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Medical Device Company Lazurite Announces Agreement with UH Ventures to Conduct Formative Human Factors Study on its ArthroFree™ Wireless Surgical Camera
by
August 27, 2021
The novel ArthroFree™ platform, when approved, is expected to be the world’s first FDA approved fully wireless, minimally invasive modular camera system for the operating room, featuring the patented Meridiem™ light engine. (Photo: Business Wire)

CLEVELAND–(BUSINESS WIRE)–Medical device and technology company Lazurite Holdings LLC (formerly Indago) today announced that it has contracted with University Hospitals (UH) Ventures – the innovation and commercialization arm of University Hospitals Health System in Cleveland – to conduct a formative human factors study on its ArthroFree™ wireless surgical camera as part of a broader multisite study. Human factors, or usability studies, are intended to demonstrate the performance of a device within an environment that simulates its real environment of use and by people who are the potential users.

The ArthroFree system is expected to be the world’s first FDA-approved fully wireless, minimally invasive camera system for the operating room (OR). It is expected to deliver OR efficiency gains, cost savings, improved safety, and reduced sterilization requirements through eliminating cords and cables, and significant reduction of the risk of OR burns and fires with its proprietary low-heat, high-power light engine technology. And the modular ArthroFree system is designed to be fully drop-in compatible with current operating room technology. The coming market launch, following anticipated receipt of FDA market clearance in 2022, will initially focus on orthopedic applications, particularly in sports medicine.

“We are excited to have UH Ventures and UH’s orthopedic surgeons and surgical staff working with us on this capstone study,” said Lazurite CEO and founder Eugene Malinskiy. “UH Ventures has built a strong reputation for its support of innovation, both from within UH and with outside organizations.

“And of course, the Department of Orthopedics at University Hospitals is consistently recognized as one of the nation’s finest orthopedics programs. UH is investing heavily in its highly respected sports medicine program. They are entering their eighth season as the official health care partner of the Cleveland Browns and also serve in the same role for the Cleveland Monsters and the Cleveland Ballet. In addition, their $236 million expansion project at the Ahuja Medical Center campus on Cleveland’s East Side includes a new family sports medicine complex that will treat an estimated 1,350 athletes in its first year.

“We hope this study will be the beginning of a broader, longer-term collaboration between Lazurite and University Hospitals. The connection with UH will certainly benefit us when we launch ArthroFree into the market. I believe the partnership will further advance University Hospitals’ reputation as an innovative leader in advancing new medical technology.”

“We are delighted to work with Lazurite on their formative human factors study,” said Kipum Lee, Managing Director of Innovation & Product Strategy, UH Ventures. “The ArthroFree system has all the marks of a breakthrough technology, so it represents a great opportunity for our surgeons and surgical teams to not only use it in this pre-approval period but to study it in an-depth manner. This type of immersive observation and data gathering is one of the key engagement services we provide through our UH Ventures platform. And the fact that Lazurite is a Cleveland-based company makes this collaboration all the more exciting.”

“Our surgeons and surgical teams are excited to work hands-on with the ArthroFree system as part of this study,” said James Voos, M.D., Chair, Department of Orthopedic Surgery at UH Cleveland Medical Center, and the head surgeon on the project. “This aligns with our focus on continuing to advance our orthopedic clinical, educational and research objectives.”

Dr. Voos has overall responsibility for the planning, growth and operational management of the department’s clinical activities, plus oversight of resident teaching programs and research. He also oversees the continued development and expansion of sports medicine across the UH system.

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.

About UH Ventures

Launched in 2018, UH Ventures draws on its resources, toolkits, and ever-growing network to develop and deploy innovation. This can be in the form of a new product or business, an optimized UH asset, a sustainable partnership, or an investment. For more information, see https://ventures.uhhospitals.org

About Lazurite

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.