Moon Surgical receives second FDA clearance, covering its commercial Maestro™ surgical robotics system

The company will now be deploying its Maestro System in the United States and Europe in a Limited Market Release, ahead of a broader launch in 2025.

PARIS and SAN FRANCISCO, June 5th, 2024 -- Moon Surgical, a French-American pioneer in surgical innovation, announced today the United States Food and Drug Administration (FDA) clearance for the commercial version of its unique Maestro surgical system.

“At Moon Surgical, we are innovating and inspiring the art of surgery. Our Maestro System introduces a new category of surgical robotics tailored for the broad laparoscopy market, enabling robotics utilization on an unprecedented scale. We enable healthcare providers to enhance existing tools and optimize surgical services with data-driven insights," said Anne Osdoit, CEO of Moon Surgical, and a Partner at Sofinnova Partners' medtech accelerator, MD Start. "This clearance is very timely and will bolster the remarkable traction we’ve had following the recent SAGES conference, with US sites eagerly lining up to join our Limited Market Release.”

Maestro is designed to support surgeons, operating room staff and patients in the 18.8 million annual soft tissue surgical procedures not currently supported by available telerobotic systems. Maestro is small, adaptable, and is integrated into existing clinical workflows over any laparoscopic indication. Its capabilities can bolster operating room efficiency, allowing for alternative labor models while providing shorter and more predictable procedure duration. The System is equipped with NVIDIA Holoscan, a powerful edge computing platform that allows real-time algorithms based on Artificial Intelligence to be deployed in the operating room for immediate benefits during surgery.

“The team at Moon Surgical has been impressively delivering on schedule while adding resources to get ready for its commercial phase,” commented Fred Moll, Chair of the Moon Surgical board. “After a fantastic initial experience in Europe in a real-world, multi-specialty setting, we are eager to implement Maestro programs at select US sites over the next few months.”

Moon Surgical’s Maestro System obtained CE mark in September 2023 and has been used to treat over 200 patients to date in general, bariatric and gynecologic surgery at two European pilot sites.

About Moon Surgical

Moon Surgical, based in Paris, France, and San Francisco, California, is building the OR of the future, one that is digitalized, efficient, and sustainable. The combined power of the transformative Maestro System and the intelligent Maestro Insights empowers healthcare teams to make confident decisions and provide better surgical care for their patients. Founded in 2020, Moon Surgical prides itself on staying nimble, prioritizing innovation, and fostering inclusivity, creativity, and collaboration among its multi-cultural team members.

Moon Surgical. Inspiring and Innovating the Art of Surgery.

For investor and media inquiries, please email us at info@moonsurgical.com.

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