Microvascular Therapeutics Inc

MVT-100 Manufacturing and Commercialization. - 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.