Bio-Matrix Scientific Group Announced Today It Is Evaluating CAD/CAM Designs for Its Stem Cell Instruments, Anticipating Near Term Mold Completion and 510k Testing
Related News: Stem Cell CompaniesBio-Matrix Scientific Group Inc. (BMXG) announced today that it is evaluating its CAD/CAM designs for stem cell and tissue management instrumentation.
The Company anticipates submitting a 510(k) filing for its stem cell and tissue management instruments toward the end of May 2005.
A 510(k) filing with the FDA is a necessary requirement prior to the introduction of a medical device into commercial distribution for the first time.
A company spokesperson indicated that these CAD/CAM designs should be finalized in the next couple of days, with completion of the Company's first set of molds by the first part of the next week. Once the molds are completed, the Company will proceed with a limited production run in order to start its Beta testing prior to making its 510(k) filing.
The medical devices produced from a limited production run are expected to be used for testing, mold design verification, product samples, and for the 510(k) regulatory approvals.
More information will be available shortly on the Company's new web site: www.BMXGonline.com.
Posted on March 29, 2005 02:38 PM