Monday, June 17, 2024

First human clinical study for MRI-guided device placement in the brain

AiM Medical Robotics Inc. (AiM), a developer of MRI-compatible intraoperative robotics for neurosurgery and other applications, announced a collaboration with Brigham and Women’s Hospital (BWH) and the Surgical Navigation and Robotics (SNR) Lab at Harvard to validate their cutting-edge robot for deep brain stimulation in Parkinson’s patients. The study will take place in BWH’s Advanced Multimodality Image-Guided Operating (AMIGO) Suite, a state-of-the-art clinical research facility. 

AiM also reported a successful cadaver trial at the PracticePoint facility, demonstrating precise delivery of bilateral DBS leads using real-time MRI guidance. Prior to AiM’s approach, DBS leads may miss the intended target area due to the brain shifting from the time of pre-operative imaging and surgery due to creating access holes in the skull. 

This demonstration highlights the robot’s ability to account for brain shifts. Additionally, AiM announced a partnership with Synaptive Medical to integrate their Modus Nav neuro-navigation software with the robot, creating an optimized workflow for unparalleled precision and efficiency in neurosurgery.

The startup aims to launch its compact, MRI-compatible surgical robot, which will facilitate intelligent intraoperative surgical planning and guidance through real-time soft tissue imaging. This advanced robot specifically addresses the issue of brain shift during surgery.

According to the company website, the firm targets its services for patients undergoing neurosurgery for Functional brain disorders (Parkinson’s, Epilepsy, etc.) and cancer while providing cost savings to hospitals by eliminating errors and reducing procedure time by up to 50%.

This groundbreaking technology is essential for addressing the challenge of brain shift, a common issue that results in inconsistent and suboptimal outcomes in many surgical procedures. The movement of the target relative to the skull during surgery often leads to the need for additional surgeries, with 34% of deep brain stimulation lead placements requiring removal or revision due to missing the intended anatomical targets in the brain. 

AiM has developed a cutting-edge product for image-guided stereotactic neurosurgery, the culmination of approximately 15 years and $15M of NIH-funded academic research. The company is now ready to enter the $4.3B market, offering a solution to the challenges associated with the precise and safe intracranial placement of neuromodulation, ablation, and drug delivery devices. By making intraoperative MRI guidance a standard practice, AiM aims to enhance hospital efficiency, ensure procedural consistency, and ultimately improve patient outcomes.

In addition, AiM Medical Robotics has partnered with Synaptive Medical (Synaptive), a Toronto-based medtech company that provides solutions for surgical, imaging, and data challenges. This collaboration integrates Synaptive’s Modus Nav neuro-navigation software platform with AiM’s stereotactic neurosurgery robot, resulting in enhanced visualization, navigation, and control capabilities. The platform leverages intraoperative MRI updates for precise targeting and MRI-based localization and tracking of AiM’s robot. 

By combining AiM’s MRI-compatible robotic stereotactic frame with Synaptive’s advanced navigation software and intraoperative MRI, they have created an optimized workflow that delivers unparalleled precision and efficiency for deep brain interventions. This collaboration represents a significant advancement in improving patient outcomes and driving the field of neurosurgery forward.