Galen Robotics, Inc., a leading medtech company specializing in advanced robotic surgical systems, today announced U.S. Food and Drug Administration (FDA) De Novo classification grant and authorization to market the Galen ES® Robotic System for use in rigid microlaryngeal procedures. This milestone achievement marks a significant step in Galen Robotics’ mission to meet underserved markets with its surgical robotic assistant.

The Galen ES is a cooperatively powered surgical assist device for ear, nose, and throat (ENT) surgery. It facilitates ENT surgical procedures, including instrument placement in conjunction with Microlaryngeal Alligator Forceps. The device works in partnership with the surgeon’s movements to assist with precise and stable positioning of an instrument while maintaining the surgeon’s direct physical control of the instrument.

“Our team is incredibly proud the Galen ES Robotic System was granted FDA clearance in record time,” announced Bruce W Lichorowic, President & CEO of Galen Robotics, Inc. “With our De Novo granted, Galen looks forward to further advancing the field of surgical robotics, revolutionizing surgical techniques, and providing innovative solutions to healthcare professionals.” Lichorowic continued, “Achieving this milestone with $25 million in funding during Covid is truly remarkable compared to other medical device companies who are spending hundreds of millions to achieve the same goal. The Galen ES System holds great promise in revolutionizing challenging ENT surgeries by providing existing surgical instruments with its advanced features that empower skilled ENT surgeons. We anticipate significantly improved surgical precision and better patient outcomes.”

Galen Robotics’ Galen ES Robotic System offers the potential for instrument stability in challenging microlaryngeal surgeries. The system’s advanced functionality and quick setup time aim to enhance the capabilities of otolaryngologists, with the intent of providing improved outcomes for patients.

The original technology for the Galen ES is based on a license from a continuing research relationship between Galen Robotics, Inc. and Johns Hopkins Technology Ventures. With the De Novo granted by the FDA, Galen Robotics looks forward to further advancing the field of surgical medicine, revolutionizing surgical techniques, and providing innovative solutions to healthcare professionals. Galen’s primary purpose is to provide valuable assistance during narrow corridor surgeries where space is limited, and where delicate structures need to be handled with utmost care.

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“We are honored to introduce our innovative technology platform to the market,” states David Saunders, Co-Founder and CTO of Galen Robotics Inc. “Galen will be the first surgical robotic company to launch as a service under the name Digital Surgery as a Service (DSAAS™). The development of DSAAS is the result of years of dedicated effort, focused on expanding to various microsurgical procedures, facilitating widespread adoption across the medical community.”

The Galen ES is intended to assist in the movement of the specified Microlaryngeal Alligator Forceps to a surgeon-selected position within a surgical field and remain in place until moved elsewhere by the operator. The Galen ES is indicated to be used in rigid microlaryngeal procedures where the specified Microlaryngeal Alligator Forceps would be utilized by an experienced trained otolaryngologist performing microlaryngeal surgery in an operating room environment in patients at least 18 years old.

Available now, orders have already been accepted for the Galen ES and are being deployed to leading surgical centers nationwide. To learn more about the Galen ES and Galen Robotics, visit www.galenrobotics.com. 

About Galen Robotics

Galen Robotics is the pioneer of Digital-Surgery-as-a-Service (DSaaS). Galen provides the world’s first cooperatively powered robotic surgical assistant platform for Ear, Nose, and Throat (ENT) surgery. Galen Robotics was founded in 2016, bringing together Silicon Valley resources and the groundbreaking work and research in surgical robotics at Johns Hopkins University. Galen Robotics is headquartered in Baltimore, Maryland.

“Galen Robotics” is a registered trademark of Galen Robotics, Inc.

“Galen ES” is a registered trademark of Galen Robotics, Inc.

For more information about Galen Robotics, please see https://www.galenrobotics.com/