Pixee Medical Surgery Solution Has Received Clearance to Enter U.S. Knee Surgery Market with Vuzix AR M400 Smart Glasses

Rhea-AI Summary

On May 3, 2021, Vuzix Corporation (NASDAQ: VUZI) announced that Pixee Medical received FDA clearance for its Knee+ total knee replacement surgery solution. This approval allows Pixee to use Vuzix's M400 Smart Glasses, more than doubling its deployed systems in ambulatory surgical centers. The Knee+ platform, which aids orthopedic surgeons with real-time positioning, is expected to enhance surgical efficiency. The U.S. represents half of the global market for knee replacements, with Pixee planning to initiate surgeries shortly to demonstrate its platform's effectiveness.

Positive

• FDA clearance for Knee+ enhances Vuzix's credibility in the AR market.
• Orders from Pixee Medical will significantly increase the deployment of Vuzix M400 Smart Glasses.
• The U.S. knee replacement market represents a substantial growth opportunity, as it accounts for 50% of global surgeries.

Negative

• None.

ROCHESTER, N.Y., May 3, 2021 /PRNewswire/ -- Vuzix® Corporation (NASDAQ: VUZI), ("Vuzix" or, the "Company"), a leading supplier of Smart Glasses and Augmented Reality (AR) technology and products, today announced that Pixee Medical, a France-based supplier of high-performance computer-assisted surgery solutions, has received 510K clearance from the U.S. Food and Drug Administration (FDA) for its Knee+ total knee replacement surgery solution and placed a follow-on Vuzix M400 Smart Glasses order that will more than double the total amount of systems deployed to date by Pixee Medical to ambulatory surgical centers.

Knee+ is a patented platform designed to assist orthopedic surgeons to perform surgeries better and faster by providing real-time positioning of instruments, directly in their field of view. Knee+ is intuitive and requires minimal training even for those who have never utilized navigation or robots since it does not change the overall technique for 90% of surgeons who use a conventional technique. Knee+ consists of proprietary software using unique computer vision and artificial intelligence algorithms and running on connected Vuzix M400 Smart Glasses, with no bulky capital equipment or disposables required. The solution is simple, accurate and much less expensive than surgical assistance robots.

The United States represents 50% of the worldwide market for knee replacement surgeries, and according to estimates there are more than 30,000 orthopedic surgeons in the U.S who carry out approximately 600,000 total knee replacements annually. Pixee Medical plans to start surgeries as soon as possible in the US with Digitally Augmented Surgeons to prove the efficiency of its breakthrough, affordable, and efficient solution, especially adapted for the growing surgery vertical of ambulatory surgical centers.

"The FDA's clearance of Knee+ is an important step forward and we plan to quickly expand our platform to perform hip and shoulder replacements," states Sébastien Henry, Founder and CEO of Pixee Medical. "In addition, our platform is designed to become the cornerstone of data acquisition and exchange during surgery as well as a plug-and-play hub for accessories like connected instruments, robotic arms and wireless tools. Vuzix' M400 Smart Glasses play a vital role within our Knee+ solution."

"We are thrilled to see Pixee Medical receive FDA clearance for Knee+ and we look forward to supporting the worldwide distribution of their innovative AR solution, particularly now in the U.S. market, which accounts roughly half of the world's annual knee surgeries," said Paul Travers, President and Chief Executive Officer at Vuzix. "The Vuzix M400 Smart Glasses are lightweight, comfortable and completely wireless and their high-performance camera is ideal for reading QR-code markers and precisely calculating the 3D coordinates of the instruments used during Knee+ surgeries."

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 192 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 2021 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 Vuzix Smart Glasses, our current and future relationship and business opportunities with Pixee Medical, the impact of their 510K clearance, 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
ed_mcgregor@vuzix.com  
Tel: (585) 359-5985

Vuzix Corporation, 25 Hendrix Road, Suite A, West Henrietta, NY 14586 USA,
Investor Information – IR@vuzix.com  www.vuzix.com 

 

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SOURCE Vuzix Corporation

FAQ

What FDA clearance did Pixee Medical receive related to VUZI?

Pixee Medical received FDA clearance for its Knee+ total knee replacement surgery solution.

How does the FDA clearance impact Vuzix Corporation (VUZI)?

The FDA clearance allows Pixee Medical to use Vuzix M400 Smart Glasses, potentially boosting Vuzix's sales and credibility in the AR field.

What is the significance of the U.S. market for Vuzix after the FDA clearance?

The U.S. market accounts for approximately 50% of total knee replacement surgeries worldwide, representing a significant growth opportunity for Vuzix.

How many orthopedic surgeries occur annually in the U.S.?

Approximately 600,000 total knee replacements are performed annually by over 30,000 orthopedic surgeons in the U.S.

What advantages does the Knee+ solution offer?

The Knee+ solution aids surgeons with real-time positioning of instruments, is intuitive, requires minimal training, and is less expensive than surgical robots.