BioCardia Inc (BCDA)
NASDAQHealth CareBiotechnologySnapshot 2026-11-04
NASDAQHealth CareBiotechnologySnapshot 2026-11-04
QuarterlyIQ Insights · BCDA
How strong the business is — where it ranks within its sector on capital efficiency and cash generation, and how well management has been executing.
How management runs the business: capital, margins, balance sheet, and how reliably they guide and deliver.
A guidance track record builds as the company issues and delivers on guidance.
Priorities management has stated in recent disclosures, with status and evidence drawn from earnings calls, filings, and press releases.
We are working to complete the electronic trial master file, conduct 3 rd party Japanese good clinical practice audits to PMDA standards, and structure clinical research data in accordance with CDISC…
Stated in 1 of 2 supplied quarters. Management reported: “We are working to complete the electronic trial master file, conduct 3 rd party Japanese good clinical practice audits to PMDA standards, and structure clinical research data in accordance with CDISC Standards, which support data consistency, traceability, and regulatory compliance.” “We expect to soon engage a Designated Marketing Authorization Holder, or DMAH, as the local regulatory representative to enable BioCardia sales of CardiAMP Cell Therapy in Japan.”
Each factor is a parallel diagnostic with a clear read of what it shows and how names like it have historically fared. Never aggregated into a single score.
Operating income rose in 1 of the last 3 quarter-over-quarter moves. Historically, Health Care names rated neutral grew net income 51% of the time over the next year (vs 41% for the rest of the cohort, n=13498).
Not investment advice. Scores describe historical and current data; they are not forecasts of future returns. Consult a licensed advisor before making investment decisions.
“We are working to complete the electronic trial master file, conduct 3 rd party Japanese good clinical practice audits to PMDA standards, and structure clinical research data in accordance with CDISC…”
Four clinical sites have enrolled in the study and are actively recruiting patients.
Stated in 1 of 2 supplied quarters. Management reported: “Four clinical sites have enrolled in the study and are actively recruiting patients.” “Three additional patients are expected to qualify for the study this month, and two are scheduled for their procedures this month.”
“Four clinical sites have enrolled in the study and are actively recruiting patients.”
FDA has advised us that we would receive these minutes soon and we anticipate submitting the follow-on pre-submission incorporating agency advice which could enable Helix approval via the DeNovo path…
Stated in 1 of 2 supplied quarters. Management reported: “FDA has advised us that we would receive these minutes soon and we anticipate submitting the follow-on pre-submission incorporating agency advice which could enable Helix approval via the DeNovo pathway.” “Heart3D is being advanced towards regulatory approval via the software as a medical device 510(k) submission route.”
“FDA has advised us that we would receive these minutes soon and we anticipate submitting the follow-on pre-submission incorporating agency advice which could enable Helix approval via the DeNovo path…”
Please note that registered participants will receive their dial-in number upon registration.
Stated in 1 of 2 supplied quarters. Management reported: “Please note that registered participants will receive their dial-in number upon registration.” “For those who have not registered, to listen to the call by phone, interested parties within the U.S. should call 1-833-316-0559 and international callers should call 1-412-317-5730 and ask to be connected to the BioCardia call.”
“Please note that registered participants will receive their dial-in number upon registration.”
Prepare and submit regulatory approval for CardiAMP Cell Therapy to Japan's PMDA in Q4 2026, addressing PMDA's requests and engaging a local regulatory representative.
Over the trailing year it converted 0.72x of net income into operating cash flow.
Not enough signal yet.
Not enough signal to read sensitivity to the broad stock market, the US dollar, long-term interest rates, real (inflation-adjusted) rates, Fed net liquidity (low R² over the window).
12 material management or governance events in the past 24 months, led by legal/regulatory items. Historically, Health Care names rated volatile grew net income 45% of the time over the next year (vs 45% for the rest of the cohort, n=10076).
Not investment advice. As of 2026-11-04.