{"success":true,"data":{"pressRelease":{"id":"67526","rtpr_id":"nGNX9zvYPw","ticker":"BCDA","exchange":"NASDAQ","all_tickers":["BCDA"],"title":"BioCardia Letter to Stockholders on 2026 Priorities and Strategic Opportunities","author":"Globe Newswire","published_at":"2026-06-18T12:00:00.699Z","article_body":"SUNNYVALE, Calif., June 18, 2026 (GLOBE NEWSWIRE) -- BioCardia(®), Inc.\n[Nasdaq: BCDA], a global leader in cellular and cell-derived therapeutics for\nthe treatment of cardiovascular and pulmonary diseases, today announced that\nthe Company’s Chief Executive Officer, Peter Altman, issued the following\nletter to shareholders.\n\nDear Fellow Shareholders,\n\nUpon completion of our recent capital raise, I am providing this update on our\nstrategy, top priorities, and business development opportunities to ensure\nunderstanding and appreciation of what is ahead.\n\nThis quarter, with Japan’s Pharmaceutical and Medical Device Agency’s\n(PMDA) support for potential approval of CardiAMP(®) Cell Therapy for the\ntreatment of ischemic heart failure of reduced ejection fraction (HFrEF), the\nsubmission for approval is a top priority. This effort is synergistic with our\nother important programs.\n\nIn Japan, we have the opportunity to help patients having few additional\ntreatment options and build the business with our first in class CardiAMP\nautologous minimally invasive cardiac cell therapy for ischemic HFrEF. There\nare an estimated 300,000 patients in Japan with ischemic heart failure. We\nexpect the initial approval by PMDA would focus on enabling treatment for a\nsubgroup of 20,000 patients. This is a compelling business opportunity, as\nprevious cardiac cell therapies in Japan for treatment of chronic ischemic\nheart failure have had reimbursement at $124,000 per procedure.\n\nThe submission for approval planned for end of 2026 is a meaningful milestone\nthat could be transformative for our business. Strategic partners are expected\nto view the completed submission as a sign that our product will be in the\nmarket soon. The work to be done to complete the submission is significant as\nit involves ensuring strict regulatory audit readiness for our CardiAMP Cell\nTherapy System product candidate.\n\nJapan is a trusted Reference Country and a Primary Member of MDSAP\n\nApproval in Japan enables expedited registration based on reference country\napprovals in other regions of the world. Countries in Southeast Asia, Latin\nAmerica, and the Middle East often designate Japan as a trusted \"Reference\nCountry.\" These countries will often bypass secondary clinical testing, lower\ntheir local evaluation timelines, and reduce registration fees for potential\ndistribution partners. Japan is also a primary member of the Medical Device\nSingle Audit Program (MDSAP), alongside the United States, Canada, Australia,\nand Brazil. When our manufacturing plant passes a single, comprehensive MDSAP\naudit satisfying Japan’s PMD Act requirements, that audit report is accepted\nby other participating nations, avoiding the need for multiple independent\nfactory inspections.\n\nCardiAMP HF II Trial Enrollment in USA\n\nWe are also driving to enroll the confirmatory CardiAMP HF II Trial in the\nUnited States, which the FDA has said may support Premarket Approval. Each of\nthe four active study centers has patients in the queue and we are working to\nonboard additional centers. The physicians and nurses on the clinical research\nteams at our U.S. centers are greatly interested in travelling to Japan to\ntrain and support their colleagues when they are ready to begin CardiAMP cell\ntherapy procedures. Physicians from Japan may also come to observe CardiAMP HF\nII clinical cases and train on the procedures in advance of potential future\napproval in Japan.\n\nPipeline-in-a-Product: Local Delivery to the Heart\n\nOur cell therapy programs utilize our Helix Transendocardial Delivery Catheter\n(Helix™) and our Heart3D™ fusion imaging platform (Heart3D). This system\naddresses the single greatest bottleneck facing cardiac cell, gene, and\nprotein regenerative medicine today: inefficient localized delivery. By\npairing our tissue-engaging helical needle with our partnered Heart3D fusion\nimaging platform, we have a therapeutic-agnostic infrastructure capable of\nservicing over fifty biotherapeutic programs currently in development. A\nnumber of these programs are in Japan, and Japan PMDA has already advised\nBioCardia that other developers would be enabled to use Helix with the\napproval of CardiAMP cell therapy. Worldwide, we have active early discussions\nwith eight gene and cell therapies today intended for cardiac indications. No\nother delivery platform is as advanced or has close to the clinical experience\nthat Helix has.