CLEVELAND--(BUSINESS WIRE)--Medical device and technology company Lazurite Holdings LLC announced that its modular ArthroFree™ wireless arthroscopic camera system has been recognized by the American Orthopaedic Society for Sport Medicine (AOSSM) as a winner of its inaugural annual ACE (Accelerating the Cutting Edge) Award recognizing cutting-edge innovation in the field of orthopedic sports medicine. This highly competitive award was judged by a panel of distinguished doctors and AOSSM members.
The award results were announced at the combined annual meeting of AOSSM and the Arthroscopy Association of North America (AANA) held at Music City Center in Nashville. The event attracted more than 1,600 international surgeon attendees.
The ACE Award guidelines indicate that the competitive award represents AOSSM’s “recognition of industry partners’ contribution to the field and the importance of corporate innovations that impact our members and their patients.” In addition to ArthroFree, GraftNet by Arthrex and BioBrace by BioRez were also recognized.
“We are tremendously excited and proud to receive this inaugural award, especially at our first exhibition of ArthroFree,” Lazurite’s Chief Executive Officer and founder Eugene Malinskiy said. “It’s very gratifying to have met with so many enthusiastic visitors at our booth. Conference attendees demoed our pre-production models of ArthroFree, met with our team, and also had the opportunity to speak directly with several physician champions who were at our booth with us.”
The ArthroFree system is expected to be the world’s first FDA-approved fully wireless, minimally invasive camera system for the operating room. The modular system incorporates the company’s proprietary low heat, high intensity Meridiem™ light engine technology along with advanced camera, battery, and wireless transmission technologies. ArthroFree is designed to deliver improved operating room productivity, patient safety, and economic value through cost-savings, energy efficiency and reduced setup/breakdown times. And the ArthroFree system is designed to be fully drop-in compatible with current operating room technology.
Mark Froimson, MD, Chair of the Board of Managers of Lazurite, said, “Our experience exhibiting at this event along with this prestigious award mark the start of a new phase for ArthroFree on our path to gaining FDA clearance and launching this transformational new product. It’s always exciting to see surgeons’ reactions when they first experience this game-changing, innovative technology. As a result of winning this award, I think a lot more surgeons are going to want to experience the ArthroFree system in the coming months.”
The ArthroFree™ wireless arthroscopic camera system has not yet received FDA clearance and is not currently approved for human use. It is not intended for commercial distribution; orders cannot be accepted at this time. The company plans to submit its 510(k) premarket notification in late 2021 and expects to receive FDA approval to launch the product in the first half of 2022.
About the ACE Award
The new ACE Award was open to the 80+ exhibitors at the combined annual meeting. Eligible products included devices, procedures, techniques, materials, etc. introduced since the July 2020 AOSSM Annual Meeting. A panel of AOSSM members, free of significant financial or intellectual conflicts of interest, reviewed submitted entries and selected 6-8 products as finalists for review at the exhibitors’ booths during the annual meeting. The judges had the discretion to choose up to three winners.
The mission of AOSSM is to be the premier global, sports medicine organization representing the interests of orthopedic surgeons and other professionals who provide comprehensive health services for the care of athletes and active people of all ages and abilities.
Lazurite (formerly Indago) is a pre-revenue medical device startup company backed by private capital. The company has raised more than $18 million to date from institutional investors, family offices, and more than 50 physician champions. Founded in Cleveland in 2015, Lazurite has developed novel technology that will enable it to create the operating room of the future. The company’s product pipeline features the modular ArthroFree™ wireless camera system, which is expected to be the first FDA-approved fully wireless minimally invasive camera system platform designed for the operating room, and other innovative new products based on the company’s novel and patented Meridiem™ light engine technology. Lazurite’s technologies are protected by a comprehensive intellectual property portfolio encompassing our ArthroFree wireless surgical camera system and our novel MeridiemTM light source as well as other products currently in development. For more information, see: https://lazurite.co.
Forward Looking Statements
This press release includes "forward-looking statements." Forward-looking statements can be identified by words such as: "anticipate," "intend," "plan," "believe," "project," "estimate," "expect," "may," "should," "will," “designed,” “milestone,” and similar references to future periods. Examples of forward-looking statements include, among others, statements we make regarding our regulatory submission timeline for ArthroFree™. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based only on our current beliefs, expectations, and assumptions regarding the future of our business, future plans and strategies, projections, anticipated events and trends, the economy, and other future conditions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks, and changes in circumstances that are difficult to predict and many of which are outside of our control. Our actual results may differ materially from those indicated in the forward-looking statements. Therefore, you should not rely on any of these forward-looking statements. Any forward-looking statement made by us in this press release is based only on information currently available to us and speaks only as of the date on which it is made. We undertake no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.
Lazurite™, ArthroFree™, and Meridiem™ are trademarks of Lazurite Holdings LLC.