BioCardia Inc (BCDA)
NASDAQHealth CareBiotechnologySnapshot 2026-09-04
$1.08-0.92%
Close 2026-09-04 · 1-day change
NASDAQHealth CareBiotechnologySnapshot 2026-09-04
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.
Prepare and submit CardiAMP Cell Therapy regulatory submission to Japan PMDA in Q4 2026 for ischemic heart failure treatment approval.
Stated as a priority in 3 of last 3 quarters. Management has consistently emphasized preparing and submitting CardiAMP Cell Therapy for PMDA approval in Japan by Q4 2026. The company targets a patient subgroup of 20,000 within an estimated 300,000 ischemic heart failure patients in Japan. This regulatory milestone is central to BioCardia's strategy and trajectory is delivering with active preparation and regulatory alignment.
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=13363).
Not investment advice. Scores describe historical and current data; they are not forecasts of future returns. Consult a licensed advisor before making investment decisions.
“BioCardia is preparing for regulatory submission in Japan in Q4 2026.”
“CEO: 'Submission for approval planned for end of 2026 is a meaningful milestone.'”
“Japan's PMDA supports Shonin pre-market regulatory submission for CardiAMP Cell Therapy approval.”
Drive enrollment in the confirmatory CardiAMP HF II clinical trial in the United States to support FDA Premarket Approval.
Stated as a priority in 3 of last 3 quarters. Management reports active enrollment at four clinical sites with patients scheduled for procedures and efforts to onboard additional centers. The FDA has indicated the trial may support Premarket Approval. Enrollment progress is ongoing and consistent with management's stated focus.
“BioCardia continues to actively enroll in the CardiAMP HF II trial with multiple patients scheduled for procedures.”
“CEO: 'Driving enrollment in CardiAMP HF II trial in the USA to support FDA Premarket Approval.'”
“Four active study centers have patients in the queue; working to onboard additional centers.”
Develop and seek strategic partnerships for Helix transendocardial delivery catheter and Heart3D fusion imaging platform to enable cardiac biologics delivery.
Stated as a priority in 3 of last 3 quarters. Management has secured FDA acceptance of Helix pre-submission meeting minutes and plans to submit a follow-on pre-submission this quarter. Heart3D is progressing toward 510(k) regulatory submission. Business development efforts for partnerships around these platforms are ongoing, consistent with management's stated growth strategy.
“FDA accepted Helix pre-submission meeting minutes; preparing follow-on pre-submission this quarter.”
“Heart3D fusion imaging advancing towards regulatory approval via 510(k) submission route.”
“CEO: 'Engaged in business development around cell therapies and delivery technologies for partnerships.'”
Advance clinical allogeneic mesenchymal stem cell (MSC) therapy platform targeting cardiac and pulmonary diseases with potential for multiple partnerships.
Stated as a priority in 2 of last 3 quarters. Management highlights two FDA approved INDs for the allogeneic MSC platform targeting cardiac and pulmonary diseases. The company is pursuing partnerships to develop these assets. Progress is consistent with management's stated development and partnering focus.
“CEO: 'Our allogeneic MSC therapy platform targets cardiac and pulmonary indications with two FDA approved INDs.'”
“CEO: 'Manufacturing clinical grade cells and IP enables partnering for multiple indications.'”
Manage cash burn prudently to extend operational runway into 2027, supported by recent capital raise and cost controls.
Stated as a priority in 3 of last 3 quarters. Management raised $4.9 million net proceeds and ended 2026-Q2 with $4.1 million cash, up from $2.5 million at 2025-Q4. Net loss decreased from $2.0 million in 2025-Q2 to $1.6 million in 2026-Q2, reflecting cost reductions and modest cash burn. The trajectory is delivering on extending cash runway into 2027.
“Raised net proceeds of approximately $4.9 million under ATM facility; cash and equivalents $4.1 million.”
“Research and development expenses decreased; net loss decreased compared to prior year periods.”
“CEO: 'Modest cash burn and efficient capital use to extend runway into 2027.'”
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, real (inflation-adjusted) rates, long-term interest rates, Fed net liquidity (low R² over the window).
11 material management or governance events in the past 24 months, led by legal/regulatory items. Historically, Health Care names rated volatile grew net income 53% of the time over the next year (vs 50% for the rest of the cohort, n=3986).
Not investment advice. As of 2026-09-04.