Development of an Osteoinductive Spinal Fusion Implant for Enhanced Fusion Rates

PROJECT SUMMARY The objective of this Phase II SBIR is to test the safety and efficacy of an osteoinductive lumbar spinal fusion implant in an ovine modelIn preliminary worklower impedance piezoelectric materials that generate power for direct currentDCelectrical stimulation applications were manufactured and electromechanically characterizedIn an osteoinductive spinal fusion implant designan insulated piezoelectric composite acts as a power generator to supply negative DC electrical stimulation to a Titanium electrode that is mounted on the surface of the implantIn the Phase I STTR researcha more cost effective and mechanically sound method of manufacturing the piezoelectric lumbar spinal fusion implant was developed using easy to use epoxy materialsEvoke Medical has formed strategic partnerships that will allow us to will designbuildand test PEEK based piezoelectric interbody implants that can be manufactured in volume at a reasonable costIn lumbar spine fusionthe success rate reported in published studies ranges from approximatelyThis disparity is primarily due to the high number of difficult to fuse patientse gsmokersdiabeticsDC electrical stimulation has been shown to help increase success rates in the difficult to fuse population and accelerate the rate of bone healing in all patientsPreliminary large animal studies using an encapsulated piezoelectric composite spinal fusion implant showed that it could generate faster and better healing in spine fusionWhile preliminary studies show great promisethe concept must be proven with PEEK based implants and tested with sufficient numbers of animals to show statistical differencesThe premise of the Phase II proposal is that an interbody implant with integrated DC stimulation will promote a faster and more robust spinal fusion in comparison to the current standard of care in a large animal modelWith the cost effective manufacturing methods and demonstration of safety and efficacy in Phase IIEvoke Medical can then move forward with commercialization of this potentially disruptive technology that may eventually increase success rates of spinal fusion in the difficult to fuse populationsIn Specific Aimwe will implement the cost effective methods of manufacturing stacked layered PEEK based piezoelectric composite TLIF implants that were developed in the Phase I workIn Specific Aimwe will prove that the PEEK based piezoelectric TLIF implants can meet or exceed mechanical requirements of a legally marketed TLIF predicate device using recommended ASTM standards for interbody testing while maintaining the ability to produce sufficient power for bone healingIn Specific Aimwe will demonstrate safety and efficacy of the piezoelectric TLIF implant in an ovine modelThe results of this work will set the stage for Phase III funding of early clinical trials required for regulatory clearance and subsequent acquisition by a large medical device companyThe thoracolumbar spine interbody market is over $B year with a compound annual growth rate ofThe proposed device is hypothesized to increase the success of healing and decrease the time to healthus decreasing overall cost of care and human suffering PROJECT NARRATIVE Back pain is the second most common cause for physician visits in the USAwithof all people experiencing severe back pain at some timeSpinal fusion surgery is often used to alleviate pain and reestablish stability for the most severe casesCurrently overfusion surgeries are performed each year in the US and growing at a rate of overper yearThe success rate of spinal fusion ranges from approximatelywith poor healing in the difficult to fuse patientse gsmokersdiabeticsThe Evoke Medical solution will provide a non pharmacologicalcost effective way to create spinal fusion implants that will provide bone healing electrical stimulation from a humanandapos s body motionOur spinal fusion implant will give surgeons a way to successfully improve their patient care while simultaneously reducing cost of care and improving patient outcomes