MVT-100 Manufacturing and Commercialization.

项目摘要/摘要 本商业化准备计划(CRP)(SB1)提案旨在将 由母公司SBIR第二阶段拨款(NHLBI第二阶段SBIR，R44HL137447-01)资助的MVT-100产品。 该计划将为质量体系的最终确定提供资金，以支持商业化和扩大生产 适用于初始产品发布和最终确定监管策略，以产生商业上可行的标签 对MVT-100的索赔。 这一具体建议是针对微血管治疗公司的新的、专利的、改进的、 静电中性，MB USCA，MVT-100，将首先开发用于超声心动图通过 加速了FDA指定的505(B)(2)发展途径。Definity®是一种阴离子MB(净 MVT-100专为常温储存而设计。 我们的目标是开发和全面实施质量体系，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，随后开发用于放射超声成像，并作为 用于治疗/治疗应用的平台。 因此，具体目标如下：1)最终确定并实施质量体系控制。我们的目标是 建立质量体系控制体系，为MVT-100的全面大规模生产做好准备。2)发展和发展 优化必要的工业生产方法，以确保一致和受控的扩大GMP MVT-100的制造。里程碑是获得一致的和受控的扩大生产 流程。最后，3)最终确定我们的监管战略，并为市场研究获得技术援助。 我们将获得一个明确的监管战略，并为MVT-100制定一个随时可用的愿景。 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的MB不仅是超声心动图的改进产品，而且生物效应更小 也是放射学、分子成像和治疗学产品开发的平台。在MVT-100被 获准用于超声心动图，并在商业规模生产到位后，我们的计划是筹集额外的资金 资本来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.