Naviswiss

The company's history shows a focus on phased development and regulatory approvals. After a period of research and development, Naviswiss achieved CE mark approval in Europe in 2018, followed by clearances in Japan and Australia. A significant milestone was receiving FDA clearance for its hip navigation technology in June 2020, enabling its entry into the substantial U.S. market. This was followed by FDA clearances for its Naviplan digital pre-operative planning tool in 2021 and its Naviswiss Knee application in early 2023. The company has secured funding through several rounds, including a CHF 5 million Series E round in late 2019 to support U.S. and Japanese market entry.

At the helm is CEO Jan Stifter, who joined in April 2017. Stifter brings extensive experience in computer-assisted surgery, having been involved in the field since 1998 and previously serving as Director of Navigation at a multinational orthopedic company. His background in engineering, computer science, and business directly informs the company's direction in developing accessible and efficient surgical technology.

The Naviswiss product platform is designed to be implant-agnostic, compatible with implants from various manufacturers. Its core offering is a handheld, imageless navigation system that provides surgeons with real-time data on critical parameters like cup alignment, leg length, and offset during hip and knee replacement surgeries. Key products include Naviswiss Hip (for both primary and revision surgeries), Naviswiss Knee, and the Naviplan CT-based planning software. The system's miniaturized trackers and instruments are a central feature, enabling less invasive surgical techniques and eliminating the line-of-sight issues common with larger navigation systems. This technology aims to improve the accuracy and predictability of joint replacements, potentially reducing revision rates and the need for intraoperative radiation.