TransEnterix Provides Corporate Update
- Sold five Senhance™ Systems globally in fourth quarter of 2018
- Achieved preliminary unaudited revenue of approximately
$7.4 millionfor the fourth quarter of 2018
- Received Taiwanese FDA approval for the Senhance System instruments in fourth quarter of 2018
- Launched Ultrasonic Instrument System in CE Mark countries in fourth quarter of 2018
- Preliminary unaudited cash and cash equivalents of approximately
$73 millionas of December 31, 2018
“2018 was a significant year for
Fourth Quarter and Full Year 2018 Revenue Outlook
For the fourth quarter ended
During the quarter, the Company sold five Senhance Systems, with one
sold in the U.S, three sold in the EMEA (
Total 2018 revenue is expected to be approximately
Preliminary unaudited cash and cash equivalents as of
Acquisition Agreement with MST
The addition of MST's technology, IP portfolio and R&D team will support
Instrument Portfolio Expansion
Ultrasonic Instrument System
September 6, 2018, the Company announced it filed its application for FDA510(k) clearance for its Senhance™ Ultrasonic Instrument System, ahead of expectations. The Company expects to obtain FDA510(k) clearance in the first quarter of 2019.
As announced on
October 1, 2018, the Company received CE Mark for its Senhance Ultrasonic Instrument System. The Ultrasonic Instrument System was commercially launched and in use in CE Mark countries in the fourth quarter of 2018.
3mm Diameter Instrument Set
October 11, 2018, the Company received FDA510(k) clearance for its expanded instrument set, including 3mm diameter instruments. The clearance of the 3mm diameter instruments will allow the Senhance System to be used for microlaparoscopic surgeries, enabling surgeons to operate through tiny incisions considered virtually scarless for patients.
- The Company received CE Mark for its 5mm diameter articulating instruments during the fourth quarter of 2018.
The Company submitted its application for
FDA510(k) clearance for its 5mm diameter articulating instruments during the fourth quarter of 2018.
Expansion of Geographic Regulatory Approvals
- The Company received Taiwanese FDA approval for the Senhance System instruments during the fourth quarter. This follows the approval of the Senhance System in the second quarter of 2018.
This press release contains "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, which 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, including whether we will be able to leverage the
tremendous progress we made in 2018 and bring benefits of Senhance
Surgery to more patients, surgeons, and hospitals both in the U.S. and
internationally; whether 2018 fourth quarter revenue will be