Biocarpet: The Next Generation Endovascular Device for Peripheral Arterial Disease

项目摘要 据估计，超过1000万美国人患有外周动脉疾病(PAD)。放任不管 PAD会导致严重的肢体缺血和最终截肢。PAD症状通常会进展，需要以下一种 以下干预措施：球囊血管成形术、支架置入术或血管搭桥术。球囊血管成形术和 药物洗脱支架径向扩张狭窄的动脉--一种机械损伤血管导致 再狭窄和装置失效。这种故障机制导致两年的通畅率为50%，而 血管成形术和药物洗脱球囊。80%至90%的晚期PAD患者存在 股动脉和月国动脉的疾病--弯曲和复杂的关节运动是常见的。这些 复杂的弯曲力加剧了治疗挑战，并经常导致支架断裂和发病率增加 再狭窄的可能性。PAD的黄金标准治疗是外科搭桥术，手术本身表现为最初的2年。 对于解剖复杂的病变，通畅率高达67%。所有焊盘不可接受的故障率 治疗清楚地表明了对PAD进行更持久和成功治疗的迫切需要。 我们的团队已经开发出生物地毯--一种完全可生物降解的电纺薄片，它的形状 在展开后病人的血管解剖情况。我们的方法不仅显著减少了 部署过程中的血管壁应力，但也允许生物地毯的零应力状态与宿主的状态相同 动脉--通常是弯曲的或复杂的解剖结构。假设这是为了进一步减少血管损伤。 对管腔内搏动和关节屈曲的反应-这是一种常见的血管狭窄 下肢周围血管系统。 这项催化提案的总体目标是最终确定生物地毯的设计和原型，建立 它的体内交付能力和改进的性能，并在临床上取得了重大进展 翻译我们的技术。这一目标将通过完成以下目标来实现。R61阶段 该提案有三个目标：R61.1：完成生物地毯设计，制造设备原型，以及 量化其体外递送能力和性能；R61.2：建立我们设备的体内递送能力 动脉粥样硬化猪的弯曲关节；R61.3：生成详细说明 在未来FDA提交之前需要的特定里程碑。该提案的R33阶段有两个 目标：R33.1：证明与黄金标准相比，我们的设备在体内的性能得到了改善 血管内支架；R33.2：生成详细说明上市时间表的正式业务模式文档，必需 未来投资、市场分析和金融风险概况。这一催化奖的资助进一步整合 我们的研究团队与采购的加速器合作伙伴(包括监管和业务专业知识)一起 加速我们团队将这一新平台技术转化为临床的目标。

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.