Clear Guide Medical, Inc. SBIR Phase I Award, September 2020

Clear Guide Medical, Inc. Summary In this proposal, Clear Guide will develop a novel MRI-compatible, on-patient augmented reality needle guidance system to make MRI-guided interventions simpler and faster. With minimal changes to physicians’ existing workflow and without using special headgear, this device could reduce the time of MRI-guided procedures by minimizing the necessity of multiple MRI scans currently used in the “advance-and-scan” method of detecting the instrument tip. With the augmented reality guidance, physicians can see real-time “in MRI” visualization of the instrument tip as it advances through the body on a medical grade monitor, without the overhead of special needles or long calibration times. More importantly, the augmented reality guidance is also projected directly onto the patient allowing the physician to focus on the patient and to confidently follow the preplanned needle path without multiple MRI scans to check the needle’s progress. In the Phase I project, Clear Guide will produce a commercialize-able prototype that has been tested and validated. Clear Guide has already tested for electromagnetic interference in the MR suite and shown that no interference in image quality by the device occurs. Clear Guide will get data to validate the expectation of reduced procedure time through a feasibility study measuring procedure time and accuracy in both a phantom model and torso cadaver study at Children’s National Medical Center. Public health implications of this proposal include increasing the ability of many different clinical practitioners to perform a MR-guided biopsy accurately, making this technology available for different clinical settings. By enabling more MRI-guided procedures, especially for children, the device will reduce the need for CTs and ionizing radiation.Project Narrative This NIH Phase I SBIR proposal will result in a cost-effective MRI-guidance interventional tool for MRI-guided procedures like biopsies and injections. With minimal changes to physician’s existing workflow, this device can reduce the time of MRI-guided procedures because the “advance-and- scan” method of detecting the instrument tip can be minimized by real-time “in MRI” visualization of the instrument tip as it advances through the body, without the overhead of special needles or long calibration times. This novel augmented reality guidance is projected directly onto the patient allowing the physician to focus on the patient and to confidently follow the preplanned needle path without multiple MRI scans to check the needle’s progress.