Filing Analysis
BioCardia, Inc. received a deficiency notice from Nasdaq because its common stock has traded below the $1.00 minimum bid price for 30 consecutive business days. The company has been granted a 180-day compliance period ending February 16, 2027, to regain compliance.
🚩 Red Flags
- Minimum bid price deficiency (trading below $1.00).
- Potential for a mandatory reverse stock split to maintain listing.
- Risk of delisting from the Nasdaq Capital Market if compliance is not met or an appeal is unsuccessful.
📋 Key Facts
- Received written notice from Nasdaq on August 19, 2026.
- Deficiency is based on Nasdaq Listing Rule 5550(a)(2) regarding the Minimum Bid Price Requirement.
- The company has 180 calendar days to regain compliance, with a deadline of February 16, 2027.
- Compliance can be achieved if the closing bid price is $1.00 or more for at least 10 consecutive business days.
- The company may be required to effect a reverse stock split to qualify for a second 180-day compliance period if the initial period is not met.
BioCardia, Inc. filed an 8-K to furnish its quarterly financial results for the period ended June 30, 2026. The filing serves as a formal announcement of the company's recent earnings release.
📋 Key Facts
- Report date: August 12, 2026
- Reporting period: Quarter ended June 30, 2026
- The filing includes Exhibit 99.1 containing the press release of financial results.
BioCardia, Inc. issued a press release on June 18, 2026, containing a letter to shareholders. The letter provides general updates regarding the company's business strategy, top priorities, and business development opportunities.
📋 Key Facts
- The filing date is June 18, 2026.
- The company released a shareholder letter via a press release (Exhibit 99.1).
- The content focuses on business strategy and development opportunities.
BioCardia reports that it believes it has regained compliance with Nasdaq Listing Rule 5550(b)(1) regarding the minimum $2.5 million stockholders' equity requirement. This was achieved through an 'At The Market' offering that raised $4.9 million in net proceeds between April 1 and June 5, 2026.
🚩 Red Flags
- Recent failure to meet minimum equity requirements for exchange listing.
- Heavy reliance on equity dilution (ATM offering) to solve regulatory compliance issues.
- Nasdaq will continue to monitor compliance, and failure in the next periodic report could lead to delisting.
📋 Key Facts
- Company was notified on April 10, 2026, that stockholders' equity fell below the required $2.5 million minimum.
- Nasdaq granted an extension until October 7, 2026, to regain compliance.
- The company sold 4,004,330 shares via an ATM offering with H.C. Wainwright & Co. between April 1, 2026, and June 5, 2026.
- Net proceeds from the offering totaled $4.9 million at an average share price of $1.27.
- The company believes stockholders' equity now exceeds the $2.5 million threshold.
BioCardia, Inc. announced the sale of 3,509,604 shares of common stock via its 'At The Market' (ATM) offering agreement with H.C. Wainwright & Co. The transactions occurred on June 5, 2026, at an average price of $1.279 per share.
🚩 Red Flags
- Dilution: The issuance of over 3.5 million shares increases the total share count, potentially diluting existing shareholders.
📋 Key Facts
- Total shares sold: 3,509,604
- Average sale price: $1.279 per share
- Transaction date: June 5, 2026
- Offering mechanism: 'At The Market' (ATM) agreement
- Underwriter: H.C. Wainwright & Co.
BioCardia announced that it received meeting minutes from the FDA's Center for Biologics Evaluation and Research (CBER) regarding the CardiAMP Cell Therapy System. The minutes confirm that the ongoing CardiAMP Heart Failure II Trial can be used to support a Premarket Approval (PMA) application for treating ischemic heart failure.
📋 Key Facts
- FDA meeting minutes received on June 5, 2026.
- The focus is on the CardiAMP Cell Therapy System for ischemic heart failure of reduced ejection fraction (HFrEF).
- FDA confirmed the CardiAMP Heart Failure II Trial is sufficient to support a Premarket Approval (PMA) for market clearance.
BioCardia, Inc. announced that Japan's PMDA supports the submission for regulatory approval of CardiAMP® cell therapy for ischemic heart failure (HFrEF) based on three completed clinical trials.
📋 Key Facts
- PMDA supports submission for regulatory approval for ischemic HFrEF patients with elevated biomarkers of heart stress (NTproBNP) on stable guideline directed medical therapy (GDMT).
- PMDA noted that positive outcomes seen in the trial were credible.
- Estimated initial eligible patient population in Japan is 20,000 out of 300,000 patients.
- PMDA requested additional documentation regarding patient GDMT status, revascularization eligibility, and details on all-cause death, transplantation, or LVAD implantation.
- Clinical results showed increased exercise tolerance (average improvement of 179 seconds) and an 82% reduction in angina episodes by six months.
BioCardia announced positive two-year follow-up results from the preliminary open-label cohort of its CardiAMP Cell Therapy in Chronic Myocardial Ischemia Trial (CardiAMP CMI) at the Euro PCR conference. The data demonstrated that the therapy was well tolerated and resulted in sustained improvements in exercise tolerance and a significant reduction in angina episodes.
📋 Key Facts
- Presented results of the CardiAMP CMI preliminary open-label cohort at the Euro PCR conference in Paris on May 21, 2026.
- The minimally invasive procedure was well tolerated with no treatment-emergent major adverse cardiac events reported.
- Patients demonstrated an average increase in exercise tolerance of 179 seconds, which persisted through the two-year follow-up period.
- Angina episodes were reduced by an average of 82% at six months post-treatment.
BioCardia, Inc. announced its financial results for the first quarter ended March 31, 2026, via a press release. The filing serves as a routine quarterly earnings update furnished to the SEC.
📋 Key Facts
- Financial results for the quarter ended March 31, 2026, were released on May 15, 2026.
- The information was furnished under Item 2.02 (Results of Operations and Financial Condition).
- A press release was included as Exhibit 99.1.
BioCardia announced positive feedback from an FDA Pre-Submission Meeting regarding its Helix Transendocardial Delivery Catheter System. The FDA confirmed two potential marketing clearance pathways and raised no concerns regarding the device's safety or performance.
