{"filings":[{"id":705281,"accession_number":"0001437749-26-018670","cik":925741,"company_name":"BioCardia, Inc.","ticker":"BCDA","form_type":"8-K","filed_at":"2026-05-28T12:00:11+00:00","items":["7.01","9.01"],"status":"ready","headline":"BioCardia Japan PMDA supports CardiAMP cell therapy submission for HFrEF; submission planned Q4 2026","summary_kind":"llm","event_type":"regulatory","confidence":"high","bullets":["PMDA Consultation Record confirms alignment on remaining questions; positive outcomes credible.","Estimated 20,000 of 300,000 Japanese HFrEF patients initially eligible for CardiAMP therapy.","BioCardia plans PMDA submission in Q4 2026 with a Designated Marketing Authorization Holder.","Clinical data showed 179 sec average exercise tolerance improvement and 82% angina reduction.","PMDA requested additional details on GDMT compliance, revascularization ineligibility, and adverse events."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"positive","materiality_score":0.7,"calibrated_materiality_score":0.7,"market_cap_usd":10240662.993085282,"market_cap_bucket":"microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":564083,"accession_number":"0001437749-26-017994","cik":925741,"company_name":"BioCardia, Inc.","ticker":"BCDA","form_type":"8-K","filed_at":"2026-05-21T12:00:10+00:00","items":["7.01","9.01"],"status":"ready","headline":"BioCardia CardiAMP CMI trial: +179 sec exercise tolerance, 82% fewer angina episodes at EuroPCR","summary_kind":"llm","event_type":"other_material","confidence":"high","bullets":["Open-label cohort results presented at EuroPCR; no treatment-emergent major adverse cardiac events.","Exercise tolerance improved by avg 179 seconds, sustained over 2-year follow-up.","Angina episodes reduced by avg 82% by 6 months after treatment.","All patients had refractory angina despite guideline-directed medical therapy and prior revascularization.","Data support continued clinical development of autologous cell therapy for chronic myocardial ischemia."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"positive","materiality_score":0.7,"calibrated_materiality_score":0.7,"market_cap_usd":10240662.993085282,"market_cap_bucket":"microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":452758,"accession_number":"0001437749-26-017222","cik":925741,"company_name":"BioCardia, Inc.","ticker":"BCDA","form_type":"8-K","filed_at":"2026-05-15T12:05:59+00:00","items":["2.02","9.01"],"status":"ready","headline":"BioCardia Q1 net loss $2.3M; PMDA determines CardiAMP safety/efficacy likely sufficient for Japan approval","summary_kind":"llm","event_type":"earnings","confidence":"high","bullets":["Net loss $2.3M in Q1 2026 vs $2.7M in Q1 2025; cash $951k as of March 31, 2026.","PMDA Formal Clinical Consultation determined clinical safety and efficacy likely sufficient for market clearance; alignment on foreign data.","FDA expressed no safety concerns, benefits intriguing; confirmed PMA pathway; recommended continuing CardiAMP HF II confirmatory trial.","FDA agreed on two Helix clearance pathways; milestones: Euro PCR presentation Q2 2026, Japan Shonin submission Q4 2026."],"consensus_eps_estimate":null,"consensus_eps_actual":-0.21,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":"2026-Q1","consensus_source":"xbrl_only","sentiment":"positive","materiality_score":0.8,"calibrated_materiality_score":0.8,"market_cap_usd":10240662.993085282,"market_cap_bucket":"microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":99836,"accession_number":"0001437749-26-015753","cik":925741,"company_name":"BioCardia, Inc.","ticker":"BCDA","form_type":"8-K","filed_at":"2026-05-08T23:59:59+00:00","items":["7.01","9.01"],"status":"ready","headline":"BioCardia announces FDA alignment on Helix catheter clearance pathways; no safety concerns","summary_kind":"llm","event_type":"regulatory","confidence":"high","bullets":["FDA agreed two pathways for Helix marketing clearance: simultaneous with CardiAMP cell therapy approval or DeNovo via follow-on pre-submission.","FDA raised no concerns on Helix safety data, device performance, or compatibility with general classes of agents.","FDA's preferred route is simultaneous approval with CardiAMP cell therapy for heart failure.","BioCardia aims to pursue both pathways to enhance development and commercial partnering."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"positive","materiality_score":0.7,"calibrated_materiality_score":0.7,"market_cap_usd":10240662.993085282,"market_cap_bucket":"microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":99835,"accession_number":"0001437749-26-013535","cik":925741,"company_name":"BioCardia, Inc.","ticker":"BCDA","form_type":"8-K","filed_at":"2026-04-28T23:59:59+00:00","items":["8.01","9.01"],"status":"ready","headline":"BioCardia announces allowance of Japanese patent for Heart3D Fusion Imaging software","summary_kind":"llm","event_type":"other_material","confidence":"high","bullets":["Japanese patent allowed for 'Target Site Selection, Entry, and Update with Automatic Remote Image Annotation'.","Patent protects Heart3D Fusion Imaging used for treatment planning and navigation during CardiAMP Cell Therapy procedures.","Claims cover transposing pre-op CT/MRI 3D images onto 2D orthogonal images to generate combined 3D model in sterile field.","Technology supports CardiAMP cell therapy for ischemic heart failure and Helix intramyocardial delivery system.","Company working on Japan PMDA submission and US regulatory discussions for these product candidates."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"positive","materiality_score":0.3,"calibrated_materiality_score":0.3,"market_cap_usd":10240662.993085282,"market_cap_bucket":"microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":99834,"accession_number":"0001437749-26-012764","cik":925741,"company_name":"BioCardia, Inc.","ticker":"BCDA","form_type":"8-K","filed_at":"2026-04-20T23:59:59+00:00","items":["7.01","9.01"],"status":"ready","headline":"BioCardia announces PMDA acceptance of CardiAMP data for ischemic heart failure clearance in Japan","summary_kind":"llm","event_type":"regulatory","confidence":"high","bullets":["PMDA determined CardiAMP safety/efficacy data likely sufficient for market clearance in ischemic heart failure.","Alignment reached on acceptability of US foreign clinical data, indications for use, and introduction approach.","Company will await formal minutes from PMDA for detailed feedback and filing timeline.","CEO Dr. Peter Altman states company on track for first minimally invasive biologic therapy approved in Japan."