The federal safety watchdog’s expanded 510(k) decision doubles the Research Triangle Park, N.C.-based company’s addressable market, president & CEO Todd Pope said in prepared remarks.
“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,” Pope said.
“We have utilized Senhance broadly across a wide range of general surgery, upper GI surgery and colorectal procedures at our institution,” added Dr. Frank Willeke of Germany’s St. Marien Hospital. “We believe this procedural expansion for the U.S. 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.”
The news sent TRXC shares up 28.8% to $4.03 apiece today in pre-market trading.