FDAnews
www.fdanews.com/articles/73597-bio-matrix-manufactures-set-of-stem-cell-devices

BIO-MATRIX MANUFACTURES SET OF STEM CELL DEVICES

June 23, 2005

Bio-Matrix Scientific Group has manufactured its first complete set of disposable instruments for stem cell research and tissue transfer procedures.

"We now have a complete set of our instruments, and we are ready to start the next phase, which is beta testing pre-510(k)," said Bio-Matrix Managing Director and Chief Operating Officer Brian Pockett. "This process is anticipated to take two weeks, after which the company can undergo the 510(k) testing with the FDA."

The San Diego, Calif.-based company anticipates entering full manufacturing of these instruments sometime in late August, conditional to passing the FDA's 510(k) process. Once the 510(k) is achieved, the company expects to see revenues from the FDA-approved devices "sometime in the third quarter this year."