Vertify Probe Intraoperative device for measurement of bone quality
Project Abstract:
Problem Definition The rapid growth of the elderly population with a higher incidence of osteoporosis makes orthopedic spine surgery more challenging Poor bone quality osteoporosis increases instrumentation screw failure leading to revision surgeries enormous health resource consumption and poor quality of life for patients Current bone quality assessment is through bone density DEXA scans However these scans are not typically performed unless surgeons already suspect osteoporosis and have the time to scan the spine preoperatively plus the information is not specific enough to predict risk of hardware failure Intended Customer The novel Vertify Probe device will provide surgeons with bone quality information in order to make the best surgical procedure decisions Patient outcomes will be improved through higher quality application of hardware ie pedicle screws reduced hardware failures and revision surgeries Patients will receive better outcomes hospitals will offer better surgeries payers will experience costsavings and medical device companies will incorporate screw augmentation products Solution The Vertify Probe measures properties of bone in realtime including stiffness and compressive strength during standard surgical procedures This differs from imagebased bone density scans as we believe direct measurements of bone strength leads to the best information for the surgeon This information will enable the surgeon to make decisions to improve patient outcomes by selecting optimal instrumentation or bone augmentation strategies Proposed Work To date two scaled up 2X designs demonstrated proofofconcept measurements KYNETIC funds will be used to develop and test a true scale ie 1X prototype with integrated measurement feedback and seek surgeon evaluation to improve device design and acceptance by the orthopedic and neurosurgery communities Efficacy studies will also be pursued as device validation will be important for potential investors Milestones through four funding cycles 1 Fabricate a true scale 1X surgeonapproved design 2 Validate Vertify Probes performance over current standards through efficacy driven cadaver data 3 Prepare Vertify Probe for commercialization Deliverables By the end of the total funding period we will have a true scale prototype with foam block and cadaver efficacy data compared to the current standard DEXA We will also prepare a detailed plan for future FDA approval and manufacturing Team Strengths Dr Williams has experience in the design fabrication and characterization of microsystems including the integration of electrical and mechanical sensors for micromechanical devices Dr Boakye has over 20 years of experience in general neurosurgery and complex spinal neurosurgery He runs the Department of Neurosurgery Outcomes Research Program and Spinal Cord Research Lab and supervises many outcomesbased research projects Dr Voor has over 29 years of experience in orthopedic design and testing He has developed new orthopedic implants and related technologies that has resulted in 8 patents 4 licenses and products brought to market
