TransEnterix Provides Corporate Update
- Announces four Senhance system sales in third quarter of 2018
- Preliminary unaudited revenue of approximately
$5.4 millionfor the third quarter of 2018
Preliminary unaudited cash and cash equivalents of approximately
$82 millionas of September 30, 2018
- Announced entry into acquisition agreement for technology assets and IP of MST Medical Surgery Technologies
- Received CE Mark for Senhance Ultrasonic Instrument System
“We made significant progress during the third quarter, including the
continued adoption of Senhance, driven by the advancement of our sales
and marketing strategy, the announcement of the MST acquisition
agreement and the expansion of our instrument portfolio," said Todd M.
Pope, President and CEO at
Third Quarter 2018 Revenue Outlook
For the third quarter ended
In the US, UPMC purchased a Senhance Surgical System to be utilized at
Magee-Womens Hospitalin Pittsburgh. Magee combines a wealth of specialty services with a focus on gynecologic and obstetric services. UPMC is a $19 billionworld-renowned health care provider and insurer, which is focused on new models of accountable, cost-effective, and patient-centered care.
In EMEA (
Europe, Middle East, Africa), three systems were sold:
A system was sold to
Maxima Medical Center, in Veldhoven, the Netherlands, which is a member of a cooperative association of the 20 largest Dutch teaching hospitals that work together in areas of education and quality control, to guarantee the best level of healthcare.
- Two systems were sold to distributors, one of which was a demonstration system purchased to support territory marketing and regulatory initiatives.
- A system was sold to
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 and accelerate
Instrument Portfolio Expansion
Ultrasonic Instrument System
September 6, 2018, the Company announced that it had filed its application for FDA510(k) clearance for its Senhance Ultrasonic Instrument System, ahead of expectations. The Company expects to achieve an FDA510(k) clearance in the first quarter of 2019.
As announced on
October 1, 2018, the Company received a CE Mark for its Senhance Ultrasonic Instrument System. The Company continues to expect to commercially launch the Ultrasonic Instrument System in CE Mark countries in the fourth quarter of 2018.
3mm Diameter Instrument Set
The Company continues to anticipate receiving
FDA510(k) clearance for its expanded instrument set, including 3mm diameter instruments, by the end of 2018.
The Company continues to expect to submit its application for
FDA510(k) clearance for its 5mm diameter articulating instruments during the fourth quarter of 2018.
- The Company continues to expect to receive CE Mark for its 5mm diameter articulating instruments during the fourth quarter of 2018.
Expansion of Geographic Regulatory Approvals
The Company continues to expect to receive Taiwanese FDA approval for
the Senhance Surgical System instruments by the end of 2018. In the
second quarter of 2018, the Company received approval in
Appointment of Chief Commercial Officer
This press release includes statements relating to the anticipated third
quarter 2018 financial results, the acquisition agreement with MST, the
Senhance Surgical System, the Senhance Ultrasonic Instrument System and
our current regulatory and commercialization plans for these and our
other products. 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 the preliminary unaudited 2018 third
quarter revenue will be approximately