SynderBio Inc. — Department of Health and Human Services STTR Phase I: 102

Description

Bladder cancer is the fifth most commonly diagnosed cancer in the United StatesThree quarters of the nearlymen and women diagnosed with bladder cancer just this year will have a less aggressive form of the disease whichafter treatmentwill require frequent visits to the urologist for invasivepainful cystoscopy procedures for the remainder of their lifetimes to determine if the cancer has returnedAnd the disease will recur in about half of these patientsThis is a significant contributing factor to why bladder cancer is considered the most expensive cancer to treat per case and why there exists a compelling need to make the surveillance of bladder cancer recurrence less invasive for patients and more cost effective for the healthcare systemUnfortunatelythe current methods of detecting bladder cancer in urine specimensan ideal alternative to cystoscopyare not sufficiently accurate to replace cystoscopySynderBio Incis developing a device that could be placed at the point of care in the urologistandapos s clinic to rapidly process urine specimens in a way that improves the diagnostic accuracy of routine urine cytology preparations that have been used for decadesbut that lack the sensitivity to detect low grade bladder cancersSynderBioandapos s first in class technology is based on findings that intrinsic biophysical properties can distinguish benign and malignant cellsSynderBio achieves a rapid enrichment of malignant cells by a patented application of brief pulses of very high level fluid shear stress that destroys benign cellsleaving malignant cells that are resistance to this stress and remain intact and viableSynderBioandapos s approach is innovative becauseunlike its use of a unique biophysical biomarkerall of its competitors use specific molecular biomarkers to identify cancer cells in urine specimensThe long term goal of this project is to improve significantly the detection of bladder cancer recurrence in urine specimens using SynderBioandapos s productThe Phase I hypothesis is that resistance to fluid shear stress is a biomarker that can be used to enrich malignant urothelial cellsThe Aims of the Phase I STTR feasibility project are toDetermine if bladder carcinoma cell lines exhibit greater resistance to FSS in vitro compared to benign urothelial cellsandDetermine the feasibility of FSS to improve cytology from bladder cancer patientsPhase II objectives are totransform SynderBioandapos s current pre prototype device into a commercial ready productandexpand the clinical testing of this device to determine the extent to which it will improve the accuracy of urine based testing for bladder cancerThe commercial opportunity for SynderBioandapos s product is significantOvermillion people worldwide are living with bladder cancerIn the USbladder cancer surveillance is estimated to be a billion dollar market bySynderBioandapos s cell separation technology can also be applied to other cancer diagnostic and research purposesincluding solid tissue biopsiesThusthere is significant commercial potential for SynderBio to build a business to address bladder cancer and other unmet clinical diagnostic needsthereby improving human health and quality of life PROJECT NARRATIVE Bladder cancer is a commonoften treatable disease for which most patients must spend their lifetimes after initial diagnosis and treatment regularly returning to the clinic for invasive cystoscopy procedures to determine if the cancer has recurredThere is an unmet medical need to improve significantly the accuracy urine based diagnosis of bladder cancer to minimize the pain and cost of invasive cystoscopy proceduresSynderBio proposes to demonstrate the feasibility of developing a first in class device to use a biophysical biomarker to produce a practical and accurate point of care urine based diagnostic for bladder cancer