VENARUM MEDICAL LLC — Department of Health and Human Services SBIR Phase II: NHLBI

Description

Project SummaryAbstract Venarum MedicalLLCVenarumproposes to verify the pre clinical safety of the Endoscopic Venous Valve SystemEVVSa novel patent pending valve replacement solution for treatment and mitigation of serious complications of chronic venous diseaseCVDsuch as chronic venous insufficiencyCVIand related dysfunctional venous valvesThis endovascularly delivered device is intended to reduce the risk of edemaulcersamputation or other related complicationsIt is based on the principle that a novel Nitinol stent like scaffold embedded in a biocompatiblethrombus resistant polymer with a polymericsame material as scaffold coatinginner valve comprised of flexible valve leafletsplaced at near the site of valve failure will significantly reduce reflux while allowing self flushinglittle no blood stagnationand adequate forward flowCVI and related valve dysfunction is a costly long term and progressive disease that afflicts approximatelymillion Americans per yearAssociated venous valve reflux leads to blood clotting and or fluid leakage into skin and other tissues in the legs and anklesResulting health issues are severe and costly to treatCVI can manifest itself in both superficial and deep veinsbut deep veins are the most crucial to circulationCurrent clinical solutions treat only the symptoms of CVI but not the underlying physiological causesso effective treatment of CVI in deep veins is an unmet clinical needThe past few decades have seen dramatic improvements in understanding the causes and course of CVIand vast progress in the use of Nitinol stents and long dwelling polymer based devicesArmed withlessons learnedand a unique design approachVenarum is developing a prosthetic endovascular venous valve comprising a stent like Nitinol frame with an integral novel polymer leaflet valve securely attached to its inner structureThe implant operates at similar flow and pressure conditions as in the body with low opening and closing pressure differentialsprovides adequate forward flowminimizes reflux and thrombus formationand is suitable for percutaneous endovascular deliveryFurtherthe valve prosthesis is designed for precise deploymentcanalization of the vein lumenmigration resistanceand long term durability post deploymentVenarum proposes the mentorship of an individual from a statistically underrepresented group in most biomedical relevant disciplines and in the corporate business environmentThis candidate will develop strong and versatile engineering technical skills will cultivating appreciationinterestand knowledge of aspects required to run a successful medical device businessVenarum has successfully completed the EVVS feasibility development and with that have completed all tasks proposed for Phase ISuccessful Phase I development includedOptimization of the best proof of feasibility valve structure and related test methodologiesBench and characterization function testing of the two best valvesandCompletion of acute non GLP animal studies including proof of ease of use and positioningdevice stabilityproper flow including assessment of forwardflowstagnation and refluxDuring Phase II of the EVVSmuch of the test method development and final testing must be determined and executedDuring this periodVenarum will also be submitting additional patent applications and the next phase of fundingThe mentorship candidate has demonstrated both strong technical and writing abilitiesAs suchit is Venarum s intention to involve the candidate in the business aspects as well as the engineering assignments necessary to the development of the EVVS Project Narrative A serious complication of chronic venous diseaseCVDChronic Venous InsufficiencyCVIand related venous valve dysfunctionis a costly long term and progressive condition that afflictsmillion AmericansThe resulting venous valve reflux in the legs leads to blood clotting or fluid blood cell leakage into the skin and other tissues causing serious health complicationsVenarum s proposed prosthetic endovascular venous valve system may produce dramatic improvement in the technical and medical understanding of CVD problemsand could enable a treatment option for CVI patients that does not exist today