Press Release
TransEnterix Provides 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 inLouisiana , 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
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
In
Training Sites
In the third quarter, the Company established the first training center for the Senhance Surgical System in the
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
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
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
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
Fourth Quarter and Full Year 2020 Revenue
During the quarter ended
Balance Sheet
As of
On
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
About
At
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
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For
Investor Contact:
invest@transenterix.com
Or
Media Contact:
terri.clevenger@icrinc.com
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