BioCardia Receives Consultation Record from Japan's PDMA for CardiAMP Approval
Written by Emily J. Thompson, Senior Investment Analyst
Updated: 2 days ago
0mins
Source: NASDAQ.COM
- Regulatory Support: BioCardia Inc. has received a Consultation Record from Japan's Pharmaceutical and Medical Devices Agency (PDMA) to support the regulatory approval of CardiAMP cell therapy for ischemic heart failure, marking a significant step in the company's international expansion.
- Therapy Background: CardiAMP is a cell therapy that delivers a patient's own bone marrow cells to the heart via a catheter to increase capillary density and reduce tissue fibrosis, having previously received breakthrough designation from the U.S. FDA, indicating its potential in treating heart diseases.
- Market Access Requirements: The PDMA has requested BioCardia to provide post-marketing supply plans, patient selection criteria, clinical decision-making frameworks, and appropriate medical infrastructure and specialist involvement, which will impact the market access process for CardiAMP.
- Clinical Trial Support: BioCardia will support its submission to the PDMA with positive outcomes from three clinical trials demonstrating CardiAMP's effectiveness in reducing elevated biomarkers linked to heart stress and the incidence of heart failure, with the review process expected to take approximately seven months.
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Analyst Views on BCDA
Wall Street analysts forecast BCDA stock price to rise
2 Analyst Rating
2 Buy
0 Hold
0 Sell
Moderate Buy
Current: 0.917
Low
6.00
Averages
15.50
High
25.00
Current: 0.917
Low
6.00
Averages
15.50
High
25.00
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About BCDA
BioCardia, Inc. is a clinical-stage company developing cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases. It is advancing two cell therapy platforms derived from bone marrow, such as CardiAMP autologous mononuclear cell therapy platform is being advanced for two clinical indications: ischemic heart failure with reduced ejection fraction (HFrEF) and refractory angina resulting from chronic myocardial ischemia. Its immunomodulatory allogeneic mesenchymal stem cell (MSC) therapy platform is being advanced as a cell therapy for two clinical indications: the treatment of ischemic HFrEF (CardiALLO), which is actively enrolling, and acute respiratory distress syndrome. Its CardiAMP autologous and CardiALLO allogeneic cell therapies are the Company’s biotherapeutic platforms with three clinical stage product candidates in development. These therapies are enabled by its Helix biotherapeutic delivery and Morph vascular navigation product platforms.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
BioCardia Receives Consultation Record from Japan's PDMA for CardiAMP Approval
- Regulatory Support: BioCardia Inc. has received a Consultation Record from Japan's Pharmaceutical and Medical Devices Agency (PDMA) to support the regulatory approval of CardiAMP cell therapy for ischemic heart failure, marking a significant step in the company's international expansion.
- Therapy Background: CardiAMP is a cell therapy that delivers a patient's own bone marrow cells to the heart via a catheter to increase capillary density and reduce tissue fibrosis, having previously received breakthrough designation from the U.S. FDA, indicating its potential in treating heart diseases.
- Market Access Requirements: The PDMA has requested BioCardia to provide post-marketing supply plans, patient selection criteria, clinical decision-making frameworks, and appropriate medical infrastructure and specialist involvement, which will impact the market access process for CardiAMP.
- Clinical Trial Support: BioCardia will support its submission to the PDMA with positive outcomes from three clinical trials demonstrating CardiAMP's effectiveness in reducing elevated biomarkers linked to heart stress and the incidence of heart failure, with the review process expected to take approximately seven months.
See More
BioCardia Secures FDA Breakthrough Designation and Medicare Reimbursement
- FDA Breakthrough Designation: BioCardia has received FDA breakthrough designation for its cardiac cell therapy, which is expected to enhance market acceptance and patient willingness to undergo treatment, especially with Medicare reimbursement set at $20,000 per procedure.
- Positive Clinical Trial Signals: The CARDIAMP heart failure trial has shown statistically significant improvements in heart function and quality of life for treated patients, indicating the therapy's potential impact in the cardiac treatment landscape.
- Japanese Market Opportunity: Japan's Pharmaceutical and Medical Devices Agency is inclined to accept BioCardia's data for regulatory submission, with an initial market opportunity targeting approximately 20,000 patients, providing a strategic direction for future growth despite limited immediate revenue potential.
- Effective Financial Management: BioCardia's financial management has led to a decrease in total expenses by $460,000 to $2.3 million in Q1, although cash and cash equivalents stand at only $951,000, reflecting the company's ongoing challenges in balancing cost control with operational needs.
See More
BioCardia Q1 2026 Earnings Call Highlights
- FDA Breakthrough Progress: BioCardia's CardiAMP cell therapy has received FDA breakthrough designation, with Medicare reimbursement currently set at $20,000 per treatment, which is expected to significantly enhance market acceptance and drive revenue growth.