🚩 Red Flags
- The preferred regulatory pathway ties the Helix system's approval to the success and timing of the CardiAMP cell therapy system.
📋 Key Facts
- FDA identified two distinct pathways for Helix marketing clearance.
- FDA raised no concerns regarding Helix safety data, device performance, or compatibility with general classes of agents.
- FDA's preferred route for Helix approval is simultaneous with the approval of the CardiAMP cell therapy system for heart failure.
- FDA suggested a follow-on pre-submission could enable Helix approval via the DeNovo pathway.
- The meeting outcome was disclosed via a press release on May 8, 2026.
BioCardia announced the allowance of a Japanese patent for its Heart3D™ Fusion Imaging software. The patent covers technology used for treatment planning and real-time navigation during the company's CardiAMP Cell Therapy procedures.
📋 Key Facts
- Allowance of Japanese Patent titled 'Target Site Selection, Entry, and Update with Automatic Remote Image Annotation' on April 28, 2026
- The patent protects Heart3D™ Fusion Imaging (Heart3D) software
- The technology is intended for treatment planning and real-time navigation during CardiAMP Cell Therapy procedures
- The disclosure was made under Item 8.01 (Other Events) and included a press release as Exhibit 99.1
BioCardia announced a positive outcome from its formal clinical consultation with Japan's PMDA, which indicated that existing US clinical data for the CardiAMP Cell Therapy is likely sufficient for market clearance in Japan. The company achieved alignment on the use of foreign data, indications for use, and post-marketing study requirements.
📋 Key Facts
- Formal consultation with Japan's Pharmaceutical and Medical Device Agency (PMDA) occurred on April 20, 2026.
- PMDA determined that US clinical safety and efficacy evidence for CardiAMP is likely sufficient for Japanese market clearance.
- Alignment was reached on the acceptability of foreign clinical data and the approach for therapy introduction in Japan.
- The company is awaiting official minutes from the PMDA to provide a detailed feedback and filing timeline.
BioCardia, Inc. received a deficiency notice from Nasdaq on April 10, 2026, for failing to maintain the minimum stockholders' equity requirement of $2.5 million. The company's reported equity was $895,000 as of December 31, 2025, significantly below the threshold.
🚩 Red Flags
- Stockholders' equity is approximately 64% below the required minimum threshold.
- The deficiency indicates substantial capital depletion as of the end of fiscal year 2025.
- Risk of delisting if the compliance plan is rejected or if the company fails to raise sufficient capital.
📋 Key Facts
- Received Nasdaq notice on April 10, 2026, regarding non-compliance with Listing Rule 5550(b)(1).
- Stockholders' equity was $895,000 as of December 31, 2025, versus the $2.5 million requirement.
- The company has until May 25, 2026, to submit a plan to regain compliance.
- If the plan is accepted, Nasdaq may grant an extension of up to 180 calendar days from the notice date.
- The notice does not result in immediate delisting; the stock continues to trade under 'BCDA'.
BioCardia announced the submission of CardiAMP HF clinical study data to the FDA and plans to discuss an accelerated approval pathway for its heart failure treatment system.
📋 Key Facts
- Submitted CardiAMP HF clinical study data to the FDA on April 2, 2026.
- Seeking accelerated approval pathway for the CardiAMP System for ischemic chronic heart failure with reduced ejection fraction (HFrEF).
- Plans to meet with the FDA to discuss the regulatory pathway for the device.
- The information was disclosed under Item 7.01 (Regulation FD) via a press release.
BioCardia, Inc. announced its financial results for the fiscal year ended December 31, 2025, via a press release on March 24, 2026.
📋 Key Facts
- The company reported financial results for the full year ended December 31, 2025.
- The report was filed under Item 2.02 (Results of Operations and Financial Condition).
- A press release detailing the results was furnished as Exhibit 99.1.
- The filing was signed by CEO Peter Altman, Ph.D.
BioCardia, Inc. announced that the FDA has accepted its pre-submission package for the Helix Transendocardial Delivery Catheter. The device is intended for the delivery of therapeutic and diagnostic agents directly into the heart muscle.
📋 Key Facts
- The FDA accepted the pre-submission package on March 17, 2026.
- The product involved is the Helix Transendocardial Delivery Catheter ('Helix').
- The device is designed for intramyocardial therapeutic and diagnostic agent delivery.
- The filing was made under Item 8.01 (Other Events).
BioCardia announced late-breaking echocardiography results from its Phase III CardiAMP HF clinical trial for ischemic heart failure. The data was presented at the Technology and Heart Failure Therapeutics conference on March 3, 2026.
📋 Key Facts
- The company reported Phase III clinical trial results for ischemic heart failure of reduced ejection fraction (HFrEF).
- Results were presented by Dr. Amish Raval, National Co-Principal Investigator, at the Technology and Heart Failure Therapeutics conference.
- The disclosure was made under Item 7.01 (Regulation FD) and included a press release as Exhibit 99.1.
- The presentation occurred on March 3, 2026.
BioCardia, Inc. announced the completion of its FDA Q-Submission program pre-submission for its Helix Transendocardial Delivery Catheter. This is a regulatory milestone aimed at seeking approval for intramyocardial therapeutic and diagnostic agent delivery.
📋 Key Facts
- Completed Pre-Submission under the FDA Q-Submission program on February 10, 2026.
- The submission concerns the Helix Transendocardial Delivery Catheter.
- Target application is for intramyocardial therapeutic and diagnostic agent delivery.
BioCardia, Inc. announced that its CardiAMP Cell Therapy echocardiography data has been selected for a Late Breaking Clinical Trial Oral Presentation at the upcoming Technology and Heart Failure Therapeutics (THT) Meeting in March 2026.
📋 Key Facts
- Echocardiography data from CardiAMP Cell Therapy was accepted for oral presentation.
- Presentation is scheduled for the THT Meeting, taking place March 2-4, 2026, in Boston, MA.
- The announcement was made via press release on February 3, 2026.
BioCardia, Inc. announced the completion of its third preliminary clinical consultation with Japan's PMDA regarding its CardiAMP Cell Therapy for Heart Failure (HFrEF). The regulator has agreed to allow the company to proceed to a formal clinical consultation.
