Blog Exposure - TransEnterix Files FDA 510(k) Submission for its Senhance(TM) Surgical System
Stock Monitor: Mettler-Toledo Intl. Post Earnings Reporting
LONDON, UK / ACCESSWIRE / February 16, 2018 / Active-Investors.com has just released a free research report on TransEnterix, Inc. (NYSE: TRXC). If you want access to this report 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 February 14, 2018, the medical device Company, which focuses on digitizing the interface between the surgeon and the patient to improve minimally invasive surgery, declared that it has filed the 510(k) submission with the FDA for expanding the indications for its Senhance™ Surgical System. Additionally, the Company also shared an update about its year-to-date commercial results for the quarter ending March 31, 2018. Register today and get access to over 1000 Free Research Reports by joining our site below:
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Active-Investors.com is focused on giving you timely information and the inside line on companies that matter to you. This morning, TransEnterix most recent news is on our radar and our team decided to put out a fantastic report on the company that is now available for free below:
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Purpose for the FDA 510(K) Submission
The Company filed the FDA 510(k) submission to expand indications to include laparoscopic inguinal hernia and laparoscopic cholecystectomy (i.e. gallbladder removal) surgery in the list of covered procedures.
TransEnterix collected the data for this submission using its broad CE mark that includes full use in the abdominal and pelvic cavities, and specific uses in the thoracic cavity.
In fact, clinicians outside of the United States are also using Senhance to tackle a number of procedures and specialties. An important aspect of the Company strategy is to collect human clinical data from these experiences to enhance applicability of the system. The Company puts in strategy into action through this FDA filing.
In this regard, Dr. Dietmar Stephan, Head of Minimally Invasive and Robotic Surgery at St. Marien Hospital in Siegen, Germany shared that his team has conducted over 150 Senhance surgeries across a number of general surgery and colorectal cases since the Hospital bought the Senhance System a year ago. Their clinical experience as well as those of other European hospitals, was leveraged for showing the results of Senhance in hernia and gallbladder surgery. Furthermore, his team would continue generating clinical data and successfully expanding Senhance System's utilization in laparoscopic surgery.
Indication Expansion to More than Double Addressable Market in the US
At present, the Senhance Surgical System has been approved use in the US for laparoscopic colorectal surgery and laparoscopic gynecologic surgery, which accounts for nearly 1.5 million procedures in the US annually. Every year, approximately 760,000 inguinal hernia and 1.2 million laparoscopic cholecystectomy procedures are performed in the US.
FDA Clearance for these expanded indications is expected by mid-2018. If FDA approves this submission, Senhance Surgical System's total addressable market for procedures in the US will more than double to approximately three million. Thus, the system would then be used for the most common abdominal surgeries in the US in general surgery, gynecology as well as colorectal surgery.
Second Senhance Sale in the First Quarter of 2018
TransEnterix has delivered one Senhance System and has received an additional order so far in the quarter ending March 31, 2018. For the additional order, the Company expects to deliver and recognize revenue in this quarter itself.
Distributors in the Company's EMEA (Europe, Middle-East, and Africa) region have made both these sales to end-user hospitals.
Stock Performance Snapshot
February 15, 2018 - At Thursday's closing bell, TransEnterix's stock dropped 2.78%, ending the trading session at $1.40.
Volume traded for the day: 2.19 million shares.
Stock performance in the previous six-month period – up 104.44%; and past twelve-month period – up 4.48%
After yesterday's close, TransEnterix's market cap was at $287.36 million.
The stock is part of the Healthcare sector, categorized under the Medical Instruments & Supplies industry. This sector was up 1.1% at the end of the session.
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