Project Summary It is estimated that over 10 million Americans have peripheral arterial disease (PAD). Left untreated PAD will lead to critical limb ischemia and eventual amputation. PAD symptoms often progress requiring one of the following interventions: balloon angioplasty, stent placement, or vascular bypass. Balloon angioplasty and drug eluting stents radially expand stenosed arteries -- a mechanical insult that damages the vessel leading to restenosis and device failure. This failure mechanism leads to a two-year patency rate of 50% and 60% for angioplasty and drug eluting balloons, respectively. 80 to 90% of patients with advanced PAD present with disease in the femoral and popliteal arteries – where tortuosity and complex joint motion is common. These complex bending forces exacerbate treatment challenges and often lead to stent fracture and increased rates of restenosis. The gold standard treatment of PAD is surgical bypass, which itself displays a primary 2 year patency rate of up to 67% for anatomically complex lesions. The unacceptable failure rates of all PAD treatments clearly demonstrate the critical need for a more durable and successful treatment of PAD. Our team has developed the Biocarpet – a fully biodegradable electrospun sheet that takes the shape of the patient’s vascular anatomy following deployment. Our approach not only imposes significantly reduces vascular wall stress during deployment, but also allows the Biocarpet’s zero stress state to be that of the host artery – which is often tortuous or anatomically complex. This is hypothesized to further reduce vascular injury in response to intraluminal pulsation and joint flexion – a common occurrence in the stenotic vessels of the lower limb peripheral vasculature. The overall goal of this Catalyze proposal is to finalize the Biocarpet design and prototype, establish its deliverability and improved performance in-vivo, and make significant progress toward the clinical translation of our technology. This goal will be met by completing the following objectives. The R61 phase of this proposal has three Objectives: R61.1: Finalize the Biocarpet design, fabricate a device prototype, and quantify its in-vitro deliverability and performance; R61.2: Establish the in-vivo deliverability of our device into the bending joint of an atherosclerotic pig; R61.3: Generate a Regulatory Path document that details the specific milestones that are required prior to a future FDA submission. The R33 phase of this proposal has two objectives: R33.1: Demonstrate the improved in-vivo performance of our device compared to a gold standard endovascular stent; R33.2: Generate a formal Business Model document detailing timeline to market, required future investment, market analysis, and financial risk profile. Funding of this Catalyze award further integrate our research team with the procured Accelerator Partners (including both regulatory and business expertise) to accelerate our team’s goal of clinical translating this novel platform technology.

Project Narrative Over 10 million Americans have peripheral arterial disease, a disease that, if left untreated, leads to amputation. Current treatment options for peripheral arterial disease fail up to 50% of the time within two years. This proposal seeks to develop and begin the commercialization of a novel and more robust treatment for this devastating disease.