\n\nPipeline-in-a-Product: Off the Shelf MSC Therapies\n\nOur allogeneic mesenchymal stem cell (MSC) therapy platform is targeted\ntowards cardiac and pulmonary indications where we have two FDA approved\nInvestigational New Drug Applications (INDs), with anti-inflammatory\nmechanisms of action having potential applications across multiple high-value\nindications. Our manufacturing of clinical grade cells and supportive\nintellectual property enables us to partner in multiple indications that can\nbe independently developed and partnered for value creation with other\npharmaceutical developers. Japan PMDA and FDA have approved mesenchymal stem\ncell therapies for graft versus host disease, although the approval in Japan\ncame ten years before the approval in the USA.\n\nIn addition to partnering on distribution of CardiAMP, any significant\npartnership for our secured pipeline assets would be transformative for our\nbusiness.\n\nFinancial Strategy and Capital Allocation\n\nBioCardia has always had a modest cash burn for a publicly traded company. The\nrecent clean financing closed last week should enable us to complete the\nsubmission of CardiAMP HF to Japan PMDA, enroll in CardiAMP HF II, and\ncontinue discussions around our pipeline opportunities. We are looking forward\nto revised SEC regulations later this year that may enable easier access to\ncapital for smaller reporting companies.\n\nNear-Term Milestones and Outlook\n\nWe are entering a period of high-impact catalysts:\n* Shonin Submission of CardiAMP Cell Therapy to Japan PMDA (Q4 2026)\n* Continued CardiAMP Cell Therapy development in the USA with FDA engagement\n* Strategic partnership / licensing progress in Helix/Heart3D for cell, gene,\nand protein delivery to the heart\n* Strategic partnerships / licensing around our clinical allogeneic MSC\nplatform\nWe believe these milestones create a compelling opportunity for value\ncreation, particularly considering public market precedents for companies with\nsimilar clinical profiles and regulatory positioning.\n\nConclusion\n\nBioCardia is focused on potential near term regulatory approval for a\nsignificant unmet need in Japan, a mission that is synergistic with our other\nefforts. We are a focused, capital-efficient organization advancing\ntherapeutic solutions to address enormous unmet need. We have differentiated\nplatforms, significant protective intellectual property, multiple shots on\ngoal, and a clear path to near-term value inflection.\n\nWe remain deeply committed to advancing therapies for life-threatening and\nchronic conditions while delivering on our responsibility to our stockholders.\n\nWe appreciate your continued support and look forward to updating you on our\nprogress in the months ahead.\n\nSincerely,\n\nPeter Altman, PhD, FAHA\n\nChief Executive Officer, BioCardia Inc.\n\nAbout BioCardia(®)\n\nBioCardia, Inc., headquartered in Sunnyvale, California, is a global leader\nin cellular and cell-derived therapeutics for the treatment of cardiovascular\nand pulmonary disease. CardiAMP(®) autologous and CardiALLO™ allogeneic\ncell therapies are the Company’s biotherapeutic platforms with three cardiac\nclinical stage product candidates in development. These therapies are enabled\nby its Helix™ biotherapeutic delivery and Morph(®) vascular navigation\nproduct platforms, and soon the Heart3D™ fusion imaging platform. BioCardia\nselectively partners on biotherapeutic delivery with peers developing\nimportant biologic therapies. For more information visit www.biocardia.com.\n\nForward Looking Statements:\n\nThis press release contains forward-looking statements that are subject to\nmany risks and uncertainties. Forward-looking statements include, among other\nthings, statements relating to filings and communications with Japan’s PMDA\nand the FDA, submission for and subsequent market clearance of the CardiAMP\nCell Therapy, partnering opportunities, enrollment in our clinical trials and\nanticipated upcoming milestones. These forward-looking statements are made as\nof the date of this press release.