📋 Key Facts
- Completed third preliminary clinical consultation with Japan’s Pharmaceutical and Medical Device Agency (PMDA) on Dec 16, 2025.
- The subject of discussion is CardiAMP Cell Therapy for Heart Failure with Reduced Ejection Fraction (HFrEF).
- PMDA has granted permission to advance to a formal clinical consultation phase.
- Potential path to regulatory approval in Japan contingent on formal consultation results regarding safety and efficacy data.
BioCardia, Inc. announced the appointment of Marvin Slosman to its Board of Directors and Audit Committee, alongside the conclusion of Dr. Richard Krasno's term. The company also reported results from its Annual Meeting, including the ratification of its independent auditor and approval of equity plan amendments.
🚩 Red Flags
- None identified in this filing.
📋 Key Facts
- Marvin Slosman appointed to the Board and Audit Committee; currently CEO of InspireMD, Inc.
- Dr. Richard Krasno completed his term on the board effective December 2, 2025; departure was not due to disagreement with the company.
- Shareholders approved an amendment/extension to the 2016 Equity Incentive Plan through October 31, 2035.
- PKF San Diego, LLP ratified as the independent registered public accounting firm for fiscal year ending Dec 31, 2025.
- Annual Meeting quorum was established with 55.72% of voting power present.
BioCardia, Inc. announced the appointment of Farhan Shahab as the new Vice President of Quality on November 24, 2025.
📋 Key Facts
- Appointment of Farhan Shahab as Vice President of Quality.
- Announcement date: November 24, 2025.
- The filing is under Item 8.01 (Other Events) and includes a press release as Exhibit 99.1.
BioCardia, Inc. filed an 8-K to furnish its quarterly financial results for the period ended September 30, 2025. The filing serves as a formal announcement of the company's recent operational and financial performance.
📋 Key Facts
- Report date: November 12, 2025
- Reporting period: Quarter ended September 30, 2025
- The filing includes an earnings press release as Exhibit 99.1
- The information is furnished under Item 2.02 and is not considered 'filed' for purposes of Section 18 liability.
BioCardia, Inc. announced the enrollment of the first patient in its Phase 3 CardiAMP HF II clinical trial at Henry Ford Health. The trial focuses on patients with ischemia heart failure and reduced ejection fraction.
📋 Key Facts
- First patient enrolled at Henry Ford Health for the Phase 3 CardiAMP HF II clinical trial.
- Trial target population: patients with ischemia heart failure of reduced ejection fraction.
- Announcement date: November 10, 2025.
BioCardia, Inc. announced a clinical milestone regarding its Phase 3 CardiAMP HF II trial. The company has enrolled the first patient at the University of Wisconsin School of Medicine and Public Health.
📋 Key Facts
- First patient enrollment achieved at University of Wisconsin School of Medicine and Public Health.
- The event pertains to the ongoing Phase 3 CardiAMP HF II clinical trial.
- Announcement date: October 30, 2025.
BioCardia, Inc. has announced the date for its 2025 Annual Meeting of Stockholders and established a record date for determining stockholder eligibility to vote.
📋 Key Facts
- Annual Meeting Date: December 2, 2025, at 9:00 a.m. PT.
- Record Date: October 8, 2025.
- Location: Wilson Sonsini Goodrich & Rosati, P.C., Palo Alto, California.
- Stockholder Proposal Deadline: October 17, 2025 (per Rule 14a-8).
- Director Nomination/Other Proposal Deadline: October 17, 2025.
BioCardia, Inc. announced that it has regained compliance with Nasdaq's Equity Rule (Listing Rule 5550(b)(1)). As a result, the company's common stock will remain listed on the Nasdaq Capital Market.
🚩 Red Flags
- Previous non-compliance with the Nasdaq Equity Rule suggests historical liquidity or market capitalization issues common in micro-cap stocks.
📋 Key Facts
- Received formal written notice from Nasdaq Staff regarding compliance status.
- Regained compliance with Listing Rule 5550(b)(1) (the 'Equity Rule').
- Common stock continues to be listed on The Nasdaq Capital Market.
BioCardia, Inc. reports that it has regained compliance with Nasdaq's minimum stockholders' equity requirement of $2.5 million following several rounds of capital raising. The company achieved this through multiple private placements and an 'At The Market' offering, bringing total net proceeds from these activities to approximately $7.4 million.
🚩 Red Flags
- History of delisting risk due to insufficient stockholders' equity.
- Significant dilution caused by multiple share/warrant issuances at prices as low as $1.25 (below previous private placement prices).
- Heavy reliance on dilutive financing to maintain exchange listing status.
📋 Key Facts
- Regained compliance with Nasdaq Listing Rule 5550(b)(1) regarding the $2.5 million minimum stockholders' equity requirement.
- Completed a large private placement on September 19, 2025, selling 4,800,000 shares and warrants at $1.25 per share, netting ~$5.1 million.
- Executed two prior private placements in April and June 2025, netting $719,000 and $529,000 respectively.
- Utilized an 'At The Market' (ATM) offering with H.C. Wainwright & Co., LLC to sell 446,215 shares at an average price of $2.55 between April and September 2025, netting ~$1.0 million.
- Nasdaq will continue to monitor compliance in the next periodic report.
BioCardia, Inc. announced a positive preliminary clinical consultation with Japan's PMDA regarding the acceptability of CardiAMP Heart Failure Trial data for future regulatory submission.
📋 Key Facts
- Preliminary clinical consultation held with Japan’s Pharmaceutical and Medical Devices Agency (PMDA).
- Discussion focused on the acceptability of clinical data from the CardiAMP Heart Failure Trial.
- The meeting serves as preparation for a formal clinical consultation regarding an application for approval in Japan.
BioCardia, Inc. completed a public offering of 4.8 million shares of common stock and warrants at $1.25 per share, raising approximately $5.1 million in net proceeds. The offering included significant participation from company directors and executive officers.
🚩 Red Flags
- Significant dilution: Issuance of 4.8M shares plus warrants for up to another 4.8M shares.
- Insider participation: Directors and officers are participating in the offering, which can sometimes indicate a lack of external investor appetite at higher valuations.
