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：将开发一种新型的下一代经皮接入装置（PAD），重点是先发制人地减少导管相关的出口部位感染，用于提供需要长期通过皮肤接入的慢性、维持生命的治疗。一旦导管刺入皮肤，ViaDerm II 就会利用真空辅助去除渗出物并增殖真皮成纤维细胞。此外，它还使用了一种具有稳定性和表面处理能力的装置结构，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 ViaDerm II 并对其进行验证以供人类使用，并在全球范围内实现该产品的商业化。 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、透析以及使用中心静脉通路的化疗或其他疗法。 ViaDerm 将与合作伙伴合作，整合市场，并将 ViaDerm 的增值技术与其现有和新产品线一起销售。 ViaDerm II 将满足市场对长期抗感染设备未满足的需求，该设备在商业上包装为无菌、现成产品。在第二阶段，ViaDerm 将与行业合作伙伴合作，重点关注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。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 预计将开发更多的新应用，扩大其 PAD 产品系列。该提案的意义和商业潜力是巨大的。据估计，每年有数十万个需要可靠、长期或长期经皮接入的设备被使用。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，根据全球销量 170 万台，ViaDerm LLC 预计第五年的收入将接近 1.7 亿美元。如果成功，这种创新的 PAD 不仅将改善生活质量，减少与当前疗法相关的医疗并发症和医疗费用，而且为开发新的紧急疗法提供先发制人、抗感染的新皮肤通路选择。