FDA clears Quantum Surgical's liver-cancer-focused ablation robot

French developer Quantum Surgical has scored an FDA clearance for its robot designed specifically to target liver cancer. 

The company’s Epione system helps plan and perform minimally invasive ablation surgery as an outpatient procedure by deploying computer-guided needles through the skin to single out and destroy tumors.

Quantum Surgical began the commercial rollout of its robot this past January, with its first surgeries performed at the Gustave Roussy cancer research hospital outside Paris. Epione received a CE mark in Europe in September 2021.

Physicians at Gustave Roussy previously participated in Quantum Surgical’s clinical trial, and the company reported using the Epione to treat a patient with liver cancer through an outpatient procedure in late 2020.

The study included 21 participants and involved ablation of 24 liver lesions at Gustave Roussy and Montpellier University Hospital, including primary tumors and secondary liver metastases from other cancer sites. According to the company, all of the tumors were destroyed successfully, and subsequent exams showed no complications from the procedure. 

Paired with a CT scanner, the cart-based Epione system helps plan out the procedure by defining the tumor’s margins using 2D and 3D images. The system then synchronizes the robot’s movements with the patient’s breathing and uses probes to precisely burn out tumor cells. The device’s single arm is compatible with a range of needle types and ablation systems.

Quantum Surgical said it plans to extend the clinical reach of the Epione system to other organs and procedures. The company raised 40 million euros in financing, or about $48 million, last October to help power its commercial launch.

Half of that amount was provided through an investment from Ally Bridge Group, with the remainder raised from backers including the European Investment Bank, Bpifrance and Caisse d’Epargne Languedoc Roussillon.

Quantum Surgical’s co-founder and CEO, Bertin Nahum, previously led French robotics developer Medtech SA—the maker of the Rosa Brain and Rosa Spine systems that was acquired by Zimmer Biomet in 2016 for about $132 million.

The Rosa Spine system recently left the fold to be a part of the company’s nascent ZimVie spinout, a billion-dollar business focused on the spine and dental segments, while the Rosa One Brain neurosurgery platform still resides within Zimmer Biomet.

Multiple companies have been developing systems that aim to bring a steady, robotic hand to needle-based procedures, including some looking to make their hardware as small as possible.

Former Fierce 15 winner XACT Robotics received an FDA clearance in 2020 for its compact device, which is mounted over the patient before automatically inserting the needle for CT-guided procedures such as ablations and biopsies. 

Meanwhile, Interventional Systems’ Micromate includes a small, boxlike robot that attaches to the operating table and allows surgeons to conduct percutaneous procedures from another room without exposing themselves to imaging radiation.

By comparison, Quantum Surgical aims to give its robot more flexibility when it comes to delivering a needle at difficult angles by using a fully articulated robotic arm mounted on a bedside cart.