\n\nWe may use terms such as “believes,” “estimates,” “anticipates,”\n“expects,” “plans,” “intends,” “may,” “could,”\n“might,” “will,” “should,” “approximately” or other words that\nconvey the uncertainty of future events or outcomes to identify these\nforward-looking statements. Although we believe that we have a reasonable\nbasis for each forward-looking statement contained herein, we caution you that\nforward-looking statements are not guarantees of future performance and that\nour actual results may differ materially from the forward-looking statements\ncontained in this press release. Factors that could cause or contribute to\nsuch differences include, but are not limited to, the Company’s liquidity\nposition and its ability to raise additional funds, as well as the Company’s\nability to successfully progress its clinical trials. As a result of these\nfactors, we cannot assure you that the forward-looking statements in this\npress release will prove to be accurate. Additional factors that could\nmaterially affect actual results can be found in BioCardia’s Form 10-K filed\nwith the Securities and Exchange Commission on March 24, 2026, under the\ncaption titled “Risk Factors” and in its subsequently filed Quarterly\nReports on Form 10-Q. BioCardia expressly disclaims any intent or obligation\nto update these forward-looking statements, except as required by law.\n\nMedia Contact:\nMiranda Peto, Investor Relations\nEmail: mpeto@BioCardia.com\nPhone: 650-226-0120\n\nInvestor Contact:\nDavid McClung, Chief Financial Officer\nEmail: investors@BioCardia.com\nPhone: 650-226-0120\n\n(https://www.globenewswire.com/NewsRoom/AttachmentNg/4641bb53-4913-4654-a337-79383a5c7ab9)\n\n\n\nGlobeNewswire, Inc. 2026","article_body_html":"","raw_payload":{"data":{"id":"nGNX9zvYPw","title":"BioCardia Letter to Stockholders on 2026 Priorities and Strategic Opportunities","author":"Globe Newswire","ticker":"BCDA","created":"2026-06-18T12:00:00.699Z","tickers":["BCDA"],"exchange":"NASDAQ","article_body":"SUNNYVALE, Calif., June 18, 2026 (GLOBE NEWSWIRE) -- BioCardia(®), Inc.\n[Nasdaq: BCDA], a global leader in cellular and cell-derived therapeutics for\nthe treatment of cardiovascular and pulmonary diseases, today announced that\nthe Company’s Chief Executive Officer, Peter Altman, issued the following\nletter to shareholders.\n\nDear Fellow Shareholders,\n\nUpon completion of our recent capital raise, I am providing this update on our\nstrategy, top priorities, and business development opportunities to ensure\nunderstanding and appreciation of what is ahead.\n\nThis quarter, with Japan’s Pharmaceutical and Medical Device Agency’s\n(PMDA) support for potential approval of CardiAMP(®) Cell Therapy for the\ntreatment of ischemic heart failure of reduced ejection fraction (HFrEF), the\nsubmission for approval is a top priority. This effort is synergistic with our\nother important programs.\n\nIn Japan, we have the opportunity to help patients having few additional\ntreatment options and build the business with our first in class CardiAMP\nautologous minimally invasive cardiac cell therapy for ischemic HFrEF. There\nare an estimated 300,000 patients in Japan with ischemic heart failure. We\nexpect the initial approval by PMDA would focus on enabling treatment for a\nsubgroup of 20,000 patients. This is a compelling business opportunity, as\nprevious cardiac cell therapies in Japan for treatment of chronic ischemic\nheart failure have had reimbursement at $124,000 per procedure.\n\nThe submission for approval planned for end of 2026 is a meaningful milestone\nthat could be transformative for our business. Strategic partners are expected\nto view the completed submission as a sign that our product will be in the\nmarket soon. The work to be done to complete the submission is significant as\nit involves ensuring strict regulatory audit readiness for our CardiAMP Cell\nTherapy System product candidate.\n\nJapan is a trusted Reference Country and a Primary Member of MDSAP\n\nApproval in Japan enables expedited registration based on reference country\napprovals in other regions of the world. Countries in Southeast Asia, Latin\nAmerica, and the Middle East often designate Japan as a trusted \"Reference\nCountry.\" These countries will often bypass secondary clinical testing, lower\ntheir local evaluation timelines, and reduce registration fees for potential\ndistribution partners. Japan is also a primary member of the Medical Device\nSingle Audit Program (MDSAP), alongside the United States, Canada, Australia,\nand Brazil. When our manufacturing plant passes a single, comprehensive MDSAP\naudit satisfying Japan’s PMD Act requirements, that audit report is accepted\nby other participating nations, avoiding the need for multiple independent\nfactory inspections.