FRANCE – Quantum Surgical, a French company, has received FDA approval for its robot, Epione, that is specifically designed to target liver cancer.
The clearance allows the Epione interventional oncology robot to be marketed in the United States, with Quantum Surgical planning to expand the platform’s indications to other organs.
Quantum Surgical also stated that it intends to create artificial intelligence (AI)-based decision-support features for the Epione platform.
The Epione system from the company aids in the planning and execution of minimally invasive ablation surgery as an outpatient procedure by deploying computer-guided needles through the skin to identify and destroy tumors.
Quantum Surgical began commercializing its robot in January, with the first surgeries taking place at the Gustave Roussy cancer research hospital outside of Paris. In Europe, Epione will be granted a CE mark in September 2021.
Gustave Roussy physicians previously participated in Quantum Surgical’s clinical trial, and the company reported using the Epione in an outpatient procedure to treat a patient with liver cancer in late 2020, Fierce Biotech reports.
The study enrolled 21 people and involved the 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 successfully destroyed, and subsequent examinations revealed no complications from the procedure.
When used in conjunction with a CT scanner, the cart-based Epione system aids in procedure planning by defining tumor margins using 2D and 3D images.
The system then synchronizes the movements of the robot with the patient’s breathing and employs probes to precisely burn out tumor cells. The single arm of the device is compatible with a variety of needle types and ablation systems.
Quantum Surgical stated that it intends to expand the clinical reach of the Epione system to include additional organs and procedures
Epione’s commercial launch
Last October, the company raised 40 million euros (approximately US$48 million) in financing to help power its commercial launch.
The European Investment Bank, Bpifrance, and Caisse d’Epargne Languedoc Roussillon provided half of the funding, with the remainder coming from other sources such as Ally Bridge Group.
Bertin Nahum, Quantum Surgical’s co-founder and CEO, previously led French robotics developer Medtech SA, the maker of the Rosa Brain and Rosa Spine systems, which were acquired by Zimmer Biomet in 2016 for approximately US$132 million.
The Rosa Spine system recently left Zimmer Biomet to join the company’s nascent ZimVie spinout, a billion-dollar business focused on the spine and dental segments, while the Rosa One Brain neurosurgery platform remains.
Several companies have been working on systems to bring a steady, robotic hand to needle-based procedures, with some aiming to make their hardware as small as possible.
In 2020, the FDA approved XACT Robotics’ 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 is a small, box-like robot that attaches to the operating table and allows surgeons to perform percutaneous procedures from another room without being exposed to imaging radiation.
Quantum Surgical, on the other hand, intends 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.