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"positive","materiality_score":0.9,"calibrated_materiality_score":0.9,"market_cap_usd":10240662.993085282,"market_cap_bucket":"microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":99833,"accession_number":"0001437749-26-012412","cik":925741,"company_name":"BioCardia, Inc.","ticker":"BCDA","form_type":"8-K","filed_at":"2026-04-15T23:59:59+00:00","items":["3.01"],"status":"ready","headline":"BioCardia receives Nasdaq delisting notice for equity shortfall; has until May 25 to submit compliance plan","summary_kind":"llm","event_type":"regulatory","confidence":"high","bullets":["Stockholders' equity was $895,000 as of Dec. 31, 2025, well below the $2.5M minimum required by Nasdaq Listing Rule 5550(b)(1).","Notice received April 10, 2026; company must submit a plan to regain compliance by May 25, 2026.","If Nasdaq accepts the plan, it may grant up to 180 days from April 10 to evidence compliance.","Common stock continues trading on Nasdaq Capital Market under symbol BCDA; no immediate effect on listing.","Failure to regain compliance could lead to delisting; company intends to submit a plan and may request a hearing if plan is rejected."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"negative","materiality_score":0.85,"calibrated_materiality_score":0.85,"market_cap_usd":10240662.993085282,"market_cap_bucket":"microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":99832,"accession_number":"0001437749-26-010967","cik":925741,"company_name":"BioCardia, Inc.","ticker":"BCDA","form_type":"8-K","filed_at":"2026-04-02T23:59:59+00:00","items":["7.01","9.01"],"status":"ready","headline":"BioCardia files FDA meeting request for CardiAMP HF accelerated approval; subgroup shows risk reduction","summary_kind":"llm","event_type":"regulatory","confidence":"high","bullets":["Submitted CardiAMP HF clinical study data to FDA; meeting expected Q2 2026 under Breakthrough Designation.","Subgroup with elevated biomarkers showed 47% relative risk reduction in all-cause cardiac death.","Same subgroup had 37% relative risk reduction in non-fatal major adverse cardiac events (stroke, MI, hospitalization).","Quality of life improvements were statistically significant (p=0.04) in the elevated-biomarker subgroup.","Seeking accelerated approval for CardiAMP System in ischemic HFrEF."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"positive","materiality_score":0.7,"calibrated_materiality_score":0.7,"market_cap_usd":10240662.993085282,"market_cap_bucket":"microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":116089,"accession_number":"0001437749-26-009609","cik":925741,"company_name":"BioCardia, Inc.","ticker":"BCDA","form_type":"8-K","filed_at":"2026-03-24T23:59:59+00:00","items":["2.02","9.01"],"status":"ready","headline":"BioCardia reports 2025 net loss $8.2M; cash $2.5M; regulatory milestones for CardiAMP anticipated","summary_kind":"llm","event_type":"earnings","confidence":"high","bullets":["Net loss $8.2M (2025) vs $7.9M (2024); revenue $0; cash $2.5M at year-end.","R&D expenses $5.0M (+$0.6M YoY) due to CardiAMP HF trial closeout and Japan regulatory work.","CardiAMP HF II trial enrolling at 4 sites; Yale echo data showed reduced LV remodeling in treated patients.","FDA Q-Sub on CardiAMP approval pathway expected Q1 2026; Japan PMDA formal consultation Q2 2026.","Helix delivery system Pre-Submission accepted by FDA; meeting with CDRH/CBER scheduled Q2 2026."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"neutral","materiality_score":0.65,"calibrated_materiality_score":0.65,"market_cap_usd":10240662.993085282,"market_cap_bucket":"microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":116088,"accession_number":"0001437749-26-008499","cik":925741,"company_name":"BioCardia, Inc.","ticker":"BCDA","form_type":"8-K","filed_at":"2026-03-17T23:59:59+00:00","items":["8.01","9.01"],"status":"ready","headline":"BioCardia FDA accepts pre-submission package for Helix catheter; review meeting early Q2","summary_kind":"llm","event_type":"regulatory","confidence":"high","bullets":["FDA accepted pre-submission package for Helix Transendocardial Delivery Catheter; substantive review and meeting scheduled early Q2 2026.","CDRH to lead review in consultation with CBER; Helix enables minimally invasive intramyocardial delivery of therapeutics/diagnostics.","CEO states FDA marketing clearance would be meaningful for business; Helix is platform for cardiac cell, gene, and protein therapeutics.","CardiAMP Cell Therapy Breakthrough Designation (enabled by Helix) acknowledged by FDA in this submission."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"positive","materiality_score":0.6,"calibrated_materiality_score":0.6,"market_cap_usd":10240662.993085282,"market_cap_bucket":"microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":116087,"accession_number":"0001437749-26-006481","cik":925741,"company_name":"BioCardia, Inc.","ticker":"BCDA","form_type":"8-K","filed_at":"2026-03-03T23:59:59+00:00","items":["7.01","9.01"],"status":"ready","headline":"BioCardia reports positive echo results from Phase III HFrEF trial; reduced ventricular remodeling","summary_kind":"llm","event_type":"other_material","confidence":"high","bullets":["CardiAMP cell therapy reduced left ventricular end-diastolic volume (p=0.06) and end-systolic volume (p=0.09).","In patients with elevated NTproBNP, volume reductions were clinically meaningful and statistically significant (p=0.02, p=0.01).","Results correlated with reduced major adverse cardiovascular events and improved quality of life.","Echocardiography outcomes by Yale core lab; data presented at THT 2026."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"positive","materiality_score":0.75,"calibrated_materiality_score":0.75,"market_cap_usd":10240662.993085282,"market_cap_bucket":"microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":116086,"accession_number":"0001437749-26-003582","cik":925741,"company_name":"BioCardia, Inc.","ticker":"BCDA","form_type":"8-K","filed_at":"2026-02-10T23:59:59+00:00","items":["8.01","9.01"],"status":"ready","headline":"BioCardia files FDA Pre-Submission for Helix transendocardial catheter approval","summary_kind":"llm","event_type":"regulatory","confidence":"high","bullets":["Completed Pre-Submission (Q-Submission) to FDA for Helix catheter for intramyocardial delivery.","Data from 15 well-controlled clinical trials supports safety and effectiveness.","Pre-Submission under CardiAMP Cell Therapy System FDA Breakthrough Designation.","Goal to align with FDA on regulatory pathway and timing within next 45 days.","CEO states Helix aims to be first approved transendocardial delivery catheter in US."