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SUNNYVALE, Calif., March 12, 2024 (GLOBE NEWSWIRE) -- BioCardia, Inc. [Nasdaq: BCDA], a developer of cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today announced Centers for Medicare & Medicaid Services (CMS) approval for reimbursement coverage of the confirmatory Phase III clinical trial of CardiAMP autologous cell therapy for the treatment of patients with ischemic heart failure. CMS has reviewed the CardiAMP Heart Failure II Trial and approved the investigational product, related and routine items and services for purposes of Medicare coverage. CMS previously published a New Technology APC (Ambulatory Payment Classifications) code that covers the CardiAMP Cell Therapy investigational study procedure, including the BioCardia investigational products utilized to perform the study procedure, allowing the study centers to be reimbursed for the study procedure and products. The CardiAMP Heart Failure II Trial is FDA approved to enroll up to 250 patients at up to 40 clinical centers. The study includes an eligibility requirement that patients demonstrate a pre-specified NT-proBNP level at baseline. The primary endpoint is a hierarchical composite assessment consisting of all-cause death, the cardiac death equivalents of heart transplant and left ventricular assist device (LVAD) implantation, heart failure hospitalizations, worsening heart failure events treated as an outpatient, and change in quality-of-life, with a follow-up duration ranging from a minimum of 12 to a maximum of 24 months. The CMS coverage approval is supported by the scientific rigor of the protocol design and the results from the interim data from the CardiAMP Heart Failure Trial recently presented at the Technology and Heart Failure Therapeutics 2024 annual meeting. Across all patients there was a reduction in cardiac death equivalents and major adverse cardiac and cerebrovascular events. In the subgroup of patients targeted in the CardiAMP Heart Failure II Trial, results showed large absolute and relative risk reduction of heart death equivalents of the patients in the treated group. Treated patients also had reduced major adverse cardiac events and greatly improved quality of life. “We are pleased that CMS has provided coverage support for the confirmatory CardiAMP Heart Failure II study.” said Peter Altman, PhD., BioCardia’s President and Chief Executive Officer. “To my knowledge, no therapy has been proven to reduce mortality in these patients, and CardiAMP Heart Failure II has great potential to achieve this outcome by confirming our CardiAMP Heart Failure Trial results.” About the CardiAMP Cell Therapy Program Designated by the FDA as a Breakthrough Therapy, CardiAMP Cell Therapy uses a patient’s own bone marrow cells delivered to the heart in a minimally invasive, catheter-based procedure to potentially stimulate the body’s natural healing response. CardiAMP Cell Therapy incorporates three proprietary elements not previously utilized in investigational cardiac cell therapy: a pre-procedural cell analysis for patient selection, a high target dosage of cells, and a proprietary delivery system that has been shown to be safer than other intramyocardial delivery systems and exponentially more successful in cell retention. The CardiAMP clinical development for heart failure is supported by the Maryland Stem Cell Research Fund and is reimbursed by CMS for both treatment and control procedures. CAUTION - Limited by United States law to investigational use. About BioCardia® BioCardia, Inc., headquartered in Sunnyvale, California, is developing cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary disease. CardiAMP autologous and CardiALLO allogeneic cell therapies are the Company’s biotherapeutic platforms for the treatment of heart disease. BioCardia also works with partners to provide its proprietary biotherapeutic delivery system along with preclinical and clinical development services for biotherapeutic delivery to the heart. Forward Looking Statements: This press release contains forward-looking statements that are subject to many risks and uncertainties. Forward-looking statements include, among other things, statements relating to completing follow-up in the CardiAMP Heart Failure Trial, the probability of success of the CardiAMP clinical trials, ability to offset clinical costs utilizing Medicare reimbursement, anticipated milestones and events, and the ultimate success of our clinical cell therapy programs. These forward-looking statements are made as of the date of this press release. We may use terms such as “believes,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” “approximately” or other words that convey the uncertainty of future events or outcomes to identify these forward-looking statements. Although we believe that we have a reasonable basis for each forward-looking statement contained herein, we caution you that forward-looking statements are not guarantees of future performance and that our actual results may differ materially from the forward-looking statements contained in this press release. Factors that could cause or contribute to such differences include, but are not limited to, the Company’s liquidity position and its ability to raise additional funds, as well as the Company’s ability to successfully advance its clinical trials. As a result of these factors, we cannot assure you that the forward-looking statements in this press release will prove to be accurate. Additional factors that could materially affect actual results can be found in BioCardia’s Form 10-K filed with the Securities and Exchange Commission on March 29, 2023, under the caption titled “Risk Factors” and in its subsequently filed Quarterly Reports on Form 10-Q. BioCardia expressly disclaims any intent or obligation to update these forward-looking statements, except as required by law. Media Contact: Miranda Peto, Marketing / Investor RelationsEmail: mpeto@BioCardia.comPhone: 650-226-0120 Investor Contact: David McClung, Chief Financial OfficerEmail: investors@BioCardia.comPhone: 650-226-0120

