Leonardo Biosystems and NanoMedical Systems have signed a development contract in which NMS will develop and establish a commercial process to manufacture nanoporous silicon particles for Leonardo's multi-stage drug delivery system.
"The expertise in the fabrication of massively-parallel nanofluidic structures in silicon gained in the development of our own drug delivery products enables us to support Leonardo in bringing their manufacturing process to a commercial performance level," said Randy Goodall, president and CEO of NanoMedical Systems. "Our medical device engineering quality system is designed to produce an FDA-compliant process that will bring Leonardo to the doorstep of clinical testing of their innovative drug delivery products."
With the support of university researchers and NMS, Leonardo has formed prototype particles, demonstrating all the necessary unit processes to make the particles. Under the collaboration, NMS will engineer, refine, and integrate these steps in a manner that prepares Leonardo for manufacturing particles suitable for clinical trials.
"NMS's familiarity with silicon materials and their capability to do the work under an FDA-compliant quality system makes them an ideal partner," said Bruce D. Given, M.D., CEO of Leonardo Biosystems. "Creation of a commercial-scale manufacturing process compliant with regulatory requirements is on the critical path for Leonardo to translate its exciting animal proof of concept data into clinical reality. With NMS as a partner, we look forward to moving ahead aggressively with our development program."