
invest@transenterix.com or Media Contact: Terri Clevenger, +1
203-682-8297 terri.clevenger@icrinc.com
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