Clinical Validation of the Multiple Biopsy Device, a Novel Endoscopic Biopsy Technology

Project Abstract The objective of this proposal is to complete clinical validation of the Multiple Biopsy DeviceMBDan endoscopic device that will revolutionize endoscopic practice by improving the efficiency of endoscopic biopsyeliminating the loss of critical specimensand improving the safety of endoscopic biopsy for both practitioners and patientsOvermillion endoscopic procedures will require endoscopic biopsy in the yearand the number of diagnostic endoscopic procedures is expected to grow byper year over the next decadeCurrently marketed biopsy devices require a separate pass of the device everybitesClinical protocols for endoscopic biopsy require multiple passes to satisfy the total number of specimens needed to achieve diagnostic certaintyadding significant time pressures to already overburdened endoscopistsWe have developed a device that will allow the acquisition of an unlimited number of biopsies from one pass of the biopsy deviceThe MBD operates by mechanically harvesting a mucosal specimen taken for histologic analysisthen transporting the specimen to a collection device located outside of the endoscopeBiopsies from different lesions or locations can be segregated in separate sample cups to avoid confusion about their site of originationFurthermorethe MBD collection container will greatly speed up transfer of specimens from the collection device to formalin cupswhile eliminating the risk of impalement by the central spike during the retrieval of samples from the cups of the biopsy forcepsThe following specific aims will complete MBD validation in preparation for regulatory submissionSASpecific AimiDesign and implement a Design Trace MatrixDTMRisk Management Plan and associated protocols for manufacturing and testing clinical grade MBDsiiConstruct an adequate number of medical devices using contract manufacturers for supplying components for final assembly and packaging by EADincluding a sterilization safety study SAConduct a phase I Feasibility Study to support a future pivotal trialThis will consist of a RBDPB crossover trialas detailed in the Research Strategy sectionnSuccessful completion of this SBIR funded development program will support the commercialization of a paradigm shifting diagnostic device that will dramatically improve the process of endoscopic biopsywhile maximizing patient and ancillary staff safety Project Narrative Endoscopy Assist DevicesLLCwill clinically validate the Multiple Biopsy DeviceMBDa novel technology that will enable endoscopists to take and retrieve an unlimited quantity of biopsy specimens with one pass of the biopsy deviceThis feature will greatly expedite acquisition times when multiple samples are required for diagnosiswhile eliminating lost specimens and the risk of lacerations from the spike found on current biopsy devicesIn the present applicationwe propose to clinically validate the MBD in a first in human clinical trialThe work completed during the period of this grant will position the MBD for subsequent commercialization efforts and licensing opportunities