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"positive","materiality_score":0.65,"calibrated_materiality_score":0.65,"market_cap_usd":10240662.993085282,"market_cap_bucket":"microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":116085,"accession_number":"0001437749-26-002723","cik":925741,"company_name":"BioCardia, Inc.","ticker":"BCDA","form_type":"8-K","filed_at":"2026-02-03T23:59:59+00:00","items":["8.01","9.01"],"status":"ready","headline":"BioCardia announces acceptance of CardiAMP HF echocardiography data for late-breaking presentation at THT 2026","summary_kind":"llm","event_type":"other","confidence":"high","bullets":["Echocardiography data from CardiAMP HF trial accepted for Late Breaking Clinical Trial Oral Presentation at THT Meeting.","Presentation by Dr. Amish Raval, Professor of Medicine at UW School of Medicine and Public Health and CardiAMP HF National Co-PI.","THT meeting takes place March 2-4, 2026 in Boston, MA.","Title: 'Autologous Cell Therapy May Curb Pathological Ventricular Remodeling in Chronic Ischemic HFrEF Patients Selected for Favorable Cell Characteristics.'"],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"neutral","materiality_score":0.5,"calibrated_materiality_score":0.5,"market_cap_usd":10240662.993085282,"market_cap_bucket":"microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":132524,"accession_number":"0001437749-25-037910","cik":925741,"company_name":"BioCardia, Inc.","ticker":"BCDA","form_type":"8-K","filed_at":"2025-12-16T23:59:59+00:00","items":["7.01","9.01"],"status":"ready","headline":"BioCardia advances CardiAMP Cell Therapy to formal PMDA consultation for HFrEF in Japan","summary_kind":"llm","event_type":"regulatory","confidence":"high","bullets":["Completed third preliminary clinical consultation with Japan's PMDA for CardiAMP Cell Therapy (HFrEF).","PMDA will allow BioCardia to proceed to formal clinical consultation; potential path to regulatory filing.","Data from three completed Phase I-III trials show improved survival, reduced MACE, and better heart function vs control.","CEO Peter Altman notes therapy offers a new mechanism of microvascular repair for ischemic HFrEF patients."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"positive","materiality_score":0.6,"calibrated_materiality_score":0.6,"market_cap_usd":10240662.993085282,"market_cap_bucket":"microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":132523,"accession_number":"0001437749-25-036711","cik":925741,"company_name":"BioCardia, Inc.","ticker":"BCDA","form_type":"8-K","filed_at":"2025-12-03T23:59:59+00:00","items":["5.02","5.07","7.01","9.01"],"status":"ready","headline":"BioCardia elects Marvin Slosman to board; Dr. Richard Krasno completes term","summary_kind":"llm","event_type":"leadership","confidence":"high","bullets":["Marvin Slosman, CEO of InspireMD, elected to BioCardia board effective Dec. 2, 2025.","Dr. Richard Krasno, a director since 2016, completed his term and departed the board on Dec. 2, 2025.","At the annual meeting, shareholders elected Slosman, Jay M. Moyes, and Simon H. Stertzer as Class III directors.","Shareholders also approved amendment to 2016 Equity Incentive Plan extending term to 2035 and increasing share reserve.","Ratification of PKF San Diego as auditor approved; advisory vote on executive compensation passed."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"neutral","materiality_score":0.6,"calibrated_materiality_score":0.6,"market_cap_usd":10240662.993085282,"market_cap_bucket":"microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":132522,"accession_number":"0001437749-25-036076","cik":925741,"company_name":"BioCardia, Inc.","ticker":"BCDA","form_type":"8-K","filed_at":"2025-11-24T23:59:59+00:00","items":["8.01","9.01"],"status":"ready","headline":"BioCardia appoints Farhan Shahab as VP of Quality","summary_kind":"llm","event_type":"leadership","confidence":"high","bullets":["Farhan Shahab named Vice President of Quality, effective November 24, 2025.","Shahab brings over 25 years of experience in quality and regulatory roles at Medtronic, AngioScore, and Welldoc.","CEO Peter Altman says Shahab's expertise will accelerate commercialization of investigational products.","Shahab holds a BS in Chemical Engineering from UMass and an MBA from University of Phoenix.","He is Regulatory Affairs Certified (RAC) and Certified Auditor (Exemplar Global)."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"neutral","materiality_score":0.3,"calibrated_materiality_score":0.3,"market_cap_usd":10240662.993085282,"market_cap_bucket":"microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":132521,"accession_number":"0001437749-25-034442","cik":925741,"company_name":"BioCardia, Inc.","ticker":"BCDA","form_type":"8-K","filed_at":"2025-11-12T23:59:59+00:00","items":["2.02","9.01"],"status":"ready","headline":"BioCardia reports Q3 2025 results, $6M financing, and regulatory milestones for cell therapies","summary_kind":"llm","event_type":"earnings","confidence":"high","bullets":["Closed $6.0 million financing with net proceeds of $5.2 million in September 2025.","Net loss decreased to $1.5 million for Q3 2025 from $1.7 million in Q3 2024.","Positive preliminary clinical consultation with Japan’s PMDA for CardiAMP heart failure trial.","Plans to submit Helix transendocardial delivery catheter for FDA DeNovo 510(k) in Q4 2025.","Cash balance of $5.3 million on Sept 30, 2025, providing runway into Q2 2026."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":0.0,"consensus_period":"2025-Q3","consensus_source":"xbrl_only","sentiment":"neutral","materiality_score":0.8,"calibrated_materiality_score":0.8,"market_cap_usd":10240662.993085282,"market_cap_bucket":"microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":132520,"accession_number":"0001437749-25-033949","cik":925741,"company_name":"BioCardia, Inc.","ticker":"BCDA","form_type":"8-K","filed_at":"2025-11-10T23:59:59+00:00","items":["8.01","9.01"],"status":"ready","headline":"BioCardia announces first patient enrolled at Henry Ford Health in Phase 3 CardiAMP HF II trial","summary_kind":"llm","event_type":"other_material","confidence":"high","bullets":["First patient enrolled at Henry Ford Health in Phase 3 CardiAMP HF II trial for ischemic heart failure with reduced ejection fraction.","Prior CardiAMP HF study showed reduced mortality and major adverse cardiac events in patients with elevated NTproBNP.","Phase 3 is a 250-patient randomized, placebo-controlled confirmatory study using a three-tier composite primary endpoint.","Primary endpoint composite: all-cause death, nonfatal MACE, and validated quality of life measure.","CEO notes ~2 million US and EU patients with NYHA Class II/III symptoms who may benefit."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"positive","materiality_score":0.6,"calibrated_materiality_score":0.6,"market_cap_usd":10240662.993085282,"market_cap_bucket":"microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":132519,"accession_number":"0001437749-25-032289","cik":925741,"company_name":"BioCardia, Inc.","ticker":"BCDA","form_type":"8-K","filed_at":"2025-10-30T23:59:59+00:00","items":["8.01","9.01"],"status":"ready","headline":"BioCardia enrolls first patient at Wisconsin in Phase 3 CardiAMP HF II trial","summary_kind":"llm","event_type":"other_material","confidence":"medium","bullets":["First patient enrolled at University of Wisconsin School of Medicine and Public Health in Phase 3 CardiAMP HF II trial.","Trial is 250-patient randomized placebo-controlled study for ischemic HFrEF patients with elevated NTproBNP.","Dr. Amish Raval serves as national co-principal investigator; UW is a prestigious cardiology center.","Therapy uses autologous cells; cell population analysis defines doses; Helix system includes Morph DNA steerable platform."