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OrganaBio and RxMP Therapeutics: A Pioneering Partnership

In a significant development for the medical industry, OrganaBio, LLC and RxMP Therapeutics, Inc. have announced a partnership aimed at advancing the manufacturing of RMP-402, a state-of-the-art hemostatic drug. This collaboration will see OrganaBio serve as the contract manufacturing partner for RxMP, specializing in cGMP production, ensuring the highest standards of quality and efficacy in the development of RMP-402, which is designed to address severe hemorrhage effectively.

The Importance of RMP-402

RMP-402 represents a novel approach to managing severe bleeding, designed to provide swift hemostatic responses without elevating the risks associated with off-target clotting. As a first-in-class therapeutic, it encompasses manufactured allogeneic red cell membrane particles—components that naturally occur in human blood. This innovative product aims not only at civilian applications but also holds significant promise in military settings, where rapid and efficient management of bleeding can be a critical factor in survival.

Market Relevance and Unmet Needs

The global market for trauma and surgical bleeding management is valued at approximately $12 billion annually, and uncontrolled bleeding is a leading cause of preventable death. With RMP-402, RxMP is poised to address this pressing health crisis, providing vital solutions where conventional methods may fall short. The collaboration between OrganaBio and RxMP will enable accelerated processes from development to patient care, which is critically important in emergency medical scenarios.

A Strong Foundation for Manufacturing

Under the partnership agreement, OrganaBio will facilitate the technology transfer required for the RMP-402, supporting its cGMP production. This is made possible through OrganaBio’s expansive infrastructure that emphasizes quality management systems and regulatory compliance. This collaboration harnesses OrganaBio's strengths in quality assurance and analytical development alongside RxMP's innovative hemostatic technology to push RMP-402 through essential developmental milestones.

Justin Irizarry, CEO of OrganaBio, expressed his enthusiasm about this partnership, stating, "We are honored that RxMP has entrusted us with the manufacturing of RMP-402, a product with the potential to change clinical approaches to managing life-threatening bleeding events. Our committed efforts are directed at helping to deliver this essential product to those who need it most."

Building Confidence and Future Steps

Shawna Khouri, COO of RxMP Therapeutics, commented on the significance of selecting OrganaBio as their manufacturing partner. Emphasizing the importance of efficiency in addressing uncontrolled bleeding, Khouri stated that having a reliable manufacturing partner allows RxMP to concentrate on advancing their regulatory strategies and deepening collaborations with vital stakeholders, such as the U.S. Department of Defense.

In 2025, RxMP successfully reached consensus with the U.S. FDA regarding their proposed GMP manufacturing process for RMP-402, marking a critical step forward. Additionally, a Cooperative Research and Development Agreement (CRADA) with the Department of Defense’s Institute of Surgical Research has been established to further validate the therapeutic potential of RMP-402, especially in combat casualty scenarios where rapid response is paramount.

About the Companies

OrganaBio

Founded in Miami, Florida, OrganaBio is a vertically integrated company specializing in blood and cell products. Through its FDA-registered subsidiaries, it operates ethical supply chains for human tissues and provides comprehensive solutions for cell and gene therapy, enhancing the translation of innovative therapies from the lab to clinical application.

RxMP Therapeutics

Also on the cutting edge of medical innovation, RxMP Therapeutics focuses on developing therapies to address severe hemorrhage effectively. With RMP-402 leading their product lineup, they utilize insights from natural biological processes to create next-generation solutions that: - Minimize risks of clotting. - Tailor their application for both civilian and military needs.

This partnership not only represents a significant step for both companies but also sets a precedent in how collaborative efforts in the medical field can effectively address critical health challenges, compelling stakeholders from across sectors to work together in pursuit of improved patient outcomes.