BIOSENSICS LLC — Department of Health and Human Services SBIR Phase II: NIAMS

Description

PROJECT SUMMARY ABSTRACT The skeleton is the third most common site of metastatic cancerand nearly half of all cancers metastasize to boneAs a result of new and aggressive treatments cancer patients are living longerbut at sites of skeletal metastasis fractures occur inof affected bones after minimal traumaThis significantly impacts patient functioning and quality of lifeWhile much has been learned about the mechanisms of skeletal metastasisclinicians continue to make subjective assessments regarding a patientandapos s fracture riskWe have developed a methodcalled Computed Tomography based Rigidity AnalysisCTRAto use computed tomographyCTimages to calculate the minimal rigidity of a bone containing a neoplastic lesion for the purposes of estimating load capacity and predicting pathologic fracturesThe CTRA method has been validated in ex vivopre clinicaland in vivo studiesAn alpha version of CTRA was developed for research purposesWhile it is not intended or marketed for clinical useit is being used clinically in several different hospitals at the discretion of a medical doctorPhysicians using CTRA have been inconsistently reimbursed by public and private payers under CPT codeUnlisted Diagnostic Radiographic ProcedureThis generic code is used when no other specific procedure code existsAt low volumes during initial deployment this is feasiblebut for CTRA to become a standard of careFDAkclearance and a non generic Category I CPT code are neededThrough an ongoing Direct Phase II SBIR we are developing a commercial quality CTRA software package that will integrate with hospital picture archiving and communication systemsPACSand fully automate the CTRA processThis CRP grant will help us bridge the gap between product development and successful medical software commercializationThereforethe first two aims fall into the category of Technical Assistancewhereas the last two aims fall into the Late Stage Randamp D categories followsAimprepare all required documentation for an FDAksubmission for CTRA softwareAimprepare an application to the American Medical AssociationAMAfor a Category I CPT codeAimsoftware design verification and validation activitiesand Aimeliminate the need for an imaging phantomGiven the clinical need and proven accuracy of the approachthe Musculoskeletal Tumor SocietyMSTSsupports the commercialization of CTRA and has already committed to assisting us in the process of applying for a CPT codesee MSTS Letter of SupportPROJECT NARRATIVEWe have developed a technique called CT based Rigidity AnalysisCTRAto predict bone fracture containing a neoplastic lesiontumorand validated its efficacy in number of studiesThis is an important health care questionsince the consequences of such fractures are rather grimThis proposal aims to take CTRA from the laboratory to the clinics by bridging the gap between product development and successful medical software commercialization