- Japanese Regulatory Advancement: Following a formal consultation with Japan's PMDA, BioCardia received feedback indicating a willingness to accept existing data, with plans to submit the Shonin application in approximately seven months, further expanding its international market presence.
- Improved Financial Position: The company reported a net loss of $2.3 million for Q1 2026, with cash used in operations at $1.7 million, decreasing from $2.5 million in the previous quarter, indicating initial success in cost control measures.
- Market Opportunity Assessment: With around 300,000 patients suffering from ischemic heart failure in Japan, BioCardia anticipates an initial addressable patient population of about 20,000, suggesting a potential market size of $400 million based on the $20,000 reimbursement in the U.S., highlighting strong commercial prospects.
See More
BioCardia Q1 Earnings Miss Expectations
- Earnings Performance: BioCardia reported a Q1 GAAP EPS of -$0.21, missing expectations by $0.04, indicating challenges in profitability that could undermine investor confidence.
- Increased Cash Usage: The net cash used in operations for the three months ended March 2026 was approximately $1.7 million, up from about $1.6 million in the same period in 2025, primarily due to the timing of supplier payments, reflecting pressure on cash flow management.
- Liquidity Position: The company ended the quarter with cash and cash equivalents totaling $951K, indicating insufficient liquidity that may limit future investment and operational flexibility.
- Regulatory Progress Outlook: BioCardia is preparing for the FDA submission of CardiAMP, and despite the current financial underperformance, successful regulatory approval could present significant market opportunities and growth momentum for the company.
See More
BioCardia to Report Q1 2026 Financial Results on May 15
- Earnings Call Announcement: BioCardia will hold a conference call on May 15, 2026, at 4:30 PM EDT to report its Q1 2026 financial results, highlighting advancements in cellular therapeutics for cardiovascular and pulmonary diseases.
- Participation Details: Registered participants can obtain their dial-in numbers via the provided link, while unregistered individuals can listen by calling 1-833-316-0559 for U.S. or 1-412-317-5730 for international calls, advised to join 10 minutes early.
- Webcast and Replay Availability: The call will be available via live webcast, accessible through a designated link, with a replay available approximately one hour post-call until August 15, 2026, allowing investors to catch up on missed information.
- Company Overview: BioCardia specializes in cellular and cell-derived therapeutics for treating cardiovascular and pulmonary diseases, with its CardiAMP and CardiALLO platforms providing innovative solutions for heart disease treatment, showcasing the company's expertise in biotherapeutics.
See More
BioCardia Aligns with FDA on Helix Catheter System for Heart Treatment
- FDA Alignment: BioCardia announced alignment with the FDA following a pre-submission meeting regarding the Helix transendocardial delivery catheter system, with no safety concerns raised, indicating a favorable outlook for market clearance.
- Targeted Delivery Capability: The Helix system is designed for minimally invasive, targeted delivery of therapeutic and diagnostic agents to the heart, allowing for precise injections, superior retention, and effective delivery to hard-to-reach areas, enhancing treatment efficacy.
- Cell Therapy Approval: Concurrently, the CardiAMP investigational cell therapy received FDA approval for heart failure treatment, utilizing the patient's bone marrow cells to repair heart tissue by increasing capillary density and reducing fibrosis, showcasing promising clinical potential.
- Follow-On Pathway Suggestion: The FDA suggested a follow-on pre-submission to facilitate Helix's approval via the DeNovo pathway, further accelerating the commercialization of this technology and enhancing BioCardia's competitive position in regenerative medicine.
See More
BioCardia Receives Consultation Record from Japan's PDMA for CardiAMP Approval
- Regulatory Support: BioCardia Inc. has received a Consultation Record from Japan's Pharmaceutical and Medical Devices Agency (PDMA) to support the regulatory approval of CardiAMP cell therapy for ischemic heart failure, marking a significant step in the company's international expansion.
- Therapy Background: CardiAMP is a cell therapy that delivers a patient's own bone marrow cells to the heart via a catheter to increase capillary density and reduce tissue fibrosis, having previously received breakthrough designation from the U.S. FDA, indicating its potential in treating heart diseases.
- Market Access Requirements: The PDMA has requested BioCardia to provide post-marketing supply plans, patient selection criteria, clinical decision-making frameworks, and appropriate medical infrastructure and specialist involvement, which will impact the market access process for CardiAMP.
- Clinical Trial Support: BioCardia will support its submission to the PDMA with positive outcomes from three clinical trials demonstrating CardiAMP's effectiveness in reducing elevated biomarkers linked to heart stress and the incidence of heart failure, with the review process expected to take approximately seven months.
