Latest news with #BioCardia
Yahoo
15-05-2025
- Business
- Yahoo
BioCardia Inc (BCDA) Q1 2025 Earnings Call Highlights: Progress in Cardiac Cell Therapy Amid ...
Release Date: May 14, 2025 For the complete transcript of the earnings call, please refer to the full earnings call transcript. BioCardia Inc (NASDAQ:BCDA) reported positive safety and meaningful benefits from their cardiac cell therapy for heart failure patients, addressing a significant unmet clinical need. The company is actively engaging with the FDA and Japan's PMDA to align on pathways for making their therapy available, indicating progress towards regulatory approval. BioCardia Inc (NASDAQ:BCDA) is enrolling patients in the Cardiac Heart Failure 2 trial, which aims to confirm previous results and enhance enrollment. The Helix biotherapeutic delivery system is being prepared for submission for approval, potentially becoming the first approved transendocardial biotherapeutic delivery system in the U.S. BioCardia Inc (NASDAQ:BCDA) has a strong focus on partnerships, which could create meaningful value for shareholders across their four platforms: CardiAM, Cardiello, Helix, and Morph DNA. Total expenses increased by $396,000 quarter over quarter, driven primarily by research and development costs. The company reported a net loss of $2.7 million in Q1 2025, up from $2.3 million in Q1 2024. Cash and cash equivalents were low at $949,000 at the end of the quarter, necessitating a small financing to support ongoing operations. The Cardiac Heart Failure trial did not hit its primary endpoint, introducing significant risks to the approval pathway. BioCardia Inc (NASDAQ:BCDA) faces challenges in the lengthy and uncertain process of deal discussions and partnerships, which can take a long time to finalize. Warning! GuruFocus has detected 7 Warning Signs with BCDA. Q: Can you discuss the levels of maturity in your business development deals and any ongoing discussions? A: Peter Altman, CEO: We have several active discussions with large-cap strategics, particularly around our Morph Axis pro product family, which is already approved and in use. The cardiac electrophysiology market is growing rapidly, and our technology can help access this market. On the Helix side, we are in talks with potential partners for biotherapeutic delivery. Our Cardialo cell therapy has demonstrated safety, and we are open to partnerships for other clinical indications. For Cardiam, we are focused on the approval process in Japan and have ongoing discussions with potential distributors. Q: How does the potential approval process in Japan compare to the FDA's BLA acceptance, and what is its significance? A: Peter Altman, CEO: The process in Japan is similar to the FDA's BLA acceptance. Japan's PMDA is rigorous, and we expect clarity on approval submission within six months. Approval would provide clarity for distribution partners and help us prepare for commercial launch. Our extensive clinical data and minimally invasive delivery method position us favorably compared to peers in Japan. Q: Can you explain the strategy behind running the confirmatory trial while also submitting to the FDA for approval? A: Peter Altman, CEO: We believe in our therapy and are continuously developing evidence. Although our previous trial did not hit its primary endpoint, we are advancing with a second trial, which is reimbursed by Medicare, reducing costs. The new trial focuses on the greatest responders and includes improvements like using our new Morph DNA platform and a revised endpoint to enhance trial power. Q: Does the recent "most favored nation" pricing policy or tariffs impact your business? A: Peter Altman, CEO: Currently, the "most favored nation" policy does not impact us as we are not selling Cardiam outside the U.S. We aim to benchmark international pricing based on U.S. reimbursement. Tariffs are complex, but most of our manufacturing is U.S.-based, minimizing impact. We price based on value, and our margins remain strong even at competitive pricing. Q: What are the financial highlights for the first quarter of 2025? A: David McClung, CFO: Total expenses increased to $2.7 million, driven by R&D expenses related to cardiac heart failure trials. SG&A expenses were stable at $1.2 million. Net loss was $2.7 million, with cash and equivalents at $949,000 before additional financing. We continue to manage capital carefully. For the complete transcript of the earnings call, please refer to the full earnings call transcript. This article first appeared on GuruFocus.
