The MIRA Surgical System Proceeds to FDA Substantive Review for Market Authorization Under the De Novo Classification Pathway

Virtual Incision Has Achieved a Significant Milestone in Its De Novo Request and is Closer to Potential Commercial Readiness 

Lincoln, Neb. – May 18, 2023 – Virtual Incision Corporation today announced its De Novo request was submitted and is under substantive review by the U.S. Food and Drug Administration (FDA). The submission seeks authorization to market ​the ​MIRA Surgical System for use in bowel resection procedures and comes on the heels of Virtual Incision’s completed Investigational Device Exemption (IDE) clinical study.

If granted, MIRA will become the first robotic-assisted surgery (RAS) device to obtain marketing authorization through the De Novo pathway for use in bowel resection procedures, making it a trailblazer in soft tissue robotics. Beyond granting Virtual Incision the ability to commercialize MIRA in the U.S. for its intended use, authorization may lay the foundations for expanded procedural indications, entry into international markets, additional instruments and accessories, and future generations of the surgical system.

“Throughout the history of RAS, only a few companies have managed to reach this significant milestone,” said John Murphy, president, and chief executive officer of Virtual Incision. “If we are successful with our submission, the FDA De Novo pathway will establish MIRA in a brand-new medical device category of miniaturized RAS. Our design is disruptive and highly differentiated among the current landscape of available and emerging technologies. We are proud of the data we collected, as it demonstrates the capabilities of MIRA in one of the most complex multi-quadrant abdominal procedures. We also observed many operational efficiencies that make the miniaturized approach so unique and potentially scalable to the millions of patients who could be candidates for RAS each year.”

If Virtual Incision obtains marketing authorization, the company plans to initiate a limited launch of MIRA in select centers across the U.S. These centers will aim to leverage the efficiencies created with MIRA to expand the number of patients they can treat with RAS. Their experiences will serve as best practices for the broader launch. In the longer term, the objective is to enable wide adoption in any healthcare facility for any patient undergoing abdominal surgery.

 

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 platform. 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.

 

Media Contact:
Jessica Stebing
Health+Commerce
jstebing@healthandcommerce.com
260–336-6202

Disclosure and Important Safety Information

The MIRA Surgical System is intended for prescription use only. Patients should talk to their doctor to decide if surgery with a MIRA Surgical System is right for them. Patients and doctors should review all available information on nonsurgical and surgical options and associated risks in order to make an informed decision.

Serious complications may occur in any surgery, including minimally invasive surgery with the MIRA Surgical System, up to and including death. Serious risks include, but are not limited to, injury to tissues and organs, and/or conversion to other surgical techniques which could result in a longer operative time and/or complications.

For important safety information, including surgical risks and considerations, please also refer to www.virtualincision.com/safety-information. For the product’s indications for use, risks, full cautions, and warnings, please refer to the associated user manual(s).

Individual outcomes may depend on a number of factors, including but not limited to patient characteristics, disease characteristics, surgeon, and/or hospital experience.

MIRA Surgical System Precaution Statement

The demonstration of safety and effectiveness for the representative specific procedures was based on evaluation of the MIRA Surgical System as a surgical device and did not include evaluation of outcomes related to the treatment of cancer (overall survival, disease-free survival, local recurrence) or treatment of the patient’s underlying disease/condition. Device usage in all surgical procedures should be guided by the clinical judgment of an adequately trained surgeon.

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