TransEnterix Announces FDA 510(k) Submission for Senhance Indication Expansion to More than Double Addressable Market in the U.S. and Provides Commercial Update

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The Company recently filed a FDA 510(k) submission to include laparoscopic inguinal hernia and laparoscopic cholecystectomy (gallbladder removal) surgery in the indicated list of covered procedures. The clearance for these indications would allow the Senhance to be used for the most common abdominal surgeries in the U.S. in general surgery, gynecology and colorectal surgery. In collecting the data submitted, the Company leveraged its broad CE mark that includes full use in the abdominal and pelvic cavities, and specific uses in the thoracic cavity. The Company expects to achieve FDA clearance for these expanded indications by mid-year 2018.

Todd M. Pope, President and Chief Executive Officer of TransEnterix highlighted, “Clinicians are now successfully using Senhance outside of the United States to address a multitude of procedures and specialities. Collecting human clinical data from these experiences to drive expanded applicability of the system is a key element of our strategy.”  He noted,  “This FDA filing is an excellent example of this strategy in action; once cleared by the FDA, our addressable market in the United States will more than double to approximately three million procedures.”

The Senhance System is currently cleared for use in the U.S. for laparoscopic colorectal surgery and laparoscopic gynecologic surgery, accounting for approximately 1.5 million procedures in the U.S. annually. There are approximately 760,000 inguinal hernia and 1.2 million laparoscopic cholecystectomy procedures performed annually in the U.S. Upon clearance, the Senhance System’s total addressable procedures in the U.S. will more than double to approximately three million.

“We have performed more than 150 Senhance surgeries across a wide range of general surgery and colorectal cases since we purchased a Senhance System less than a year ago.” said Dr. Dietmar Stephan, Head of Minimally Invasive and Robotic Surgery at St. Marien Hospital in Siegen, Germany. ”Our clinical experience, and those of other European hospitals, was used in showing the results of Senhance in hernia and gallbladder surgery. We are continuing to generate clinical data and are successfully expanding our utilization of Senhance in laparoscopic surgery.”

Commercial Update: Thus far in the quarter ending March 31, 2018, the Company has delivered one Senhance System and has received an additional order that it expects to deliver and recognize revenue for in the quarter ending March 31, 2018. Both of these sales have come from sales to end user hospitals by distributors in the Company’s EMEA (Europe, Middle East, and Africa) region.



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