Yahoo
02-04-2025
- Health
- Yahoo
Myocardial Infarction Market Forecast Report 2025-2033 Featuring Major Players - Pfizer, BMS, AstraZeneca, Merck KGaA., Daiichi Sankyo, Novartis, Genentech, Amgen, Regeneron, Takeda
Since MI is a major source of morbidity and mortality globally, especially in aging populations, the prevalence of cardiac disease is a primary driver of growth in this sector. New treatments include clot-dissolving medications, angioplasty, and surgical procedures have grown more successful due to advances in medical research and healthcare technology, increasing survival rates and quality of life. Global Myocardial Infarction Market Dublin, April 02, 2025 (GLOBE NEWSWIRE) -- The "Myocardial Infarction Market Size and Share Analysis - Growth Trends and Forecast Report 2025-2033" report has been added to Myocardial Infarction market is expected to reach US$ 3.64 billion by 2033 from US$ 2.14 billion in 2024, with a CAGR of 6.08% from 2025 to 2033 The market for myocardial infarction is mostly being driven by the rising incidence of coronary artery disorders, which cause plaque to accumulate on the inner walls of the arteries and decrease blood supply to the heart muscle. Furthermore, another important element driving increase is the increasing incidence of several risk factors that are linked to it, including as smoking, excessive alcohol use, high cholesterol, and a lack of physical activity. Improved access to healthcare, lifestyle modifications, and heightened knowledge of cardiovascular health are further factors driving the industry's expansion. Myocardial infarctions are becoming more common due to risk factors like stress, smoking, poor diet, and physical inactivity, thus early detection and prevention are essential. The market is expanding because to advancements in pharmacological treatments, minimally invasive procedures, and diagnostic equipment that improve patient outcomes. Furthermore, chances for growth are being created by the emphasis on post-heart attack care, rehabilitation programs, and tailored medicine. But issues like exorbitant treatment prices and unequal access to healthcare still exist, especially in underdeveloped endpoint findings from the open-label roll-in cohort of the CardiAMP cell treatment in chronic myocardial ischemia trial were published by BioCardia in May 2024. At the primary six-month follow-up endpoint, the open-label roll-in cohort of patients with refractory angina and chronic myocardial ischemia demonstrated an 82% decrease in angina episodes and an average increase in exercise tolerance of 107 seconds when compared to before starting the trial medication. Increased (better) exercise tolerance and a notable decrease in angina were signs that all of the patients responded well to Drivers for the Myocardial Infarction Market Increasing Prevalence of Cardiovascular DiseasesThe market for associated therapies and diagnostics is significantly driven by the rising prevalence of cardiovascular illnesses, especially myocardial infarction. The incidence of heart disease keeps rising as the world's population ages and lifestyle factors including smoking, poor food, lack of physical activity, and high levels of stress grow more common. The rise in cardiovascular diseases is driving up demand for both treatment alternatives like drugs, stents, and surgery, as well as diagnostic tools like biomarkers and sophisticated imaging methods. Myocardial infarction has become a major focus for healthcare systems due to the need for preventive care, early identification, and efficient therapies. This has fueled advancements in medical technology and medications. Improving patient outcomes and lessening the strain on healthcare systems around the world depend on addressing these increasing in Diagnostic TechnologiesThe early identification and precise diagnosis of myocardial infarction are being greatly improved by advances in diagnostic technologies, which immediately improves treatment results. More accurate heart activity monitoring is made possible by innovations like improved electrocardiograms (ECGs), which speed up the identification of cardiac abnormalities. Furthermore, coronary angiography is now an essential tool for identifying coronary artery blockages, which enables prompt therapies like stent implantation or angioplasty. More rapid and precise diagnosis of MI is