- Restrictive covenants: The company is prohibited from issuing new equity or filing registration statements (except ATM) until November 18, 2025.
📋 Key Facts
- Sold 4,800,000 shares of Common Stock and accompanying warrants to purchase up to 4,800,000 shares.
- Combined offering price: $1.25 per share and warrant.
- Net proceeds expected: $5.1 million (after fees/expenses).
- Warrants are immediately exercisable at $1.25 per share and expire on September 20, 2027.
- Directors and executive officers purchased 734,400 shares/warrants for ~$0.9 million in gross proceeds.
- The company is subject to a lock-up agreement preventing further issuances of common stock or convertible securities through November 18, 2025.
BioCardia, Inc. announced the pricing of a public offering consisting of common stock and warrants on September 18, 2025. This filing serves as a formal disclosure of the intent to raise capital through equity securities.
🚩 Red Flags
- Dilution risk for existing shareholders due to the issuance of new common stock and warrants.
- Warrants typically include provisions that can lead to further dilution upon exercise.
📋 Key Facts
- Company issued a press release regarding the pricing of a public offering.
- The offering includes both common stock and warrants.
- Filing date: September 18, 2025.
BioCardia, Inc. issued a press release regarding primary endpoint results from the open-label roll-in cohort of its CardiAMP Cell Therapy in Chronic Myocardial Ischemia Trial. The filing is an Item 7.01 disclosure intended to provide regulatory updates via public announcement.
📋 Key Facts
- Announcement date: September 18, 2025
- Subject: Primary endpoint results of the open-label roll-in cohort for CardiAMP Cell Therapy trial
- Trial focus: Chronic Myocardial Ischemia
- Filing type: Regulation FD Disclosure (Item 7.01)
BioCardia, Inc. has entered into an exclusive development and commercialization agreement with CART-Tech, B.V. for the Heart3D™ Fusion Imaging system. The technology aims to enhance cardiac biotherapeutic delivery by fusing 2D x-ray images with 3D anatomical models.
📋 Key Facts
- Entered into an exclusive development and commercialization agreement with CART-Tech, B.V.
- The agreement focuses on the Heart3D™ Fusion Imaging system.
- Technology integrates 2D x-ray images with pre-procedure 3D anatomical models (MRI/CT) to assist in cardiac biotherapeutic delivery and biopsy.
BioCardia, Inc. filed an 8-K to announce its quarterly financial results for the period ending June 30, 2025. The filing serves as a formal announcement of the earnings release via Exhibit 99.1.
📋 Key Facts
- Report date: August 11, 2025
- Reporting period: Quarter ended June 30, 2025
- The filing includes a press release as Exhibit 99.1 regarding results of operations and financial condition.
BioCardia, Inc. issued an 8-K to provide a regulatory update regarding the anticipated timing of FDA and Japan PMDA approvals for its CardiAMP® Cell Therapy System and Helix Transendocardial Delivery Catheter.
📋 Key Facts
- Company provided updates on regulatory activities for two key products: CardiAMP® Cell Therapy System and Helix Transendocardial Delivery Catheter.
- The update concerns anticipated timing for FDA (US) and PMDA (Japan) approvals.
- Filing date is August 4, 2025.
BioCardia, Inc. announced that it has submitted its CardiAMP autologous cell therapy for clinical consultation with Japan's Pharmaceuticals and Medical Devices Agency (PMDA). This represents a regulatory milestone aimed at expanding the company's market reach into Japan.
📋 Key Facts
- Submitted CardiAMP autologous cell therapy for clinical consultation with Japan's PMDA on July 24, 2025.
- The submission is part of a strategy to seek regulatory approval in the Japanese market.
- CardiAMP is an investigational heart failure treatment.
BioCardia, Inc. announced that Henry Ford Health in Detroit, Michigan has begun enrolling patients for the company's pivotal Phase 3 CardiAMP HF II clinical trial.
📋 Key Facts
- Henry Ford Health is now enrolling patients with ischemic heart failure.
- The enrollment is part of the ongoing pivotal Phase 3 CardiAMP HF II trial.
- Announcement date: July 16, 2025.
BioCardia, Inc. completed a private placement of common stock and warrants on June 30, 2025, raising approximately $570,000 in gross proceeds. The offering included participation from several board members and executive officers.
🚩 Red Flags
- Related-party transactions: Board members (Blank, Stertzer) and executives (Altman, McClung) participated in the private placement.
- Small capital raise: The $570k gross proceeds suggest limited liquidity/runway for a micro-cap company.
📋 Key Facts
- Total gross proceeds expected: ~$570,000.
- Securities sold: 274,696 shares of common stock and 274,696 warrants.
- Combined unit price: $2.075 per unit (at-the-market offering).
- Warrant exercise price: $1.95 per share.
- Warrants expire June 30, 2030, or upon PMDA approval of CardiAMP Cell Therapy System application.
- Company to file a registration statement for resale by July 10, 2025.
BioCardia, Inc. announced that the United States Patent Office has granted US Patent No. 12,311,127 for a 'Radial and Trans-endocardial Delivery Catheter.' This represents an expansion of the company's intellectual property portfolio.
📋 Key Facts
- US Patent No. 12,311,127 granted on June 25, 2025.
- Patent title: 'Radial and Trans-endocardial Delivery Catheter'.
- The announcement was made via a press release issued on June 25, 2025.
BioCardia, Inc. has filed an 8-K to furnish its quarterly financial results for the period ended March 31, 2025 via a press release.
📋 Key Facts
- The filing is related to Item 2.02: Results of Operations and Financial Condition.
- Financial results were announced on May 14, 2025 for the quarter ended March 31, 2025.
- A press release was issued as Exhibit 99.1.
BioCardia, Inc. announced that the University of Wisconsin has begun enrolling patients for its pivotal Phase 3 CardiAMP HF II clinical trial targeting ischemic heart failure.
📋 Key Facts
- The company is conducting a pivotal Phase 3 clinical trial named 'CardiAMP HF II'.
- Patient enrollment has commenced at the University of Wisconsin in Madison, Wisconsin.
