SBIR-STTR Award

The goal of this project is to develop an operational medical device to target and mitigate intracranial hemorrhage in advance of surgical intervention. This will require the development of a prototype device that targets specific volumes of tissues. The technology could be coupled with existing or novel imaging/targeting methods. The device will be designed to treat epidural hematoma (EDH) and also demonstrated for superficial subarachnoid hemorrhage. The phase II goal of this project is to conduct FDA-suitable in vivo preclinical trials with the prototype device in preparation for human clinical trials. Although the stated objective is to treat EDH, subdural hematoma and hemorrhagic stroke treatments are logical extensions of the technology. The technologies developed in the execution of this project hold the potential to treat unrelated conditions such as invasive tumor growth or to activate drugs in specific tissues.

We have developed a device to control intracranial hemorrhage without a craniotomy.The device stops hemorrhage transcranially.This has been demonstrated in pig cadavers.We have developed a functional prototype and intend to improve and test the device on human cadavers and in vivo in pigs.By the end of the proposed work, we expect to be prepared to submit IDE paperwork with the FDA and engage investors or device manufacturers to bring the device to market.