Restore Robotics Seeks FDA 510(k) Clearance for Remanufacturing Da Vinci Xi® 8mm Monopolar Curved Scissors

*Significant cost savings for hospitals and expanded sustainability initiatives with recycling program*

PANAMA CITY BEACH, Fla., Oct. 16, 2024 /PRNewswire/ -- Restore Robotics, a leader in surgical robotics innovation, today announced that its subsidiary, Iconocare Health, submitted an additional 510(k) application to the U.S. Food and Drug Administration (FDA) on August 30, 2024. The submission seeks clearance to remanufacture Da Vinci Xi® 8mm Monopolar Curved Scissors, marking a major step in the company's ongoing commitment to providing hospitals with high-quality, remanufactured robotic instruments that significantly reduce costs and expand hospital environmental sustainability initiatives.

"With this FDA submission, we're focused on delivering cost-efficient solutions while maintaining the high standards of performance and quality that our partners rely on," said Clif Parker, CEO of Restore Robotics. "Hospitals using our remanufactured Da Vinci Xi® 8mm Monopolar Curved Scissors will see significant cost savings, allowing them to better manage their resources."

Cost Savings and Sustainability

Restore Robotics's remanufactured instruments offer hospitals substantial cost savings compared to purchasing new devices. By restoring the original manufacturer's instruments for an additional cycle of uses, hospitals can stretch their budgets further – and maximize the availability of the latest advances in robotic surgery to patients in their communities.

Sustainability and Recycling Program

As part of its environmental commitment, Restore Robotic's has launched a Da Vinci Xi® recycling program aimed at collecting expired surgical instruments from hospitals for potential remanufacturing. This program, conducted at Restore Robotic's Henderson, Nevada facility, helps reduce medical waste and promotes sustainability within the healthcare sector.

"Our recycling initiative not only results in significant cost benefits for hospitals but also reduces the environmental footprint of surgical care," added Kevin May, COO of Restore Robotics. "By extending the lifecycle of robotic instruments, we're making a meaningful contribution to healthcare sustainability."

Marketing and Distribution Partnership with Encore Medical Device Repair

Through its marketing and distribution partnership with Encore Medical Device Repair, Restore Robotics is able to efficiently deliver remanufactured instruments to hospitals and surgical centers across the U.S., for use on the Da Vinci® platform, expanding access to

affordable, high-quality robotic instruments. Rick Ferreira, Chairman of the Board of Encore Medical Device Repair said "Restore Robotics' focus on making remanufactured robotic instruments available to US hospitals shows the company's unrelenting focus on asset stewardship that benefits patients and providers alike. We are proud to partner with Restore Robotics to ensure safe, regulated remanufacturing can make a real difference in the financial and environmental sustainability of robotic procedures."

About Restore Robotics

Based in Panama City Beach, Florida, Restore Robotics is a pioneer in the surgical robotics field, offering innovative solutions that enhance the performance and sustainability of surgical systems. The company's recycling operations are based at its facility in Henderson, Nevada.

About Encore Medical Device Repair

Encore Medical Device Repair is a leading provider of medical device repair services, specializing in extending the life of critical medical instruments through expert repair and remanufacturing. Partnering with Restore Robotics, Encore ensures that hospitals and surgical centers have access to reliable, high-quality, and cost-effective robotic instruments.

For more information, please visit restorerobotics.com or contact:

Clif Parker

CEO, Restore Robotics

info@restorerobotics.net

678-619-0011

Restore Robotics is an independent entity and is not affiliated with Intuitive Surgical®, Inc. or its affiliates. Intuitive Surgical's® products, including the da Vinci® Surgical System and any related trademarks, are the property of Intuitive Surgical, Inc. All registered trademarks and product names mentioned herein are the property of their respective owners.

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SOURCE Restore Robotics