The broader impact/commercial potential of this I-Corps project is to ablate brain tumors and other cranial soft tissues with less infection, better outcomes, and reduced cost compared to current alternatives. Currently, there are around 700,000 individuals diagnosed with brain tumor in the US, with another 80,000 expected to be diagnosed this year (National Brain Tumor Society, 2017). Nearly two thirds, or 54,000, of these patients will undergo surgery as a first course of treatment at one of 5,000 neurosurgical centers in the US. The majority of patients are currently treated with invasive cranial flap resection procedures. Furthermore, the proposed technology may offer a therapeutic option for the 13,000 patients with high-risk primary malignant tumors that may be considered inoperable with current surgical approaches. The thermal ablation medical device market represents a $2.2B opportunity in the US, with ultrasound thermal ablation technology valued at $334M with an annual market growth rate of 13.5% (BCC Research, 2017). This innovation would offer a unique tool for neurosurgeons apart from cranial surgical navigation tools with a $459M US market, which are currently considered the standard of care for cranial surgery.
This I-Corps project will explore a minimally invasive high-intensity focused ultrasound (HIFU) device to ablate brain tumors and other cranial soft tissues, which features a hybrid transducer tip to apply therapeutic ultrasound to the targeted anatomy while simultaneously using ultrasound imaging to visualize the surgery site. Our simulation modeling determined the appropriate parameters for an initial prototype to precisely focus ultrasound and create a lesion using a flexible transducer phased array in a heterogeneous medium volume simulating cerebrospinal fluid and brain tissue (Zhang et al., 2017, AAPM Annual Meeting). These data showed that our system could provide the same efficacy of treatment with two orders of magnitude less power than non-invasive, transcranial HIFU devices. The project team then built a prototype based on the simulation results, and showed proof-of-concept functionality using a bovine serum albumin protein phantom. One of the primary challenges of this project will be to maintain the acoustic performance of the probe as the project moves toward miniaturization of the technology to fit the probe within the brain ventricles. The team will pursue further customer discovery to gain a deeper understanding of the clinical workflow, revenue streams, reimbursement, and regulatory aspects, with the goal to build an evidence-based business plan.
This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.
