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 provided a
preliminary 2020 year-end corporate update.
Recent Highlights
- Senhance® Surgical System received its registration certificate
by the Russian medical device regulatory agency, Roszdravnadzor,
allowing for its sale and utilization throughout the Russian
Federation
- Southern Surgical Hospital, a hospital based in Louisiana,
entered into an agreement to lease and utilize a Senhance Surgical
System
- First pediatric cases utilizing Senhance completed in October,
representing the first time that 3mm instruments were used in
robotic pediatric surgery
- First surgical procedures successfully completed using the
Intelligent Surgical Unit™ (ISU™), leveraging augmented
intelligence and machine vision capabilities on the Senhance
Surgical System
Year-End Highlights
- In 2020, ten Senhance Systems were installed under operating
leases, nine clinical programs were initiated, and over 1,450
procedures were performed globally
- At December 31, 2020, the Company had approximately $17.5
million in cash, cash equivalents and restricted cash. The Company
currently expects to have cash to support operations into the third
quarter of 2021
- Fourth quarter revenue is expected to be approximately $1.1
million
- Full year 2020 revenue is expected to be approximately $3.0 -
$3.2 million
“Looking at 2020 as a whole we are pleased with the momentum
generated across our organization during these challenging times.
We continued to expand our global footprint with new system
installations and procedure volumes rebounded in the back half of
the year across each of our geographies. In addition, we had a
number of regulatory and portfolio expansion milestones including
the introduction of machine vision and augmented intelligence which
enable the promise of digital laparoscopy,” said Anthony Fernando,
President and CEO of TransEnterix. "We built a great foundation in
2020 and we are planning to continue to execute on our strategy in
2021, bringing transformative technology to surgeons, hospitals and
patients across the globe.”
Upcoming 2021 Milestones
During the first half of 2021, the Company expects to achieve
the following regulatory milestones:
- Receive CE Mark approval for the ISU in Europe
- Receive FDA 510(k) clearance for General Surgery indication
expansion
- File for FDA 510(k) clearance for articulating instruments
- File for FDA 510(k) clearance for the next generation ISU
features
During the first half of 2021, the Company expects to publish
clinical papers in peer reviewed journals on the following
subjects:
- Health economic studies comparing Senhance Digital Laparoscopy,
laparoscopy, and robotic surgery
- Clinical performance when utilizing the Senhance Surgical
System
- Operating room efficiency and surgeon ergonomics when utilizing
Senhance Surgical System
Market Development
2020 Senhance Surgical System Placements Throughout 2020, the
Company initiated ten clinical programs: three in the US, four in
Europe, and three in Asia.
In December 2020, the Company announced that Southern Surgical
Hospital, a hospital based in Louisiana, has signed an agreement to
initiate a Senhance Digital Laparoscopic program. This will
represent the third Senhance Surgical program initiated in the
state of Louisiana since 2018 (May 2018 - LSU Health’s University
Medical Center New Orleans, January 2020 - Ochsner Baptist Medical
Center). LSU Health, in addition to utilizing a Senhance system in
their Digital Laparoscopy program, is home to one of the Senhance
Surgical training centers in the southeast United States.
Training Sites In the third quarter, the Company established the
first training center for the Senhance Surgical System in the
Asia-Pacific region in Japan at the Saitama Medical University
International Medical Center in the Greater Tokyo Area. The
Asia-Pacific region has been a major contributor of new system
placements and surgical cases utilizing the Senhance Surgical
System and the Asia-Pacific laparoscopy device market is expected
to grow from $1.26 billion in 2019 to $1.87 billion by 2024,
according to Market Data Forecast, Inc. The training center is
expected to drive increased utilization of our eight system
installations in the Asia-Pacific region and encourage further
adoption of our technology in additional hospitals.
Procedure Volumes In 2020, surgeons performed over 1,450
procedures utilizing the Senhance Surgical System, representing a
10% decrease over the previous year, which was less than our goal
as a result of the COVID-19 pandemic. These procedures included
general surgery, gynecology, urology, colorectal and bariatric
surgical cases.
Foundational Sites As of December 31, 2020, the Company had 11
foundational sites, up from 7 at the start of 2020. Foundational
sites are hospitals that are performing clinical procedures with
the Senhance Surgical System at an annualized rate of greater than
100 procedures per year.
Clinical Validation
During 2020, there were 15 peer-reviewed clinical papers
published providing further support of the clinical utility of the
Senhance Surgical System across gynecology, general surgery,
urology and colorectal procedures demonstrating the utility breadth
and the complexity of procedures being performed.
Portfolio Expansion
Intelligent Surgical Unit™(ISU™) The Company received 510(k)
clearance for the ISU that enables machine vision capabilities on
the Senhance Surgical System. On September 23, 2020, the Company
announced the first surgical procedures successfully completed
using the ISU.
