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TransEnterix, Inc. Reports Operating and Financial Results for the Fourth Quarter and Full Year 2018
February 26, 2019 at 6:55 AM EDT
RESEARCH TRIANGLE PARK, N.C.(BUSINESS WIRE)--Feb 26, 2019 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 announced its operating and financial results for the fourth quarter and full year 2018.
Sold five Senhance Systems globally in the fourth quarter in 2018
Total revenue of $7.5 million in the fourth quarter of 2018
Received U.S. FDA clearance for Senhance Ultrasonic System subsequent to the end of the 2018 fourth quarter
Received U.S. FDA clearance for 3mm diameter instruments
Received CE Mark for articulating instruments and submitted its application for U.S. FDA 510(k) clearance during the fourth quarter
Received Taiwanese FDA approval for the Senhance System instruments in the fourth quarter of 2018
Closed acquisition of substantially all of the assets of MST Medical Surgery Technologies Ltd., an Israel-based medical technology company
2018 was a transformative year for TransEnterix, as we continued to drive the global commercial adoption of the Senhance System both in terms of expanding our installed base as well as expanding the applicability of the Senhance System by increasing its indications for use, expanding the variety of instruments available with the Senhance System, and expanding into new geographies by receiving additional regulatory clearances, said Todd M. Pope, President and CEO of TransEnterix. In 2019, we see a significant opportunity to leverage all of the progress we made in 2018 to continue to grow the adoption of the Senhance System globally.
Commercial and Clinical Update
In the quarter ended December 31, 2018, the Company sold five Senhance Systems, with three sold in EMEA (Europe, Middle East, and Africa), one in the U.S., and one in Asia.
Instrument Portfolio Expansion
Ultrasonic Instrument System
On October 1, 2018, the Company announced that it had received a CE Mark for its Senhance Ultrasonic Instrument System, and during the fourth quarter this system was commercially launched in CE Mark countries. Advanced energy devices, including ultrasonic devices, represent some of the most versatile and critical tools for surgeons in minimally invasive surgery. These instruments deliver controlled energy to effectively ligate and divide tissue, and minimize thermal injury to surrounding structures.
The following information was filed by Transenterix Inc. (TRXC) on Wednesday, February 27, 2019 as an 8K 2.02 statement, which is an earnings press release pertaining to results of operations and financial condition. It may be helpful to assess the quality of management by comparing the information in the press release to the information in the accompanying 10-Q Quarterly Report statement of earnings and operation as management may choose to highlight particular information in the press release.
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