Moon Surgical sets up robotic assistant launch with FDA clearance, first-in-human study

Moon Surgical quickly cleared two development stages this month as it blasts toward its goal of providing laparoscopic surgeons with a robotic helper on the operating table.

The company, previously known as MastOR, secured its first 510(k) clearance from the FDA for its Maestro surgical system and shortly followed that up with the announcement that it had completed its first-in-human study of the hardware.

The Maestro device aims to provide two extra, flexible arms that can hold minimally invasive probes, cameras and instruments in place during a procedure. They are placed alongside the patient opposite the surgeon, who can then manipulate them by hand and equip them with nearly any off-the-shelf laparoscopic tool.

Based in Paris and San Francisco, Moon Surgical said last week it had wrapped up 30 procedures in humans spanning seven different clinical uses, all completed within 10 days at the CHU Saint-Pierre university hospital in Brussels, Belgium. 

Fourteen of the cases included the removal of the gallbladder; others included bariatric interventions, hernia repairs, colorectal procedures and gastric reflux surgery.

The company estimates that more than 18 million soft-tissue surgical procedures are performed by hand worldwide each year that could benefit from the steady grip offered by robotic assistance. Moon Surgical also hopes the Maestro can increase operating room efficiency while allowing surgeons to place devices exactly where they want them.

"At Moon Surgical, we are creating a new category of surgical robotics that will change the scale at which robotics can be deployed and enable healthcare providers to do more with the tools they already have," CEO Anne Osdoit said in a release. The company also said it has its eye on select high-volume surgical centers in the U.S., and that it is currently finalizing the development of its first commercial system.

This past June, Moon Surgical raised $31.3 million in a series A round led by GT Healthcare Capital & Partners. Other backers included Johnson & Johnson Innovation, Cathay Health and Sofinnova Partners, which previously delivered seed funding and supported incubation efforts. 

Individual medtech investors included Yann Fleureau, CEO of Cardiologs; Siddarth Satish, vice president of digital innovation at Stryker; Sacha Loiseau, CEO of Mauna Kea Technologies; and Richard Leparmentier, general manager of Telos Health. GT Healthcare’s Alan Au joined Moon Surgical’s board, while Cathay Health’s Steve Oesterle and J&J’s robotics guru Fred Moll signed on as board advisers.