The information provided on EL7.AI is for educational and informational purposes only and does not constitute financial advice.
The information provided on EL7.AI is for educational and informational purposes only and does not constitute financial advice.
| Factor | Score | Distribution | Value | Avg | Rank |
|---|---|---|---|---|---|
Valuation | 2 | — | 20.8x | Bottom tier | |
Growth | 28 | -100.0% | 6.1% | Bottom tier | |
Quality | 48 | 834.8% | 6.6% | Around median | |
Safety | 23 | 0.1x | 0.7x | Bottom tier | |
Capital Return | 86 | — | 2.02% | Top tier | |
Momentum | 13 | -55.9% | 4.1% | Bottom tier | |
Sentiment | 86 | 2 | 3 | Top tier |
BioCardia, Inc. (BCDA) operates as a clinical-stage biotechnology company specializing in the development of advanced cellular therapies and custom delivery devices for the treatment of cardiovascular diseases. The company's business model is based on developing and commercializing innovative therapeutic solutions that address unmet medical needs, most notably the CardiAMP Cell Therapy system for the treatment of ischemic heart failure resulting from myocardial infarction, which holds a Breakthrough Therapy designation from the US Food and Drug Administration (FDA) and currently benefits from Medicare program reimbursements of up to $20,000 per therapeutic procedure in the United States.
According to the recent financial report for the first quarter of 2026 ended March 31, 2026, operating results showed a decrease in total expenses to $2.3 million compared to approximately $2.7 million in the same quarter of 2025. This decrease was driven by a decline in research and development expenses of $295,000 to reach $1.2 million as a result of the termination of the first CardiAMP Heart Failure trial, while general and administrative expenses amounted to $1.0 million. The company recorded a net loss of $2.3 million for the first quarter of 2026 compared to a loss of $2.7 million for the corresponding quarter of the previous year, with cash flow used in operating activities amounting to $1.7 million, ending the period with a critical cash balance of only $951,000. Historically, annual data for 2017 indicates revenues of $479,000 with a gross loss of $211,000 and an annual net loss of $12.3 million.
BioCardia's market capitalization is approximately $5.0 million, with a wide 52-week trading range of $0.78 to $2.45. The stock has a consensus analyst recommendation of 'Buy', and it currently trades below the analyst consensus target price due to the gap between the current market valuation and the anticipated commercial opportunities for its therapies in the United States and Japan.
Figures in the text are as of 2026-06-15; the live price is shown at the top of the page.
BioCardia ended the first quarter ended March 31, 2026 with cash and cash equivalents of only $951,000, while net cash used in operating activities was $1.7 million during the same quarter. Management expects to complete one or more financing transactions during the second quarter of 2026 to fund the approval submission to Japan's PMDA and continue the CardiAMP HF II trial. This means that the current liquidity situation represents a major pressure that requires urgent funding to ensure operational continuity.
The company aims to submit a formal Shonin approval application to Japan's PMDA within 7 months, with expectations of obtaining approval and starting commercialization within 19 months. The company estimates the initial target market at approximately 20,000 patients suffering from ischemic heart failure, and based on a reimbursement value similar to the US market of $20,000 per procedure, this opportunity represents a potential market of $400 million. The post-marketing phase will include a clinical study supported by financial reimbursement in cooperation with leading medical societies in Japan.
The company continues to enroll patients in the CardiAMP HF II trial through 4 currently active centers, with plans for additional expansion once financial resources become available. The study is designed to include a maximum of 250 patients, but the company only needs to enroll 160 patients to reach a statistical power of 80%. The US FDA considers the successful completion of this trial a key step to support a Premarket Approval (PMA) application for the treatment of ischemic heart failure.
Automated analysis for informational purposes only — not investment advice.
During the recent pre-submission meeting with the US FDA, it was agreed that there are two regulatory pathways to obtain marketing clearance for the Helix transendocardial delivery system. The agency's preferred pathway is concurrent approval with the CardiAMP cell therapy system for the treatment of heart failure. The proposed alternative pathway is to submit an additional application incorporating the agency's feedback to obtain approval via the de novo pathway as a standalone delivery device.
Insider activity shows a strong positive signal with net purchases of 24,156 shares over the past three months extending through June 2026. Ten insider purchases were recorded against zero sales, the latest of which was a transaction on June 9, 2026. This activity coincides with the company's CEO strengthening his personal stake following positive regulatory developments with the US FDA and Japan's PMDA.