Transenterix Pops On FDA Clearance For Senhance Indication Expansion

Transenterix Inc TRXC announced Tuesday that its laparoscopic Senhance Surgical System was approved by the FDA for two additional indications. 

What Happened 

The Senhance Surgical System received regulatory clearance for laparoscopic inguinal hernia and laparoscopic cholecystectomy, or gallbladder removal, procedures.

Why It’s Important

With about 760,000 inguinal hernia and 1.2 million laparoscopic cholecystectomy procedures in the U.S. annually, the indication expansion more than doubles the device’s total addressable domestic market beyond 3 million annual operations.

"These expanded procedures are commonly performed at over 95 percent of hospitals in the United States,” President and CEO Todd Pope said in a press release. “We believe this indication expansion will significantly increase the applicability of Senhance to more institutions, particularly those with a busy general surgery practice."

Transenterix’s stock popped 27.2 percent premarket on the news.

What’s Next

Pope alluded in the press release to a regulatory strategy to expand indications beyond laparoscopic colorectal, gynecologic, inguinal hernia and cholecystectomy surgery.

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Photo courtesy of Transenterix.