Virtual Incision Announces Successful Completion of the First Hysterectomy Performed with the MIRA™ Surgical System

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Clinical study results intended to be used in regulatory submissions for gynecologic indications

New study begins on the heels of FDA marketing authorization for use in adults undergoing colectomy procedures

LINCOLN, Nebraska – July 30, 2024 – Virtual Incision Corporation, the developer of the MIRA Surgical System (MIRA), today announced the successful completion of the first surgery in a clinical study assessing the safety and efficacy of its miniaturized robotic-assisted surgery (miniRAS) device in benign hysterectomy procedures.

More than one million women in the U.S. alone undergo surgery for benign gynecologic conditions annually.1 A minimally invasive approach can shorten the hospital stay, reduce blood loss and decrease complication rates compared to open surgery. Robotic-assisted surgery (RAS) devices, like MIRA, could elevate the surgeon’s vision, precision, and control when operating through a small incision, ultimately enabling the techniques to be performed on a broader range of patients.2 However, about 90 percent of U.S. operating rooms (ORs) are still lacking access to RAS, most often due to complex logistics such as dedicated space, specially trained staff, long turnover times and a substantial cost for the equipment.3.

MIRA’s innovative tray-to-table design could offer healthcare facilities the advantages of RAS without requiring them to organize the OR around the device. The miniRAS device’s compact, approximately two-pound (less than one kg), framework is portable and designed to make any OR robot-ready within minutes.

The MIRA Surgical System Hysterectomy Study is an international prospective clinical study designed to evaluate device performance and safety of the MIRA Surgical System when used to robotically assist in benign hysterectomy procedures. Outcomes from this study are planned to support future U.S. and international regulatory submissions for benign gynecologic indications. This study is the second clinical study of MIRA. The first study, under a U.S. Food and Drug Administration (FDA) Investigational Device Exemption (IDE) protocol, supported the De Novo marketing authorization for MIRA in colectomy procedures that was announced in February 2024.

This first surgery was successfully completed at the Geneva University Hospitals by Jean Dubuisson, M.D., Ph.D., a gynecologic surgeon and the principal investigator for the MIRA Surgical System Hysterectomy Study.

“Completing the first hysterectomy with the MIRA Surgical System is an exciting milestone for our hospital and for the entire field of gynecology,” said Dr. Dubuisson. “Robotic-assisted surgery is a valuable tool, but technology access is still a challenge due to cost, time and operating room space. Miniaturization has the potential to overcome these issues and enable more women to have a minimally invasive option for their surgery. We are pleased with the results so far and look forward to further assessing the device in the MIRA Hysterectomy Study.”

“At Virtual Incision, we are anchored in clinical excellence as our first priority,” said Piet Hinoul M.D., Ph.D., chief medical officer of Virtual Incision. “We are encouraged by the results of our clinical and preclinical work to date, and we believe that miniaturized robotic-assisted surgery will have broad applications across a wide variety of procedures. We are grateful to the Geneva University Hospital team for their contributions, as well as to the patients who are willing to participate in this important work. We are excited to reach this milestone as part of our mission to make every operating room robot-ready.

In parallel to conducting the MIRA Surgical System Hysterectomy Study, Virtual Incision is continuing to innovate in the field of miniaturized surgical robotics. New iterations are in design that will enable MIRA to be applied across specialties including general surgery, urology, and other soft tissue and solid organ 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 colectomy procedures without the logistical inefficiencies of traditional mainframe robotics. The easily accessible device weighs approximately two pounds (less than one kg) 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.

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 our website or follow us on LinkedIn and X.

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. For important safety information, indications for use, risks, and warnings, please refer to www.virtualincision.com/safety-information.

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.

References:

  1. Life Science Intelligence 2021 Report on Obstetrics and Gynecology.
  2. Lenfant L, Canlorbe G, Belghiti J, Kreaden US, Hebert AE, Nikpayam M, Uzan C, Azaïs H. Robotic-assisted benign hysterectomy compared with laparoscopic, vaginal, and open surgery: a systematic review and meta-analysis. J Robot Surg. 2023 Dec;17(6):2647–2662. doi: 10.1007/s11701-023–01724‑6. Epub 2023 Oct 19. PMID: 37856058; PMCID: PMC10678826.
  3. Hazan, A., Perse, J., Coover, P. June 2022. State of the Robotics Surgery Market. Goldman Sachs.

