Detection and Alerting System for Seizure Onset (DASSO)

DESCRIPTION (provided by applicant): We wish to improve treatment for patients with deep-seated brain tumors. With the help of the MRI-guided and nanoparticle-enabled system we are constructing, therapeutic access to these tumors will be provided through the delicate nooks, crannies, and membranes of the skull. In preliminary studies, we have demonstrated the ability to bypass the blood-brain barrier traumatically and to manipulate magnetic nanoparticles (MNPs) in mouse brains. By the end of Phase I, we will have built and tested an MRI-compatible gradient insert system capable of delivering magnetic nanoparticles (MNPs) to selected regions in normal mouse brains. Using the data collected from the Phase I mouse study, we will have run simulations of a large-scale magnetic insert system, in order to demonstrate the feasibility of targeting deep- seated brain and skull-base targets in humans. Discussions are well underway with investors to match the Phase II NCI contribution (see Letter of Support). Strategicpartner Chemicell is conducting toxicity and other studies in support of an eventual investigational new drug application (IND) of the drug to be used in Phase II of this study. The potential market size for this product can be estimated to be in the rangeof several hundred million dollars, based on either the number of potential surgical users and practice sizes (i.e., 4,000 neurosurgeons, averaging 8 physicians/practice, at an expected price per system of 1 million) or the purchase price and valuationsfor companies with similar products (Sentinelle Medical, acquired for 85 million by Hologic, and 2 billion valuation for Intuitive Surgical). PUBLIC HEALTH RELEVANCE PUBLIC HEALTH RELEVANCE: We wish to improve treatment for patients with deep-seated brain tumors. With the help of the MRI-guided and nanoparticle-enabled system we are constructing, therapeutic access to these tumors will be provided through the delicate nooks, crannies, and membranes of the skull. In preliminary studies, we havedemonstrated the ability to bypass the blood-brain barrier without trauma, and to manipulate magnetic nanoparticles (MNPs), in mouse brains.