eCential Robotics Receives FDA Clearance for its Surgical Robotic Platform for Spine Surgery

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GIERES, France, September 1, 2022 /PRNewswire/ — eCential Robotics, a growing French medical technology company that designs and manufactures a system that unifies 2D/3D imaging, surgical navigation and robotics, today announced 510(k) clearance for the FDA of its 3D imaging, navigation and robotic guidance system, securing the penetration of its unified robotic platform in United States.

Having recently entered into a partnership with American implant companies, eCential Robotics is now targeting access to the North American market.

Securing the US market penetration plan in the medium term

Created in 2009 by Stéphane Lavallée, CEO, eCential Robotics aims to enhance the safety and precision of surgical procedures, while offering simplicity and speed of use. With the objective of allowing surgeons to operate in a reliable and simple environment for the best benefit of patients, eCential Robotics has focused its development on a unique and innovative concept: to focus surgical workflows on the essentials to make bone surgery simple enough in clinical routine that it becomes a standard of care. eCential Robotics welcomes implant companies to create specific Apps for multiple indications including spine, cranial, traumatology, orthopedics, sports medicine.

Historically, after several years devoted to the massive development of its unique technology and workflow, eCential Robotics obtained CE marking and successfully launched the commercialization of its first platform in France. Ten units were sold and installed in Europe and over two thousand surgeries performed. To support the penetration of the North American market, an eCential Robotics, Inc. subsidiary was created in December 2020. In the first quarter of 2022, eCential Robotics conducted preclinical evaluation tests in the UNITED STATES with neurosurgeons and orthopedists and hired its first local applications engineer. FDA 510(k) clearance of intraoperative 2D and 3D robotic imaging, navigation and guidance platform, with first universal application in spine surgery, now secures North American market access plan during of the next few years.

“FDA clearance of the eCential Robotics Unified Platform recognizes the reliability and robustness of our product, confirms confidence in eCential Robotics’ unique concept of focusing surgical workflows on the essentials through a unified, open and multi-application system, and also encourages our ambition to expand our presence in United Statessaid Ms. Laurence Chabanas, Chief Strategy Officer of eCential Robotics and UNITED STATES CEO. “This 510(k) is fundamental to our strategy. We are excited about these bold new and disruptive technologies and the role eCential Robotics can play in redesigning bone surgery procedures and restoring quality of life for patients,” she added.

The eCential Robotics team will exhibit at the SMISS 2022 and NASS 2022 congresses in the United States and demonstrate their robotic arm.

The only fully unified solution available

In its basic design, the eCential Robotics surgical platform unifies intraoperative 2D/3D imaging, navigation and robotics. As the only fully unified solution available, it avoids the pitfalls of traditional image navigation matching, such as unreliable calibration and registration steps, and streamlines the surgical workflow by automating many steps techniques. A single user interface for all devices allows control of imaging, navigation, and robotics functionality from a single graphical input and output display screen. The system is also a fully open solution, meaning it can be used with implants from any manufacturer. Built around a range of applications (“Apps”) currently dedicated to spine surgery, the eCential Robotics platform will extend in the future to multiple bone surgery indications.

The Unified Open Platform is a medical device that provides 2D/3D medical imaging and stereotactic guidance. The system consists of three interconnected mobile units: a mobile C-arm, a mobile visualization station and a mobile collaborative robot. The Mobile X-Ray System is a 5-axis imaging robot supporting 2D imaging and 3D imaging of anatomical structures and high contrast objects. The navigation function with freehand navigation and robotic guidance is based on the standard and established technique of navigation systems using 3D optical position tracking technology, including a stereoscopic camera, the computer platform with monitors, software navigation system, a robotic arm and instruments equipped with marker spheres to allow exact location in space.

“With still huge potential for innovation, eCential Robotics simplifies the entire workflow for a seamless surgical experience,” declared David Armandtechnical director of eCential Robotics.

About eCential Robotics

eCential Robotics is a Grenoble-based company specializing in surgical robotics. It develops and markets a unique system combining 2D/3D robotic imaging and real-time navigation. With 80 patents and 7 brands, it pursues a breakthrough innovation strategy. It provides orthopedists and neurosurgeons with easy-to-use advanced technology to visualize their operations, especially minimally invasive surgery. The eCential Robotics platform is a universal system open to all implants.

Winner of the Bpifrance World Innovation Challenge in 2018, the company designs and produces all its equipment in Grenoble, France, including hardware and software. Please visit www.ecential-robotics.com and follow us on LinkedIn (eCential Robotics) and Twitter (@ecentialrobot).

Media contact Investor Relations

Marie CABRIERES
[email protected]
+33 4 58 00 55 20

Benjamin Colas
[email protected]
+33 7 85 58 35 14

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