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"neutral","materiality_score":0.4,"calibrated_materiality_score":0.4,"market_cap_usd":10240662.993085282,"market_cap_bucket":"microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":132518,"accession_number":"0001437749-25-030649","cik":925741,"company_name":"BioCardia, Inc.","ticker":"BCDA","form_type":"8-K","filed_at":"2025-10-07T23:59:59+00:00","items":["5.08"],"status":"ready","headline":"BioCardia sets 2025 annual meeting for Dec 2; record date Oct 8; nomination deadline Oct 17","summary_kind":"llm","event_type":"other","confidence":"high","bullets":["Annual meeting on Tuesday, December 2, 2025 at 9:00 a.m. PT in Palo Alto, CA.","Record date for voting: close of business on October 8, 2025.","Deadline for Rule 14a-8 proposals and director nominations: October 17, 2025.","Universal proxy rule notices also due by October 17, 2025."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"neutral","materiality_score":0.15,"calibrated_materiality_score":0.15,"market_cap_usd":10240662.993085282,"market_cap_bucket":"microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":132517,"accession_number":"0001437749-25-030217","cik":925741,"company_name":"BioCardia, Inc.","ticker":"BCDA","form_type":"8-K","filed_at":"2025-10-02T23:59:59+00:00","items":["8.01","9.01"],"status":"ready","headline":"BioCardia regains Nasdaq compliance; stock continues trading on Capital Market","summary_kind":"llm","event_type":"regulatory","confidence":"high","bullets":["Received Nasdaq notice on Oct 1, 2025 confirming compliance with Listing Rule 5550(b)(1).","Company improved balance sheet and raised new capital to meet equity requirements.","Common stock (BCDA) will continue to trade on Nasdaq Capital Market without interruption.","Resolution removes previous delisting risk associated with equity deficiency."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"positive","materiality_score":0.6,"calibrated_materiality_score":0.6,"market_cap_usd":10240662.993085282,"market_cap_bucket":"microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":149052,"accession_number":"0001437749-25-029768","cik":925741,"company_name":"BioCardia, Inc.","ticker":"BCDA","form_type":"8-K","filed_at":"2025-09-24T23:59:59+00:00","items":["3.01"],"status":"ready","headline":"BioCardia regains Nasdaq compliance after raising $7.35M through equity offerings","summary_kind":"llm","event_type":"regulatory","confidence":"high","bullets":["Raised net proceeds of $0.7M (Apr), $0.5M (Jun), $5.1M (Sep public offer), and $1.0M from ATM sales (Apr–Sep 2025).","Believes stockholders' equity now exceeds the $2.5M minimum for continued listing under Nasdaq Rule 5550(b)(1).","Earlier Nasdaq extension to Sep 29, 2025; compliance will be monitored at next periodic report.","Warrants exercisable earlier of 2030 or PMDA approval of CardiAMP Cell Therapy System."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"positive","materiality_score":0.85,"calibrated_materiality_score":0.85,"market_cap_usd":10240662.993085282,"market_cap_bucket":"microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":149051,"accession_number":"0001437749-25-029547","cik":925741,"company_name":"BioCardia, Inc.","ticker":"BCDA","form_type":"8-K","filed_at":"2025-09-22T23:59:59+00:00","items":["8.01","9.01"],"status":"ready","headline":"BioCardia gets positive PMDA preliminary consultation on CardiAMP HF trial for Japan approval","summary_kind":"llm","event_type":"regulatory","confidence":"high","bullets":["Positive preliminary PMDA consultation on CardiAMP Heart Failure Trial data; formal clinical consultation expected by year-end 2025.","PMDA requested clarifications on composite endpoints, statistical power, NTproBNP subgroup risk-benefit, Japan target patient count, and US development status.","BioCardia completing responses to PMDA questions; 178 ischemic HF patients across three trials under review.","Focus on autologous cell therapy for patients with few therapeutic options, per CEO Peter Altman."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"positive","materiality_score":0.65,"calibrated_materiality_score":0.65,"market_cap_usd":10240662.993085282,"market_cap_bucket":"microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":149050,"accession_number":"0001437749-25-029457","cik":925741,"company_name":"BioCardia, Inc.","ticker":"BCDA","form_type":"8-K","filed_at":"2025-09-19T23:59:59+00:00","items":["8.01","9.01"],"status":"ready","headline":"BioCardia closes $5.1M net equity offering with insider participation","summary_kind":"llm","event_type":"other_material","confidence":"high","bullets":["Sold 4,800,000 shares of common stock and warrants for 4,800,000 shares at combined price of $1.25 per unit, raising $6M gross proceeds.","Net proceeds expected to be approximately $5.1 million after deducting placement agent fees and expenses.","Directors and executive officers purchased 734,400 shares/warrants, contributing $0.9M of gross proceeds.","Warrants immediately exercisable at $1.25 per share, expiring September 20, 2027, with 4.99% beneficial ownership limitation.","Company agreed to no additional equity issuance until Nov 18, 2025, and no variable rate transactions until Mar 19, 2026."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"neutral","materiality_score":0.6,"calibrated_materiality_score":0.6,"market_cap_usd":10240662.993085282,"market_cap_bucket":"microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":149049,"accession_number":"0001437749-25-029353","cik":925741,"company_name":"BioCardia, Inc.","ticker":"BCDA","form_type":"8-K","filed_at":"2025-09-18T23:59:59+00:00","items":["7.01","9.01"],"status":"ready","headline":"BioCardia prices $6M public offering of 4.8M shares and warrants; up to $6M more from warrant exercise","summary_kind":"llm","event_type":"other_material","confidence":"high","bullets":["Public offering of 4,800,000 shares and short-term warrants for 4,800,000 shares at $1.25 per unit.","Gross proceeds of $6 million upfront; potential additional $6 million if warrants fully exercised on cash basis.","Short-term warrants exercisable at $1.25 per share, expire two years from issuance.","Closing expected September 19, 2025; H.C. Wainwright acting as exclusive placement agent.","Net proceeds to be used for working capital, advancing biotherapeutic candidates and delivery partnership business."