Media Contact:

Jenna Kane

Health+Commerce

jennakane@healthandcommerce.com

(480) 388‑9587

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Virtual Incision Announces Publication of Data from its U.S. Investigational Device Exemption Study in the Clinical Journal, Diseases of Colon and Rectum

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 – Data demonstrate the safety and efficacy of the MIRA Surgical System, a novel miniaturized robotic-assisted surgery device, in adults undergoing colectomy procedures

LINCOLN, Neb. – April 30, 2024 – Virtual Incision Corporation, the developer of the MIRA™ Surgical System (MIRA), today announced data from its Investigational Device Exemption (IDE) clinical study has been published in Diseases of Colon and Rectum. The study was designed to assess the safety and efficacy of MIRA, the world’s first miniaturized robotic-assisted surgery device, in adults undergoing colectomy procedures. Results were provided to the Food and Drug Administration (FDA) as part of the submission to support the de novo marketing authorization of the device.

The data demonstrated the following results:

  • The primary efficacy endpoint, the successful completion of pre-defined procedural steps without conversion to open surgery, was met.
  • The primary safety endpoints, overall intraoperative and postoperative adverse events (AEs), and the incidence of serious AEs (device and procedure-related) were also met. There were no intraoperative surgical complications.

“There is a growing body of clinical evidence that suggests short-term outcomes, complications, and quality of life are all improved following a minimally invasive approach for colon surgery,” said John H. Marks, MD, FACS, FASCRS, director of the Colorectal Center at Lankenau Medical Center, chief of the section of colorectal surgery at Main Line Healthcare, and an investigator for the study. “Utilization of robotic-assisted surgery for colectomy procedures is growing and these results suggest that miniaturized robotic-assisted surgery devices can be successfully used in these complex procedures. We’re excited to continue to build upon data supporting the use of miniRAS and look forward to learning more about the potential positive impact on patient and health economic outcomes.”

“The publication of the IDE study data in Diseases of Colon and Rectum marks a key milestone for MIRA as an evidence-based option for surgeons seeking safe and effective outcomes for patients following colectomies,” said Piet Hinoul, MD, PhD, chief medical officer of Virtual Incision. “We look forward to further assessing this miniRAS device for a wide range of procedures and are eager to bring the benefits of robotic-assisted surgery to more patients across the globe.”

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 our website or follow us on LinkedIn and X.

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 colectomy procedures without the logistical inefficiencies of traditional mainframe robotics. The easily accessible device weighs approximately two pounds (less than one kg) 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.

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. For important safety information, indications for use, risks, and warnings, please refer to www.virtualincision.com/safety-information.

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:

Jenna Kane

Health+Commerce

jennakane@healthandcommerce.com

(480) 388‑9587

Virtual Incision to Showcase Miniaturized Robotic-Assisted Surgery at SAGES 2024

-MIRA, the world’s first miniaturized robotic-assisted surgery device, will make its debut at the national conference for gastrointestinal and endoscopic surgeons 

 – Scientific program includes four presentations that highlight Virtual Incision’s technology, including one-year follow-up of the cancer patient cohort from the U.S. Investigational Device Exemption clinical study 

LINCOLN, Neb. – April 10, 2024 – Virtual Incision Corporation, the developer of the MIRA Surgical System (MIRA), today announced its participation at the 2024 Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) conference taking place April 17–20 in Cleveland.  

Attendees are invited to “Meet MIRA” in the exhibit hall at Virtual Incision booth #736. They will be able to gain hands-on experience with the world’s first miniaturized robotic-assisted surgery (miniRAS) system, which recently received FDA marketing authorization. MIRA’s tray-to-table design has the potential to accelerate adoption of robotic-assisted surgery by integrating into any operating room within existing surgical workflows. 

