AiM Medical Robotics starting 1st human clinical study for MRI-compatible surgical robot

AiM Medical Robotics is taking the next steps to validate its robot for deep brain stimulation in Parkinson’s patients. The company is partnering with the Surgical Navigation and Robotics (SNR) Lab at Harvard and has entered into a clinical research agreement with the Clinical Trial Office at Brigham and Women’s Hospital (BWH).

AiM is bringing a compact, MRI-compatible surgical robot to market. The company says the robot will facilitate intelligent intraoperative surgical planning and guidance through real-time soft tissue imaging. In particular, the robot will work to counteract the issue of brain shift.

Brain shift happens when the surgical target moves relative to the skull during surgery. It can lead to inconsistent and suboptimal outcomes in many procedures. AiM says that it’s been reported that 34% of deep brain stimulation lead placements require another surgery or removal because of this issue.

The company says its robot for image-guided stereotactic neurosurgery results from 15 years and $15 million of NIH-funded research. AiM says it’s ready to introduce its robot to a $4.3 billion market for addressing the challenges related to the efficient, accurate, and safe intracranial placement of neuromodulation, ablation, and drug delivery devices.

During the study, participating surgeons will use AiM’s stereotactic neurosurgery robot to accurately deliver deep brain stimulation (DBS) leads with real-time MRI guidance for patients with Parkinson’s Disease. The company says it’s thrilled to be collaborating with Dr. Reese Cosgrove, Head of Epilepsy and Functional Neurosurgery, on this project.

With the study, AiM is building on the long-standing and successful joint research efforts of AiM’s CEO Gregory Fischer and SNR Lab’s Pedro Moreira and Noby Hata. Moreira acted as the lead investigator for the trial at BWH. Fischer spoke at the recent Robotics Summit & Expo.

The study will occur in BWH’s Advanced Multimodality Image-Guided Operating (AMIGO) Suite, the hospital’s state-of-the-art clinical research facility.

In addition to its clinical study, Aim also announced a completed cadaver trial and a collaboration with Synaptive Medical.

AiM reports a successful cadaver trial

AiM says that it has successfully demonstrated its robot’s ability to precisely deliver DBS leads using real-time MRI guidance in a cadaver trial on May 10, 2024. The trial took place at the PracticePoint Accelerator Facility and was conducted with the clinical team from BWH.

Typically, DBS leads may miss the intended target area due to brain shifting that occurs between pre-operative imaging and surgery. This means that the access holes in the patient’s skulls might be misaligned. AiM says this demonstration highlights the robot’s ability to account for brain shift.

During the trial, the team used AiM’s robot in a fully direct, MRI-guided procedure for DBS lead placement in a human cadaver. The team says the AiM platform successfully completed the full procedure entirely within the MRI suite, achieving high levels of efficiency and accuracy.

AiM’s previous work with the robot included a successful 30-patient trial for MRI-guided robot-assisted prostate cancer biopsy.

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Synaptive Medical to integrate its software into AiM’s robot

AiM’s partnership with Synaptive Medical will involve integrating Synaptive’s Modus Nav neuro-navigation software with AiM’s robot. The companies say this creates an optimized workflow for unparalleled precision and efficiency in neurosurgery by enhancing visualization, navigation, and control.

The software platform will use intraoperative MRI updates to ensure precise targeting and MRI-based localization and tracking of AiM’s robot.

AiM and Synaptive say that by combining AiM’s MRI-compatible robotic stereotactic frame, Synaptive’s advanced navigation software, and intraoperative MRI, the two companies have created an optimized workflow that delivers unparalleled precision and efficiency for deep brain interventions. This collaboration marks a significant step forward in improving patient outcomes and advancing the field of neurosurgery, AiM says.

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