MICRO-LEADS INC — Department of Health and Human Services SBIR Phase I: NINDS

Description

In this SBIR FastTrack proposalMicro Leads will develop HDa high resolutionchannel spinal cord stimulation therapy to provide more pain relief with greater specificity for those suffering from chronic neuropathic pain and opioid dependenceOvermillion in the U Ssuffer from debilitating pain in the trunk and extremities anddepend on opioids to ease their sufferingOpioid abuse has claimed the lives of overover the past decade and has resulted in devastating reductions in quality of lifein ability to workand in mental health for the livingSpinal cord stimulationSCShas provided pain relief forof those with chronic extremity pain and eliminated opioid use entirely in more thanDespite these advantagesSCS has had a limited success treating isolated pain of the kneefootgroinor low backThe lateral positioned fibers of the spinal cordexthe dorsal root entry zone and dorsal hornrepresent a more selective neural targeting opportunity yet currentimplantable plate type surgical leads are too rigid and bulky to access these fibers without a significant risk of paralysis or nerve root compressionHDprovides an ultra thin and conformal blanket of stimulation contacts across the entire width of the spinal cordActive lead technology embeds a tiny electronic chip within the surgical lead and doubles the number of therapy contacts compared with current technology without increasing the number of lead wiresCollectivelythese features improve therapy and simplify surgical workflowA novel Active Lead Controller Implantable Pulse GeneratorAL IPGpowers the chip safelysynchronizes with the active lead electronicsconfigures theprogrammabletherapy groupsand ensures therapy pulses are delivered to the tissueHDtherapy is a highly significantnovel solution for the treatment of patients suffering from chronic pain and opioidsPHASEA cadaveric pilot run followed by a non significant risk intraoperative studynwill be performed to inform the geometric and electrophysiological design parameters of high resolution HDarraysThe study will evaluate activation of medial and lateral spinal targets as measured by intraoperative neuromonitoring of electromyographyAt the end of Phasethe clinical feasibility of HDsurgical leads will be establishedPHASEIn Phasewe have HDactive leads assembled by a GMP manufacturerWe will develop an external Active Lead Pulse Generator and charger which will be submitted for IDE approvalWe will perform an Early Feasibility Study Human Trial using active HDand AL IPG hardwarensubjectsntherapy groupsnwaveformsDuring Phasewe will also perform mechanical and electrical design verification testing and chronic safety studies in large animals to demonstrate functional performance to inform the final deviceBy the end of Phasewe will have completed all necessary tasks to inform the final device design and to enable follow on implanted longitudinal studies of chronic pain and opioid reduction The FastTrack SBIR seeks to develop HDa high resolution spinal cord stimulation therapy for treating chronic neuropathic pain of the lower extremitiesgroinand lower backThe device development will result in a clinical trial in people to demonstrate feasibility and to inform final device designThe proposal will motivate further development and productization of an SCS therapy which can reduce pain and remove the dependence upon chronic opioids