In addition to the exhibit, miniRAS will be included as part of the scientific program. Thought leaders will share clinical data, insights on the current technology landscape, and details of how miniaturization enabled the recent remote surgery simulation on the International Space Station. Dr. Michael Jobst will present one-year follow-up of the cancer patient cohort from the U.S. Investigational Device Exemption clinical study as part of the multi-presentation Scientific Session on Friday, April 19, 2024 at 11:00 A.M. 

“SAGES marks the premiere of the MIRA Surgical System at a major national surgical conference,” said John Murphy, chief executive officer at Virtual Incision. “It is a significant milestone as we embark on the commercialization of a brand-new category of miniaturized robotic-assisted surgery. We look forward to engaging with the attendees to demonstrate how this technology can elevate minimally invasive surgery by making every operating room robot-ready.”  

 

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 colectomy 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, 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. 

 

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. For important safety information, indications for use, risks, and warnings, please refer to www.virtualincision.com/safety-information. 

 

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 X. 

 

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:
Shay Smith
Health+Commerce
shay@healthandcommerce.com 

Virtual Incision’s MIRA Surgical System to be Featured Among Elite AI-Enabled Innovations at NVIDIA GTC

Company To Showcase What is On Horizon For Miniaturized Robotic-Assisted Surgery and AI

LINCOLN, Neb. — March 18, 2024 — Virtual Incision Corporation, the developer of the MIRA Surgical System (MIRA), today announced the company will showcase MIRA at NVIDIA GTC. The global AI conference is focused on exploring what’s next in AI, computer graphics, data science, machine learning, and autonomous machines across industries. Virtual Incision will be featured in booth 1332 at the Healthcare Pavilion located inside the Expo Hall. The event will take place March 18–21, 2024 in San Jose, Calif.

During the conference, attendees will have the opportunity to perform a series of simulated surgical tasks with MIRA, the world’s first miniaturized robotic-assisted surgery (miniRAS) platform. The system utilizes the NVIDIA Jetson platform to collect, convert, and enhance visual data from MIRA’s integrated articulating camera. In addition, Virtual Incision will show examples of how Jetson can be used in future iterations of MIRA to enable capabilities such as low-latency remote surgery, intra-procedure AI-enhanced visualization, and post-procedure data analysis.

“As a robotics platform, MIRA is inherently designed to leverage computer assistance and artificial intelligence,” said Shane Farritor, Ph.D., co-founder and chief technology officer at Virtual Incision. “In the future, this can be used to inform decisions, reduce errors and enable remote surgery to ultimately have a positive impact on patient outcomes. We are excited to combine NVIDIA technology with MIRA’s small form factor to potentially bring cutting-edge technology to millions of patients each year, without disrupting the operational workflow of healthcare facilities.”

Virtual Incision’s presence at GTC comes after a series of recent significant milestones for the company in 2024. Earlier this year, the experimental device spaceMIRA, a space-focused iteration of MIRA, was the first surgical robot to be sent to the International Space Station (ISS). spaceMIRA leveraged NVIDIA Jetson to collect, compress, and send the visual data via satellite link so that a simulated remote surgery could be successfully performed by surgeons at the company’s headquarters in Lincoln, Neb.

Additionally, Virtual Incision received FDA marketing authorization for MIRA for use in adults undergoing colectomy procedures. In 2024, the company expects to begin commercialization with selected centers in the United States and is planning clinical studies in other abdominal surgery applications such as gynecology and general surgery.

“The potential for AI and robotics in healthcare is vast,” said David Niewolny, director of business development for healthcare/med tech at NVIDIA. “The MIRA Surgical System leverages key computing elements from the NVIDIA accelerated computing and AI platform. Together, we're working towards transforming the future of surgery to potentially enhance the precision, safety, and efficiency."

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, 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.

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. For important safety information, indications for use, risks, and warnings, please refer to www.virtualincision.com/safety-information.

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 X.

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.

