Product: A novel subdermal passive cooling prosthesis that controls drug-resistant focal epilepsy by exerting a mild, broadspectrum anti-inflammatory effect with no detectable side effects. The device is very competitive because it requires no removal of brain tissue, implanted power supply, circuitry or moving parts, it is MRI compatible, economical to build, and is im¬plant¬ed in the skull opening performed as routine standard of care for localization of the epileptic focus in drug-resistant epilepsy patients. In preclinical blind and randomized studies in the only realistic model of drug-resistant focal epilepsy in the rat the predicted the failure in clinical trial of J&J's investigational antiepileptic drug carisbamate, our subdermal prosthesis effectively cooled the epileptic focus and safely controlled virtually all seizures in most animals.
Target Market: there are 700,000 people suffering from drug-resistant focal epilepsy in the USA, and 50,000 new cases per year. Washington State has 45,000 such patients, plus 1,000 new cases a year. These patients suffer from a wide range of cognitive disability due to untreatable seizures, and increased mortality rate.
Competitive Analysis: Resective surgery is the most effective treatment for drug-resistant epilepsy, but is available only to patients with epileptic foci in brain regions that can be removed without significant functional impairments. It is very expensive and results in complete seizure remission in only up to 50-75% of patients. It also may result in irreversible side effects that vary depending on the site and function of excised brain tissue. Many patients are not willing to consider this option for fear of brain resection. Alternative treatment is limited to surgically implanted brain (Neuropace inc., CA) or vagal nerve (Cyberonics inc., TX) stimulators. Both are expensive and barely effective, decreasing seizure frequency by just 38%. Our subdermal cooling prosthesis is expected to be much cheaper, safer, and effective than these alternatives.
Technical Plan: The basic research to establish mild passive focal cooling as an effective treatment for drug-resistant focal epilepsy is complete. We now want to de-risk the technology for commercialization by demonstrating that the device focally cool the human brain as predicted from the experimental work in rat and humans we conducted. The UW C4C and Therma Neurosciences team have already discussed the technology with numerous local entrepreneurs, CEO candidates, Medtronic Inc. and Integra Inc, and there is general agreement that this test is necessary at this stage of development. We propose to 1) 3D print the prototype in surgical titanium, a procedure already FDA approved for several cranioplasty prosthesis, and 2) test the prototype in the operating room in 12 patients undergoing surgery for treatment of drug-resistant focal epilepsy in our UW Regional Epilepsy Center. For each patient, the prosthesis will be placed in contact with the dura mater within the craniectomy performed as standard of care, with the scalp positioned to cover the prosthesis, as it would be chronically implanted to treat focal epilepsy. We will monitor temperature and epileptiform ECoG activity and determine the extent and depth of cooling induced by the device alone. Then, the scalp overlying the prosthesis will be cooled with sterile gel packs kept at the targeted temperatures to obtain dose responses. We antici¬pate the target cooling of the epileptic focus by 2oC will be achieved by changing the temperature of the scalp in the range of 0oC (no scalp cooling) to 3oC. The data will allow us to complete a finite-element model of heat dissipation through the passive prosthesis which will allow us to finalize the design of the implanted passive prosthesis and of the external scalp cooling device. With these human data, our technology will be ideally positioned for our new start up, Therma Neurosciences Inc., to license the technology from the University of Washington before SBIR applications and its first round of equity investment.
Sponsor Award Number: 16624563