Product Development

Accomplishments

Valor Medical has created and bench-evaluated various formulations of Neucrylate that will meet the specific needs and characteristics of multiple neurological applications. Patents covering these formulations have been filed and are pending. The formulations have also been tested for specific characteristics that will fulfill the clinical requirements for each neuro indication identified. Valor Medical will first address the cerebral aneurysm indication, then coil salvage, followed by brain arteriovenous malformations (AVMs) and finally, a formulation for vascular brain tumors.

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 is rapidly moving forward with the documentation to meet the requirements for obtaining a CE Mark. The Company has engaged a Notified Body to guide, assist, and audit during this process. The first CE Mark audit has been completed. Valor Medical expects to be issued a CE Mark in Q3-2010. The Company then plans to begin European sales in Q-3, 2010.