# # #

CONTACT:
Shay Smith
Health+Commerce shay@healthandcommerce.com
(707)971‑9779

Virtual Incision Receives FDA Authorization for the MIRA Surgical System as the First Miniaturized Robotic-Assisted Surgery Device

– New category challenges industry standards in soft tissue robotic-assisted surgery and has the potential to expand access to minimally invasive care

– De Novo premarket review pathway establishes initial indication for adults undergoing colectomy procedures and lays the foundation for expansion into other abdominal procedures

 

LINCOLN, Neb. — February 24, 2024 — Virtual Incision Corporation announced the U.S. Food and Drug Administration (FDA) has granted marketing authorization of the MIRA™ Surgical System (MIRA), the world’s first miniaturized robotic-assisted surgery (miniRAS) device, for use in adults undergoing colectomy procedures. The device was submitted via the FDA’s De Novo Classification process, a rigorous pathway designed to classify novel medical devices with no current legally marketed predicate. FDA authorization was based in part on findings from the company’s U.S. Investigational Device Exemption (IDE) clinical study. The announcement was made by Virtual Incision’s president and chief executive officer, John Murphy, at the SAGES 5th Annual Next Big Thing Innovation Weekend in Houston.

“Today marks a turning point in surgical robotics as we have hit a significant milestone in making miniaturized robotic surgery a reality,” said John Murphy. “For more than a decade, our team has been dedicated to our core mission of making every operating room robot-ready. I’m incredibly proud to see our efforts come to fruition. We extend our gratitude to the FDA for its thoughtful review of MIRA’s technology and our clinical evidence. Whether as a complement to the existing mainframes or as a stand-alone platform, miniaturization has the potential to accelerate the adoption of robotic-assisted surgery.”

Minimally invasive surgery (MIS), a type of surgery that involves smaller incisions, has transformed the surgical care landscape and patient outcomes through decreased pain, reduced complications, and shorter recovery time.1 The introduction of robotic-assisted surgery has further expanded the use and effectiveness of MIS for complex procedures, offering surgeons more precision and control than what is possible with conventional techniques. Despite its advantages, roughly 90 percent of U.S. operating rooms (ORs) are still without access to the technology,2 most often due to complex logistics such as dedicated operating room space, specially trained staff, added steps during setup and turnover, and a substantial cost for the equipment. The “in-a-tray” form factor of miniRAS has the potential to overcome these challenges and could impact millions of U.S. patients each year.

MIRA’s innovative tray-to-table design could offer healthcare facilities the advantages of robotic surgery without requiring them to organize the OR around the device, a current challenge of existing mainframe surgical robots. MIRA’s compact, approximately two-pound (less than one kg) framework is portable and designed to minimize setup time, which could enable any OR to be robot ready within minutes.

“Colectomy is one of the most complex multi-quadrant abdominal procedures with nearly 50 percent still being performed as open surgery.3 Data from our IDE clinical study demonstrated that MIRA can successfully be used to mobilize the colon in a minimally invasive way,4” said Piet Hinoul M.D., Ph.D., chief medical officer of Virtual Incision. “Starting with a difficult multi-quadrant procedure like a colectomy presents an exciting opportunity for us to address a high unmet need before we expand into other indications. We’re thankful to the investigators and patients who participated in our IDE clinical study that propelled us to marketing authorization.”

Virtual Incision will begin commercialization of MIRA through its First Access Program in centers to be selected across the United States. The company will ramp up MIRA’s production and expand to additional sites over time.

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. Studies of MIRA in gynecological procedures are planned in 2024. 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 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 our website or follow us on LinkedIn and X.

 

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 colectomy procedures without the logistical inefficiencies of traditional mainframe robotics. The easily accessible device weighs approximately two pounds (less than one kg) 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.

 

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. For important safety information, indications for use, risks, and warnings, please refer to www.virtualincision.com/safety-information.

 

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.

