Elucent Medical

Elucent Medical, Inc. is a medical technology company focused on developing surgical navigation solutions to improve outcomes in oncologic procedures. Founded in 2013 and headquartered in Eden Prairie, Minnesota, the company was established by a team with a successful track record in the med-tech space, including individuals from the former NeuWave Medical. The founding team includes Dr. Lee Wilke, a professor of surgery and director of the UW Health Breast Center; Fred Lee, a professor of imaging science; and Dan Van der Weide, an engineering professor. The impetus for the company came from Dr. Wilke, who identified the need for a more precise and less invasive method for locating tumors during breast-conserving surgery, aiming to replace traditional hook-wire localization techniques.

Elucent Medical operates in the surgical devices market, providing its technology to hospitals and surgical centers. Its business model centers on the sale of its integrated surgical guidance system and the associated disposable components. The company targets surgeons, particularly those specializing in breast cancer, with plans to expand into thoracic and other soft tissue applications. The company has secured significant funding to support its commercialization and development efforts, including a $42.5 million Series C round in April 2024.

The company's core offering is the EnVisio™ Surgical Navigation System, which utilizes In-Body Spatial Intelligence (iSI) to provide real-time, 3D guidance during surgery. This system works in conjunction with the SmartClip®, a permanently implantable, wireless soft tissue marker. The SmartClip can be placed at the time of biopsy to mark a lesion. During surgery, the EnVisio system, which includes a SmartSensor™ that attaches to standard surgical instruments and a SmartSurface™ that generates a spatial field, tracks the SmartClip's location, providing the surgeon with continuous data on the tumor's distance, depth, and direction. This allows for precise navigation to the tumor, aiming to minimize the removal of healthy tissue, reduce the likelihood of needing a second surgery due to positive margins, and eliminate the often uncomfortable pre-surgical hook-wire placement procedure for patients. The system received FDA 510(k) clearance in 2019 and has since been used in thousands of procedures. More recently, the company received an FDA Breakthrough Device Designation for its next-generation EnVisio X1 system, which is in development for broader soft tissue applications, including video- and robotic-assisted surgeries.

Keywords: surgical navigation, medical devices, oncology, breast cancer surgery, soft tissue marker, lumpectomy, tumor localization, real-time 3D navigation, surgical guidance, EnVisio, SmartClip, med-tech, surgical oncology, tissue-sparing surgery, minimally invasive surgery, surgical instruments, FDA clearance, thoracic surgery, In-Body Spatial Intelligence, cancer treatment, surgical technology, robotic-assisted surgery, video-assisted surgery