TransEnterix Provides 2019 Year End Corporate Update
January 06 2020 - 6:55AM
Business Wire
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
year-end corporate update.
“The challenges we faced in 2019 shouldn’t overshadow the
significant progress we made in putting the pieces in place to make
2020 a transformative year for TransEnterix,” said Anthony
Fernando, President and CEO of TransEnterix. "We have recently
signed agreements with two hospitals that will be initiating their
digital laparoscopy programs utilizing the Senhance® System
beginning in the first quarter of 2020. In addition, our current
Senhance clinical sites are performing more volume and more complex
surgery than ever before. We believe we are on the cusp of
introducing transformative technological capabilities in augmented
intelligence and instrumentation.”
Fourth Quarter Senhance System Placements
As part of the Company’s market development efforts, during the
quarter ended December 31, 2019, the Company entered into two
customer agreements: one in the United States and one in Germany to
lease Senhance Systems to allow such hospitals to perform Senhance
surgeries. These Senhance Systems are expected to be installed in
January 2020 and clinical cases are expected to begin in the first
quarter.
Clinical Cases
In 2019, surgeons performed over 1,600 procedures utilizing the
Senhance System, representing a 194% increase over the previous
year. During 2019, there were 16 peer-reviewed clinical papers
published featuring results of the Senhance System across
gynecology, general surgery, urology and colorectal procedures
demonstrating the breadth of usage and the complexity of procedures
being performed.
Product Portfolio Initiatives
During 2019, the Company completed the following product
portfolio initiatives:
- Obtained Senhance System FDA 510(k) clearance for the Senhance
Ultrasonic Instruments
- Obtained Japanese regulatory approval for the Senhance System
and reimbursement for 98 procedures
- Initiated a European limited market release of 5mm articulating
instruments
- Developed and launched the Senhance System Simulator
- Completed CE submission for expanded indications for pediatric
patients
- Expanded list of visualization systems compatible with the
Senhance System to include systems from KARL STORZ and Olympus
AutoLap Sale
The Company sold the AutoLap laparoscope positioning system and
related assets for $17.0 million and has received all payments
related to this transaction.
Fourth Quarter and Full Year 2019 Revenue
During the quarter ending December 31, 2019, the Company expects
to report preliminary unaudited revenue of approximately $0.6
million. For the full year, preliminary unaudited 2019 revenue is
expected to be approximately $8.3 - $8.5 million, representing
revenues from the sale of a total of three Senhance Systems and
related revenues from consumables and service contracts.
Balance Sheet
As of December 31, 2019, the Company had no debt and had
preliminary unaudited cash, cash equivalents and restricted cash of
approximately $10.6 million. As previously announced, the Company
is evaluating strategic alternatives to raise additional capital to
support the growth of the business.
As of December 31, 2019, there were approximately 20.7 million
shares of common stock outstanding.
2020 Corporate Objectives
The Company expects to make significant progress in 2020 as it
continues to build out its leadership position in Digital
Laparoscopy by focusing on the following key corporate
objectives:
- Expand the number of sites using the Senhance System in the
United States, Europe, and Japan and convert more existing sites
into “foundational” sites that are on a rate to perform 100+ cases
annually with multiple surgeons or specialties;
- Double the number of clinical cases performed on the Senhance
System over the prior year;
- Generate meaningful clinical and economic evidence that
supports utilization of the Senhance System and increase the number
of surgeon advocates to reinforce key messages; and,
- Complete the following product portfolio initiatives:
- launch the scene cognition and augmented intelligence module in
the United States by mid-2020;
- expand the European launch of 5mm Articulating Instruments and
submit for US clearance in the fourth quarter; and,
- obtain general surgery and bariatric indications in the US, and
obtain a pediatric indication in Europe.
About TransEnterix
TransEnterix is a medical device company that is digitizing the
interface between the surgeon and the patient to improve minimally
invasive surgery by addressing the clinical and economic challenges
associated with current laparoscopic and robotic options in today's
value-based healthcare environment. The Company is focused on the
commercialization of the Senhance System, which digitizes
laparoscopic minimally invasive surgery. The system allows for
robotic precision, haptic feedback, surgeon camera control via eye
sensing and improved ergonomics while offering responsible
economics. The Senhance System is available for sale in the US, the
EU, Japan and select other countries. For more information, visit
www.transenterix.com.
Forward-Looking Statements
This press release includes statements relating to the Senhance
System and our current commercialization plans for this product and
related products in 2020. 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 2020 will be a transformative year for
TransEnterix, whether we are on the cusp of introducing
transformative technological capabilities in augmented intelligence
and instrumentation; whether one Senhance System will be installed
in each of the United States and Germany, respectively, in January
2020, with the resulting clinical cases beginning in the 2020 first
quarter; whether 2019 fourth quarter revenue will be approximately
$0.6 million; whether 2019 revenue for the full year will be
approximately $8.3 - $8.5 million; whether cash, cash equivalents
and restricted cash will be $10.6 million as of December 31, 2019;
and whether the Company will achieve any of its 2020 corporate
objectives. 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, 2018,
filed with the SEC on February 27, 2019 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/20200106005312/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
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