EQS Group-Ad-hoc: Medacta Group SA / Key word(s): Regulatory Approval
Medacta to Introduce NextAR: First FDA-Cleared Augmented Reality-Based
Surgical Platform for Total Knee Replacement
13-Jul-2020 / 07:00 CET/CEST
Release of an ad hoc announcement pursuant to Art. 53 KR
The issuer is solely responsible for the content of this announcement.
*Press Release*
*Medacta to Introduce NextARTM: First FDA-Cleared Augmented Reality-Based
Surgical Platform for Total Knee Replacement*
*- *Milestone achievement in orthopaedic technology further strengthens
Medacta's profile
- New surgical platform has the potential to improve surgical efficiency
with economic benefits to the healthcare system
- Enhanced visualization via augmented reality boosts Medacta's personalized
medicine offering
_CASTEL SAN PIETRO, 13 July 2020_ - Medacta today announced it has received
clearance from the U.S. Food and Drug Administration (FDA) for its NextARTM
Augmented Reality based surgical platform for total knee arthroplasty (TKA)
procedures.
The NextARTM TKA is the first application of a new platform technology,
which will be extended to hip, shoulder and spine procedures, designed and
engineered with Artificial Intelligence and Machine Learning that make
pre-operative CT-based planning and analysis efficient and precise.
The NextARTM TKA Application has the goal to improve efficiency and
precision in total knee replacement and deliver personalized planning, with
low upfront capital investment required by clinics and hospitals, as well as
economic benefits to the healthcare system through OR efficiency and low
cost per procedure. This new platform will be an optimal solution
particularly for U.S. ambulatory surgery centers (ASCs), which provide
same-day surgical care.
The Augmented Reality glasses provided with the NextARTM Platform allow the
surgeon to visualize surgical actions and information in real-time, directly
on the operative field. This improves the user experience and helps the
surgeon remain focused on the patient at all times.
"With enhanced visualization via augmented reality, the NextARTM Platform is
an innovative and efficient tool for ultra-precise, patient-specific
treatment," said Dr Michael McAuliffe (MBBS FRACS), an orthopaedic surgeon
at St Andrew's Ipswich Hospital in Queensland, Australia, and a member of
the expert surgeon panel that Medacta collaborated with to develop the
NextARTM TKA Application. "With the NextARTM TKA Application, we are able to
track 3D soft tissue behavior during a surgery in real time. This
functionality is an exciting advancement from traditional computer-assisted
or robotic-assisted surgical systems that only track the relative movement
of the knee bones, not the actual soft tissue."
The NextARTM TKA Application, with a precise reconstruction of the patient
bone morphology, allows direct tracking of the collateral ligaments and a 3D
analysis of soft tissue behavior throughout the whole range of motion during
surgery, bringing patient-specific ligament balancing to the next level.
In addition to advanced planning tools, Medacta has developed the NextARTM
TS, a revolutionary infrared single-use tracking system that has the
potential to vastly improve surgery efficiency while helping surgeons
execute pre-op plans.
"The new NextARTM TKA Application allows for great precision and control,
ultimately translating to great efficiency in the operating room," said
Jonathan Vigdorchik, M.D., an orthopaedic surgeon at the Hospital for
Special Surgery (HSS) in New York and collaborator on this platform.
"Particularly in today's environment, as surgeons and health systems look to
recover surgeries that were deferred during the COVID-19 pandemic,
efficiency in the operating room will become even more crucial than before.
The NextARTM Platform with its Single-Use Infrared Tracking System will be a
valuable solution to meet these new levels of market demand."
The NextARTM TKA works in conjunction with the Medacta GMK Sphere Medially
Stabilized Knee implant, which has been proven to facilitate restoration of
natural patient-specific kinematics.
"We are proud to be part of the NextARTM Platform project that represents
the next step forward for personalized medicine in orthopaedics," said PD
Dr. med. Sandro Fucentese, Head of Knee Surgery at the Balgrist University
Hospital and collaborator on this platform. "For many years we have been
collaborating with Medacta in developing personalized solutions that have
been relevant at the global level. The NextARTM Platform perfectly fits into
this philosophy relying on a solid and established ecosystem and expertise."
Francesco Siccardi, CEO of Medacta, said: "Patients and surgeons are
attracted by improved outcomes and innovation, the NextARTM Platform is one
Medacta answer to the current race in orthopaedic technology and I am very
excited about this milestone achievement. Requiring a very limited
investment in capital equipment, the NextARTM Platform perfectly represents
Medacta's commitment to develop solutions that are able to improve patient
outcomes and healthcare system sustainability."
For more information on the NextARTM Platform, please visit
nextar.medacta.com [1]
*Contact*
Medacta Group SA
Corrado Farsetta, CFO
Phone: +41 91 696 60 60
investor.relations@medacta.ch
*About Medacta*
Medacta is an international company specialized in the design and production
of innovative orthopaedic products and the development of accompanying
surgical techniques for joint replacement, spine surgery, and sports
medicine. Established in 1999 in Switzerland, Medacta's products and
surgical techniques are characterized by innovation. Medacta is a pioneer in
developing new offerings on the basis of minimally invasive surgical
techniques, in particular its Anterior Minimally Invasive Surgery (AMIS)
technique for hip replacements. Medacta has leveraged its orthopaedic
expertise and comprehensive understanding of the human body to develop the
sophisticated MySolutions technology, which offers surgeons highly
personalized pre-operative planning and implant placement methodologies by
creating advanced personalized kinematic models and 3D planning tools for
use in hip, knee, shoulder and spine procedures.
End of ad hoc announcement
Language: English
Company: Medacta Group SA
Strada Regina
6874 Castel San Pietro
Switzerland
Phone: +41 91 696 6060
E-mail: info@medacta.ch, investor.relations@medacta.ch
Internet: www.medacta.com
ISIN: CH0468525222
Listed: SIX Swiss Exchange
EQS News ID: 1091815
End of Announcement EQS Group News Service
1091815 13-Jul-2020 CET/CEST
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July 13, 2020 01:01 ET (05:01 GMT)
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