\n\nCardiAMP HF II Trial Enrollment in USA\n\nWe are also driving to enroll the confirmatory CardiAMP HF II Trial in the\nUnited States, which the FDA has said may support Premarket Approval. Each of\nthe four active study centers has patients in the queue and we are working to\nonboard additional centers. The physicians and nurses on the clinical research\nteams at our U.S. centers are greatly interested in travelling to Japan to\ntrain and support their colleagues when they are ready to begin CardiAMP cell\ntherapy procedures. Physicians from Japan may also come to observe CardiAMP HF\nII clinical cases and train on the procedures in advance of potential future\napproval in Japan.\n\nPipeline-in-a-Product: Local Delivery to the Heart\n\nOur cell therapy programs utilize our Helix Transendocardial Delivery Catheter\n(Helix™) and our Heart3D™ fusion imaging platform (Heart3D). This system\naddresses the single greatest bottleneck facing cardiac cell, gene, and\nprotein regenerative medicine today: inefficient localized delivery. By\npairing our tissue-engaging helical needle with our partnered Heart3D fusion\nimaging platform, we have a therapeutic-agnostic infrastructure capable of\nservicing over fifty biotherapeutic programs currently in development. A\nnumber of these programs are in Japan, and Japan PMDA has already advised\nBioCardia that other developers would be enabled to use Helix with the\napproval of CardiAMP cell therapy. Worldwide, we have active early discussions\nwith eight gene and cell therapies today intended for cardiac indications. No\nother delivery platform is as advanced or has close to the clinical experience\nthat Helix has.\n\nPipeline-in-a-Product: Off the Shelf MSC Therapies\n\nOur allogeneic mesenchymal stem cell (MSC) therapy platform is targeted\ntowards cardiac and pulmonary indications where we have two FDA approved\nInvestigational New Drug Applications (INDs), with anti-inflammatory\nmechanisms of action having potential applications across multiple high-value\nindications. Our manufacturing of clinical grade cells and supportive\nintellectual property enables us to partner in multiple indications that can\nbe independently developed and partnered for value creation with other\npharmaceutical developers. Japan PMDA and FDA have approved mesenchymal stem\ncell therapies for graft versus host disease, although the approval in Japan\ncame ten years before the approval in the USA.\n\nIn addition to partnering on distribution of CardiAMP, any significant\npartnership for our secured pipeline assets would be transformative for our\nbusiness.\n\nFinancial Strategy and Capital Allocation\n\nBioCardia has always had a modest cash burn for a publicly traded company. The\nrecent clean financing closed last week should enable us to complete the\nsubmission of CardiAMP HF to Japan PMDA, enroll in CardiAMP HF II, and\ncontinue discussions around our pipeline opportunities. We are looking forward\nto revised SEC regulations later this year that may enable easier access to\ncapital for smaller reporting companies.\n\nNear-Term Milestones and Outlook\n\nWe are entering a period of high-impact catalysts:\n* Shonin Submission of CardiAMP Cell Therapy to Japan PMDA (Q4 2026)\n* Continued CardiAMP Cell Therapy development in the USA with FDA engagement\n* Strategic partnership / licensing progress in Helix/Heart3D for cell, gene,\nand protein delivery to the heart\n* Strategic partnerships / licensing around our clinical allogeneic MSC\nplatform\nWe believe these milestones create a compelling opportunity for value\ncreation, particularly considering public market precedents for companies with\nsimilar clinical profiles and regulatory positioning.\n\nConclusion\n\nBioCardia is focused on potential near term regulatory approval for a\nsignificant unmet need in Japan, a mission that is synergistic with our other\nefforts. We are a focused, capital-efficient organization advancing\ntherapeutic solutions to address enormous unmet need. We have differentiated\nplatforms, significant protective intellectual property, multiple shots on\ngoal, and a clear path to near-term value inflection.\n\nWe remain deeply committed to advancing therapies for life-threatening and\nchronic conditions while delivering on our responsibility to our stockholders.\n\nWe appreciate your continued support and look forward to updating you on our\nprogress in the months ahead.\n\nSincerely,\n\nPeter Altman, PhD, FAHA\n\nChief Executive Officer, BioCardia Inc.