xvision is the first augmented reality (AR) guidance system for surgery. At its core, xvision is a wireless headset that allows surgeons to see 3D visualization of the spine directly on the patient, alongside 2D axial and sagittal views, giving surgeons the ability to accurately guide instruments and implants during procedures.
The customized headset contains a high-speed processor, headlight, built-in surgical tracking system and optical transparent display lenses that project images directly onto a surgeon’s retina. Compatible with all intraoperative 3D scanners, the wireless system is O.R.-ready with a two-minute setup.
“It is making computer-assisted technology more accessible to surgeons, and when you are performing surgery on someone’s spine, you need accurate information,” said President and Chief Commerical Officer Tim Murawski. “As a company, we aim to improve healthcare by augmenting surgery with cutting edge technologies that solve unmet clinical needs and instill technological confidence in the surgical workflow. We want surgeons to perform surgery how they were trained, by introducing accurate tools that are not disruptive and cumbersome, but intuitive and seamless, so they are not only purchased, but used.”
How it Works
The xvision headset allows surgeons to visualize the 3D anatomy of the patient’s spine, through his skin, by looking directly at the patient, as if they had “x-ray” vision. When the system is in use, the patient has a registration marker rigidly attached to his spine. The xvision software determines where the anatomy is in relation to the registration marker, and the information is transferred wirelessly to the headset. A transparent display attached to the headset will project the 3D anatomical and instrument detail for the surgeon without obstructing the operative field.
Surgeons also have the 2D axial and sagittal cuts within view to help guide instrumentation. This helps them to place screws and other instrumentation within the spine accurately.
“It’s approved as an aid for precisely locating anatomical structures in either open or percutaneous spine procedures,” Mr. Murawski said. “It is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the spine, can be identified relative to CT imagery of the anatomy.”
Computer-assisted guidance systems have long been a tool for providing crucial information to surgeons. Other image guidance systems have existed for some time, yet many surgeons are not utilizing the technology.
“Although there are currently other augmented reality devices used in medicine today, as well as other image guidance systems, this is the first of its kind to combine these two tools to be used during surgery,” Mr. Murawski said. “Other image guidance systems have a separate 2D screen, where the surgeon needs to look away from the patient to see the data, and also bulky equipment that takes up valuable O.R. space.”
The xvision system is contained in a lightweight headset, and the surgeon only needs to keep his eyes on the patient, not a distant screen.
“The pitfalls of the previously existing systems consist of line of sight issues, bulky O.R. equipment, a sizable monetary investment and a steep learning curve,” Mr. Murawski said. “The xvision system was designed to solve these issues while giving surgeons an improved experience and the accuracy and information they need.”
The xvision spine system was created specifically for surgery, and no other AR applications outside of surgery. It has demonstrated a 98.9% overall accuracy in a percutaneous implant placement laboratory study.
With more than one million spinal surgeries per year in the U.S., cost is also an important factor. With that in mind, Augmedics has priced the xvision system at a fraction of the cost of traditional image guidance systems.
Augmedics received FDA clearance for the xvision spine system in 2019, and is now selling the systems in the U.S. In June, the company completed its first spinal fusion surgery with the system at Johns Hopkins Hospital and its first minimally-invasive surgery case at Midwest Orthopaedics at Rush.
As the first and only AR guidance system for surgery, Augmedics said they have no direct competitors. Their biggest indirect competitors include traditional guidance systems that utilize larger capital equipment and 2D screens from Medtronic, Stryker and 7D Surgical, among others.
In mid-June, Augmedics announced it raised $15 million in Series B financing, led by its U.S. staff. Twenty U.S. employees invested $4 million via a company, AUG Management LLC. Existing shareholders, AO Invest and Terralab Ventures, participated in the financing round with a $3.2 million investment, and undisclosed investors converted the remaining $7.8 million SAFE notes.
The funding will assist the company in their plans to expand their use cases beyond spine in the near future.
“We will continue to apply the xvision technology to other types of surgery and will continue to improve our product,” Mr. Murawski said. “We also plan to expand our sales beyond the U.S. and into other markets, including the EU.”
Heather Tunstall is an ORTHOWORLD Contributing Editor.