SBIR Phase II: Permanent Attachment of Antimicrobial Peptides to Central Venous Catheters.

该SBIR第II阶段项目继续SteriCoat开发用于中心静脉导管的永久性抗菌涂层。 目前的浸出抗菌技术不具备在植入寿命期间保护这些器械所需的有效性持续时间，尤其是对于外周插入中心静脉导管（PICC）。 该二期项目的研究将集中在专有聚合物技术与一期开发的栓系抗菌肽（AmP）技术的整合上，以最大限度地提高固定化AmP在体内的功效和生物利用度。 还将开展工作，以确保SteriCoat涂层技术的可制造性，包括原型生产。将该制剂转移至聚氨酯管的腔内和腔外表面后，将在体外和体内证明其有效性和生物相容性。 在第二阶段项目结束时，SteriCoat将拥有一个抗菌CVC模型，该模型使用行业思想领袖设计的模型在体内证明了有效性，并将准备扩大规模和生产。SBIR第二阶段项目解决了美国每年困扰170万患者并导致99，000人死亡的医院感染，其中大部分与医疗器械有关。 现有的缓释抗菌涂层不足以解决器械感染问题。 它们的寿命有限，并且担心耐药性和毒性，因为药物会分布在血液中。 SteriCoat正在开发一种使用抗菌肽（AmPs）的永久涂层，以防止中心静脉导管（CVC）的细菌定植，这是一个3.5亿美元的市场。 该项目的目标是提供一种基于聚硅氧烷的抗微生物CVC模型，该模型采用AmPs进行表面功能化，并测试这种方法抵抗细菌定植的能力。 在该II期项目结束时，SteriCoat将验证原型导管的体内有效性，并准备开始GLP研究，以获得FDA产品批准。 此外，该第II阶段技术目标的实现将为生物活性配体呈递领域的额外研究开辟途径，因为所开发的技术可以提高除抗菌剂之外的许多生物材料应用的功效。

This SBIR Phase II project continues SteriCoat's development of a permanent antimicrobial coating for use on central venous catheters. Current leaching antimicrobial technology does not possess the duration of efficacy required to protect these devices over the lifetime of implantation, especially for peripherally inserted central lines (PICCs). Research during this Phase II project will focus on the integration of proprietary polymer technology with tethered antimicrobial peptide (AmP) technology developed in Phase I to maximize the efficacy and bioavailability of the immobilized AmPs in vivo. Work will also be performed to ensure the manufacturability of SteriCoat's coating technology, including prototype production. After transitioning this formulation to the intra- and extraluminal surfaces of a polyurethane tube, efficacy and biocompatibility will be demonstrated both in vitro and in vivo. By the end of this Phase II project, SteriCoat will have an antimicrobial CVC model with efficacy proven in vivo using the models designed by industry thought leaders and will be ready for scale-up and manufacturing.This SBIR Phase II project addresses the hospital infections afflicting 1.7 million patients and killing 99,000 in the US annually, the majority of which are associated with medical devices. Existing slow-release antimicrobial coatings are insufficient in addressing device infection. They have a limited lifespan and concerns over drug resistance and toxicity because the drug gets distributed in the bloodstream. SteriCoat is developing a permanent coating using antimicrobial peptides (AmPs) to prevent bacterial colonization of central venous catheters (CVCs), a $350M market. The goal of this project is to deliver a polyurethane-based antimicrobial CVC model which incorporates a surface functionalization with AmPs and to test the ability of this approach in resisting bacterial colonization. By the end of this phase II project, SteriCoat will have verified in vivo efficacy of prototype catheters and be positioned to begin GLP studies for FDA product approval. In addition, achievement of the technical objectives of this Phase II will open up avenues for additional investigation in the field of bioactive ligand presentation as the developed technology could lend to the efficacy of many biomaterial applications in addition to antimicrobials.