BioCardia outlines Japan Shonin filing in ~7 months with target approval timeline for CardiAMP
BioCardia (NASDAQ:BCDA) announced a plan to file its application under the Japanese Shonin process within approximately seven months, aiming for regulatory approval of its CardiAMP Cell Therapy around 19 months from now. The company highlighted recent milestones including FDA breakthrough designation and Medicare reimbursement at $20,000 per treatment procedure.
Topics: biotech cardiovascular_treatment FDA_breakthrough_designation reimbursement