International industry executive Piet Hinoul joins Virtual Incision as chief medical officer, Dmitry Oleynikov transitions to chief surgeon Read more
Study results will be used to support the first FDA De Novo request for market authorization of the MIRA Surgical System as Virtual Incision makes progress towards its mission to expand RAS access
Lincoln, Neb. – February 22, 2023 – Virtual Incision Corporation, a medical device company spearheading the development of the world’s first miniaturized robotic-assisted surgery (RAS) system, today announced the completion of its U.S. Food and Drug Administration (FDA) Investigational Device Exemption (IDE) clinical study. The study was designed to evaluate the company’s MIRA Surgical System for use in bowel resection procedures. This is an important achievement towards bringing new technologies to hospitals and their surgical robotics programs regardless of the site of care.
The surgical cases were completed at three hospitals across the country. Patients who participated in the study were followed after their procedure to fulfill study requirements. The complete data will be correlated and submitted to the FDA as part of the company’s De Novo request for market 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 investigators are very encouraged by our experiences trialing the MIRA Surgical System,” said Michael A. Jobst, MD, colorectal surgeon. “Across the sites, we’ve seen MIRA efficiently integrate into existing RAS programs and witnessed how it is mobile enough for use in any operating room. Some sites have even completed multiple cases in a single day. We are eager to fulfill the clinical requirements of the study in hopes that MIRA can help expand RAS access to more patients in the future.”
There are 5 million Americans who undergo abdominal soft tissue procedures annually, however, more than 90 percent go without access to RAS. If authorized by the FDA, MIRA’s miniaturized, strong, and easy-to-use design could potentially increase the overall availability of RAS. It has the potential to integrate into any facility or operating room by serving as a complement to the existing mainframe RAS systems, or by expanding into new sites of care and geographies as a standalone. Virtual Incision aims to increase patient access through a clinically, operationally, and economically sound platform available to all providers.
“Completing MIRA’s IDE clinical study is a critical milestone in our journey to making RAS more accessible,” said John Murphy, president and chief executive officer of Virtual Incision. “Currently, less than 10 percent of the 90,000 operating rooms in the U.S. are equipped with mainframe RAS systems. Beyond the incredible progress of the industry pioneer, it’s still in the early days of the adoption of soft tissue surgical robotics. Our ultimate goal is to develop world-class miniature RAS devices with the required strength and dexterity to enable positive clinical outcomes for a broad range of procedure types.”
About the MIRA Surgical System MIRA is the world’s first miniaturized robotic-assisted surgery (RAS) system. Its small, sleek design is planned to offer the benefits of RAS during bowel resection 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.
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 200 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.
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MIRA will go into space for simulated surgical testing aboard the ISS thanks to a NASA grant
Lincoln, Neb. – August 2, 2022 – Virtual Incision Corporation, a medical device company pioneering the world’s first miniaturized robotic-assisted surgery (RAS) platform, today announced that its MIRA™ Platform will test its skills in space on a 2024 technology demonstration mission aboard the International Space Station (ISS). The opportunity is driven by a recently awarded grant from the National Aeronautics and Space Administration (NASA).
“The Virtual Incision MIRA platform was designed to deliver the power of a mainframe robotic-assisted surgery device in a miniaturized size, with the goal of making RAS accessible in any operating room on the planet,” said John Murphy, CEO of Virtual Incision. “Working with NASA aboard the space station will test how MIRA can make surgery accessible in even the most faraway places.”
Although it is not yet available for sale, MIRA is currently in the final stages of its U.S. clinical trial under an Investigational Device Exemption to support U.S. Food and Drug Administration (FDA) market authorization. Weighing approximately 2 pounds, its small size makes it appealing to surgeons and hospital staff and also makes it ideal for use within the tight space and mass requirements of a long-duration space mission. Once aboard, MIRA will operate inside a microwave-oven-sized experiment locker and perform activities that simulate those used in surgery, such as cutting simulated tissue and manipulating small objects.
“NASA has ambitious plans for long-duration space travel, and it’s important to test the capabilities of technology that may be beneficial during missions measured in months and years,” said Shane Farritor, co-founder and chief technology officer at Virtual Incision. “MIRA continues to push the boundaries of what’s possible in RAS, and we are pleased with its performance so far during clinical trials. We’re excited to take it a step further and help identify what could be possible in the future as space travel is becoming more of a reality for mankind.”
NASA’s grant was awarded to the University of Nebraska-Lincoln through the Established Program to Stimulate Competitive Research (EPSCoR) at the University of Nebraska Omaha. Farritor serves as professor of engineering at the University of Nebraska-Lincoln, where he has led research on the potential use of surgical robots in space. Farritor co-founded Virtual Incision with Dmitry Oleynikov MD, combining their experience in engineering and minimally invasive surgery to help create MIRA. Prior to Virtual Incision, Farritor studied at the Kennedy Space Center, Goddard Space Flight Center, and the Jet Propulsion Laboratory.
