viewTransEnterix Inc.

TransEnterix shares pop after FDA approves its robotic surgery system for more procedures

Company says FDA clearance doubles total addressable market in US to more than three million annual procedures

Shares of TransEnterix soared nearly 26% in morning trade

Shares of TransEnterix Inc. (NYSEAMERICAN:TRXC) soared in pre-market trade Monday after the North Carolina medical-device company announced that it has won U.S. Food and Drug Administration approval for “expanded indications” for its Senhance Surgical System.

Shares of TransEnterix soared nearly 26% to US$3.93 in morning trade. A year ago, shares were trading at US$0.58.

TransEnterix is the maker of surgical robots and medical instruments used in minimally invasive surgery. It’s focused on commercializing its Senhance Surgical Robotic System, which gives surgeons greater haptic or tactile feedback, and eye sensing camera control. 

The company announced Monday that the FDA has now cleared the Senhance System for laparoscopic inguinal hernia and laparoscopic cholecystectomy (gallbladder removal) surgery.

It’s a huge market as there are approximately 760,000 inguinal hernia and 1.2 million laparoscopic cholecystectomy procedures performed annually in the U.S., the company said. With this clearance, Senhance System's total addressable annual procedures in the U.S. has more than doubled to over three million.  

“This indication expansion immediately doubles the addressable market for Senhance in the US and validates our regulatory strategy to successfully add to our indications for use,” said TransEntrix CEO Todd M. Pope.

“These expanded procedures are commonly performed at over 95% of hospitals in the United States. We believe this indication expansion will significantly increase the applicability of Senhance to more institutions, particularly those with a busy general surgery practice,” he added.

READ: TransEntrix soars after it posts smaller than expected 1Q loss on surging sales of its surgical robots

In the U.S., 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.

“We have utilized Senhance broadly across a wide range of general surgery, upper GI surgery and colorectal procedures at our institution,” said Professor Dr Frank Willeke, chief of surgery at St. Marien Hospital in Siegen, Germany.

“We believe this procedural expansion for the US will allow surgeons there to incorporate the Senhance, as we have, as a highly-efficient, enabling and very promising technology that can impact the vast majority of surgeries commonly performed by general surgeons and their sub-specialties,” he added.

The company sold two Senhance Systems in the first quarter and said that thus far in the current quarter it had sold three Senhance Systems, including one in the United States.


Quick facts: TransEnterix Inc.

Price: 0.3624 USD

Market: NYSE
Market Cap: $36.2 m

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