- The trial focuses on patients with ischemic heart failure.
BioCardia, Inc. announced the enrollment of the first patient in its Phase III CardiAMP HF II clinical trial for heart failure treatment. This represents a significant milestone in the development of the company's lead autologous cell therapy program.
📋 Key Facts
- First patient enrolled in Phase III randomized procedure placebo-controlled double-blind CardiAMP HF II clinical trial.
- Trial location: BayCare Morton Plant Hospital in Clearwater, Florida.
- Focus: Lead autologous cell therapy program for heart failure treatment.
BioCardia, Inc. entered into a Securities Purchase and Registration Rights Agreement for a private placement of common stock and warrants to raise approximately $775,000 in gross proceeds. The offering includes participation from several board members and executive officers.
🚩 Red Flags
- Related-party transactions: Multiple board members and executive officers (CEO/CFO) are participating in the private placement.
- Small capital raise: The $775k gross proceeds represent a relatively small amount of liquidity, suggesting potential ongoing need for capital.
📋 Key Facts
- Private placement of 406,818 shares of common stock and 406,818 warrants at a combined unit price of $1.905 per share.
- Warrants are exercisable until April 23, 2030, or upon approval by the Japanese PMDA regarding CardiAMP Cell Therapy System.
- Gross proceeds expected to be approximately $775,000 before transaction expenses.
- The company intends to file a registration statement for resale of these securities on or before May 3, 2025.
- Expected closing date is April 23, 2025.
BioCardia, Inc. announced that an independent Data Safety Monitoring Board (DSMB) reviewed safety data from its CardiALLO Phase 1/2 clinical trial and recommended the study continue as designed. The review focused on the 30-day safety of the 20 million cell dosing cohort.
📋 Key Facts
- DSMB conducted a planned review of 30-day safety data for the CardiALLO Allogeneic Cell Therapy Phase 1/2 trial.
- The review specifically covered the roll-in 20 million cell dosing cohort.
- No treatment-emergent major adverse cardiac events (MACE) were observed.
- No clinical evidence of immune reactions to the implanted allogeneic cells was detected.
- DSMB recommendation: Continue the study as designed.
BioCardia, Inc. announced that Emory University School of Medicine has begun enrolling patients for the company's pivotal Phase III CardiAMP HF II clinical trial. This represents a progress update in the development of their therapeutic pipeline for ischemic heart failure.
📋 Key Facts
- Emory University School of Medicine (Atlanta, GA) is now actively enrolling patients.
- The enrollment is part of the ongoing pivotal Phase III CardiAMP HF II clinical trial.
- The trial targets patients with ischemic heart failure.
BioCardia, Inc. received a notice from Nasdaq stating it is in non-compliance with the minimum stockholders' equity requirement of $2.5 million after reporting only $837,000 as of December 31, 2024. The company must submit a compliance plan by May 16, 2025.
🚩 Red Flags
- Delisting notice for failure to meet minimum stockholders' equity requirements
- Significant deficit in required capital ($837k actual vs $2.5M required)
- Risk of delisting if a compliance plan is not accepted or executed successfully
📋 Key Facts
- Nasdaq notified the company on April 1, 2025, regarding non-compliance with Nasdaq Listing Rule 5550(b)(1).
- Stockholders' equity was $837,000 as of December 31, 2024, falling short of the $2.5 million requirement.
- The company has until May 16, 2025, to provide a plan to Nasdaq to regain compliance.
- If a plan is accepted, Nasdaq may grant an extension of up to 180 days from April 1, 2025, to evidence compliance.
BioCardia, Inc. issued a press release to clarify the timing of a conference call regarding two-year CardiAMP-HF clinical results scheduled for March 31, 2025.
📋 Key Facts
- Conference call scheduled for March 31, 2025, at 4:30pm EDT.
- The call will address the two-year CardiAMP-HF clinical results.
- Information is provided via Regulation FD disclosure (Item 7.01).
BioCardia, Inc. announced two-year outcomes from its Phase 3 CardiAMP-HF clinical trial for treating ischemic heart failure. The results demonstrated significant reductions in 'heart death equivalents' and major adverse cardiac events (MACCE) across patient subgroups.
📋 Key Facts
- Phase 3 CardiAMP-HF study involved 115 patients across 18 centers in the US and Canada.
- In patients with elevated NTproBNP biomarkers, there was a 47% relative risk reduction in heart death equivalents (all-cause death, transplantation, or LVAD implantation).
- In all treated patients, there was a 20.9% relative risk reduction in heart death equivalents and a 44.6% relative risk reduction in non-fatal MACCE.
- Clinical improvements noted include improved quality-of-life scores (MLHFQ) and increased Six Minute Walk Distance.
- Results were presented at the American College of Cardiology’s Annual Scientific Session.
BioCardia, Inc. filed an 8-K to furnish its press release announcing financial results for the fiscal year ended December 31, 2024.
📋 Key Facts
- Report date: March 26, 2025
- Subject matter: Announcement of annual financial results for the year ended December 31, 2024
- The filing is furnished under Item 2.02 and is not considered 'filed' for purposes of Section 18 liability.
BioCardia, Inc. announced that the Japan Patent Office has granted Japanese Patent No. 7641330 for a 'Radial and Transendocardial Delivery Catheter'. The patent term is set to expire on or after September 30, 2034.
📋 Key Facts
- Patent granted by the Japan Patent Office: Japanese Patent No. 7641330
- Title of invention: 'Radial and Transendocardial Delivery Catheter'
- Patent expiration date: On or after September 30, 2034
- Filing date: March 10, 2025
BioCardia announced the completion of source data verification and the freezing of primary outcomes data for its Phase 3 CardiAMP HF study. This clinical trial evaluates an autologous cell therapy for treating ischemic heart failure with reduced ejection fraction (HFrEF).
📋 Key Facts
- Completed source data verification for the Phase 3 CardiAMP HF study.
- Primary outcomes data has been frozen as of February 27, 2025.
- The study is a double-blind, randomized, placebo-controlled trial.
- Target indication: Ischemic heart failure with reduced ejection fraction (HFrEF).