 

CONTACT:
Shay Smith
Health+Commerce
shay@healthandcommerce.com
(707)971‑9779

 

References

  1. Reza MM, Blasco JA, Andradas E, Cantero R, Mayol J. Systematic review of laparoscopic versus open surgery for colorectal cancer. Br J Surg. 2006 Aug;93(8):921–8.
  2. Hazan, A., Perse, J., Coover, P. June 2022. State of the Robotics Surgery Market. Goldman Sachs.
  3. Sheetz KH, Norton EC, Dimick JB, Regenbogen SE. Perioperative Outcomes and Trends in the Use of Robotic Colectomy for Medicare Beneficiaries From 2010 Through 2016. JAMA Surg. 2020 Jan 1;155(1):41–49.
  4. Virtual Incision data on file

 

 

 

Virtual Incision’s Miniaturized Surgical Robot En Route to the International Space Station for Testing of Long-Range Remote Capabilities

spaceMIRA becomes the first surgical robot on the Space Station through partnership with the University of Nebraska and NASA

LINCOLN, Neb. and CAPE CANAVERAL, Fla. — January 30, 2024 — Virtual Incision Corporation, the developer of the MIRA Surgical System (MIRA), today announced that spaceMIRA is currently in transit to the International Space Station. The device is aboard a Northrop Grumman Cygnus cargo spacecraft carried by a SpaceX Falcon 9 rocket. The 2024 technology demonstration mission is driven by a grant awarded from the National Aeronautics and Space Administration (NASA) to the University of Nebraska through the Established Program to Competitive Research (EPSCoR) program.

Testing with spaceMIRA on the International Space Station will assess the impact of zero gravity when performing simulated surgical tasks. During a portion of the experiment, a surgeon operator at Virtual Incision’s headquarters in Lincoln, Nebraska will utilize remote-controlled technology to direct the movements of the robot.

Learnings about remote surgery could potentially impact healthcare in space and across the globe. In the U.S. alone, one-third of counties do not currently have access to a local surgeon,1 and the shortage of surgeons could rise to more than 30,000 within the next ten years.2 Remote surgery could serve as an option for these patients by enabling procedures to be performed from a distant location.

The ideal device for these applications would be controlled by a surgeon through a console, enabling them to direct the movements of a camera and instruments inside the patient's body. This type of technology, called robotic-assisted surgery (RAS), has been available for decades. While some exploratory work in remote surgery has been conducted, it is still typically performed with the surgeon in the same operating room as the patient.3 Although there are many complexities associated with remote operations, miniaturization of RAS could be a breakthrough by dramatically simplifying workflows at the site where the patient is located.

MIRA, the first miniaturized robotic-assisted surgery (miniRAS) device in development, is roughly 1,000 times lighter than existing technologies. As the only small form factor RAS device, it has the potential to make remote surgery more feasible by enabling transportation, storage, and setup time at an unprecedented scale. The University of Nebraska researchers leveraged MIRA’s unique design to create an iteration that enables pre-programmed as well as long-distance remote surgery operation modes.

“When we started this work at the University of Nebraska, we shared a collective vision that miniRAS could make robotic-assisted surgery available to any patient, any time, anywhere,” said Shane Farritor, Ph.D., co-founder and chief technology officer at Virtual Incision and professor of mechanical engineering at the University of Nebraska. “Exploring the use of miniRAS in extreme environments helps our teams understand how we can remove barriers for patients.”

“As thrilling as it is to have our technology in space, we expect the impact of this research will be most notable on Earth,” said John Murphy, president and CEO of Virtual Incision. “The introduction of miniRAS has the potential to revolutionize healthcare by making every operating room robot ready. We are taking a significant step by developing MIRA, an investigational device currently under review by the FDA. The testing with spaceMIRA will tell us more about the future potential of miniRAS as it might be applied to remote surgery applications.”

About the MIRA Surgical System

MIRA is the world’s first miniaturized robotic-assisted surgery (miniRAS) system in development by Virtual Incision. 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 the spaceMIRA Surgical System

spaceMIRA is a specially designed space-focused iteration of MIRA, the world’s first miniaturized robotic-assisted surgery (miniRAS) system. Similar to MIRA, its small and sleek design aims to offer the capabilities of robotic-assisted surgery (RAS) in a compact and convenient form factor. The modifications of spaceMIRA enable pre-programmed and long- distance remote surgery capabilities for the experiment on the International Space Station (ISS).

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 X.

