Medacta Group SA / Key word(s): Regulatory Approval
27-May-2021 / 19:00 CET/CEST
Release of an ad hoc announcement pursuant to Art. 53 KR
The issuer is solely responsible for the content of this announcement.
Medacta Announces the Registration of the Knee, Shoulder and Spine Applications of its NextAR Augmented Reality Surgical Platform in Europe, and the Addition of the Shoulder Application to the American Market
- Medacta's Knee, Shoulder and Spine Applications received CE-marking, and Medacta's Shoulder Application also obtained FDA-clearance.
- NextAR Augmented Reality Surgical Platform enhances Medacta's personalized medicine offering and further enriches the MySolutions ecosystem.
- One single hardware for all the joint and spine applications makes this technology smart and efficient, and Augmented Reality has the potential to improve surgical accuracy.
- Thanks to the limited upfront capital investment and reduced cost per case, the platform enhances healthcare system sustainability, in particular for US Ambulatory Surgery Centers.
CASTEL SAN PIETRO, 27 May 2021 - Medacta Group SA ("Medacta", SIX:MOVE) today announced it has received CE marking for the NextARTM Knee (NextAR TKA), Shoulder and Spine Applications as part of its NextAR Augmented Reality (AR) Surgical Platform. Also, Medacta's NextAR Shoulder Application has received clearance from the US Food and Drug Administration (FDA), further expanding the US NextAR offering, which already includes the Knee Application, FDA-cleared in 2020.
Francesco Siccardi, CEO of Medacta says: "With our NextAR Platform we wanted to take another step forward in personalized medicine, improving accuracy in computer-assisted surgery. Efficiency in the operating room is crucial for surgeons and hospitals, and NextAR has the potential to provide significant benefits to healthcare systems around the world. We are proud to have developed an extremely versatile platform, with a single, compact hardware that applies to both joint and spine applications. NextAR perfectly fits in Medacta's vision and in our sophisticated MySolutions personalized ecosystem, focused on delivering advanced personalized solutions that support the surgeon's care of each patient."
NextAR is Medacta's proprietary AR platform that makes image-based planning and analysis efficient and precise, offering smart delivery tools for an accurate and personalized surgery. NextAR's smart delivery tools include:
- NextAR TS, Medacta's proprietary tracking system, a compact, single-use and ready-to-use solution;
- NextAR Augmented Reality Smart Glasses, that allow for the visualization of surgical actions superimposed onto the operative field.
Its smart delivery tools may improve efficiency in computer-assisted surgery by offering a compact solution that avoids the need for a bulky external detection platform. With a low upfront capital investment and overall low cost per case compared to other technologies, this translates into greater efficiency in the operating room, which is particularly relevant for US Ambulatory Surgery Centers (ASCs).
NextAR is the first platform to offer Augmented Reality solutions for both spine and joint replacement procedures. Indeed, a single hardware will apply to diverse software, with economic benefits for the healthcare systems.
NextAR is part of the MySolutions ecosystem, which enhances Medacta's personalized medicine offering. Together with a comprehensive implant portfolio and surgical techniques, MySolutions empowers Medacta's holistic approach to personalized medicine aiming at bringing value at every step throughout the entire patient journey: preoperative, intraoperative, and postoperative.
NextAR Knee: Intraoperative Personalized Precision and Optimized Balance in Total Knee Replacement
NextAR Knee, the first FDA-cleared Augmented Reality surgical platform for total knee replacement, is now CE-marked. With a precise reconstruction of patient bone morphology, the NextAR Knee application 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.
NextAR Shoulder: Real-Time Guidance in Shoulder Arthroplasty
NextAR Shoulder enhances the preoperative implants-bone preparation plan with unique intraoperative orientation assessments, allowing surgeons to track real-time positioning through Augmented Reality. Also, the CT-based preoperative plan allows for accurate personalized planning and active range of motion (ROM) simulation, supporting surgeons in performing a more accurate placement of the glenoid component compared to traditional techniques.
Prof. Dr. med. Matthias Zumstein, orthopaedic surgeon at the Orthopädie Sonnenhof KLG in Bern, Switzerland, has collaborated with Medacta to develop the NextAR Shoulder application. "Accurate positioning of glenoid implants is still one of the most challenging steps during the procedure. The long-term survival of a reversed prosthesis is highly dependent on stable bone fixation and correct positioning of the glenoid components. Planning and virtual visualization of the positioning during the surgical procedure is already provided in the community. The step forward of this technology is the real transfer of the planning into the surgical procedure, defined as augmented reality, using intraoperative guidance. We think that NextAR Shoulder represents a great answer to this challenging next step. I am very happy to have participated in the development of this application, and even more so now that this innovative solution is also available in the complex ecosystem of shoulder arthroplasty," says Prof. Zumstein.
NextAR Spine: Accurate Screw Positioning in Spine Surgery
Univ.-Prof. Dr. Bernhard Meyer, Chair of Neurosurgery at the Technical University of Munich, has collaborated with Medacta engineers to develop the NextAR Spine application. "This novel technology will be a great help in the precise localization of anatomical structures especially during percutaneous spine surgery, and will also provide added value in open and mini-open procedures. By employing intelligently miniaturized components, NextAR Spine is a versatile platform that improves the surgical set up while avoiding the use of bulky detection equipment. I am confident that with NextAR, augmented reality will be widely adopted by surgeons and will support the accurate placement of implants in spine surgery, thus increasing safety for patients," says Prof. Meyer.
NextAR Spine indications span from the thoracic spine to the pelvis, and include pedicle screw placement, iliosacral screw placement and interbody device placement.
With NextAR Spine, surgeons can create a real-time positioning through 3D intraoperative scans or match the low-dose preoperative planning with the 3D intraoperative scan to accurately guide the pedicle screw placement.
For more information on NextAR, please visit nextar.medacta.com.
Medacta International SA
Senior Director Global Marketing
Phone: +41 91 696 60 60
Medacta International SA
Gianna La Rana
Head of Investor Relations
Phone: +41 91 696 14 95
Medacta is an international company specializing in the design, production, and distribution of innovative orthopaedic products, as well as in the development of accompanying surgical techniques. Established in 1999 in Switzerland, Medacta is active in joint replacement, spine surgery, and sports medicine. Medacta is committed to improving the care and well-being of patients and maintains a strong focus on healthcare sustainability. Medacta's innovation, forged by close collaboration with surgeon leaders globally, began with minimally invasive surgical techniques and has evolved into personalized solutions for every patient. Through the M.O.R.E. Institute, Medacta supports surgeons with a comprehensive and tailored program dedicated to the advancement of medical education. Medacta is headquartered in Castel San Pietro, Switzerland, and operates in over 40 countries.
End of ad hoc announcement