November 19, 2024Medtronic (NYSE: MDT) announced that it expects to submit an application to the U.S. Food and Drug Administration (FDA) for the use of its Hugo surgical robot in urological procedures in early 2025.

Medtronic Chairman and CEO Geoff Martha said on the company's second-quarter earnings call that the medical technology giant expects to file in the first quarter of the 2025 calendar year.

During the conference call, Martha stated that the company is "laying a solid foundation for future growth." In addition to Hugo's application, Medtronic also highlighted the launch of its Touch Surgery Live Stream and the rapid enrollment in hernia and gynecology studies.

"We continue to invest in the Hugo platform," Martha said. "We have completed the data collection required for the urology application and expect to submit the application to the FDA in the first quarter of the 2025 calendar year. We are also seeing rapid enrollment in our next two indication studies in the United States—hernia and gynecology studies."

Martha expects that ICG fluorescence imaging technology will be introduced for Hugo in some countries soon. He also anticipates adding the company's LigaSure vessel sealing technology to Hugo in 2025.

Hugo is a modular, multi-quadrant platform designed for a variety of surgical procedures.It features wristed instruments, 3D visualization, and surgical video capture options in Touch Surgery Enterprise.Medtronic first unveiled Hugo in September 2019, positioning it as a potential competitor to long-term industry leader Intuitive Surgical.

The company continues to build on the Hugo platform and has added more clinical studies earlier this year to expand its indications to hernia and gynecology fields.

"We are absolutely committed to... not just being involved, but helping to lead the way as we have done in the spine field," said Martha when discussing surgical robotics.

In September, the company strengthened its efforts in surgical robotics by appointing Dr. James Porter as Chief Medical Officer for robotic surgery technology and digital technology.

Medtronic's entry into the soft tissue robot-assisted surgery field represents a significant growth opportunity for Medtronic, as well as for Intuitive Surgical, which currently dominates the soft tissue robotic surgery market, as it signifies an expanding market.In recent years, several medical technology companies have also entered the surgical robotics market, hoping to compete with Intuitive. Intuitive has held the leading position in surgical robots for over 20 years, with no signs of slowing down. In the orthopedic field, Stryker has launched surgical robots for hip and knee replacements and plans to expand into shoulder and spine applications. Zimmer Biomet has introduced its own orthopedic surgical robot, ROSA, for total knee replacements.

Surgical robots for soft tissue applications and endoscopic procedures are also on the rise. In 2019, Johnson & Johnson Medical Technologies acquired Auris Health, along with its surgical robot used in bronchoscopic diagnostic and therapeutic procedures. The Versius robotic system by CMR Surgical has expanded to cover over 130 types of complex and benign surgeries as the UK-based company grows its presence outside the United States. Versius is utilized across seven surgical specialties, performing procedures such as colectomies, hernia repairs, hysterectomies, sacrocolpopexies, and lobectomies. Many other medical technology companies, including Moon Surgical, SS Innovations, Noah Medical, Corin Group, and others, are also developing surgical robots. This makes for a highly competitive market.

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