also made possible by the development of cardiac biomarkers, which recognize particular proteins released during a heart attack. The MI market is growing as a result of these technologies, which not only make it easier to identify myocardial infarction early but also increase patient treatment, improving recovery, lowering complications, and improving Initiatives and ProgramsThe market is expanding as a result of the active measures being taken by governments and health organizations around the world to address the growing incidence of cardiovascular disorders, such as myocardial infarction. In addition to encouraging healthy lifestyles and early identification of heart diseases, these initiatives seek to increase public awareness of heart health. Public health campaigns aimed at lowering risk factors including smoking, eating poorly, and not exercising are examples of preventive programs that are growing in popularity. In order to guarantee that patients with heart disease receive prompt interventions, governments are also expanding access to healthcare services and treatment alternatives. These programs are crucial in lowering the incidence of MI and bolstering the market for myocardial infarctions as a whole by financing research, giving treatment subsidies, and enhancing access to diagnostics and in the Myocardial Infarction Market Lack of Healthcare Access in Developing RegionsA major obstacle to the prompt diagnosis and treatment of myocardial infarction (MI) in many developing nations is the lack of access to medical facilities, diagnostic equipment, and qualified personnel. Remote and rural locations frequently lack the infrastructure needed to support sophisticated diagnostic tools like coronary angiography and ECGs, which are crucial for early heart attack detection. Furthermore, a lack of qualified cardiologists and other medical professionals postpones appropriate treatment, which worsens patient outcomes and raises mortality rates. The problem is made worse by the delay in delivering life-saving procedures like angioplasty or medications that dissolve clots. The effectiveness of myocardial infarction care is hampered by these impediments to healthcare access, which also emphasize the need for better infrastructure and healthcare delivery systems in these Effects and Drug ResistanceTreating myocardial infarction (MI) presents major hurdles due to side effects and treatment resistance. For example, some patients may experience allergic reactions or gastrointestinal bleeding as a result of antiplatelet medications, which are frequently used to prevent blood clots following a heart attack. Furthermore, some people may not respond well to these medications because of genetic variables, which could result in less-than-ideal results. This variation highlights the need for more individualized and customized treatment plans that modify medicines according to a patient's genetic profile, medical background, and particular risk factors. A crucial area for future advancement in cardiovascular care, customized medicine has the potential to improve overall patient outcomes, decrease side effects, and increase the efficacy of MI treatments. Company Analysis: Overview, Recent Development, Revenue Analysis Pfizer Sanofi-Aventis/Bristol-Myers Squibb AstraZeneca Merck Daiichi Sankyo Eli Lilly and Company Takeda Novartis Genentech Amgen Regeneron/Sanofi Boehringer Ingelheim Idorsia Pharmaceuticals Faraday Pharmaceuticals CSL Behring Immediate Therapeutics Mitsubishi Chemical Group Kancera Bayer Recardio Mesoblast Key Questions Answered in Report1. How big is the Myocardial Infarction industry?The global Myocardial Infarction market size was valued at US$ 2.14 billion in 2024 and is expected to reach US$ 3.64 billion in 2033.2. What is the Myocardial Infarction growth rate?The global Myocardial Infarction market is expected to expand at a compound annual growth rate (CAGR) of 6.08% from 2025 to 2033.3. Who are the key players in Myocardial Infarction industry?Some key players operating in the Myocardial Infarction market includes Pfizer Inc., Bristol-Myers Squibb Co, AstraZeneca plc., Merck KGaA., Daiichi Sankyo Co Ltd, Novartis International AG, Genentech, Amgen, Regeneron, Takeda.4. What are the factors driving the Myocardial Infarction industry?Rising rates of cardiovascular disease, aging populations, increased