CE marking certification allows the commercialization of Knee+ across the European Union and other CE mark geographies by using implants manufacturers as distributors
ROCHESTER, N.Y., May 7, 2020 /PRNewswire/ -- Vuzix® Corporation (NASDAQ: VUZI), ("Vuzix" or, the "Company"), a leading supplier of Smart Glasses and Augmented Reality (AR) technology and products, announces that Pixee Medical, a France-based medical company, has received CE marking certification for Knee+, the first orthopedic navigation system using augmented reality smart glasses for total knee arthroplasty.
The unique patented technology, combining proprietary computer vision and deep learning algorithms, uses Vuzix' M400 Smart Glasses to precisely track instruments and implants during surgeries. Compared to bulky and expensive robotic solutions, Knee+ is simple to use, cost effective and does not require preoperative DICOM or disposables.
The CE marking certification for Knee+ is a major milestone for Pixee Medical as it allows the commercialization of its innovative product across the European Union and other CE Mark geographies by using implant manufacturers as distributors. Pixee Medical was also granted ISO 13485:2016 certification and is pursuing and expecting FDA approval (510k) for Knee+ before the end of 2020.
"Pixee Medical has developed a device which aims to apply AR to knee and then shoulder surgery, guiding the practitioner through connected glasses, like a GPS. The solution is simple, accurate and much less expensive than surgical assistance robots. We're excited to work directly with Vuzix AR Smart Glasses to offer this solution to European Union and other CE mark geographies through implant manufacturers and distributors," commented Sébastien Henry, Founding President of Pixee Medical.
"The introduction of the Vuzix M400 Smart Glasses has opened up a new vertical in the medical space for Vuzix. The team at Pixee Medical has created an innovative path to bring the Vuzix M400 Smart Glasses into the operating room to perform knee replacement surgeries," said Paul Travers, President and Chief Executive Officer at Vuzix.
Pixee Medical raised over 2.5 million € and won the last French I-Nov contest with a grant of 1.2 million € in order to support technological breakthroughs in computer assisted orthopedic solutions. The next development for Pixee Medical is a shoulder implant navigation system, which will display a hologram in the surgeon's glasses to precisely guide him, through the skin, during an operation.
About Pixee Medical
The Pixee Medical company was founded in 2017 with the goal of creating high-performance, computer-assisted surgical solutions using advanced computer vision and artificial intelligence technologies, while remaining affordable in the challenging health system environment. Our team is composed of experts in orthopedic and computer assisted surgery with recent graduates at the forefront of technology. Our vision is to augment surgeon's capabilities by creating new clinical pathways that are both efficient and effective. We aim to market our first surgical devices in 2020, in Europe and abroad, in compliance with our ISO 13485 certification, CE marking and to enter soon the US market with a forthcoming FDA 510(k).
About Vuzix Corporation
Vuzix is a leading supplier of Smart-Glasses and Augmented Reality (AR) technologies and products for the consumer and enterprise markets. The Company's products include personal display and wearable computing devices that offer users a portable high-quality viewing experience, provide solutions for mobility, wearable displays and augmented reality. Vuzix holds 157 patents and patents pending and numerous IP licenses in the Video Eyewear field. The Company has won Consumer Electronics Show (or CES) awards for innovation for the years 2005 to 2020 and several wireless technology innovation awards among others. Founded in 1997, Vuzix is a public company (NASDAQ: VUZI) with offices in Rochester, NY, Oxford, UK, and Tokyo, Japan. For more information, visit Vuzix website, Twitter and Facebook pages.
Forward-Looking Statements Disclaimer
Certain statements contained in this news release are "forward-looking statements" within the meaning of the Securities Litigation Reform Act of 1995 and applicable Canadian securities laws. Forward looking statements contained in this release relate to the Vuzix Blade Smart Glasses, our relationship with Pixee Medical, future business opportunities, and among other things the Company's leadership in the Smart Glasses and AR display industry. They are generally identified by words such as "believes," "may," "expects," "anticipates," "should" and similar expressions. Readers should not place undue reliance on such forward-looking statements, which are based upon the Company's beliefs and assumptions as of the date of this release. The Company's actual results could differ materially due to risk factors and other items described in more detail in the "Risk Factors" section of the Company's Annual Reports and MD&A filed with the United States Securities and Exchange Commission and applicable Canadian securities regulators (copies of which may be obtained at www.sedar.com or www.sec.gov). Subsequent events and developments may cause these forward-looking statements to change. The Company specifically disclaims any obligation or intention to update or revise these forward-looking statements as a result of changed events or circumstances that occur after the date of this release, except as required by applicable law.
Media and Investor Relations Contact:
Ed McGregor, Director of Investor Relations, Vuzix Corporation firstname.lastname@example.org Tel: (585) 359-5985
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