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Blog Exposure - FDA Approved Expanded Indications for TransEnterix's Senhance Surgical System

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LONDON, UK / ACCESSWIRE / May 31, 2018 / If you want access to our free research report on TransEnterix, Inc. (NYSE: TRXC ), all you need to do is sign up now by clicking the following link www.active-investors.com/registration-sg/?symbol=TRXC as the Company's latest news hit the wire. On May 29, 2018, the Company announced that the US Food and Drug Administration (FDA) has granted 510(k) clearance for expanded indications of the Company's Senhance Surgical System for laparoscopic inguinal hernia and laparoscopic cholecystectomy (gallbladder removal) surgery. Register today and get access to over 1,000 Free Research Reports by joining our site below:


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This Indication Expansion Immediately Doubles Addressable Market for Senhance in the US

Todd M. Pope, President and Chief Executive Officer of TransEnterix, stated that this indication expansion immediately doubles the addressable market for Senhance in the US and validates the Company's regulatory strategy to successfully add to its indications for use.

According to him, these expanded procedures are commonly performed at over 95% of hospitals in the United States.

Todd added that TransEnterix believes that this indication expansion will significantly increase its applicability to more institutions, particularly those with a busy general surgery practice.

Post announcement of the news, shares of the Company surged in p-remarket trade.

With this Clearance, Senhance System's Total Addressable Annual Procedure in the US has More than Doubled to Over Three Million

There are approximately 760,000 inguinal hernia and 1.2 million laparoscopic cholecystectomy procedures performed annually in the US. With this clearance, Senhance System's total addressable annual procedure in the US has more than doubled to over three million. In the US, Senhance is now cleared for laparoscopic colorectal, gynecologic, inguinal hernia, and cholecystectomy surgery. This enables Senhance to be used for some of the most common abdominal surgeries, including procedures in general surgery and gynecology.

TransEnterix Filed FDA 510(k) Submission for Senhance Indication Expansion in February 2018

The Company filed a FDA 510(k) submission to expand the indication for use of its Senhance Surgical System on February 14, 2018. In collecting the data submitted, TransEnterix leveraged its broad CE mark that included full use in the abdominal and pelvic cavities, and specific uses in the thoracic cavity. The clearance for these expanded indications was expected by mid-year 2018.

TransEnterix Received FDA 510(k) Clearance for Senhance Surgical Robotic System in 2017

In October 2017, TransEnterix received FDA 510(k) clearance for the Senhance Surgical Robotic System. With this clearance, the Senhance became the first new market entrant into the field of abdominal surgical robotics since 2000.

Using the system, a surgeon directs small surgical instruments and a camera with precise movements and comfort. The system builds on the foundation of laparoscopy and features the security of haptic feedback and eye-sensing camera control for the first time in a robotic surgery platform. Additionally, the Senhance utilizes an open architecture, which allows hospitals and surgeons to leverage existing technology investments within the operating room ecosystem.

About TransEnterix, Inc.

Founded in 2006 and headquartered in Morrisville, North Carolina, TransEnterix is a medical device company that is pioneering the use of robotics 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.

Stock Performance Snapshot

May 30, 2018 - At Wednesday's closing bell, TransEnterix's stock ended the trading session flat at $3.41.

Volume traded for the day: 4.70 million shares, which was above the 3-month average volume of 3.05 million shares.

Stock performance in the last month – up 98.26%; previous three-month period – up 79.47%; past twelve-month period – up 633.02%; and year-to-date - up 76.68%

After yesterday's close, TransEnterix's market cap was at $704.44 million.

The stock is part of the Healthcare sector, categorized under the Medical Instruments & Supplies industry. This sector was up 1.4% at the end of the session.

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