MVT-100 Manufacturing and Commercialization.

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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.