Virtual Incision also announced its filing for an Investigational Device Exemption (IDE) with the U.S. Food and Drug Administration (FDA). An IDE approval will allow the company to initiate a confirmatory clinical study of the MIRA Surgical Robotic Platform in support of regulatory pathway to approval. The study will evaluate the safety and efficacy of the MIRA platform for colon resection surgeries in patients at a number of U.S. investigational sites.
MIRA is an investigational robot that will enable surgeons to perform minimally invasive surgeries in any hospital or surgery center, without the need for a dedicated space or for the infrastructure typically required for other “mainframe” robotic systems. Weighing only two pounds, the miniature single incision platform has full robotic capabilities, and can easily be moved from room to room.
Virtual Incision’s goal is to increase patients’ access to minimally invasive abdominal surgery and to maximize hospital efficiency in various settings at a price point significantly lower than currently available robotic systems.
“We designed the MIRA Surgical Robotic Platform with the fundamental understanding that minimally invasive procedures offer tremendous benefits to patients. We believe our portable and affordable abdominal robot has the potential to bring these benefits to many more patients,” said John Murphy, president and CEO of Virtual Incision. “The planned IDE clinical study of MIRA is the critical next step for the company.”
“Beyond our 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,” said Shane Farritor, Ph.D., Virtual Incision’s co-founder and chief technology officer.
“The Virtual Incision team has developed a unique robotic platform that has incredible potential to transform surgery,” said Steve Kirby, founding partner, Bluestem Capital. “With its foundational intellectual property – including more than 200 patents and applications – we are convinced that Virtual Incision will be leading the next wave of innovation in robotic surgery with the pioneering MIRA system.”
“Demand for minimally invasive surgeries continues to increase, and we are enthusiastic about the promise of the MIRA platform to meet this demand, while also delivering unparalleled flexibility,” said Dmitry Oleynikov, M.D., Virtual Incision’s co-founder and chief medical officer. “We are focused on expanding access to minimally invasive robotic procedures and delivering this innovation to the many centers where a smaller, simpler and less costly solution is needed.”
The MIRA Surgical Robotic Platform is an investigational device that is not available for sale in the United States.
For more information, visit virtualincision.com.