Pediatric Indication The Company received CE Mark approval for
an expanded indication to treat pediatric patients. During the
fourth quarter of 2020, the Company announced the first pediatric
surgical cases with Senhance Surgical System at Maastricht
University Medical Center+ in the Netherlands.
General Surgery Indication The Company submitted an application
for 510(k) approval for an expanded General Surgery indication for
use for the Senhance Surgical System to the FDA.
Russian Regulatory Approval During the fourth quarter of 2020,
the Company received approval for the Senhance Surgical System in
the Russian Federation allowing for its sale and utilization
throughout the Russian Federation. We believe that the Russian
robotic surgery market is underserved and provides an opportunity
to grow Senhance Surgical System placements and sales.
Fourth Quarter and Full Year 2020 Revenue
During the quarter ended December 31, 2020, the Company expects
preliminary unaudited revenue of approximately $1.1 million. For
the full year, preliminary unaudited 2020 revenue is expected to be
approximately $3.0 - $3.2 million, representing revenues from
Senhance Surgical System leasing and related revenues from
instruments, accessories and services.
Balance Sheet
As of December 31, 2020, the Company had preliminary unaudited
cash, cash equivalents and restricted cash of approximately $17.5
million, and there were approximately 116.2 million shares of
common stock outstanding.
On October 9, 2020, the Company filed a prospectus supplement,
relating to an “at the market” offering (ATM Offering) of up to an
aggregate of $40.0 million of shares of the Company’s common stock,
through Cantor Fitzgerald & Co. (Cantor), as sales agent under
an existing Sales Agreement. During the quarter ended December 31,
2020, the Company raised gross proceeds of approximately $9.3
million, and net proceeds of approximately $9.0 million under the
ATM Offering.
As a result of the restructuring completed in the first quarter
of 2020, cost optimization efforts, and equity financings, together
with anticipated cash received from operating activities, including
cash from system sales and leases, instruments and accessories, and
services, we believe that cash on hand will be sufficient to meet
our anticipated cash needs into the third quarter of 2021.
COVID-19 Pandemic
The COVID-19 pandemic continues to have a significant impact on
the Company’s operations, primarily due to the temporary cessation
of elective surgical procedures in many markets, and the challenges
and restrictions caused by stay-at-home orders, social distancing
requirements and travel restrictions. The Company’s business and
customers were negatively impacted by the COVID-19 pandemic, which
suspended many elective surgical procedures globally, curtailed
travel and necessarily diverted the attention of hospital
customers. The Company has taken steps, and continues to take
further actions, to minimize the impact of the COVID-19 pandemic on
its business. A variety of travel restrictions have caused delays
in product installation and training activities. Since the second
quarter of 2020, the Company has seen elective surgical procedures
recommence in the United States, Europe and Japan, but not, to
date, to the levels seen before the COVID-19 pandemic. This has
significantly impacted its ability to implement its market
development activities to place its Senhance Systems, provide
training, and increase the use of the Senhance Systems in place.
Given the dynamic nature of this health emergency, the full impact
of the COVID-19 pandemic on ongoing business, results of operations
and overall financial performance cannot be reasonably estimated at
this time.
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/.
Forward-Looking Statements
This press release includes statements relating to the Senhance
System and our preliminary 2020 results. 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
include whether we will be able to continue to progress our
strategic plan in 2021; whether 2020 fourth quarter revenue will be
approximately $1.1 million; whether 2020 revenue for the full year
will be approximately $3.0 - $3.2 million; whether cash, cash
equivalents and restricted cash will be $17.5 million as of
December 31, 2020; whether the Russian robotic surgery market is
underserved and provides an opportunity to grow Senhance Surgical
System placements and sales; whether we can continue to increase
Senhance System placements and sales, whether we can continue to
add foundational sites and receive regulatory clearances and
approvals that we seek, whether our cash on hand will be sufficient
to meet our anticipated cash needs into the third quarter of 2021
and whether we can continue to support our operations through
capital raising transactions. For a discussion of the risks and
uncertainties associated with TransEnterix's business, please
review our filings with the Securities and Exchange Commission
(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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20210106005275/en/
For TransEnterix, Inc. Investor Contact:
Mark Klausner, +1 443-213-0501 invest@transenterix.com
Or
Media Contact: Terri Clevenger, +1 203-682-8297
terri.clevenger@icrinc.com
TransEnterix (AMEX:TRXC)
Historical Stock Chart
From Mar 2024 to Apr 2024
TransEnterix (AMEX:TRXC)
Historical Stock Chart
From Apr 2023 to Apr 2024