Novel, Long-Term Percutaneous Access Device for Chronic Therapy

用于慢性治疗的新型长期经皮接入装置

• 批准号: 8726459
• 负责人: Scott I Merz
• 金额: $ 73.4万
• 依托单位: VIADERM, LLC
• 依托单位国家: 美国
• 财政年份: 2011
• 资助国家: 美国
• 起止时间: 2011-02-07 至 2016-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8726459
• 关键词: Address; Animal Model; Animals; Cardiac; Caring; Catheters; Cell-Matrix Junction; Chronic; Clinical; Clinical Protocols; Clinical Research; Clinical Trials; Competence; Complement; Complication; Data; Dermal; Development; Devices; Dialysis procedure; Digestive System Disorders; Drug Delivery Systems; Economics; Effectiveness; Exudate; Family; Family suidae; Fibroblasts; Generations; Goals; Healed; Health Care Costs; Heart; Heart failure; Hemodialysis; Human; In Situ; Infection; Kidney Failure; Life; Literature; Malignant Neoplasms; Marketing; Measures; Mechanics; Medical Device; Microbial Biofilms; Modeling; Modification; Outcome; Parenteral Nutrition; Patients; Peritoneal Dialysis; Phase; Probability; Proliferating; Qualifying; Quality of life; Recruitment Activity; Reporting; Research; Resistance; Safety; Sampling; Science; Site; Skin; Small Business Innovation Research Grant; Solutions; Source; Sterile coverings; Sterility; Structure; Surface; System; Technology; Testing; Tissues; Vacuum; Venous; Work; Wound Healing; antimicrobial; base; chemotherapy; commercialization; design; experience; healing; health care delivery; improved; industry partner; innovation; interest; life-sustaining therapy; medical complication; meetings; next generation; novel; pre-clinical; pressure; prototype; public health relevance; research clinical testing; success; tissue culture; wound

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.

描述：一种新型的下一代经皮通路装置（PAD）将被开发出来，专注于先发制人地减少导管相关的出口部位感染，用于需要长期通过皮肤通路的慢性、维持生命的治疗。ViaDerm II使用真空辅助去除渗出物和增生的真皮成纤维细胞，只要导管穿透皮肤。此外，它还使用了一种设备结构，可以实现稳定性和表面处理，在临床前和人体研究中显示可以实现细胞附着。该提案的总体目标是开发、测试和验证ViaDerm II的人类使用，并在全球范围内将该产品商业化。ViaDerm LLC打算与每一种治疗的市场领导者建立战略合作伙伴关系：心脏辅助、透析和化疗或其他使用中心静脉通路的治疗。ViaDerm将与合作伙伴一起整合市场，并将ViaDerm的增值技术与现有的和新的产品线结合起来销售。ViaDerm II将解决市场对长期抗感染设备的需求，这种设备被商业包装为无菌的现成产品。在II期，ViaDerm将与行业合作伙伴共同努力，专注于获得监管部门的批准，并根据初步临床试验经验完善产品设计。III期的终点将是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希望开发更多的新应用，扩大其PAD产品系列。这一建议的意义和商业潜力是巨大的。据估计，每年使用数十万个需要可靠、长期或长时间经皮通路的装置。这些患者患有心力衰竭、肾衰竭、癌症和慢性消化系统疾病。Foresight 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。Foresight发现，该技术的全球潜在市场总额约为23.5亿美元，并预计ViaDerm LLC第五年的收入将接近1.7亿美元，基于全球170万台的销量。如果成功，这种创新的PAD不仅将提高生活质量，减少与当前治疗相关的医疗并发症和医疗成本，而且还将为开发新的紧急治疗方法提供先发制人、抗感染的新皮肤通道选择。