ZENFLOW, INC. — Department of Health and Human Services SBIR Phase II: 400

Description

Project Summary Abstract SignificanceUrinary retentionfrequencyand urgency related to benign prostatic hyperplasiaBPHrepresent an unmet clinical need for many millions of men in the USMedications can be expensivehave side effects like loss of libidoand prove ineffective inof patientsSurgery is effectivebut can result in post operative pain and carries a high risk of permanent sexual side effects such as retrograde ejaculation and erectile dysfunctionA number of shortcomings have prevented minimally invasive attempts from attaining widespread adoptionMechanical devices have failed due to difficult placementmigrationand encrustation caused by urine exposurewhereas energy therapies have failed to achieve durable resultsZenflow has developed the Spring System to provide a superior minimally invasive and permanent solution for men who experience inadequate relief or side effects from drugsbut decline to undergo invasive surgical procedures such as transurethral resection of the prostateTURPUnlike other minimally invasive attemptsthe Spring nitinol implant is delivered through a flexible cystoscope in an easyten minute office procedure that does not damage tissueWith uniquely low COGS of less than $the Spring will also substantially reduce costs to the healthcare system substantially over all existing treatment optionsPreliminary DataWe have performed preclinical validation in two acute caninesthirteen chronic caninesnine followed to at leastdaysand ten cadaver specimensAfter refining the placement procedure in early studieswe have verified that the Spring implant can be placed accurately and reliably by a trained urologistIn animal studiesthe implant has demonstrated its ability to fully invaginate into the urethral wallexpand the urethral lumenand avoid urine exposureNo encrustation has occurredand no migration has occurred when the device was placed propertyDelivery of the implant across all animal studies took three minutes on averageWe have supplemented these studies with a comprehensive suite of bench top verification and validation testswhich confirm deliverability and circumferential strength of the implantand biocompatibility and mechanical integrity of the implant and delivery systemSpecific AimsThis project entails preclinical testing of the Spring implant and delivery system for eventual application to human patients suffering from BPH related obstructionIn Specific Aimwe will perform preliminary bench top VandV testing in preparation for human clinical trialsThe suite of tests will resemble those outlined in the De Novoksummary for the NeoTract UroLift devicewhich will be used as a predicate device forksubmissionThese tests will verifybiocompatibility of the implant and delivery system fluid path including cytotoxicitysensitizationirritationacute and chronic toxicitygenotoxicitysubchronic toxicityand implantationpackage integrityagingtransit testingand shelf lifesterilization validationmagnetic resonance compatibilityandbenchtop performance and simulated useIn Specific Aimwe will assess long term safety and feasibility of the Spring System in a six month chronic GLP animal study involving eight male hound dogsSix treatment animals will receive a Spring implant and two control animals will undergo a simulated procedureWe will log all relevant adverse events detailed in the FDA guidance document for BPH devices and will perform histopathology on all dogs after sacrifice to assess long term tissue responseIn Specific Aimwe will develop a tool and method for safe and easy removal in an office settingTo validate the ease and effectiveness of this toolwe will perform an additional chronic canine study in two dogs where the Spring device will be implantedleft in place for six monthsthen removedAfter these aims are achievedwe will submit an Investigational Device ExemptionIDEapplication to the FDA and initiate a US human clinical trial