access to healthcare, enhanced diagnostic and therapeutic options, changing lifestyles, and improvements in medicines and medical equipment are all factors driving the myocardial infarction market.5. Which Region held the largest market share in the Myocardial Infarction industry?North America is expected to hold the largest market share in the industry.6. What segments are covered in the Myocardial Infarction Market report?Drug Class, Distribution Channel and Countries segment are covered in this Attributes: Report Attribute Details No. of Pages 200 Forecast Period 2024 - 2033 Estimated Market Value (USD) in 2024 $2.14 Billion Forecasted Market Value (USD) by 2033 $3.64 Billion Compound Annual Growth Rate 6.0% Regions Covered Global Key Topics Covered: 1. Introduction2. Research Methodology3. Executive Summary4. Market Dynamics4.1 Growth Drivers4.2 Challenges5. Exploring the Disease - Background and Key Insights5.1 Introduction5.2 Risk Factors5.3 Pathophysiology5.4 Diagnosis5.5 Biomarkers5.5.1 Biomarkers Originated from Myocardial Tissues5.5.2 Biomarkers Induced by MI Incidence5.5.3 Biomarkers Preexisted Before MI Occurred5.6 Understanding Prior Myocardial Infarction - Definition and Overview5.6.1 Recurrent MI5.6.2 Reinfarction5.6.3 Peri-procedural MI5.7 Myocardial Infarction - WHO Criteria and Definition5.7.1 Understanding MI in Category A: Definition and Diagnostic Standards5.7.2 Category B definition and diagnostic criteria of MI if the requirements for diagnostic tests in Category A (above) Have Not Been Met5.7.3 Understanding Probable MI in Category C: Definition and Diagnostic Standards5.7.4 Fourth Universal Definition of Myocardial Infarction: Overview and Key Concepts6. Comprehensive Treatment and Management6.1 Antiplatelet agents6.2 Anticoagulant agents7. Practical Guidelines and Recommendations for Myocardial Infarction Care7.1 AHA/ACC/HFSA Guideline for the Management of Heart Failure: Executive Summary: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines: 20227.2 NICE Guidelines for Acute coronary syndromes: 20207.3 ESC Guidelines for the Management of Acute Myocardial Infarction in Patients Presenting with ST-Segment Elevation: 20177.4 Evidenced-based Recommendations from the Guidelines7.5 ACCF/AHA Guideline for the Management of ST-Elevation Myocardial Infarction8. Global Myocardial Infarction Market9. Market Share9.1 Drug Class9.2 Distribution Channel9.3 Country10. Drug Class10.1 Antiplatelet Agents10.2 Glycoprotein IIb/IIIa Inhibitors10.3 Antithrombotic Agents10.4 Beta-adrenergic Blockers10.5 Vasodilators10.6 Angiotensin-converting Enzyme (ACE) Inhibitors10.7 Angiotensin-receptor Blockers10.8 Analgesics10.9 Thrombolytics11. Distribution Channel11.1 Hospitals11.2 Hospital Pharmacies11.3 Drug Stores11.4 Online Drug Stores12. Country12.1 North America12.1.1 United States12.1.2 Canada12.2 Europe12.2.1 France12.2.2 Germany12.2.3 Italy12.2.4 Spain12.2.5 United Kingdom12.2.6 Belgium12.2.7 Netherlands12.2.8 Turkey12.3 Asia Pacific12.3.1 China12.3.2 Japan12.3.3 India12.3.4 Australia12.3.5 South Korea12.3.6 Thailand12.3.7 Malaysia12.3.8 Indonesia12.3.9 New Zealand12.4 Latin America12.4.1 Brazil12.4.2 Mexico12.4.3 Argentina12.5 Middle East & Africa12.5.1 South Africa12.5.2 Saudi Arabia12.5.3 UAE13. Porter's Five Analysis13.1 Bargaining Power of Buyers13.2 Bargaining Power of Suppliers13.3 Degree of Rivalry13.4 Threat of New Entrants13.5 Threat of Substitutes14. SWOT Analysis14.1 Strength14.2 Weakness14.3 Opportunity14.4 Threat15. Analysis of Marketed Therapies15.1 Key Players15.2 INSPRA (eplerenone): Pfizer15.2.1 Description of Drug15.2.2 Regulatory milestones15.2.3 Safety and efficacy15.3 PLAVIX (clopidogrel bisulfate): Sanofi-Aventis/Bristol-Myers Squibb15.3.1 Description of Drug15.3.2 Regulatory milestones15.3.3 Safety and efficacy15.4 BRILINTA (ticagrelor): AstraZeneca15.4.1 Description of Drug15.4.2 Regulatory milestones15.4.3 Safety and efficacy15.5 ZONTIVITY (vorapaxar): Merck15.5.1 Description of Drug15.5.2 Regulatory milestones15.5.3 Safety and efficacy15.6 EFFIENT/EFIENT (prasugrel): Daiichi Sankyo/Eli Lilly and Company15.6.1 Description of Drug15.6.2 Regulatory milestones15.6.3 Safety and efficacy15.7 ATACAND (candesartan): AstraZeneca/Takeda15.7.1 Description of Drug15.7.2 Regulatory milestones15.7.3 Safety and efficacy15.8 DIOVAN (valsartan): Novartis15.8.1 Description of Drug15.8.2 