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Virtual Incision Earns Approval to Complete Clinical Study for Miniaturized Surgery Platform

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April 19, 2022

Virtual Incision Corporation, which is developing a miniaturized robotic-assisted surgery (RAS) platform, has announced the Food and Drug Administration (FDA) approved an Investigational Device Exemption (IDE) supplement. This will complete the final stage of its clinical study analyzing the MIRA Platform in bowel resection procedures. Virtual Incision said the approval was supported by a favorable interim clinical study report on the safety profile of MIRA.

The company said the IDE supplement approval puts it on track to obtain the clinical evidence needed to bring innovation to the soft tissue surgical robotics industry, which has been historically dominated by a single company. Results of the study will support MIRA’s upcoming FDA De Novo application for market authorization, Virtual Incision said.

“Our clinical experience has been extremely positive so far,” said  Dr. Michael Jobst, the first surgeon in the world to operate with the device. “I was able to perform 100% of the dissection with MIRA in all my cases. We have also been pleased with its accessibility and efficiency. I operated on eight patients in five different operating rooms, and that’s something that’s just not possible with mainframe RAS platforms. MIRA has the potential to bring the benefits of minimally invasive surgery to more patients, and that’s truly exciting.” In addition to Dr. Jobst, Drs. Kelly Krier, John Marks and Henry Schoonyoung participated in the first cases of the study.

“MIRA was created to address the limitations of traditional robotic-assisted mainframe machines,” said John Murphy, president and CEO of Virtual Incision. “We miniaturized and simplified MIRA to make it more accessible, easy to use, and easy to adopt. These are the features that will allow surgeons to treat more patients each day. It is encouraging to see MIRA demonstrating the potential to help surgeons perform simplified robotic procedures safely and precisely. Completing the final stage of our clinical study will be a key milestone along MIRA’s regulatory pathway, and we will continue to focus on clinical excellence to best support the innovation we provide to patients and surgeons.”

The MIRA platform is designed to offer the benefits of RAS during abdominal procedures without the logistical inefficiencies of traditional mainframe robotics. The device weighs only two pounds, and can be used in any operating room. Virtual Incision said MIRA is quick to set up, clean up and move in between cases.

For more details on the platform, visit the Virtual Incision website here.


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