Adient Medical Inc. — Department of Health and Human Services SBIR Phase II: NHLBI

Description

PROJECT SUMMARYClinical Evaluation of a Resorbable Inferior Vena Cava FilterPulmonary embolismPEis therd leading cause of deathclaiming the lives of at leastAmericans annuallymore than breast cancerAIDSand vehicle fatalities combinedMetallic Inferior Vena CavaIVCfilters have been proven effective in reducing PE to aboutin at risk populationshoweverthey come with a heavy post deployment pricenamely the expensive retrieval procedure and long term complications such as caval penetration and end organ punctureOur proposal is the continued development to FDA clearance of the first totally absorbable IVC filter to prevent PEFollowing dissolution of blood clotsthe filter itself vanishes into COand H O withinmonthsThe value proposition is the prevention of PE without requiring filter removaland alleviation of life threateninglong term complications of metallic IVC filtersThe IVC filter prophylaxis market has been growingannually and is currently $Mwith an untapped market opportunity of approximatelyfoldThis Phase IIB SBIR program is focused on advancing the totally absorbable IVC filter and delivery system through a clinical trial at leading US academic hospitals in the pursuit of FDAkclearancePhase II feasibility has been established with MD Anderson Cancer Center and validated throughpublications in leading peer reviewed medical journalsThese studies have demonstrated preliminary safety and efficacy in large animals where the filter providedclot capture when challenged with thrombuswithout filter migrationcaval penetrationcaval thrombosisor PEThe FDA has been very receptive to our totally absorbable IVC filter and claimed our approach is bothcomprehensiveandwell thought outfollowing our two Pre submission meetingsAimComplete Filter and Delivery Systemfinalize filter and catheter delivery system with goalsMeet ISO medical device standardsDemonstrate one year shelf life in real time aging studiesandfunctionality withunitsAimConduct US Pivotal Clinical Studyconduct multicenter clinical trialmonth follow upwith goalsRecruitpatientswith proven VTE and contraindicated to anticoagulantsprophylaxisclinical successsuccessful technical deployment without subsequent PE or other complicationsPulmonary embolismIVC filter occlusionand filter migrationper SIR guidelinesAimFile Regulatory Submissionsfile appropriate regulatory documents in collaboration with CROFile IDE with FDA following completion of filter and delivery system preclinical studies and FIHFilekpackage for FDA clearance following multicenter pivotal clinical studySeek strategic partner for world wide sales and distribution