Summary: The standard of care after the removal of a brain tumor is external beam radiation (EBR). EBR systems require large capex for hospitals, while costing $40k-$120k per treatment regimen. Importantly, many patients are not candidates for repeat EBR due to concern over injury to healthy brain tissue from repeated radiation exposure. Patients have a wait time of 2-3 weeks after surgery prior to starting EBR. This delay allows remnant tumor cells to replicate and can lead to recurrence of the tumor. Our implanted device(GammaTile™ Therapy) avoids the limitations of EBR by using short-range isotope (Cesium-131) seeds in a collagen matrix. The conformable matrix provides dose control by A) offsetting the seeds from tissue and, B) regular spacing between the seeds. Placement during surgery provides immediate radiation therapy after tumor removal, thereby treating the remaining cancer cells before they can significantly replicate. In addition to demonstrating reduced recurrence rates, our device A) reduces collateral damage to surrounding healthy tissue by having a very focused therapeutic area, B) has minimal impact on clinical workflow, C) improves patient quality of life by reducing side effects & burden, D) decreases system-wide cost, and E) increases access to care. To date, over 100 patients have been treated in an IRB approved trial at the Barrow Neurological Institute and a 510(k) has been cleared by the FDA for the treatment of recurrent intracranial neoplasms(tumors).
Need: The specific pain point GT addresses is that patients who have a tumor come back (a recurrence) have by definition failed other treatment options. In many cases, they cannot have a second round of external beam radiation (EBR) because it is simply too much radiation for the surrounding healthy brain tissue and they may have already received their maximum “lifetime dose” of radiation. GT’s solution directly addresses this pain point. Once adopted for recurrent tumor treatment, GT will seek to gain clearance as a first-time treatment of new tumors.
Value: Our device A) reduces collateral damage to surrounding healthy tissue by having a very focused therapeutic area, B) has minimal impact on clinical workflow, C) improves patient and caregiver quality of life by reducing side effects and eliminating the logistics associated with the current practice of daily radiation treatments for up to six weeks post-surgery, D) assures 100% treatment compliance since GammaTile™ Therapy is performed as the last step of a tumor resection procedure and E) decreases system-wide costs by reducing the overall cost and burden of care.