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Augmedics Begins First-in-Human Clinical Trial of xvision-spine (XVS) Augmented-Reality Surgical Navigation System


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 August 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 wil be completed by the surgeons
at the end of each procedure.

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 surgeon's 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
, which was completed in November 2017 by four surgeons in
Baltimore, Maryland.

About Augmedics

Founded in 2014, Augmedics seeks to improve healthcare by developing
cutting-edge technologies that will revolutionize surgical treatment.
The company's first product, the 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

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.

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