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"neutral","materiality_score":0.65,"calibrated_materiality_score":0.65,"market_cap_usd":10240662.993085282,"market_cap_bucket":"microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":149048,"accession_number":"0001437749-25-029347","cik":925741,"company_name":"BioCardia, Inc.","ticker":"BCDA","form_type":"8-K","filed_at":"2025-09-18T23:59:59+00:00","items":["7.01","9.01"],"status":"ready","headline":"BioCardia CardiAMP trial roll-in cohort shows +80 sec exercise tolerance, 82% fewer angina episodes at 6 months","summary_kind":"llm","event_type":"other_material","confidence":"high","bullets":["Open-label roll-in cohort (N not given) met primary endpoint; no treatment-emergent major adverse cardiac events.","Average exercise tolerance improved by 80 seconds at six-month follow-up vs. pre-treatment.","Angina episodes reduced by an average of 82% at the six-month primary endpoint.","60% of patients showed substantial improvement in both exercise tolerance and angina reduction.","Results compare favorably to FDA-approved therapies Ranolazine and EECP; data to be submitted for peer review."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"positive","materiality_score":0.7,"calibrated_materiality_score":0.7,"market_cap_usd":10240662.993085282,"market_cap_bucket":"microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":149047,"accession_number":"0001437749-25-026356","cik":925741,"company_name":"BioCardia, Inc.","ticker":"BCDA","form_type":"8-K","filed_at":"2025-08-13T23:59:59+00:00","items":["8.01","9.01"],"status":"ready","headline":"BioCardia and CART-Tech enter exclusive pact for Heart3D Fusion Imaging","summary_kind":"llm","event_type":"other_material","confidence":"high","bullets":["Exclusive development/commercialization agreement for Heart3D Fusion Imaging, enhancing 2D x-rays with 3D anatomical models.","BioCardia gets exclusive global rights for biotherapeutic delivery and US rights for cardiac biopsy distribution.","Management estimates $100M annual revenue potential from Heart3D if single large-market biologic becomes standard of care.","Cross-licensing: BioCardia licenses CART-Tech IP for biotherapeutic intervention; CART-Tech licenses BioCardia IP for CRT.","Heart3D initially sold as research tool for preclinical studies, later for clinical practice."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"positive","materiality_score":0.7,"calibrated_materiality_score":0.7,"market_cap_usd":10240662.993085282,"market_cap_bucket":"microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":149046,"accession_number":"0001437749-25-025827","cik":925741,"company_name":"BioCardia, Inc.","ticker":"BCDA","form_type":"8-K","filed_at":"2025-08-11T23:59:59+00:00","items":["2.02","9.01"],"status":"ready","headline":"BioCardia Q2 net loss $2M, cash ~$1.1M after ATM; runway into Oct 2025","summary_kind":"llm","event_type":"earnings","confidence":"high","bullets":["Net loss of $2.0M for Q2 2025 vs $1.6M in Q2 2024; R&D expenses up to $1.4M.","Cash balance $980k at June 30; raised $769k via ATM at avg $2.59/share; runway into Oct 2025.","R&D expenses increased due to closeout of CardiAMP HF trial and start of CardiAMP HF II enrollment.","Phase 3 CardiAMP HF data submitted to Japan PMDA; FDA meetings on approvability expected Q4 2025.","Helix transendocardial delivery system DeNovo 510(k) submission planned Q3 2025."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":0.0,"consensus_period":"2025-Q2","consensus_source":"xbrl_only","sentiment":"negative","materiality_score":0.65,"calibrated_materiality_score":0.65,"market_cap_usd":10240662.993085282,"market_cap_bucket":"microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":149045,"accession_number":"0001437749-25-024472","cik":925741,"company_name":"BioCardia, Inc.","ticker":"BCDA","form_type":"8-K","filed_at":"2025-08-04T23:59:59+00:00","items":["8.01","9.01"],"status":"ready","headline":"BioCardia provides Q3/Q4 2025 timelines for FDA and PMDA submissions for CardiAMP and Helix","summary_kind":"llm","event_type":"regulatory","confidence":"high","bullets":["Helix DeNovo 510(k) submission to FDA planned for Q3 2025; based on >4,000 intramyocardial deliveries.","CardiAMP Cell Therapy FDA meeting request in Q4 2025 to discuss approval pathway using clinical data from three trials.","Japan PMDA clinical consultation for CardiAMP Cell Therapy expected mid Q4 2025; point-of-care platform already approved in Japan.","CardiAMP HF II trial actively enrolling at five US centers including Cleveland Clinic and Emory University."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"neutral","materiality_score":0.65,"calibrated_materiality_score":0.65,"market_cap_usd":10240662.993085282,"market_cap_bucket":"microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":149044,"accession_number":"0001437749-25-023351","cik":925741,"company_name":"BioCardia, Inc.","ticker":"BCDA","form_type":"8-K","filed_at":"2025-07-24T23:59:59+00:00","items":["8.01","9.01"],"status":"ready","headline":"BioCardia submits CardiAMP cell therapy for PMDA clinical consultation in Japan","summary_kind":"llm","event_type":"regulatory","confidence":"high","bullets":["Submitted clinical data package including full CardiAMP HF trial results and STED to Japan's PMDA on July 24, 2025.","Consultation seeks PMDA alignment on efficacy, safety, target patient population, and positioning in heart failure care.","Positive PMDA feedback could enable BioCardia to submit for market approval in Japan.","CEO expects potential post-marketing study in Japan next year if regulatory pathway is cleared."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"neutral","materiality_score":0.65,"calibrated_materiality_score":0.65,"market_cap_usd":10240662.993085282,"market_cap_bucket":"microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":149043,"accession_number":"0001437749-25-022772","cik":925741,"company_name":"BioCardia, Inc.","ticker":"BCDA","form_type":"8-K","filed_at":"2025-07-16T23:59:59+00:00","items":["8.01","9.01"],"status":"ready","headline":"Henry Ford Health enrolls first patients in BioCardia's Phase 3 CardiAMP HF II trial","summary_kind":"llm","event_type":"other_material","confidence":"high","bullets":["Henry Ford Health (Detroit) is now enrolling ischemic HFrEF patients in BioCardia's pivotal CardiAMP HF II trial.","CardiAMP HF II is a 250-patient randomized, placebo-controlled confirmatory study of autologous bone marrow cell therapy.","Primary composite endpoint includes all-cause death, nonfatal MACE, and quality of life; prior CardiAMP HF trial met significance for elevated NTproBNP patients.","Therapy involves same-day cell harvest, bedside processing, and minimally invasive catheter delivery."