Novel, Long-Term Percutaneous Access Device for Chronic Therapy

产品说明： 将开发一种新型的下一代经皮穿刺器械（PAD），重点是先发制人地减少导管相关出口部位感染，用于输送需要通过皮肤长期穿刺的慢性维持生命治疗。一旦导管穿透皮肤，ViaDerm II使用真空辅助清除渗出液并使真皮成纤维细胞增殖。此外，它使用了一种能够实现稳定性和表面处理的装置结构，在临床前和人体研究中显示能够实现细胞附着。本提案的总体目标是开发、测试和鉴定人用ViaDerm II，并在全球范围内销售该产品。ViaDerm LLC打算与每种疗法的市场领导者建立战略合作伙伴关系：心脏辅助，透析和化疗或使用中心静脉通路的其他疗法。ViaDerm将与合作伙伴一起整合市场，并将ViaDerm的增值技术与现有和新的产品线一起销售。ViaDerm II将解决市场对长期抗感染器械的未满足需求，该器械以无菌现成产品的形式进行商业包装。在第二阶段，ViaDerm将与行业合作伙伴合作，重点是获得监管机构的批准，并根据初步临床试验经验完善产品设计。第三阶段的终点将是ViaDerm II在三个目标市场的全面商业化：心脏辅助、透析和中心静脉通路。与此同时，ViaDerm希望开发更多和新的应用，扩大其PAD产品系列。这项建议的重要性和商业潜力是巨大的。据估计，每年使用数十万件需要可靠、长期或延长经皮穿刺的器械。这些患者患有心力衰竭、肾衰竭、癌症和慢性消化系统疾病。Focal Science & Technology，Inc提供了第三方商业评估，调查该技术的商业利益和市场影响潜力。Focal发现，这项技术的全球潜在市场总额约为23.5亿美元，根据全球销售的170万台，估计ViaDerm LLC第五年的收入将接近1.7亿美元。如果成功，这种创新的PAD不仅可以改善生活质量，减少与当前治疗相关的医疗并发症和医疗保健成本，还可以为开发新的紧急治疗提供先发制人的抗感染新皮肤通路选择。

DESCRIPTION: A novel, next-generation percutaneous access device (PAD) focused on pre-emptively reducing catheter related exit site infection will be developed for the delivery of chronic, life-sustaining therapies requiring long- term access through the skin. ViaDerm II uses vacuum assist to remove exudate and proliferate dermal fibroblasts as soon as the catheter penetrates the skin. In addition it uses a device structure enabling stability and a surface treatment, shown to enable cell attachment in preclinical and human studies. The overall goal of this proposal is to develop, test and qualify the ViaDerm II for human use, and commercialize the product globally. ViaDerm LLC intends to enter into strategic partnerships with a market leader in each therapy: cardiac assist, dialysis, and chemo- or other therapies using central venous access. ViaDerm will work with partners to integrate market and sell ViaDerm's value-added technology with their existing and new product lines. ViaDerm II will address the market's expressed unmet need for a long-term, infection-resistant device that is commercially packaged as a sterile, off-the-shelf product. In Phase II, working in conjunction with industry partners, ViaDerm will focus on obtaining regulatory approvals and refine the product design based on initial clinical trial experience. The endpoint of Phase III will be full commercialization of the ViaDerm II in three target markets: cardiac assist, dialysis and central venous access. In parallel, ViaDerm expects to develop additional and new applications, expanding its family of PAD products. The significance and commercial potential of this proposal is substantial. It is estimated that several hundred thousand devices requiring reliable, long-term or prolonged percutaneous access are used every year. These patients suffer from heart failure, renal failure, cancer, and chronic digestive disorders. Foresight Science & Technology, Inc has provided a third party commercial assessment investigating the commercial interest and market impact potential of this technology. Foresight found that the total global addressable market for this technology is approximately US $2.35 billion and estimates ViaDerm LLC year five revenues to approach US $170 million based on 1.7 million units sold worldwide. If successful, this innovative PAD will not only improve the quality of life, reduce medical complications and healthcare costs associated with current therapies, but provide a pre-emptive, infection resistant new skin access option for the development of new emergent therapies.