
Spinal Fusion Implant with Embedded Biomechanically Powered SensorAward last edited on: 4/12/2023
Sponsored Program
SBIRAwarding Agency
NIH : NIAMSTotal Award Amount
$274,865Award Phase
1Solicitation Topic Code
846Principal Investigator
Leighton LapierreCompany Information
Evoke Medical LLC
646 Vermont Street Suite 200
Lawrence, KS 66044
Lawrence, KS 66044
(612) 875-3037 |
evokemedical@gmail.com |
www.evokemedical.co |
Location: Single
Congr. District: 02
County: Douglas
Congr. District: 02
County: Douglas
Phase I
Contract Number: 1R43AR082237-01Start Date: 9/15/2022 Completed: 8/31/2023
Phase I year
2022Phase I Amount
$274,865Public Health Relevance Statement:
Project narrative:
Back pain is the second most common cause for physician visits in the USA, with 70-85% of all people experiencing severe back pain at some time. Spinal fusion surgery is often used to alleviate pain and reestablish stability for the most severe cases. Currently over 600,000 fusion surgeries are performed each year in the US and growing at a rate of over 5.4% per year. The success rate of spinal fusion ranges from approximately 50-90% with poor healing in the difficult-to-fuse patients (e.g. smokers, diabetics). The determination of a successful fusion is subjective and is qualitatively determined by multiple rounds of expensive post-operative x-ray and CT imaging along with potentially biased patient reported outcome measures. In addition, the progression of a "failed fusion" is not well understood and current postoperative monitoring methods are not granular enough to adequately treat the at-risk patient. The Evoke Medical solution will provide a non-pharmacological, cost-effective way to create spinal fusion implants that will provide bone healing electrical stimulation from a human's body motion, while also providing post-operative load sensing data to both the patient and physician through a mobile app. Utilizing human-powered technology, this implant can sense changes in load as the bone grows or doesn't grow adequately, and provide this patient-specific information to patients and physicians as healing progresses; all without a battery or external stimulator. This will allow the physician to make better informed postoperative treatment decisions that could greatly improve the chances of fusion success. Both the load sensing and stimulating aspects of the spinal fusion implant will give surgeons a way to successfully improve their patient outcomes while simultaneously reducing cost of postoperative monitoring.
Project Terms:
Back, Dorsum, Back Pain, Back Ache, Backache, Biofeedback, Biomechanics, biomechanical, bone, Calibration, Electric Stimulation, Electrical Stimulation, electrostimulation, Electrodes, Environment, Future, Patient Care, Patient Care Delivery, Goals, Growth, Generalized Growth, Tissue Growth, ontogeny, Health Personnel, Health Care Providers, Healthcare Providers, Healthcare worker, health care personnel, health care worker, health provider, health workforce, healthcare personnel, medical personnel, treatment provider, Human, Modern Man, implantable device, biomedical implant, implant device, indwelling device, Industry, Linear Regressions, Methods, Miniaturization, Miniaturisations, Motion, Persons, physician office visit, Office Visits, Painful, Pain, Patient Reported Measures, Patient Reported Outcomes, Patient Outcomes Assessments, Patients, Physicians, Post-Operative, Postoperative, Postoperative Period, Publishing, Risk, Safety, Ovine, Ovis, Sheep, Cell Communication and Signaling, Cell Signaling, Intracellular Communication and Signaling, Signal Transduction Systems, Signaling, biological signal transduction, Signal Transduction, Software, Computer software, Spondylosyndeses, Spinal Fusion, Spinal Column, Spine, backbone, Vertebral column, Technology, Testing, Time, X-Ray Computed Tomography, CAT scan, CT X Ray, CT Xray, CT imaging, CT scan, Computed Tomography, Tomodensitometry, X-Ray CAT Scan, X-Ray Computerized Tomography, Xray CAT scan, Xray Computed Tomography, Xray computerized tomography, catscan, computed axial tomography, computer tomography, computerized axial tomography, computerized tomography, non-contrast CT, noncontrast CT, noncontrast computed tomography, Translating, Work, Measures, Walking, Health Care Costs, Health Costs, Healthcare Costs, Outcome Measure, Custom, electric impedance, Electrical Impedance, Impedance, base, sensor, improved, Site, Area, Surface, Clinical, Phase, Physiological, Physiologic, Medical, Ensure, Failure, Rural, diabetic, Human Figure, Human body, Funding, Smoker, mechanical, Mechanics, Pulse, Physiologic pulse, Frequencies, In Situ, Texture, Spinal, Operative Procedures, Surgical, Surgical Interventions, Surgical Procedure, surgery, Operative Surgical Procedures, Visit, Surgeon, biocompatibility, biomaterial compatibility, experience, success, voltage, simulation, Self-Report, Patient Self-Report, Devices, Reporting, Abscission, Extirpation, Removal, Surgical Removal, resection, Excision, miniaturize, Bone Growth, Risk Reduction, preventing, prevent, Data, Harvest, in vivo, Collection, Patient-Focused Outcomes, Patient outcome, Patient-Centered Outcomes, Small Business Innovation Research Grant, SBIR, Small Business Innovation Research, Validation, Monitor, Process, Development, developmental, Image, imaging, Output, cost, healing, medical implant, design, designing, conditioning, Outcome, cost effective, Population, data acquisition, Implant, bone healing, bone wound healing, osseous wound healing, prototype, commercialization, data exchange, data transfer, data transmission, verification and validation, mobile application, mobile app, mobile device application, health care availability, access to health care, access to healthcare, accessibility of health care, accessibility to health care, accessibility to healthcare, health care access, health care service access, health care service availability, healthcare access, healthcare accessibility, healthcare availability, healthcare service access, healthcare service availability, mechanical load, Bone structure, skeletal structure, care costs, COVID-19, COVID19, CV-19, CV19, corona virus disease 2019, coronavirus disease 2019, coronavirus disease-19, coronavirus infectious disease-19, data tools, early phase clinical trial, early clinical trial, wireless, X-Ray Medical Imaging, Conventional X-Ray, X-Ray Imaging, Xray imaging, Xray medical imaging, conventional Xray
Phase II
Contract Number: ----------Start Date: 00/00/00 Completed: 00/00/00