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"neutral","materiality_score":0.5,"calibrated_materiality_score":0.5,"market_cap_usd":10240662.993085282,"market_cap_bucket":"microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":149042,"accession_number":"0001437749-25-021906","cik":925741,"company_name":"BioCardia, Inc.","ticker":"BCDA","form_type":"8-K","filed_at":"2025-07-02T23:59:59+00:00","items":["3.02","8.01","9.01"],"status":"ready","headline":"BioCardia raises ~$570K in private placement of stock and warrants","summary_kind":"llm","event_type":"other_material","confidence":"high","bullets":["Sold 274,696 shares and warrants at $2.075/unit, gross proceeds ~$570,000.","Warrants exercisable at $1.95/share until 6/30/2030 or PMDA approval of CardiAMP.","Directors/officers invested $360K, including CEO Peter Altman ($50K) and CFO David McClung ($10K).","Proceeds for general corporate purposes; registration statement to be filed by July 10, 2025."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"neutral","materiality_score":0.5,"calibrated_materiality_score":0.5,"market_cap_usd":10240662.993085282,"market_cap_bucket":"microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":168022,"accession_number":"0001437749-25-021210","cik":925741,"company_name":"BioCardia, Inc.","ticker":"BCDA","form_type":"8-K","filed_at":"2025-06-25T23:59:59+00:00","items":["8.01","9.01"],"status":"ready","headline":"BioCardia granted US Patent No. 12,311,127 for Helix catheter delivery system","summary_kind":"llm","event_type":"other_material","confidence":"high","bullets":["Patent covers radial and trans-endocardial delivery catheter for biologic therapies.","Protects helical needle-tipped catheter platform; cited as safest and most efficient approach.","Helix system underlies CardiAMP Cell Therapy program for ischemic cardiomyopathies and refractory angina.","CEO notes work toward separate approvals of the therapy and the delivery system."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"positive","materiality_score":0.45,"calibrated_materiality_score":0.45,"market_cap_usd":10240662.993085282,"market_cap_bucket":"microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":168021,"accession_number":"0001437749-25-016838","cik":925741,"company_name":"BioCardia, Inc.","ticker":"BCDA","form_type":"8-K","filed_at":"2025-05-14T23:59:59+00:00","items":["2.02","9.01"],"status":"ready","headline":"BioCardia Q1 2025 net loss $2.7M; CardiAMP HF two-year data shows survival benefit; Helix FDA submission planned","summary_kind":"llm","event_type":"earnings","confidence":"high","bullets":["Two-year results from Phase 3 CardiAMP HF trial (presented Mar 30) showed increased survival, fewer CV events, improved QoL; significant in NTproBNP-elevated subset (p=0.02).","CardiAMP HF II confirmatory trial underway with three active sites; primary endpoint based on hierarchical analysis.","Refractory angina roll-in cohort showed 107 sec increase in exercise tolerance and 82% reduction in angina episodes at 6 months.","R&D expenses $1.5M, SG&A $1.2M; net loss $2.7M vs $2.3M YoY; cash used in ops $1.6M.","Plans to submit CardiAMP Cell Therapy for Japan PMDA consultation and Helix delivery system for FDA approval this quarter."],"consensus_eps_estimate":-0.1683,"consensus_eps_actual":-0.59,"consensus_revenue_estimate":null,"consensus_revenue_actual":0.0,"consensus_period":"2026-Q1","consensus_source":"xbrl+finnhub","sentiment":"positive","materiality_score":0.8,"calibrated_materiality_score":0.8,"market_cap_usd":10240662.993085282,"market_cap_bucket":"microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":168020,"accession_number":"0001437749-25-014620","cik":925741,"company_name":"BioCardia, Inc.","ticker":"BCDA","form_type":"8-K","filed_at":"2025-05-06T23:59:59+00:00","items":["8.01","9.01"],"status":"ready","headline":"BioCardia initiates patient enrollment at University of Wisconsin for CardiAMP HF II Phase 3 trial","summary_kind":"llm","event_type":"other_material","confidence":"high","bullets":["University of Wisconsin now enrolling ischemic HFrEF patients in BioCardia's pivotal Phase 3 CardiAMP HF II trial.","Dr. Amish Raval named site PI and co-national PI for the study.","Trial uses autologous cell therapy with a three-tier composite outcome: death, nonfatal MACE, and quality-of-life.","Prior CardiAMP HF study met composite endpoint in elevated NTproBNP patients (p=0.02).","Advances include cell population analysis for dosing and FDA-approved Morph DNA steerable platform."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"neutral","materiality_score":0.35,"calibrated_materiality_score":0.35,"market_cap_usd":10240662.993085282,"market_cap_bucket":"microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":168019,"accession_number":"0001437749-25-013987","cik":925741,"company_name":"BioCardia, Inc.","ticker":"BCDA","form_type":"8-K","filed_at":"2025-05-01T23:59:59+00:00","items":["7.01","9.01"],"status":"ready","headline":"BioCardia announces first patient enrolled in Phase 3 CardiAMP HF II heart failure trial","summary_kind":"llm","event_type":"other_material","confidence":"high","bullets":["First patient enrolled in Phase 3 randomized, double-blind, placebo-controlled CardiAMP HF II trial at BayCare Morton Plant Hospital in Clearwater, Florida.","250-patient multicenter study targeting ischemic HFrEF patients with elevated NTproBNP; composite primary endpoint includes death, nonfatal MACE, and quality of life.","Company preparing regulatory submissions in Japan and the USA based on prior CardiAMP HF, TAC-HFT, and TABMMI trial data.","Advances include cell population analysis at screening to define treatment doses and use of FDA-approved Morph DNA steerable catheter."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"positive","materiality_score":0.7,"calibrated_materiality_score":0.7,"market_cap_usd":10240662.993085282,"market_cap_bucket":"microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":168018,"accession_number":"0001437749-25-012828","cik":925741,"company_name":"BioCardia, Inc.","ticker":"BCDA","form_type":"8-K","filed_at":"2025-04-23T23:59:59+00:00","items":["3.02","8.01","9.01"],"status":"ready","headline":"BioCardia raises $775k in private placement of common stock and warrants","summary_kind":"llm","event_type":"other_material","confidence":"high","bullets":["Gross proceeds of ~$775k from sale of 406,818 shares and 406,818 warrants at $1.905/unit.","Warrants exercisable at $1.905/share, expire Apr 23, 2030 or upon Japan PMDA approval of CardiAMP.","Directors/executives invest $575k total: Andrew Blank $250k, Simon Stertzer $200k, Peter Altman $50k, others.","Net proceeds to be used for general corporate purposes; closing expected Apr 23, 2025.","Company agrees to file resale registration statement by May 3, 2025 for shares and warrant shares."