MVT-100 Manufacturing and Commercialization.

项目总结/摘要 本商业化准备计划CRP（SB 1）提案旨在实现以下产品的商业化： 由母公司SBIR第二阶段资助（NHLBI第二阶段SBIR，R44 HL 137447 -01）资助的MVT-100产品。 该CRP将为质量体系的最终确定提供资金，以支持商业化和规模化生产 适用于最初产品发布以及最终确定监管策略以产生商业上可行的标签 关于MVT-100 这项具体的建议是针对微血管治疗的新的，专利，改进， 静电中性，MB USCA，MVT-100，将首先通过 FDA指定的加速505（B）（2）开发途径。Deepwater ®是阴离子MB（净 负电荷），需要冷藏，而MVT-100设计用于室温储存。 我们的目标是开发并全面实施质量体系，使我们的产品具有高端制造能力， 将被批准用于超声心动图，随后开发用于放射学超声成像，并作为 用于治疗/治疗诊断应用的平台。 因此，具体目标如下：1）最终确定并实施质量体系控制。目标是 有一个质量体系控制到位，并准备全面高档制造的MVT-100。2)制定和 优化必要的工业生产方法，以确保一致和受控的规模扩大GMP 制造MVT-100。军事目标是获得一致和受控的规模扩大生产 流程.最后，3）确定我们的监管策略，并获得市场研究的技术援助。 我们将获得一个明确的监管策略，并为MVT-100提供一个随时可以推出的愿景。 成功完成拟议的目标和随后的关键研究将导致一个新的，室温 用于超声心动图的稳定MB不仅产生用于超声心动图的改进产品，而且具有更少的生物效应 也是放射学、分子成像和治疗诊断产品开发的平台。在MVT-100之后， 批准用于超声心动图，并与商业规模的生产到位，我们的计划是提高额外的 建立一支销售队伍并推出产品。

PROJECT SUMMARY / ABSTRACT This Commercialization Readiness Program, CRP, (SB1) proposal is directed towards the commercialization of the MVT-100 product as funded by the parent SBIR Phase II grant (NHLBI Phase II SBIR, R44HL137447-01). This CRP will fund finalization of the Quality system to support commercialization and scale-up manufacturing suitable for initial product launch as well as finalization of regulatory strategy to yield commercially viable label claims for MVT-100. This specific proposal is directed towards development of Microvascular Therapeutics’ new, patented, improved, electrostatically neutral, MB USCA, MVT-100, which will firstly be developed for echocardiography via the accelerated 505(b)(2) pathway for development as designated by the FDA. Definity® is an anionic MB (net negative charge) and requires refrigerated storage while MVT-100 is designed for room temperature storage. Our goals are to develop and fully implement a Quality System with upscale manufacturing of our product that will be approved for echocardiography, subsequently developed for radiology ultrasound imaging, and as a platform for therapeutic/theranostic applications. Thus, the Specific Aims are as follows: 1) To finalize and implement a Quality System Control. The goal is to have a Quality System Control in place and ready for full upscale manufacturing of MVT-100. 2) To develop and optimize industrial production methods necessary to ensure consistent and controlled scale-up GMP manufacturing of MVT-100. Milestones are to obtain consistent and controlled scale-up manufacturing processes. And finally, 3) To finalize our regulatory strategy and obtain technical assistance for market research. We will obtain a defined regulatory strategy with a ready-to-launch vision for MVT-100. Successful completion of the proposed aims and subsequent pivotal study will result in a new, room temperature stable MB for echocardiography yielding not only an improved product for echocardiography with less bioeffects but also a platform for development of radiology, molecular imaging and theranostic products. After MVT-100 is approved for echocardiography, and with commercial scale manufacturing in place, our plan is to raise additional capital to build a sales force and launch the product.