Regulatory milestones15.8.3 Safety and efficacy15.9 TNKASE (tenecteplase): Genentech15.9.1 Description of Drug15.9.2 Regulatory milestones15.9.3 Safety and efficacy15.10 REPATHA (evolocumab): Amgen15.10.1 Description of Drug15.10.2 Regulatory milestones15.10.3 Safety and efficacy15.11 PRALUENT (alirocumab): Regeneron/Sanofi15.11.1 Description of Drug15.11.2 Regulatory milestones15.11.3 Safety and efficacy16. Analysis of Emerging Therapies16.1 Key Players16.2 FARXIGA/FORXIGA (dapagliflozin): AstraZeneca16.2.1 Description of Drug16.2.2 Clinical Research & Development16.2.3 Safety and efficacy16.3 JARDIANCE (empagliflozin): Boehringer Ingelheim and Eli Lilly and Company16.3.1 Description of Drug16.3.2 Clinical Research & Development16.3.3 Safety and efficacy16.4 Pelacarsen (TQJ230): Novartis16.4.1 Description of Drug16.4.2 Clinical Research & Development16.4.3 Safety and efficacy16.5 Olpasiran: Amgen16.5.1 Description of Drug16.5.2 Clinical Research & Development16.5.3 Safety and efficacy16.6 Selatogrel: Idorsia Pharmaceuticals16.6.1 Description of Drug16.6.2 Clinical Research & Development16.6.3 Safety and efficacy16.7 FDY-5301: Faraday Pharmaceuticals16.7.1 Description of Drug16.7.2 Clinical Research & Development16.7.3 Safety and efficacy16.8 CSL112: CSL Behring16.8.1 Description of Drug16.8.2 Clinical Research & Development16.8.3 Safety and efficacy16.9 IMT-358: Immediate Therapeutics16.9.1 Description of Drug16.9.2 Clinical Research & Development16.9.3 Safety and efficacy16.10 CL2020: Mitsubishi Chemical Group16.10.1 Description of Drug16.10.2 Clinical Research & Development16.10.3 Safety and efficacy16.11 MEDI6570: AstraZeneca16.11.1 Description of Drug16.11.2 Clinical Research & Development16.11.3 Safety and efficacy16.12 KAND567: Kancera16.12.1 Description of Drug16.12.2 Clinical Research & Development16.12.3 Safety and efficacy16.13 Asundexian: Bayer16.13.1 Description of Drug16.13.2 Clinical Research & Development16.13.3 Safety and efficacy16.14 Dutogliptin: Recardio16.14.1 Description of Drug16.14.2 Clinical Research & Development16.14.3 Safety and efficacy16.15 MPC-25-IC: Mesoblast16.15.1 Description of Drug16.15.2 Clinical Research & Development16.15.3 Safety and efficacy17. Regulations and Reimbursement17.1 PRALUENT (alirocumab)17.2 INSPRA (eplerenone)17.3 BRILINTA (ticagrelor)17.4 REPATHA (evolocumab)17.5 DIOVAN (valsartan)17.6 ZONTIVITY (vorapaxar)17.7 TNKase (tenecteplase)17.8 Proprotein convertase subtilisin/kexin type 9 inhibitors (PCSK9i)Companies Featured Pfizer Sanofi-Aventis/Bristol-Myers Squibb AstraZeneca Merck Daiichi Sankyo Eli Lilly and Company Takeda Novartis Genentech Amgen Regeneron/Sanofi Boehringer Ingelheim Idorsia Pharmaceuticals Faraday Pharmaceuticals CSL Behring Immediate Therapeutics Mitsubishi Chemical Group Kancera Bayer Recardio Mesoblast For more information about this report visit About is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends. Attachment Global Myocardial Infarction Market CONTACT: CONTACT: Laura Wood,Senior Press Manager press@ For E.S.T Office Hours Call 1-917-300-0470 For U.S./ CAN Toll Free Call 1-800-526-8630 For GMT Office Hours Call +353-1-416-8900Sign in to access your portfolio
Yahoo
28-03-2025
- Business
- Yahoo
BioCardia Full Year 2024 Earnings: EPS Beats Expectations, Revenues Lag
Net loss: US$7.95m (loss narrowed by 31% from FY 2023). US$2.90 loss per share (improved from US$8.20 loss in FY 2023). AI is about to change healthcare. These 20 stocks are working on everything from early diagnostics to drug discovery. The best part - they are all under $10bn in marketcap - there is still time to get in early. All figures shown in the chart above are for the trailing 12 month (TTM) period Revenue missed analyst estimates by 37%. Earnings per share (EPS) exceeded analyst estimates by 6.8%. Looking ahead, revenue is forecast to grow 83% p.a. on average during the next 3 years, compared to a 20% growth forecast for the Biotechs industry in the US. Performance of the American Biotechs industry. The company's shares are up 8.5% from a week ago. Be aware that BioCardia is showing 7 warning signs in our investment analysis and 4 of those shouldn't be ignored... Have feedback on this article? Concerned about the content? Get in touch with us directly. Alternatively, email editorial-team (at) article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned.