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"neutral","materiality_score":0.7,"calibrated_materiality_score":0.7,"market_cap_usd":10240662.993085282,"market_cap_bucket":"microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":168017,"accession_number":"0001437749-25-011992","cik":925741,"company_name":"BioCardia, Inc.","ticker":"BCDA","form_type":"8-K","filed_at":"2025-04-15T23:59:59+00:00","items":["7.01","9.01"],"status":"ready","headline":"BioCardia CardiALLO heart failure trial passes DSMB review; no safety issues","summary_kind":"llm","event_type":"other_material","confidence":"high","bullets":["DSMB recommends study continue as designed after 30-day safety review of 20M-cell dosing cohort.","No treatment-emergent major adverse cardiac events or immune reactions observed.","Company plans to enroll 39 participants in the US for Phase 1/2 CardiALLO-HF trial.","CEO cites potential for nondilutive funding and partnering, and future pivotal trial in USA, Japan.","High-dose arm targets patients with active inflammation, at least 2x effective dose of prior MSC studies."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"positive","materiality_score":0.65,"calibrated_materiality_score":0.65,"market_cap_usd":10240662.993085282,"market_cap_bucket":"microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":168016,"accession_number":"0001437749-25-011724","cik":925741,"company_name":"BioCardia, Inc.","ticker":"BCDA","form_type":"8-K","filed_at":"2025-04-11T23:59:59+00:00","items":["8.01","9.01"],"status":"ready","headline":"BioCardia initiates patient enrollment at Emory University for Phase III heart failure trial","summary_kind":"llm","event_type":"other_material","confidence":"high","bullets":["Emory University School of Medicine is now enrolling patients with ischemic heart failure in BioCardia's pivotal Phase III CardiAMP HF II trial.","Dr. Arshed Quyyumi, Professor of Medicine at Emory, will serve as principal investigator for the autologous cell therapy study.","Trial compares CardiAMP therapy to placebo; target enrollment completion in 2027 based on prior positive results presented at ACC 2025."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"positive","materiality_score":0.5,"calibrated_materiality_score":0.5,"market_cap_usd":10240662.993085282,"market_cap_bucket":"microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":168015,"accession_number":"0001437749-25-011030","cik":925741,"company_name":"BioCardia, Inc.","ticker":"BCDA","form_type":"8-K","filed_at":"2025-04-04T23:59:59+00:00","items":["3.01"],"status":"ready","headline":"BioCardia: Nasdaq notice for equity $837K vs $2.5M minimum; plan due May 16","summary_kind":"llm","event_type":"regulatory","confidence":"high","bullets":["Stockholders' equity of $837K as of Dec 31, 2024 is below Nasdaq's $2.5M minimum for continued listing.","Company must submit a compliance plan by May 16, 2025; Nasdaq may grant up to 180-day extension.","No immediate effect on trading; common stock continues on Nasdaq Capital Market under BCDA.","Company intends to submit a plan; risk of delisting if plan rejected or not accepted."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"negative","materiality_score":0.75,"calibrated_materiality_score":0.75,"market_cap_usd":10240662.993085282,"market_cap_bucket":"microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":185255,"accession_number":"0001437749-25-010087","cik":925741,"company_name":"BioCardia, Inc.","ticker":"BCDA","form_type":"8-K","filed_at":"2025-03-31T23:59:59+00:00","items":["7.01","9.01"],"status":"ready","headline":"BioCardia clarifies CardiAMP-HF call at 4:30PM EDT; no results disclosed","summary_kind":"llm","event_type":"other_material","confidence":"low","bullets":["Conference call today, March 31, 2025 at 4:30 PM EDT to discuss two-year CardiAMP-HF results.","Prior press release incorrectly stated 4:30 PM PDT; this filing corrects that error.","No actual trial results or financial data provided in this 8-K filing."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"neutral","materiality_score":0.2,"calibrated_materiality_score":0.2,"market_cap_usd":10240662.993085282,"market_cap_bucket":"microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":185254,"accession_number":"0001437749-25-009978","cik":925741,"company_name":"BioCardia, Inc.","ticker":"BCDA","form_type":"8-K","filed_at":"2025-03-31T23:59:59+00:00","items":["7.01","8.01","9.01"],"status":"ready","headline":"BioCardia Phase 3 CardiAMP-HF shows survival benefit, MACCE reduction at 2 years; primary endpoint not met","summary_kind":"llm","event_type":"other_material","confidence":"high","bullets":["Primary composite efficacy endpoint did not reach statistical significance in overall 115-patient trial.","In all treated patients: 20.9% relative risk reduction in heart death equivalents; 44.6% reduction in non-fatal MACCE.","Patients with elevated NTproBNP (50% of cohort) showed statistically significant composite of survival, MACCE, and QOL.","Treated subgroup (elevated NTproBNP) saw 47% relative risk reduction in heart death equivalents and 10.5-point MLHFQ improvement.","Company plans to discuss results with FDA and PMDA to align on regulatory pathway for this Breakthrough Therapy."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"positive","materiality_score":0.85,"calibrated_materiality_score":0.85,"market_cap_usd":10240662.993085282,"market_cap_bucket":"microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":185253,"accession_number":"0001437749-25-009399","cik":925741,"company_name":"BioCardia, Inc.","ticker":"BCDA","form_type":"8-K","filed_at":"2025-03-26T23:59:59+00:00","items":["2.02","9.01"],"status":"ready","headline":"BioCardia reports FY2024 net loss $7.9M, cash $2.4M; CardiAMP HF data to be presented at ACC March 30","summary_kind":"llm","event_type":"earnings","confidence":"high","bullets":["Net loss $7.9M vs $11.6M in 2023; net cash used in ops $8.0M vs $10.0M.","Revenue $58K vs $477K; R&D expense $4.4M (down from $7.7M); SG&A $3.7M (down from $4.4M).","CardiAMP HF trial results to be presented at ACC Late-Breaking Clinical Trials on March 30, 2025; data intended for FDA/PMDA registration.","Completed low-dose cohort of CardiALLO (BCDA-03); DSMB review Q2 2025. First commercial Morph DNA steerable introducers available.","Cash and cash equivalents $2.4M at year-end 2024."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"neutral","materiality_score":0.7,"calibrated_materiality_score":0.7,"market_cap_usd":10240662.993085282,"market_cap_bucket":"microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":185252,"accession_number":"0001437749-25-006764","cik":925741,"company_name":"BioCardia, Inc.","ticker":"BCDA","form_type":"8-K","filed_at":"2025-03-10T23:59:59+00:00","items":["8.01","9.01"],"status":"ready","headline":"BioCardia granted Japanese patent for Helix biotherapeutic delivery catheter expiring 2034","summary_kind":"llm","event_type":"other_material","confidence":"high","bullets":["Japan Patent Office issued Patent No. 7641330 titled 'Radial and Transendocardial Delivery Catheter'.","Patent term expires on or after September 30, 2034; covers helical needle-tipped catheter platform.","BioCardia CEO cites growing IP position for cell/gene therapy delivery; Japan is important initial market.","Helix System is the only catheter-based intramyocardial delivery system in active clinical use per BioCardia."