Dallas, TX (PRWEB) August 16, 2011
The National Institutes of Neurological Disorders and Stroke (NINDS) has awarded a Phase II U44 SBIR grant to MicroTransponder after the Company successfully completed the Phase I milestones. The NINDS Cooperative Program in Translational Research – Small Business Awards (SBIR) U44 is a milestone-driven cooperative agreement program involving the NINDS staff. (http://www.ninds.nih.gov/) The project ends with the filing of an IDE with the FDA.
The Phase I milestones included the successful development of a wireless neurostimulator that reduced chronic pain in 2 different animal models of neuropathy. Dr. Patrick Dougherty, professor in the Anesthesiology department at MD Anderson, was the principal investigator of the Phase I research. Additional independent preclinical research was performed by PsychoGenics, a CRO based in Tarrytown, NY. Assistance in crafting and editing the SBIR proposal, experimental design, data interpretation, and interactions with the staff at NINDS was provided by Geoff White of Discovery Consulting LLC (http://www.sbir-sttrgrantshelp.com).
Our earlier studies showed that a voltage controlled capacitive discharge (VCCD) method of stimulation of nerve activation was able to selectively recruit the large myelinated nerve fibers. In this study, our SAINT™ device was able to wirelessly activate the sciatic nerve using the VCCD waveform. The purpose of this study was to determine whether this waveform can effectively improve mechanical hyperalgesia in the Spinal Nerve Ligation (SNL) and Chronic Constriction Injury (CCI) rat model as well as cold allodynia in the CCI model. Wireless stimulation was delivered with the SAINT™ device over sciatic nerve in SNL and CCI rats over several days. Two control groups were used in the study. A control group of rats was implanted with the device, but no stimulation was delivered, and a second group of control rats simply received the nerve lesion. Our results show that the paw withdrawal threshold for the active implant group improved significantly compared to post-lesion baseline. No significant differences were observed for the lesion alone or inactive microstimulator groups. We also observed a significant improvement in cold allodynia in the active implant CCI rats after stimulation. A preliminary histopathology on the sciatic nerve showed that the stimulation itself did not have any adverse effects on the nerve. These results suggest that the VCCD exponential waveform using our wireless microstimulator effectively improves mechanical hyperalgeisa and cold allodynia in neuropathic rats.
MicroTransponder has worked very closely with the staff at NINDS to develop milestones designed to efficiently translate this technology for clinical use. Will Rosellini, CEO of MicroTransponder, stated, “A big development gap exists between basic academic research and clinical deployment. The U44 mechanism awards Companies who are able to streamline their product development to bring medical devices to patients more efficiently.” “We appreciate the hard work of the program managers Linda McGavern, PhD and Linda Porter, PhD to ensure that innovative therapies will be available for patients suffering from neurological diseases,” continued Rosellini.
About MicroTransponder, Inc.
MicroTransponder Inc. (http://www.microtransponder.com) is a medical device development company with a strong neuroscience research focus. An experienced team of scientists and engineers is developing neurostimulation device technology for the treatment of several neurological disorders including tinnitus and post stroke motor rehabilitation. For additional updates on the company, visit our CEO's blog at http://www.WillRosellini.com.