See More
BioCardia Secures FDA Breakthrough Designation and Medicare Reimbursement
- FDA Breakthrough Designation: BioCardia has received FDA breakthrough designation for its cardiac cell therapy, which is expected to enhance market acceptance and patient willingness to undergo treatment, especially with Medicare reimbursement set at $20,000 per procedure.
- Positive Clinical Trial Signals: The CARDIAMP heart failure trial has shown statistically significant improvements in heart function and quality of life for treated patients, indicating the therapy's potential impact in the cardiac treatment landscape.
- Japanese Market Opportunity: Japan's Pharmaceutical and Medical Devices Agency is inclined to accept BioCardia's data for regulatory submission, with an initial market opportunity targeting approximately 20,000 patients, providing a strategic direction for future growth despite limited immediate revenue potential.
- Effective Financial Management: BioCardia's financial management has led to a decrease in total expenses by $460,000 to $2.3 million in Q1, although cash and cash equivalents stand at only $951,000, reflecting the company's ongoing challenges in balancing cost control with operational needs.
See More
BioCardia Q1 2026 Earnings Call Highlights
- FDA Breakthrough Progress: BioCardia's CardiAMP cell therapy has received FDA breakthrough designation, with Medicare reimbursement currently set at $20,000 per treatment, which is expected to significantly enhance market acceptance and drive revenue growth.
- Japanese Regulatory Advancement: Following a formal consultation with Japan's PMDA, BioCardia received feedback indicating a willingness to accept existing data, with plans to submit the Shonin application in approximately seven months, further expanding its international market presence.
- Improved Financial Position: The company reported a net loss of $2.3 million for Q1 2026, with cash used in operations at $1.7 million, decreasing from $2.5 million in the previous quarter, indicating initial success in cost control measures.
- Market Opportunity Assessment: With around 300,000 patients suffering from ischemic heart failure in Japan, BioCardia anticipates an initial addressable patient population of about 20,000, suggesting a potential market size of $400 million based on the $20,000 reimbursement in the U.S., highlighting strong commercial prospects.
See More
BioCardia Q1 Earnings Miss Expectations
- Earnings Performance: BioCardia reported a Q1 GAAP EPS of -$0.21, missing expectations by $0.04, indicating challenges in profitability that could undermine investor confidence.
- Increased Cash Usage: The net cash used in operations for the three months ended March 2026 was approximately $1.7 million, up from about $1.6 million in the same period in 2025, primarily due to the timing of supplier payments, reflecting pressure on cash flow management.
- Liquidity Position: The company ended the quarter with cash and cash equivalents totaling $951K, indicating insufficient liquidity that may limit future investment and operational flexibility.
- Regulatory Progress Outlook: BioCardia is preparing for the FDA submission of CardiAMP, and despite the current financial underperformance, successful regulatory approval could present significant market opportunities and growth momentum for the company.
See More
BioCardia to Report Q1 2026 Financial Results on May 15
- Earnings Call Announcement: BioCardia will hold a conference call on May 15, 2026, at 4:30 PM EDT to report its Q1 2026 financial results, highlighting advancements in cellular therapeutics for cardiovascular and pulmonary diseases.
- Participation Details: Registered participants can obtain their dial-in numbers via the provided link, while unregistered individuals can listen by calling 1-833-316-0559 for U.S. or 1-412-317-5730 for international calls, advised to join 10 minutes early.
- Webcast and Replay Availability: The call will be available via live webcast, accessible through a designated link, with a replay available approximately one hour post-call until August 15, 2026, allowing investors to catch up on missed information.
- Company Overview: BioCardia specializes in cellular and cell-derived therapeutics for treating cardiovascular and pulmonary diseases, with its CardiAMP and CardiALLO platforms providing innovative solutions for heart disease treatment, showcasing the company's expertise in biotherapeutics.
See More
BioCardia Aligns with FDA on Helix Catheter System for Heart Treatment
- FDA Alignment: BioCardia announced alignment with the FDA following a pre-submission meeting regarding the Helix transendocardial delivery catheter system, with no safety concerns raised, indicating a favorable outlook for market clearance.
- Targeted Delivery Capability: The Helix system is designed for minimally invasive, targeted delivery of therapeutic and diagnostic agents to the heart, allowing for precise injections, superior retention, and effective delivery to hard-to-reach areas, enhancing treatment efficacy.
- Cell Therapy Approval: Concurrently, the CardiAMP investigational cell therapy received FDA approval for heart failure treatment, utilizing the patient's bone marrow cells to repair heart tissue by increasing capillary density and reducing fibrosis, showcasing promising clinical potential.
- Follow-On Pathway Suggestion: The FDA suggested a follow-on pre-submission to facilitate Helix's approval via the DeNovo pathway, further accelerating the commercialization of this technology and enhancing BioCardia's competitive position in regenerative medicine.
See More
