Virtual Incision Receives FDA Authorization for the First Miniaturized Robotic-Assisted Surgery Device

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Feb 27, 2024, 07:45 ET

GRAND RAPIDS, Mich., Feb. 27, 2024 /PRNewswire/ -- Virtual Incision, a cultivate(MD) portfolio company, has been granted marketing authorization of the MIRA™ Surgical System (MIRA) from the FDA. This marks a significant milestone as MIRA becomes the first miniaturized robotic-assisted surgery device in the world approved for adult colectomy procedures.

The device was submitted via the FDA's De Novo Classification process, a rigorous pathway designed to classify novel medical devices. FDA authorization was based in part on findings from the company's U.S. Investigational Device Exemption (IDE)clinical study.

R. Sean Churchill, MD, MBA, Managing Director of cultivate(MD), expressed enthusiasm for the FDA approval. "cultivate(MD) Capital Funds is proud to have partnered with Virtual Incision Corporation along their developmental journey. We have long recognized the need for mainstream robotics in medicine that can simultaneously provide minimally invasive surgery with system portability allowing use in large university based hospital systems as well as smaller community hospitals, all in a cost effective, efficient manner. Virtual Incision Corporation accomplished these goals and has redefined the future of robotic surgery."

cultivate(MD) views MIRA's innovative design as a potential game-changer in the realm of surgical technology. With its compact size (weighing less than two pounds) and a user-friendly tray-to-table setup, MIRA is designed to with the hopes of enhancing operating room efficiency. This innovative approach aims to facilitate the integration of robotic surgery in a wider range of healthcare settings, potentially overcoming the logistical challenges associated with the large surgical robots that are currently available.

"We have been in awe of watching this incredible innovative technology and team for years, creating and thinking outside of the box," said David Blue, Director of cultivate(MD) Capital Funds. "These miniature robots will be the future, and they will continue to amaze the rest of the surgical robotics world, and it will be fun seeing them lead us into this new world! We are so excited and honored to be on this journey with Virtual Incision!"

With FDA authorization in hand, Virtual Incision is set to initiate MIRA's commercial rollout in select centers in the United States.

MIRA's broader commercialization and expansion of its roadmap for future indications includes gynecology, general surgery, urology and other soft tissue and solid organ surgery.

Additionally, a new iteration of the technology tailored to general surgery is in design and expected to be used in a first-in-human study outside the U.S. later this year.

About cultivate(MD)

cultivate(MD) is a medical device venture capital firm dedicated to advancing healthcare innovation. With a keen focus on cutting-edge medical technologies, cultivate(MD) supports companies that show the potential to revolutionize healthcare delivery and patient care.

For more information, visit: https://cultivate-md.com

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 developed 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: https://virtualincision.com

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