Augmedics has begun a first-in-human clinical trial of its xvision-spine (XVS) augmented-reality surgical navigation system at Sheba Tel Hashomer Medical Center and Asaf Harofeh Medical Center, in Israel. Led by co-principal investigators Dr. Ran Harel and Prof. Yigal Mirovsky, the open label, prospective, single arm, multi-center study will evaluate the safety, performance, accuracy and usability of XVS during spine fusion procedures involving pedicle screw placement. The number of subjects will range from eight to 22, depending on the number of screws placed in each subject, with a minimum of 85 total screws placed in the study.

The first human case was completed Aug. 5, with cases expected to continue for approximately three months. Pedicle screw placement accuracy will be assessed by two independent, experienced radiologists using the Gertzbein score (GS). Usability will be evaluated using a user experience questionnaire (UEQ), which will be completed by the surgeons at the end of each procedure.
 
Augmedics’ xvision-spine system (XVS) is an augmented reality surgical navigation system designed to give surgeons “X-ray vision” during complex procedures. With XVS, surgeons can see and navigate inside a patient’s body through skin and tissue, which may lead to easier, faster and safer surgeries. The XVS system comprises a transparent near-eye-display headset and has all elements of traditional navigation systems. It accurately determines the position of surgical tools, in real-time, and superimposes them on patient’s CT data. The navigation data is then projected onto the surgeons’ retina using the transparent near-eye-display headset, allowing surgeons to simultaneously look at their patient and see the navigation data without averting their eyes to a remote screen.
 
XVS has the potential for use in many procedures, with its first intended use in minimally invasive or open spine surgeries. XVS uses patented see-through optics to project a 3D image of a patient’s spine, as well as axial and sagittal planes, onto a surgeon’s retina, in real-time, with surgical precision and outstanding depth perception.
 
“This first-in-human study is a critical step towards providing surgeons a more intuitive way to navigate in surgery that allows them to always keep their eyes on the patient,” said Nissan Elimelech, CEO of Augmedics. “We believe that XVS has the potential to deliver precise results and easier, faster and safer surgeries.”
 
The first-in-human clinical trial follows Augmedics’ successful second cadaver study, which was completed in November 2017 by four surgeons in Baltimore, Md.
 
Founded in 2014, Augmedics seeks to improve healthcare by developing technologies that will revolutionize surgical treatment. The company’s first product, xvision-spine (XVS) system, is an augmented reality surgical navigation system designed to allow surgeons to see and navigate inside a patient’s body during complex procedures. The XVS system, with XVS Software, has the intended use to precisely locate anatomical structures in either open or percutaneous neurosurgical and orthopedic procedures. Their use 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 or pelvis, can be identified relative to images of the anatomy. This can include spinal implant procedures such as pedicle screw placement, Iliosacral screw placement or interbody device placement.

Augmedics is funded by various investors, led by AO-Invest, an investment arm of the AO-Foundation, and has received numerous honors, including Technion’s BizTEC 2014, MedTech Innovator 2016, and MEDinISRAEL 2017. It was a finalist at TechCrunch Disrupt San Francisco 2017 Startup Battlefield and recognized as a leading HealthTech Innovator in the 2017 Global Digital Health 100 by the Journal of mHealth.