Development of an innovative neurosurgical planning tool for awake craniotomy

SUMMARY/ABSTRACT Brain tumors result in a disproportionate rate of cancer morbidity and mortality. Standard of care treatment includes maximal safe surgical resection, with extent of surgical resection (EOR) representing the most relevant prognostic factor for patient survival. Because EOR is dependent on the surgeon’s capability to distinguish between healthy brain tissue and tumor-invaded tissue in or adjacent to brain areas that support cognitive function, the neurosurgeon must balance clinical objectives against causing cognitive impairments. The ground truth standard-of-care procedure to facilitate this distinction is awake craniotomy with brain mapping using direct electrical stimulation mapping (DES). Knowing the location of specific functions with respect to real-time surgical targets allows the clinical team to protect those functions. However, there is no evidenced-based platform that allows clinical teams to choose the most sensitive task to map and measure a given brain region, or to understand the implications for future cognitive function of removing a specific volume of brain tissue. To fill this gap, MindTrace Technologies, Inc. is developing a cloud-based software platform to be used before, during, and after a neurosurgical procedure to improve the process of evaluating and choosing an optimal treatment plan. The MindTrace platform supports the administration of functional brain mapping protocols (functional neuroimaging, DES mapping), and the pre-processing and co-registration of behavioral and neural data in the service of optimizing the effectiveness of brain mapping during awake brain surgery. The goal of this Direct to Phase II SBIR proposal is to further improve the advanced prototype MindTrace software platform and deploy it under IRB in the context of a research study to collect prospective longitudinal data at 4 major medical centers. Completion of these Aims will result in a commercializable product and lay the empirical and technological foundation for the development of real-time AI-based predictive analytics, a large-scale clinical trial, and FDA clearance. The design of the proposed protocol is based on written feedback from FDA (qSub meeting) regarding the parameters of a dataset needed for successfully apply for Breakthrough Device Designation. The dataset to be generated by this prospective study will be the empirical basis for follow on technology development in AI/ML predictive analytics. Commercialization of the platform deployed within the current proposal represents a turn- key software product that integrates multiple sources of information to enable clinicians to plan neurosurgery more effectively in support of the best postoperative quality-of-life. This application requests supplemental TABA funding to provide marketing and labeling guidance as well as regulatory support to prepare and submit the FDA 510(k) premarket notification for MindTrace’s platform. As an early-stage startup, our regulatory budget is limited. TABA funds are requested to allow us to: 1) produce and compile product labeling and marketing materials for commercialization and 2) prepare and submit a 510(k) premarket notification. Support for these filings will likely increase the value of our enterprise.