FDA decision supported by an interim clinical study report on patient safety
Lincoln, Neb. – April 19, 2022 – Virtual Incision Corporation, a medical device company pioneering the world’s first miniaturized robotic-assisted surgery (RAS) platform, today announced the U.S. Food and Drug Administration (FDA) has approved an Investigational Device Exemption (IDE) supplement to complete the final stage of its clinical study analyzing the MIRA® Platform in bowel resection procedures. The approval was supported by a favorable interim clinical study report on the safety profile of MIRA.
The IDE supplement approval puts Virtual Incision on track to obtain the clinical evidence needed to bring innovation to the soft tissue surgical robotics industry, a market that has been historically dominated by a single player. Results of the completed study will support MIRA’s upcoming FDA De Novo application for market authorization.
The first cases of the study were completed at Bryan Medical Center in Lincoln, Neb. by Dr. Michael Jobst and Dr. Kelly Krier, and at Lankenau Medical Center in Wynnewood, Pa. by Dr. John Marks and Dr. Henry Schoonyoung.
“Our clinical experience has been extremely positive so far,” said Dr. 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 of 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.”
“MIRA was created to address the limitations of traditional robotic-assisted mainframe machines. We miniaturized and simplified MIRA to make it more accessible, easy to use, and easy to adopt,” said John Murphy, president and chief executive officer of Virtual Incision. “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.”
Lincoln, Neb., and Pleasanton, Calif. – August, 16, 2021 – Virtual Incision Corporation, a medical device company pioneering first-of-its-kind miniaturized robots for laparoscopic surgery, today announced that the world’s first surgery using the MIRA™ (“miniaturized in vivo robotic assistant”) Surgical Platform has been successfully performed by Michael A. Jobst, M.D., at Bryan Medical Center in Lincoln, Neb.
The robotically assisted right hemicolectomy procedure, which was completed using the MIRA surgical platform via a single incision within the navel, was performed as part of a clinical study of MIRA under an Investigational Device Exemption (IDE) from the U.S. Food and Drug Administration (FDA). The study will be conducted at a limited number of U.S. hospitals in support of the system’s regulatory pathway to approval.
“The MIRA platform is a true breakthrough platform for general surgery, and it is extremely gratifying to be the first surgeon in the world to use the system,” said Dr. Jobst. “The procedure went smoothly, and the patient is recovering well. I’m excited to play a part in taking the first steps toward increasing access to robotically assisted surgery, which has clear benefits for patients.”
The MIRA Surgical Platform is a portable robot that allows surgeons to perform real-time minimally invasive single incision surgeries in any hospital or health center, without the need for the dedicated space or infrastructure typically required for “mainframe” robotic systems. Weighing only two pounds, the miniature platform has full robotic capabilities, and can easily be moved from room to room. The system is designed to enable complex, multi-quadrant abdominal surgeries using a simple, handheld device.
Many hospitals currently offering robotic surgeries face challenges with scheduling because the demand for minimally invasive procedures exceeds the number of available robots. Capital costs often prohibit hospitals from purchasing additional platforms. MIRA aims to present a cost-effective alternative solution that will expand access to a larger number of patients.
“We are ushering in a new era of innovation to bring the benefits of robotic surgery to patients everywhere,” said John Murphy, Virtual Incision CEO. “This first procedure is an incredible milestone that further advances our goal to expand access to the benefits of minimally invasive robotic procedures to patients to virtually any U.S. healthcare provider, regardless of the distance from an urban center. We look forward to expanding our clinical trial to additional sites and states in the coming months.”
Virtual Incision is currently focused on expanding access to minimally invasive colorectal and lower gastrointestinal procedures, the fastest-growing operational areas for patients in the United States, with more than 400,000 surgeries performed each year. Though significant technological advancements and improved patient outcomes can reduce the total cost of care, the adoption of minimally invasive colon resection has been limited, despite increasing rates of these conditions.
“The aim of creating a miniature robotic platform has always been to enable surgical teams to perform with greater operating room efficiency and surgical precision. Today we saw firsthand the benefits that a robotic assisted platform can provide over conventional surgery,” said Dmitry Oleynikov, M.D., chief medical officer and co-founder of Virtual Incision.
Beyond its initial device design for colon resection, Virtual Incision has begun developing a family of procedure-specific mini-robots for additional operations such as hernia repair, gallbladder removal and others, potentially enabling millions more surgical procedures each year. With its foundational intellectual property – including more than 200 patents and applications – Virtual Incision is poised to lead the next wave of innovation in robotic surgery with the pioneering MIRA system.