BioCardia, Inc. announced the successful completion of enrollment and dosing for the low-dose cohort in its Phase I/II CardiALLO™ trial. The study focuses on treating patients with ischemic heart failure using allogeneic mesenchymal stem cells.
📋 Key Facts
- Completed enrollment and dosing in the low dose cohort of the CardiALLO™ Phase I/II trial as of February 13, 2025.
- The trial targets patients with ischemic heart failure of reduced ejection fraction (HFrEF).
- The therapy utilizes allogeneic mesenchymal stem cells (MSC) to treat elevated markers of heart stress and systemic inflammation.
BioCardia announced that its CardiAMP HF Phase 3 study results have been selected for a late-breaking symposium presentation at the American College of Cardiology 2025 Scientific Sessions in March 2025.
📋 Key Facts
- Study Type: Double-blind, randomized, placebo-controlled CardiAMP HF Phase 3 study.
- Event: Late-breaking symposium at the American College of Cardiology (ACC) 2025 Scientific Sessions.
- Event Date: March 29-31, 2025.
- Location: Chicago, IL.
BioCardia, Inc. announced the commercial availability of its Morph DNA steerable introducer product family on December 17, 2024. This product line is currently being utilized in the company's ongoing clinical trials.
📋 Key Facts
- Announced commercial availability of Morph DNA steerable introducer product family on Dec 17, 2024.
- The products are already integrated into the Company's active clinical trials.
- Filing includes a press release as Exhibit 99.1.
BioCardia, Inc. announced the successful completion of a consultation with Japan's Pharmaceutical and Medical Device Agency (PMDA) regarding the regulatory submission pathway for its lead therapeutic asset, BCDA-01.
📋 Key Facts
- Consultation completed with Japan’s PMDA on December 4, 2024.
- Focus of consultation: Next steps for registration submission of BCDA-01.
- Target indication: Ischemic heart failure of reduced ejection fraction in the Japanese market.
BioCardia, Inc. filed an 8-K to furnish its quarterly press release for the period ended September 30, 2024. This is a routine earnings announcement filing.
📋 Key Facts
- Report date: November 13, 2024
- Reporting period: Quarter ended September 30, 2024
- The filing includes Exhibit 99.1 containing the quarterly press release.
BioCardia, Inc. announced the completion of the final protocol-specified follow-up visit for its CardiAMP HF pivotal clinical trial. This marks a significant milestone in the company's clinical development program.
📋 Key Facts
- Completion of the last protocol-specified follow-up visit occurred on October 28, 2024.
- The study is the CardiAMP HF prospective, randomized, double-blinded, placebo procedure controlled, multi-center pivotal clinical trial.
- The filing serves as a formal announcement via press release (Exhibit 99.1).
BioCardia, Inc. has received formal notice from Nasdaq that it has demonstrated compliance with the Equity Rule (Listing Rule 5550(b)(1)) following a previous Hearings Panel decision. Consequently, the Nasdaq Panel has decided to continue the listing of the Company's securities and is closing the matter.
🚩 Red Flags
- Historical delisting risk (implied by the need for a Hearings Panel decision on May 13, 2024).
📋 Key Facts
- Received formal written notice from Nasdaq General Counsel on September 18, 2024.
- Company demonstrated compliance with Listing Rule 5550(b)(1) (the 'Equity Rule').
- The Nasdaq Hearings Panel decision dated May 13, 2024 has been resolved in the company's favor.
- Nasdaq will continue to monitor ongoing compliance with all listing requirements.
BioCardia, Inc. announced the closing of a $7.2 million public offering on September 3, 2024. The filing serves to formally disclose the completion of this capital raise via an attached press release.
🚩 Red Flags
- Public offerings in micro-cap companies often result in significant shareholder dilution.
📋 Key Facts
- The company closed a public offering totaling $7.2 million.
- Closing date of the offering was September 3, 2024.
- The announcement was made via a press release issued on September 9, 2024.
BioCardia, Inc. entered into securities purchase agreements for a registered public offering of common stock and warrants to raise approximately $6.3 million in net proceeds. The offering includes both common warrants and pre-funded warrants, with an expected closing date of September 3, 2024.
🚩 Red Flags
- Significant dilution potential due to the issuance of over 2.3 million total securities (including warrants) via common stock and pre-funded warrants.
- Use of pre-funded warrants is often a mechanism used by micro-cap companies to avoid immediate large-scale ownership reporting thresholds, which can lead to future 'overhang' as they are exercised.
📋 Key Facts
- Total expected net proceeds: $6.3 million (after fees/expenses).
- Offering consists of 1,377,990 shares of common stock and accompanying warrants at $3.00 per share.
- Pre-funded warrants offered at $2.999 per warrant to purchase up to 1,022,010 shares.
- Common Warrants are exercisable at $3.00 per share and expire on September 3, 2029.
- Pre-Funded Warrants are exercisable at $0.001 per share and have no expiration date until fully exercised.
- Placement Agent: A.G.P./Alliance Global Partners; cash commission of ~$0.3 million plus $60,000 in expenses.
- Insider participation: Directors and executive officers purchased an aggregate of 211,000 shares and accompanying warrants.
BioCardia, Inc. announced the pricing of an upsized public offering consisting of common stock and warrants on August 30, 2024. The offering includes participation from management, directors, and institutional investors.
🚩 Red Flags
- Upsized offering suggests a need for immediate liquidity or higher-than-anticipated capital requirements
- Issuance of warrants often leads to future dilution for existing shareholders
📋 Key Facts
- Announcement date: August 30, 2024
- Offering type: Upsized public offering of common stock and warrants
- Participants include management, directors, institutional investors, and certain existing investors
- The company is listed on the Nasdaq Capital Market (Ticker: BCDA)
BioCardia, Inc. announced that the FDA has cleared its Morph DNA Steerable Introducer product family under general controls of the Federal Food, Drug and Cosmetic Act.
📋 Key Facts
- FDA clearance received for the 'Morph DNA Steerable Introducer' product family.
- Clearance is subject to the general controls provisions of the Federal Food, Drug and Cosmetic Act.
- The announcement was made via an 8-K filing on August 28, 2024.
