Ultrasound Enhanced Low Dose Drug Delivery: Quantifying Uptake, Retention and Biodistribution

This Direct to Phase II SBIR project addresses the need for safe and effective drug delivery after lower extremity angioplastyGlobally overmillion people suffer from peripheral arterial diseasePADBoth the disease and economic burdens of PAD are projected to grow rapidlywith the US PAD population projected to grow toM inas costs currently exceed $BThe leading cause of this growth is an aging US population that faces a disease whose prevalence increases with advancing ageIn the advanced stages of PADangioplastythe expansion of an occluded arteryis the state of the art for treatmentHoweverthe lifespan of angioplasty can be as brief asmonths in the periphery due to restenosisthe re occlusion of the blocked artery by the overgrowth of its own cellsAs a resultit is recommended that interventionalists wait to perform angioplasty on patients until the onset of critical limb ischemiaCLIa catastrophic vessel blockage that results in severe pain and can lead to amputationIn order to address these needsSoundPipe is commercializing a platform to deliver drugs that can prevent restenosisthe Guidance by Ultrasound Imaging and Delivery Enhancement of TherapeuticsGUIDE TxsystemThis novel catheter based system uses ultrasound to simultaneously image the vasculature and enhance delivery of restenosis preventing drugs after angioplastyThe drugs are carried by microbubbles ejected from the tip of the catheter where they are guided to a precise location by intravascular ultrasoundThereunder ultrasound image guidancethe ultrasound and microbubbles enhance permeabilization of the cell membrane and release the drug from the microbubblesThis technique controls drug dose and spatial coverageproviding a versatile method for preventing restenosis after angioplastySoundPipe s technology will improve angioplasty byallowing the interventionalist to control drug dosetypeand coverage andoffering image guidance during drug deliveryThe added versatility will foster innovation in the field of intravascular drug deliveryThis Direct to Phase II SBIR will use a series of in vivo swine and rabbit studies to evaluate whetherdrug delivered by GUIDE Tx is of a sufficient dose and is retained by the arteryGUIDE Tx reduces neointimal hyperplasiasystemic doses of drug following GUIDE Tx treatment are safe and lowKey technological innovations for this project include a dual mode intravascular drug delivery and imaging systemPlans for Phase III include clinical trials to demonstrate the safety and efficacy of GUIDE Tx