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"positive","materiality_score":0.3,"calibrated_materiality_score":0.3,"market_cap_usd":10240662.993085282,"market_cap_bucket":"microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":185251,"accession_number":"0001437749-25-005355","cik":925741,"company_name":"BioCardia, Inc.","ticker":"BCDA","form_type":"8-K","filed_at":"2025-02-27T23:59:59+00:00","items":["8.01","9.01"],"status":"ready","headline":"BioCardia freezes primary outcomes data in Phase 3 CardiAMP HF trial; results at ACC 2025","summary_kind":"llm","event_type":"other_material","confidence":"high","bullets":["Source data verified and data frozen for 115 patients in double-blind, placebo-controlled Phase 3 trial for ischemic HFrEF.","Data transferred to Statistical Data Analysis Center core laboratory for analysis.","Results scheduled for Late-Breaking Clinical Trials symposium at ACC 2025 on March 30, 2025 in Chicago.","CEO states the study is intended to support safety and effectiveness for US and Japan approvals and Helix delivery system approval."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"neutral","materiality_score":0.6,"calibrated_materiality_score":0.6,"market_cap_usd":10240662.993085282,"market_cap_bucket":"microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":185250,"accession_number":"0001437749-25-003677","cik":925741,"company_name":"BioCardia, Inc.","ticker":"BCDA","form_type":"8-K","filed_at":"2025-02-13T23:59:59+00:00","items":["8.01","9.01"],"status":"ready","headline":"BioCardia completes low-dose enrollment in CardiALLO allogeneic MSC HFrEF trial","summary_kind":"llm","event_type":"other_material","confidence":"high","bullets":["Enrolled and dosed 3 patients in low-dose cohort (20M cells) of Phase I/II CardiALLO trial.","Trial is first prospective allogeneic MSC study targeting HFrEF patients with elevated heart stress/inflammation markers.","DSMB safety review expected March 2025; next dose escalation (100M cells) to follow.","Used Morph DNA steerable guide for enhancing cell delivery during treatment procedures.","Program aims to support pivotal US studies and conditional time-limited approval in Japan."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"positive","materiality_score":0.6,"calibrated_materiality_score":0.6,"market_cap_usd":10240662.993085282,"market_cap_bucket":"microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":185249,"accession_number":"0001437749-25-001886","cik":925741,"company_name":"BioCardia, Inc.","ticker":"BCDA","form_type":"8-K","filed_at":"2025-01-27T23:59:59+00:00","items":["8.01","9.01"],"status":"ready","headline":"BioCardia's CardiAMP HF Phase 3 trial accepted for late-breaking presentation at ACC 2025","summary_kind":"llm","event_type":"other_material","confidence":"high","bullets":["Results of double-blind, randomized, placebo-controlled CardiAMP HF Phase 3 study accepted for late-breaking symposium at ACC 2025 in Chicago, March 29-31.","Presentation by Dr. Amish N. Raval on March 30, 2025, in Featured Clinical Research II session.","CardiAMP HF trial evaluates autologous cell therapy in patients with heart failure with reduced ejection fraction (HFrEF).","Late-breaking clinical trial session highlights key upcoming results at a leading cardiovascular conference."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"positive","materiality_score":0.4,"calibrated_materiality_score":0.4,"market_cap_usd":10240662.993085282,"market_cap_bucket":"microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":201843,"accession_number":"0001437749-24-037688","cik":925741,"company_name":"BioCardia, Inc.","ticker":"BCDA","form_type":"8-K","filed_at":"2024-12-17T23:59:59+00:00","items":["8.01","9.01"],"status":"ready","headline":"BioCardia commercially launches Morph DNA steerable introducer product family","summary_kind":"llm","event_type":"other_material","confidence":"high","bullets":["Morph DNA steerable introducer family now commercially available; currently used in ongoing cell-therapy clinical trials.","CEO Peter Altman says sales pipeline explored organically without a direct sales force or third-party partners.","Anticipates final results of CardiAMP Heart Failure I trial and active enrollment in CardiAMP Heart Failure II by Q1 2025.","Company remains focused on its FDA breakthrough-designated cell therapy for ischemic heart failure."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"positive","materiality_score":0.5,"calibrated_materiality_score":0.5,"market_cap_usd":10240662.993085282,"market_cap_bucket":"microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":201842,"accession_number":"0001437749-24-036648","cik":925741,"company_name":"BioCardia, Inc.","ticker":"BCDA","form_type":"8-K","filed_at":"2024-12-04T23:59:59+00:00","items":["8.01","9.01"],"status":"ready","headline":"BioCardia gets positive PMDA consultation; next step after final CardiAMP HF data in Q1 2025","summary_kind":"llm","event_type":"regulatory","confidence":"high","bullets":["Completed consultation with Japan PMDA; PMDA invited next consultation after submission of final 2-year follow-up data.","PMDA remains open to using CardiAMP Heart Failure Trial and prior trials for registration in Japan.","Company anticipates final data from 125-patient CardiAMP HF trial in Q1 2025.","BCDA-01 holds FDA Breakthrough Designation; U.S. trials supported by CMS reimbursement."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"positive","materiality_score":0.75,"calibrated_materiality_score":0.75,"market_cap_usd":10240662.993085282,"market_cap_bucket":"microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":201841,"accession_number":"0001437749-24-034906","cik":925741,"company_name":"BioCardia, Inc.","ticker":"BCDA","form_type":"8-K","filed_at":"2024-11-13T23:59:59+00:00","items":["2.02","9.01"],"status":"ready","headline":"BioCardia reports Q3 2024 net loss $1.7M; CardiAMP data expected Q1 2025","summary_kind":"llm","event_type":"earnings","confidence":"high","bullets":["Net loss $1.7M for Q3 2024 vs $2.6M a year ago; R&D expenses fell to $931K from $1.9M.","CardiAMP Heart Failure Trial data lock expected Q4 2024, top line results Q1 2025.","FDA approved protocol amendment for confirmatory Heart Failure II Trial, expanding eligibility.","Japan's PMDA consultation scheduled for late November 2024 regarding US data-based approval.","Closed $7.2M upsized public offering in September 2024; FDA cleared steerable introducer sheath for commercial release."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":58000.0,"consensus_period":"2024-Q3","consensus_source":"xbrl_only","sentiment":"neutral","materiality_score":0.6,"calibrated_materiality_score":0.6,"market_cap_usd":10240662.993085282,"market_cap_bucket":"microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null}],"next_cursor":"2024-11-13T23:59:59+00:00|201841"}