Dive Brief:
- TransEnterix, maker of the Senhance robotic surgery system, said it expects to report fourth-quarter revenue of about $7.4 million and total 2018 revenue of $24 million, an increase of 238% from the prior year.
- When it gained FDA clearance for Senhance in October 2017, TransEnterix became the first new entrant to the abdominal robotics market since industry pioneer Intuitive Surgical introduced the da Vinci robot in 2000.
- TransEnterix said it sold five Senhance systems during the fourth quarter and 15 systems for the year. “We view 2019 as an opportunity to leverage the tremendous progress we made in 2018 and bring the benefits of Senhance surgery to more patients, surgeons and hospitals," said CEO Todd Pope, who called 2018 a "significant year."
Dive Insight:
TransEnterix positions itself as a more affordable alternative for robot-assisted surgery, with reusable instruments and open-platform architecture.
The Senhance system is approved for laparoscopic gynecological surgery, colorectal surgery, cholecystectomy and inguinal hernia repair, covering procedures for benign and oncologic treatments.
In becoming the second surgical robot maker to market, the Research Triangle Park, North Carolina-based company has a jump on a number of prospective competitors expected to enter the field, from Google-parent Alphabet's life sciences arm Verily, to deep-pocketed medtech heavyweights such as Medtronic and Johnson & Johnson and small startups.
In its business update on Monday, TransEnterix ticked off several milestones reached in the latest quarter, including receiving regulatory approval to sell its Senhance system instruments in Taiwan and launching its Ultrasonic instrument system in CE Mark countries.
The company said it expects to gain FDA 510(k) clearance for the Ultrasonic instrument system in the first quarter of 2019. In October, TransEnterix announced that FDA cleared a set of smaller-sized robotic instruments that will allow surgeons to operate through tiny incisions in the patient.
TransEnterix said it completed a previously announced deal to acquire Israel-based MST Medical Surgery Technologies, a developer of software for advanced visualization, scene recognition, artificial intelligence and data analytics, for an undisclosed price.
Of the five new system sales it made in the fourth quarter, one was sold in the United States, three were sold in the EMEA (Europe, Middle East and Africa) region, and one was sold in Asia, the company said.