Collaboration to Pioneer Electrolyte Gated-FET Biosensor Technology for Advanced Point-of-Care Diagnostics CALGARY, AB, Feb. 27, 2024 /PRNewswire/ - Today, CardiAI, a leading Biotechnology company specializing in cutting-edge diagnostic solutions, proudly announced a groundbreaking partnership with Carleton University's Faculty of Engineering and Design, marking a significant milestone in advancing medical diagnostics through the implementation of Electrolyte Gated-FET (EG-FET) biosensor technology. Continue Reading Dr. Anmol S. Kapoor and Dr. Ravi Prakash celebrating their groundbreaking partnership. (CNW Group/CardiAI Inc) CardiAi and Carleton University join forces to revolutionize medical diagnostics. (CNW Group/CardiAI Inc) OSDL Logo (CNW Group/CardiAI Inc) CardiAI and Carleton are joining forces to harness the potential of EG-FET biosensors for the detection of critical biomarkers in saliva and whole blood. This collaborative effort will not only revolutionize point-of-care diagnostics, but also pave the way for expanding the technology's applications to a broader range of health conditions. "We are thrilled to embark on this transformative journey with Carleton University," says Dr. Anmol S. Kapoor, Cardiologist and CEO of CardiAI. "The marriage of CardiAI's expertise in biotechnology and Carleton's prowess in electronics engineering creates a synergy that holds immense promise for the future of medical diagnostics. Together, we are committed to advancing technology that not only addresses current healthcare challenges but also opens new doors for innovation and improved patient outcomes." This strategic alliance comes at a crucial time when the global healthcare landscape is evolving, emphasizing the need for accessible and efficient medical testing. The innovative EG-FET biosensor technology is poised to play a pivotal role in democratizing healthcare by providing accurate and rapid diagnostic results, especially for individuals residing in remote areas with limited access to major hospitals. "This collaboration exemplifies the power of interdisciplinary partnerships in driving scientific progress," says Dr. Ravi Prakash, Associate Professor in Carleton's Department of Electronics and head of Carleton's Organic Sensors and Devices Laboratory. "Our department is excited to contribute to the development of cutting-edge biosensor technology that has the potential to redefine point-of-care diagnostics. By combining our research strengths, we aim to make a lasting impact on healthcare accessibility and usher in a new era of medical innovation." Key Highlights of the Partnership: Cutting-Edge Biosensor Technology: The collaboration between CardiAI and Carleton University focuses on the development and implementation of EG-FET biosensor platforms for the detection of NT-proBNP and cardiac troponin biomarkers. This technology promises to deliver highly sensitive and specific results, enhancing the precision of medical diagnostics. The partnership aims to extend beyond cardiovascular biomarkers, contributing to the development of novel diagnostic solutions for a broader range of health conditions. Global Impact: The collaborative research and development efforts will not only benefit local communities but will also have a global impact. By improving the accessibility of medical tests through point-of-care diagnostics, the partnership strives to make a positive difference in the lives of individuals worldwide, ensuring timely and accurate healthcare solutions. Integration with BioAro's BioEMR: To maximize the potential of EG-FET biosensor technology, CardiAI and Carleton University will integrate it with BioAro's BioEMR – an AI-powered Telemedicine Platform and Electronic Medical Records (EMR) system. This integration aims to create a seamless ecosystem for healthcare professionals, facilitating efficient patient management and diagnostic reporting. About CardiAI: CardiAI is a leading biotechnology company dedicated to advancing diagnostic solutions through innovative technologies. With a commitment to precision and efficiency, CardiAI strives to make a positive impact on global healthcare by developing groundbreaking diagnostic tools. About Organic Sensors and Devices Lab (OSDL): OSDL, a multi-disciplinary research facility at Carleton University, is equipped with advanced manufacturing and direct printing infrastructure and supported by Carleton University Microfab and Nanofab. Our research addresses the growing demand for non-invasive point-of-care diagnostics, rapid and cost-effective chemical and biological sensors, and environmental monitoring systems. About Carleton University: Carleton is a dynamic, research-intensive institution that engages with industry and government to address the world's most pressing issues. Carleton's Faculty of Engineering and Design is renowned for its commitment to excellence in education and research, pushing the boundaries of technological innovation and developing solutions for a more prosperous and sustainable future. SOURCE CardiAI Inc

Researchers have found that inhibiting a key protein can stop the destruction of synapses and dendritic spines commonly seen in Alzheimer's disease. Researchers at the University of Colorado Anschutz Medical Campus have found that inhibiting a key protein can stop the destruction of synapses and dendritic spines commonly seen in Alzheimer's disease. The study, whose first author is Tyler Martinez, a student in the Pharmacology and Molecular Medicine PhD program at the University of Colorado School of Medicine, was published recently in the journal eNeuro. The researchers, using rodent neurons, found that targeting a protein called Mdm2 with an experimental cancer drug known as nutlin, stopped neurotoxic amyloid-b peptides that accumulate in Alzheimer's disease (AD) from overly pruning synapses. "Cognitive impairments associated with AD correlate with dendritic spine and excitatory synapse loss, particularly within the hippocampus," said the study's senior author Professor Mark Dell'Acqua, PhD, vice-chair of the Department of Pharmacology at the CU School of Medicine. Dell'Acqua said trimming excess dendritic spine synapses is normal in the post-natal brain but can be abnormally accelerated in AD causing loss of memory and learning. "When this protein Mdm2 is turned on inappropriately it leads to pruning of the synapses when amyloid-b is present," he said. Amyloid-b is the main component of amyloid plaques found in the brain of those with AD. "When we used the drug that inhibits Mdm2 on the neurons it completely blocked dendritic spine loss triggered by amyloid-b. So inhibiting this protein is clearly working." Dendritic spines protrude from dendrites, a component of neurons, and receive synaptic signals that are critical in learning and memory. Dell'Acqua, director of the Neurotechnology Center at the CU School of Medicine, noted that much of the research into AD therapies tends to focus on eradicating amyloid plaques in the brain. "There are questions if anti-amyloid therapy is the be all and end all of AD therapy," he said. "Even if you could tolerate the high cost, the effectiveness is questionable. We are saying that it may also be possible to intervene in the process by blocking some of the impacts of amyloid-b. And you could intervene by targeting Mdm2." The next step is determining whether they can block AD progression in an animal model. If so, human trials could happen in the future. Drugs that target Mdm2 are already developed and in clinical trials for cancer but still need FDA approval. "This is an encouraging first step that gives us a new lead to pursue," Dell'Acqua said.