Medical surgical device company Asensus Surgical Inc. (TRXC:NYSE.American), developer of a Performance-Guided Surgery™ platform that digitizes the interface between the surgeon and patient, today announced that it has "received an additional FDA clearance for the Senhance Surgical System which allows for indication expansion in general surgery in the U.S."
The company advised that its Senhance® Surgical System technology platform "is the first of its kind digital laparoscopic platform that leverages augmented intelligence to provide unmatched performance and patient outcomes through machine learning."
Asensus Surgical explained that the Senhance system offers numerous features well beyond other commercially available surgical robotic systems. The firm stated that its system incorporates haptic feedback and allows for eye-tracking camera control and 3D visualization. The company additionally pointed out that the system permits use of the smallest 3 mm instruments available in the world that can be integrated for use on its robotic laparoscopic surgical platform.
The company's President and CEO Anthony Fernando commented, "The expansion into general surgery for the Senhance Surgical System is a major milestone for the growth and clinical applicability of our technology...General surgery is, by far, the largest area of manual laparoscopy which can benefit from the precision and insight of Performance-Guided Surgery. The indication expansion allows Senhance to be used in many high-value, complex reconstructive surgeries such as those used to treat reflux and obesity. Including previous indications granted, the Senhance Surgical System can now be utilized in over 2.7 million general surgical procedures performed in the U.S. annually."
Dr. Sabino Zani, assistant professor of surgery at Duke University and an investigator in the clinical studies submitted for indication expansion, remarked, "Many of the procedures we perform in general surgery require complex reconstruction throughout a wide surgical field...Senhance can now be seen as a widely applicable tool for general surgeons across the broad range of procedures that may be performed from deep in the pelvis to the upper abdomen."
The company explained that the Senhance Surgical System is designed to accurately control laparoscopic instruments during surgical procedures. The system facilitates visualization and allows for endoscopic manipulation of tissue when grasping, cutting, retracting and suturing during medical procedures.
The firm noted that the Senhance Surgical System is intended for use in adult patients in laparoscopic gynecological surgery, cholecystectomy colorectal surgery and inguinal hernia repair and now many other common general surgical procedures.
Asensus Surgical is a medical device company headquartered in Morrisville, N.C. The firm stated that "it is digitizing the interface between the surgeon and patient to pioneer a new era of Performance-Guided Surgery by unlocking the Clinical Intelligence to enable consistently superior outcomes and a new standard of surgery." The firm notted that its Senhance® Surgical System is presently available for sale in the EU, Japan, Russia and the U.S.
Asensus Surgical started the day with a market cap $546.1 million with approximately 139.3 million shares outstanding and a short interest of about 4.8%. TRXC shares opened 26% higher today at $4.95 (+$1.03, +26.28%) over yesterday's $3.92 closing price. The stock has traded today between $4.50 and $5.30 per share and is currently trading at $4.57 (+$0.65, +16.58%).[NLINSERT]
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