FDA Grants Expanded Use in General Surgery for Asensus Surgical’s Robotic Laparoscopic Platform

Source: Streetwise Reports   03/03/2021

Asensus Surgical shares traded 16.5% higher after the company reported it received clearance from the U.S. Food & Drug Administration for its Senhance© Surgical System for use in general surgical procedures.

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%).

Disclosure:
1) Stephen Hytha compiled this article for Streetwise Reports LLC and provides services to Streetwise Reports as an independent contractor. He or members of his household own securities of the following companies mentioned in the article: None. He or members of his household are paid by the following companies mentioned in this article: None.
2) The following companies mentioned in this article are billboard sponsors of Streetwise Reports: None. Click here for important disclosures about sponsor fees.
3) Comments and opinions expressed are those of the specific experts and not of Streetwise Reports or its officers. The information provided above is for informational purposes only and is not a recommendation to buy or sell any security.
4) The article does not constitute investment advice. Each reader is encouraged to consult with his or her individual financial professional and any action a reader takes as a result of information presented here is his or her own responsibility. By opening this page, each reader accepts and agrees to Streetwise Reports’ terms of use and full legal disclaimer. This article is not a solicitation for investment. Streetwise Reports does not render general or specific investment advice and the information on Streetwise Reports should not be considered a recommendation to buy or sell any security. Streetwise Reports does not endorse or recommend the business, products, services or securities of any company mentioned on Streetwise Reports.
5) From time to time, Streetwise Reports LLC and its directors, officers, employees or members of their families, as well as persons interviewed for articles and interviews on the site, may have a long or short position in securities mentioned. Directors, officers, employees or members of their immediate families are prohibited from making purchases and/or sales of those securities in the open market or otherwise from the time of the decision to publish an article until three business days after the publication of the article. The foregoing prohibition does not apply to articles that in substance only restate previously published company releases.
6) This article does not constitute medical advice. Officers, employees and contributors to Streetwise Reports are not licensed medical professionals. Readers should always contact their healthcare professionals for medical advice.