BioCardia announced that the FDA has approved a protocol amendment for its CardiAMP Heart Failure II Phase 3 clinical trial. The amendment allows previously excluded patients to receive additional cell deliveries to reach target minimum dosages based on preprocedural analysis.
📋 Key Facts
- FDA approval of a protocol amendment for the CardiAMP Heart Failure II Trial (Phase 3).
- The amendment enables patients to receive additional cell deliveries to achieve target minimum dosage.
- Dosage adjustments are informed by preprocedural CardiAMP Cell Population Analysis.
- Target indication: ischemic heart failure with reduced ejection fraction.
BioCardia, Inc. filed an 8-K to furnish its quarterly financial results for the period ended June 30, 2024. The filing consists primarily of a press release announcing the company's recent operational and financial performance.
📋 Key Facts
- Report date: August 13, 2024
- Reporting period: Quarter ended June 30, 2024
- The filing is an Item 2.02 disclosure regarding Results of Operations and Financial Condition.
- Financial results were released via a press release (Exhibit 99.1).
BioCardia, Inc. announced the submission of a 510(k) regulatory application for its patented Morph® DNA™ Steerable Introducer Sheath. This product is designed to facilitate the delivery of medical instruments into peripheral and coronary vasculature.
📋 Key Facts
- Company submitted a 510(k) application for the Morph® DNA™ Steerable Introducer Sheath on July 30, 2024.
- The product is intended to provide a pathway for medical instruments like balloon dilatation catheters and guidewires into the heart's vasculature.
- The filing includes an associated press release as Exhibit 99.1.
BioCardia, Inc. announced the commencement of patient enrollment in its pivotal Phase III clinical trial for CardiAMP Cell Therapy, targeting chronic ischemic heart failure. This filing is a regulatory disclosure regarding clinical development progress.
📋 Key Facts
- Commencement of patient enrollment in the pivotal Phase III trial of CardiAMP Cell Therapy.
- The therapy is intended for the treatment of chronic ischemic heart failure with reduced ejection fraction.
- Announcement made via press release on July 25, 2024.
BioCardia, Inc. announced the issuance of U.S. Patent No. 12,036,371 regarding a method for accessing the left atrium using a multi-directional steerable catheter. The patent is based on the company's Morph DNA technology and has an expiration date in 2035.
📋 Key Facts
- Issuance of U.S. Patent No: 12,036,371
- Patent Title: 'Method of Accessing the Left Atrium with a Multi-Directional Steerable Catheter'
- Technology basis: Morph DNA technology
- Patent term expiration: 2035
BioCardia announced successful Phase II trial results for ProtheraCytes in treating acute myocardial infarction in collaboration with CellProthera. The companies intend to advance their partnership into Phase III clinical trials.
📋 Key Facts
- Collaborative Phase II trial of ProtheraCytes was successful.
- The therapy targets the treatment of acute myocardial infarction.
- Partnership with CellProthera (private company) will continue into Phase III trials.
- Announcement made via press release on July 1, 2024.
BioCardia, Inc. reported the completion of equity sales under its At The Market (ATM) offering between April 1, 2024, and June 10, 2024. The company raised approximately $1.85 million through the sale of 335,112 shares.
🚩 Red Flags
- Continuous use of ATM offerings suggests ongoing need for liquidity to fund operations.
- Limited remaining capacity ($264k) in the current offering indicates the company may soon require a new financing round or larger offering.
📋 Key Facts
- Sold 335,112 shares of common stock between April 1, 2024, and June 10, 2024.
- Total gross proceeds from these sales amounted to approximately $1.85 million.
- Sales were conducted at then-market prices under a previously disclosed At The Market (ATM) Offering Agreement.
- Remaining capacity under the current prospectus supplement is $264,000.
BioCardia, Inc. announced the issuance of U.S. Patent No. 11,986,611 for a 'Radial and Transendocardial Delivery Catheter.' The patent protects medical methods for delivering substances to the heart via a radial artery.
📋 Key Facts
- Issued U.S. Patent No: 11,986,611 titled 'Radial and Transendocardial Delivery Catheter'.
- Patent term is set to expire in 2036.
- The technology relates to intracardiac delivery of cellular aggregates and other agglomerated materials via a radial artery.
BioCardia, Inc. has implemented a 1-for-15 reverse stock split to consolidate its outstanding shares. The split became effective on May 30, 2024, reducing the total number of outstanding shares from approximately 27.4 million to 1.8 million.
🚩 Red Flags
- Reverse stock split (often used to combat delisting or signal financial distress)
- Significant reduction in share count (1-for-15)
📋 Key Facts
- Implemented a 1-for-15 reverse stock split effective May 30, 2024, at 12:01 a.m. ET.
- Reduced authorized shares of Common Stock from 100.0 million to 50.0 million.
- Outstanding shares reduced from 27,382,599 to approximately 1,825,506 shares.
- No fractional shares were issued; any resulting fractions will be paid in cash.
- Proportional adjustments applied to equity awards and warrants.
BioCardia, Inc. held its Annual Meeting on May 20, 2024, where stockholders approved a proposal to implement a reverse stock split of common stock at a ratio between 1-for-2 and 1-for-20.
🚩 Red Flags
- Approval of a reverse stock split (often used to mitigate delisting risks or improve share price).
- Significant reduction in authorized shares accompanying the proposed split.
📋 Key Facts
- Annual Meeting held on May 20, 2024; quorum established with 57.79% of voting power present.
- Stockholders approved a reverse stock split ratio between 1-for-2 and 1-for-20 at the Board's discretion.
- Approval included a reduction in authorized shares from 100,000,000 to 50,000,000 shares if the split is effected.
- PKF San Diego, LLP was ratified as the independent registered public accounting firm for FY2024.
- Election of Jim Allen and Andrew Blank as Class II directors through 2027.
BioCardia, Inc. filed an 8-K to furnish its quarterly press release regarding financial results for the period ended March 31, 2024.
📋 Key Facts
- The filing is a standard announcement of quarterly financial results (Item 2.02).
- Reporting period: Quarter ended March 31, 2024.
- Filing date: May 14, 2024.
