TransEnterix Receives FDA Clearance for Surgical System

The gallbladder removal surgery—or laparoscopic inguinal hernia and laparoscopic cholecystectomy—may be soon be quicker and safer for patients and make gains for investors.

On Tuesday (May 29) medical device company TransEnterix’s (NYSE:TRXC) announced that its new Senhance Surgical System received US Food and Drug Administration (FDA) clearance. This clearance expands its current indications which were previously only available for laparoscopic colorectal and gynecologic surgeries.

This clearance doubles the total addressable annual procedures in the US to over three million, allowing the device to be used for some of the most common abdominal surgeries in general surgery and gynecology.

“These expanded procedures are commonly performed at over 95% of hospitals in the United States,” Todd Pope, president and CEO of TransEnterix said in the 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,”

The Senhance, previously known as the ALF-X Robotic Surgical System, features haptic feedback, robotic precision, surgeon camera control via eye sensing and improved ergonomics. The device is for sale in the US, the European Union and select other countries.

TransEnterix is “digitizing the interface” between surgeons and patients to improve minimally invasive surgery to address clinical and economic challenges associated with the current robotic and laparoscopic options. The Senhance system is the company’s only product, so this additional FDA clearance may result in a very positive revenue boost for the company.

Investor Takeaway

Following Tuesday’s announcement TransEntrix’s share price increased 7.03 percent to $3.35 as of 2 p.m. EST Wednesday (May 30). In response to the FDA announcement, TipRanks showed two analysts issued notes to investors.

Ladenburg analyst Jeffrey Cohen downgraded his action on the company from a “buy” to “neutral” but raised his price target from $3.50 to $4.00. Stifel analyst Rick Wise maintained his “buy” rating and price target of $4.00 for TransEntrix.

Investors interested in the medical device industry, specifically surgical systems, should keep an eye on TransEntrix as the company rolls out new sales opportunities with these new FDA-approved indications.

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Securities Disclosure: I, Gabrielle Lakusta, hold no direct investment interest in any company mentioned in this article.