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Eugene Malinskiy

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Lazurite is a medical device and technology company developing novel technologies for the future of surgical care with a smart platform for a highly efficient, tech-enabled suite of tools. Our product pipeline features the modular ArthroFree™ wireless surgical camera system, which is expected to be the first FDA approved fully wireless minimally invasive camera system platform designed for the operating room. The ArthroFree system is designed to replace current surgical cameras while being drop-in compatible with current operating room equipment. The ArthroFree system is expected to improve outcomes for all participants in the healthcare system – patients, surgeons, staff and others – by reducing the time, cost, and safety risks associated with minimally invasive surgery. As the ArthroFree system is a Class II medical device, we plan to submit a 510(k) for to the FDA for marketing approval using the HRX 888.1100 pathway in late 2021 and expect receipt of FDA marketing approval in early 2022. We have a comprehensive intellectual property portfolio protecting our ArthroFree wireless surgical camera system, our novel Meridiem™ light source used in it, and our other products in development. Our portfolio includes granted U.S. and Foreign utility and design patents and pending applications filed in multiple worldwide jurisdictions as well as trademark applications covering our name, our product names, and our company logo and copyrights protecting additional components of our products. Lazurite has also secured a number of trade secrets for optimizing, qualifying, and commercializing our product lines. The wireless, ergonomic, handheld, and rechargeable design of the ArthroFree wireless surgical camera system improves over current minimally invasive surgery technology by eliminating (a) the fiber-optic and power cables that tether surgical cameras to the light source and video boxes in the operating room surgical tower and (b) the need for such boxes. Current surgical camera systems are cumbersome due to the wires necessary for their operation, are costly to clean and maintain, and present unnecessarily risk of burns and infection to patients. The ArthroFree system is designed (i) for an intuitive user experience with functional elements mirroring those in existing devices, and (ii) to be drop-in compatible with current operating room systems by accepting C-mount scopes from any manufacturer and transferring video via standard interface to patient data consoles. The modular ArthroFree wireless surgical camera system is poised to disrupt minimally invasive surgery as: (a) less equipment will be needed, leading to shortened operating room set-up and take-down times, (b) surgery will be safer due to reduced potential for trips and falls with less cables in the operating room, lower chance of contamination as the ArthroFree handset is sterilizable, and elimination of potential for fires and patient burns caused by the camera with the removal of the high temperature light source, and (c) with improved operating room efficiency, a customer can expect reduced costs both directly and indirectly. The ArthroFree system represents a new paradigm. It is a transformational innovation that will drastically improve the standard of arthroscopic care. The value already delivered by the clinical practice of arthroscopy as compared to open surgery will be further enhanced by the ArthroFree wireless camera system. Arthroscopic procedures will require less time, less equipment, all at reduced cost, in a safer manner, with less energy consumption than what we currently experience today.

Pitch Video

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Executive Summary