BioCardia, Inc. issued an 8-K to announce the release of primary endpoint results from its CardiAMP® Cell Therapy trial (open label roll-in cohort). The data was presented via webcast on April 30, 2024.
📋 Key Facts
- Announced primary endpoint results for the open label roll-in cohort of the CardiAMP® Cell Therapy in Chronic Myocardial Ischemia Trial.
- Data presentation occurred via webcast on April 30, 2024.
- Results presented by Dr. Carl Pepine (University of Florida) and Dr. Amish Raval (University of Wisconsin).
- The disclosure is made under Item 7.01 (Regulation FD Disclosure).
BioCardia, Inc. filed an 8-K to furnish its press release announcing financial results for the fiscal year ended December 31, 2023.
📋 Key Facts
- Report date: March 27, 2024
- Reporting period: Fiscal year ended December 31, 2023
- The filing is a standard announcement of annual financial results via press release (Exhibit 99.1).
BioCardia, Inc. entered into a long-term partnership with StemCardia, Inc. to serve as the exclusive biotherapeutic delivery partner for StemCardia's pluripotent stem cell product candidate aimed at treating heart failure.
📋 Key Facts
- Partnership is described as 'long-term'.
- BioCardia will be the exclusive biotherapeutic delivery partner for StemCardia’s cell therapy candidate.
- The collaboration aims to advance a pluripotent stem cell product through FDA IND application and anticipated Phase I/II clinical development.
BioCardia, Inc. has failed to regain compliance with Nasdaq's Market Value of Listed Securities (MVLS) and Minimum Bid-Price requirements. The company has requested a hearing before a Nasdaq Hearings Panel to stay the delisting process.
🚩 Red Flags
- Delisting notice: Failure to meet both MVLS and Minimum Bid-Price requirements.
- Potential for trading suspension on March 15, 2024 (if not stayed by hearing request).
- Risk of Form 25-NSE filing to remove securities from Nasdaq listing.
- Delisting could impair ability to raise capital and trigger defaults in existing agreements.
📋 Key Facts
- Failed to meet MVLS Requirement ($35M minimum market value) by March 4, 2024 deadline.
- Failed to meet Minimum Bid-Price Requirement by March 11, 2024 deadline.
- Received determination letters from Nasdaq Staff on March 6 and March 12, 2024, confirming non-compliance.
- The company submitted a request for a hearing with the Nasdaq Hearings Panel on March 12, 2024.
- A hearing request stays any delisting or suspension of securities pending the Panel's decision.
BioCardia announced that the Centers for Medicare and Medicaid Services (CMS) has approved reimbursement coverage for its confirmatory Phase III clinical trial of CardiAMP autologous cell therapy. This is a significant regulatory milestone for the company's primary therapeutic candidate.
📋 Key Facts
- CMS approved reimbursement coverage for the CardiAMP Heart Failure II Trial.
- The trial targets patients with ischemic heart failure.
- Reimbursement approval applies to the confirmatory Phase III clinical trial of the CardiAMP therapy.
BioCardia announced positive interim Phase III clinical trial results for its CardiAMP autologous cell therapy. The data showed reductions in heart death equivalents and MACCE in patients with advanced chronic heart failure.
📋 Key Facts
- Interim results from a Phase III randomized controlled trial of CardiAMP autologous cell therapy were released on March 4, 2024.
- The study involved 110 randomized patients with advanced chronic heart failure.
- Data showed reductions in heart death equivalents and Major Adverse Cardiovascular Events (MACCE).
- A magnified reduction was observed specifically among patients with elevated NTproBNP levels.
- Results were presented at the Technology and Heart Failure Therapeutics 2024 annual meeting.
BioCardia, Inc. entered into a Securities Purchase and Registration Rights Agreement for a private placement of common stock and warrants to institutional investors and the company's CEO. The offering is expected to raise approximately $875,000 in gross proceeds.
🚩 Red Flags
- Significant dilution potential due to the issuance of over 1 million warrants and 2 million shares.
- Low share price ($0.43) indicates a micro-cap company in a precarious liquidity position.
- Small capital raise ($875k) relative to typical operational needs, suggesting ongoing need for frequent financing.
- Related-party transaction: The CEO is a direct participant in the private placement.
📋 Key Facts
- Private placement of 2,012,978 shares of common stock at $0.4331 per share (CEO paid a higher price of $0.4625).
- Issuance of 1,006,488 warrants to purchase common stock at an exercise price of $0.4423 per share.
- Total expected gross proceeds: approximately $875,000.
- The CEO, Peter Altman, is participating in the offering by purchasing 108,108 shares and 54,054 warrants.
- Expected closing date: February 13, 2024.
- Company committed to filing a registration statement on or before February 23, 2024.
BioCardia announced the activation of its CardiAMP HF II pivotal trial, a randomized controlled study for patients with ischemic heart failure. The FDA approved this study in Q4 2023.
📋 Key Facts
- Activation of CardiAMP HF II clinical trial.
- Trial is a randomized controlled pivotal trial of autologous cell therapy.
- Target indication: Ischemic etiology heart failure with reduced ejection fraction.
- FDA approval for the study was granted in Q4 2023.
BioCardia announced that two scientific abstracts regarding its CardiAMP and CardiALLO clinical programs have been accepted for presentation at the Technology and Heart Failure Therapeutics Conference in March 2024.
📋 Key Facts
- Two scientific abstracts accepted for presentation.
- Programs involved: CardiAMP and CardiALLO (clinical stage therapeutic programs).
- Conference: Technology and Heart Failure Therapeutics Conference.
- Event Date: March 4-6, 2024, in Boston, MA.
- Presentation Session: Late-Breaking Clinical Science/First-In-Human & Early Feasibility Studies on March 4, 2024.
BioCardia, Inc. filed an 8-K to provide a press release containing a letter to shareholders regarding business development updates for its biotherapeutic delivery and Morph Access Innovations businesses.
📋 Key Facts
- The filing is pursuant to Item 7.01 (Regulation FD Disclosure).
- The company issued a press release on January 3, 2024, containing a shareholder letter.
- The update focuses on business development for biotherapeutic delivery and Morph Access Innovations.