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:
Shay Smith
Health+Commerce
shay@healthandcommerce.com

1. Belsky D, Ricketts T, Poley S, Gaul K, Fraher E, Sheldon G. Surgical deserts in the US:
Places without surgeons. American College of Surgeons Health Policy Research Institute.
Available at: https://pubmed.ncbi.nlm.nih.gov/21449298/

2. AAMC Report Reinforces Mounting Physician Shortage. (2021, June 11). AAMC. Retrieved January 22,
2024, from https://www.aamc.org/news/press-releases/aamc-report-reinforces-mounting-physician-shortage.

3. Barba P, Stramiello J, Funk EK, Richter F, Yip MC, Orosco RK. Remote telesurgery in humans: a
systematic review. Surg Endosc. 2022 May;36(5):2771–2777.

 

Virtual Incision Extends Series C Round with Additional $30M Funding

 

Investment will accelerate advancements of the MIRA Surgical System

LINCOLN, Neb. – September 19, 2023 – Virtual Incision Corporation, the developer of the world’s first miniaturized robotic-assisted surgery (RAS) system, today announced a $30 million extension to its previous $46 million Series C financing. The round was led by current investors Bluestem Capital, Endeavour Vision, Baird Capital, cultivate(MD) Capital Funds, and PrairieGold Venture Partners, as well as new health-tech investors Arboretum Ventures and InVivium Capital.

Concurrent with the extension, Virtual Incision has appointed Tom Shehab, MD, managing partner from Arboretum Ventures, as a member of its board of directors, and Amy Kobe, general partner from InVivium Capital, as a board observer.

“We’re grateful for our investors – both existing and new – and are excited to build an even stronger medtech syndicate with the additions of Arboretum and InVivium,” said John Murphy, president and chief executive officer of Virtual Incision. “This financing, particularly in the current fundraising environment, is a significant affirmation of the promise Virtual Incision offers to both patients and shareholders.”

The $30 million funding extension will support the company’s operations well into 2025 as it seeks to disrupt the industry with miniaturized RAS (miniRAS). miniRAS aims to deliver the capabilities of traditional RAS systems through a form factor small enough to fit in a surgical tray. The compact, capable, and convenient design is uniquely positioned to expand RAS to the millions of patients who do not have access to the technology today.1

This funding comes on the heels of a series of significant milestones toward commercial readiness of the MIRA Surgical System. Earlier this year, Virtual Incision completed an Investigational Device Exemption (IDE) clinical study for MIRA’s use in bowel resection and announced that its De Novo request is under substantive review by the U.S. Food and Drug Administration (FDA). If granted marketing authorization, the company plans to initiate a limited launch of MIRA across select U.S. centers.

Virtual Incision is focused on advancing patient access to RAS, especially in routine and high-volume procedures, many of which are performed in outpatient and ambulatory surgery centers. The investment will be used to support this mission through a gynecologic clinical study planned for 2024. The company will also continue to develop a smaller iteration of the minibot to enable additional general surgery applications with a first-in-human clinical study expected next year.

In the near term, Virtual Incision will support a collaboration between NASA and the University of Nebraska-Lincoln to lay the foundation for performing telesurgery in space. A modified version of MIRA will board the International Space Station to perform simulated surgical tasks from a microwave-sized locker, a feat made possible by its RAS capabilities in miniaturized form.

“We are excited to invest in the Series C extension from our fund, Arboretum Ventures VI ($268 million fund). Consistent with our previous funds, we partner with transformational organizations at the intersection of healthcare and technology to improve patient outcomes,” said Dr. Tom Shehab. “Virtual Incision’s long-standing investor support is a signal of the company’s commitment to doing just that. The company’s recent milestones demonstrate that the momentum of miniRAS is only going to continue to build, and we’re excited to be on board.”

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.

 

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

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

LINCOLN, Neb. – May 31, 2023 – 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.

# # #

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

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

Virtual Incision Expands Leadership Team as it Prepares for New Market Growth

International industry executive Piet Hinoul joins Virtual Incision as chief medical officer, Dmitry Oleynikov transitions to chief surgeon Read more

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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