Product Development

Valor Medical has created specific formulations that will have applications in wound management and women's health. The differences in formulations,(viscosity, polymerization and adhesion), are designed to meet the need for that specific indication.

The wound management market (liquid bandage and trauma market) is projected to be approximately $1.5 billion. Valor has developed an OTC, over-the-counter, product and a 510k will be submitted in Q4-2010. The women's health market (contraception and uterine fibroid embolization) is project to exceed $3.6 billion. Valor is currently creating pre-clinical and clinical protocols for these indications that should begin in Q2-2011.

Valor Medical has created, equipped and staffed a research lab, a production facility, and a physician-teaching module. The latter facility's fluoroscopy equipment also allows The Company to test products in an endovascular system of pulsatile flowing blood or other appropriate fluids. Valor Medical has implemented, and rigorously operates under, a Quality Systems Regulation (QSR) program. Daily operations and manufacturing are performed under exacting QSR controls. Valor Medical has been issued an ISO 13485 Certification.

Processes, procedures and documentation for using and evaluating cyanoacrylates in humans have been established. The company is manufacturing product under full GMP and QSR guidelines. Valor Medical has been audited by the California Department of Health and has received a manufacturing license. Valor Medical moved rapidly with the documentation to meet the requirements for obtaining a CE Mark and engaged a Notified Body to guide, assist, and audit during this process. In May 2011 Valor Medical received CE Mark approval. The Company plans to begin European commercialization in mid-2012.