Aastrom to pursue Phase 3 CLI clinical system through FDA SPA process Aastrom Biosciences, Inc. , the leading programmer of autologous cellular treatments for the treatment of severe cardiovascular illnesses, today announced that the business will pursue a Stage 3 clinical program because of its autologous cell therapy for the treatment of crucial limb ischemia through the U Read more about this drug .S. Food and Drug Administration’s special protocol assessment procedure. Aastrom is currently completing a Phase 2b medical trial of its cell therapy in individuals with CLI and recently met with FDA officials to discuss plans for the Phase 3 program. Our latest dialogue with the FDA was very productive and identified a route for pursuing Phase 3 screening of our autologous cell technology in sufferers with essential limb ischemia, stated Tim Mayleben, president and CEO of Aastrom.
AXIOM releases HIPAA 5010 compliant version of TransSend AXIOM Systems, Inc. , today announced the general launch of its HIPAA 5010 compliant version of TransSend, a software program developed for healthcare agencies engaged in HIPAA EDI commerce specifically. TransSend insulates an organization’s back-end processing system by pushing HIPAA deal processing logic in to the Store and Forward repository. TransSend v5.5 was created specifically to meet the needs of HIPAA 5010 and provides healthcare organizations with a solution to achieve an effective compliance strategy, which our current install foundation of over 16 customers can attest to, noted Richard Howe, CEO of AXIOM. ..