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Virtual Incision Announces MIRA’s Clinical Trial Results Will Be Presented at the 2023 ASCRS Scientific Meeting

Attendees will be the first to see outcomes from the complete patient series within MIRA’s Investigational Device Exemption clinical study

Virtual Incision Corporation, the developer of the world’s first miniaturized robotic-assisted surgery (RAS) system, today announced that the data from its Investigational Device Exemption (IDE) clinical trial will be presented at the 2023 American Society of Colon and Rectal Surgeons (ASCRS) Annual Scientific Meeting in Seattle, WA. The study was designed to evaluate the safety and efficacy of MIRA for use in bowel resection procedures.

“Dr. John Marks will unveil the full patient data set to his peer group for the very first time,” said John Murphy, president and chief executive officer of Virtual Incision. “I believe many surgeons will be pleasantly surprised that MIRA’s unprecedented, miniaturized form factor can tackle a complex multi-quadrant procedure like colon resection across a broad range of patient types. We are hopeful that the data will help support the marketing authorization for MIRA, and we look forward to hearing feedback on the study results from colorectal surgeons across the country.”

Surgical cases in the IDE study were completed at three hospitals across the U.S. The data were then analyzed and submitted to the FDA as part of the company’s De Novo request for marketing authorization. Virtual Incision is the first RAS developer to complete a U.S. IDE study to support a De Novo request in bowel resection. The below presentation will include data from all three sites.

Presentation Details:

  • Title: “Clinical Assessment of a Miniature Robotically Assisted Surgical Device (RASD) for Right and Left Colectomy”
  • Speaker: John Marks, M.D., director of the Colorectal Center at Lankenau Medical Center, chief of the section of colorectal surgery at Main Line Health, and professor of surgery at the Lankenau Institute for Medical Research in Wynnewood, Pennsylvania
  • Date: Tuesday, June 6, 2023
  • Time: 2:58-3:03 PM PDT
  • Location: Room 606-609 (Seattle Convention Center)

About the MIRA Surgical System

MIRA is the world’s first miniaturized robotic-assisted surgery (RAS) system. Its small, sleek form factor is designed to offer the benefits of RAS during abdominal surgical procedures without the logistical inefficiencies of traditional mainframe robotics. The easily accessible device weighs approximately two pounds and offers internal triangulation with shoulders, arms, and infinite wrist roll inside of the body. It can be used in any operating room – a dedicated mainframe room is unnecessary. With its drape- and dock-free design and portability, MIRA is quick to set up, clean up, and move between cases. Its conveniently accessible design positions it to be used as a standalone system or a complementary tool for facilities that already own a mainframe. With MIRA, every operating room is RAS-ready. The MIRA Surgical System is an Investigational Device and is not available for sale.

About Virtual Incision

Virtual Incision is on a mission to simplify robotic-assisted surgery (RAS), so more patients and their surgeons can access its benefits every day. Headquartered in Lincoln, Nebraska, and holding over two hundred patents and patent applications, the company is developing MIRA, the first-of-its-kind miniature RAS system. Virtual Incision’s goal is to make every operating room RAS-ready. For more information, visit our website or follow us on LinkedIn and Twitter.

Cautionary Note Regarding Forward-Looking Statements

This communication contains statements that constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include but are not limited to, statements regarding our plans, beliefs, expectations, assumptions, and other statements that are not necessarily historical facts. You are cautioned that these forward-looking statements are only predictions and involve risks and uncertainties. Further, any forward-looking statement speaks only as of the date on which it is made, and we do not intend to update or revise any forward-looking statements. This communication also contains market data related to our business and industry which includes projections that are based on several assumptions we believe are reasonable and most significant to the projections as of the date of this communication. If any of our assumptions prove to be incorrect, our actual results may significantly differ from our projections based on these assumptions.

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