Benzinga | Jun 21, 2021 08:01AM EDT

BioCardia Reports European Patent Office Decision To Grant Patent On Autologous Cell Therapy Patient Selection Diagnostic Assay

BioCardia(r), Inc. (NASDAQ:BCDA), a company focused on cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today announced that the European patent office has issued a Decision to Grant European Patent No. 3593810 to BioCardia with publication on June 23, 2021. The patent broadly describes autologous cell therapy patient selection diagnostics as a solution for the problem of therapeutic variability of different patients' cells. The patent describes using such an assay approach for patient selection as well as for setting dosage levels for autologous cell-based therapies. Specific patent claims are focused on BioCardia's lead CardiAMP programs for bone marrow cells for transplantation to the heart intended to treat heart failure and chronic myocardial ischemia. This new patent is anticipated to strengthen the protection of BioCardia efforts with respect to its patient screening methods already afforded by issued patents.

"Selecting patients based on the characteristics of their own cells for a therapy created from their own cells is how we are bringing personalized medicine to cell therapy for the treatment of heart disease," said Dr. Peter Altman, BioCardia CEO. "This new patent protection is expected to enhance our ability to advance the CardiAMP Cell therapy for heart failure and chronic myocardial ischemia in Europe -- where our CardiAMP cell processing platform technology and our Helix biotherapeutic delivery offerings have already received approvals." He continued, "It is unusual in the diagnostic space to have fundamental intellectual property for an entirely new application of existing and known biological markers, let alone a clinical application that also resonates with everyone's common sense and addresses such an enormous unmet clinical need. We continue to study assay performance with respect to sensitivity, specificity, precision, and agreement for each biomarker as well as the overarching diagnostic algorithm in three laboratories today."

BioCardia believes that with success of the ongoing clinical trial of the CardiAMP cell therapy in ischemic heart failure, this patented and proprietary CardiAMP cell potency biomarker panel assay could be applicable to 1.7 million patients having heart failure in the United States and a similar number of patients with heart failure in Europe. Cardiovascular diseases remain the leading cause of mortality and a major cause of morbidity in Europe. Currently, there are more than 11 million new cases of cardiovascular disease in Europe every year. With almost 49 million people living with the disease in only the European Union (EU), the cost to the EU economies is high at (euro)210 billion a year.

BioCardia also believes that the post approval adoption profile for the CardiAMP cell therapy with its selection diagnostic cell potency biomarker assay should be rapid as it addresses a large unmet need and both heart failure cardiologists and interventional cardiologists are rapid adopters of new therapies, particularly those that appear to be synergistic with all other therapeutic strategies currently available.