\n\nAbout BioCardia(®)\n\nBioCardia, Inc., headquartered in Sunnyvale, California, is a global leader\nin cellular and cell-derived therapeutics for the treatment of cardiovascular\nand pulmonary disease. CardiAMP(®) autologous and CardiALLO™ allogeneic\ncell therapies are the Company’s biotherapeutic platforms with three cardiac\nclinical stage product candidates in development. These therapies are enabled\nby its Helix™ biotherapeutic delivery and Morph(®) vascular navigation\nproduct platforms, and soon the Heart3D™ fusion imaging platform. BioCardia\nselectively partners on biotherapeutic delivery with peers developing\nimportant biologic therapies. For more information visit www.biocardia.com.\n\nForward Looking Statements:\n\nThis press release contains forward-looking statements that are subject to\nmany risks and uncertainties. Forward-looking statements include, among other\nthings, statements relating to filings and communications with Japan’s PMDA\nand the FDA, submission for and subsequent market clearance of the CardiAMP\nCell Therapy, partnering opportunities, enrollment in our clinical trials and\nanticipated upcoming milestones. These forward-looking statements are made as\nof the date of this press release.\n\nWe may use terms such as “believes,” “estimates,” “anticipates,”\n“expects,” “plans,” “intends,” “may,” “could,”\n“might,” “will,” “should,” “approximately” or other words that\nconvey the uncertainty of future events or outcomes to identify these\nforward-looking statements. Although we believe that we have a reasonable\nbasis for each forward-looking statement contained herein, we caution you that\nforward-looking statements are not guarantees of future performance and that\nour actual results may differ materially from the forward-looking statements\ncontained in this press release. Factors that could cause or contribute to\nsuch differences include, but are not limited to, the Company’s liquidity\nposition and its ability to raise additional funds, as well as the Company’s\nability to successfully progress its clinical trials. As a result of these\nfactors, we cannot assure you that the forward-looking statements in this\npress release will prove to be accurate. Additional factors that could\nmaterially affect actual results can be found in BioCardia’s Form 10-K filed\nwith the Securities and Exchange Commission on March 24, 2026, under the\ncaption titled “Risk Factors” and in its subsequently filed Quarterly\nReports on Form 10-Q. BioCardia expressly disclaims any intent or obligation\nto update these forward-looking statements, except as required by law.\n\nMedia Contact:\nMiranda Peto, Investor Relations\nEmail: mpeto@BioCardia.com\nPhone: 650-226-0120\n\nInvestor Contact:\nDavid McClung, Chief Financial Officer\nEmail: investors@BioCardia.com\nPhone: 650-226-0120\n\n(https://www.globenewswire.com/NewsRoom/AttachmentNg/4641bb53-4913-4654-a337-79383a5c7ab9)\n\n\n\nGlobeNewswire, Inc. 2026"},"type":"article","timestamp":"2026-06-18T12:00:01.024865367Z","server_sent_at_ms":1781784001024},"received_at":"2026-06-18T12:00:01.111Z","source_url":"https://www.globenewswire.com/news-release/2026/06/18/3314112/0/en/BioCardia-Letter-to-Stockholders-on-2026-Priorities-and-Strategic-Opportunities.html"},"analysis":{"id":"56941","press_release_id":"67526","analysis_json":{"industry":{"label":"Biotechnology","sector":"Health Care"},"redFlags":["Reliance on forward-looking statements regarding regulatory approval and market adoption","Revenue potential based on historical reimbursement precedents not guaranteed for CardiAMP","Significant execution risk associated with manufacturing audits and clinical trial enrollment"],"eventType":"operations_update","narrative":"BioCardia's CEO outlined 2026 strategic priorities, targeting a Q4 submission to Japan's PMDA for CardiAMP Cell Therapy to treat ischemic heart failure with a potential initial market of 20,000 patients.\n\nThe company noted that previous therapies in Japan have achieved reimbursement of $124,000 per procedure and that approval there could expedite registrations in other regions via the MDSAP.\n\nManagement also confirmed progress on the U.S. CardiAMP HF II trial and is advancing its Helix delivery platform and MSC therapy pipeline through strategic partnerships, supported by a recent capital raise.","sentiment":"bullish","agentHooks":{"shouldPost":false,"suggestedAngle":"BioCardia letter eyes Japan approval pathway for CardiAMP with Q4 submission target."},"keyFigures":{"customDimensions":{"submission_target":"Q4 2026","pipeline_discussions":8,"japan_initial_subgroup":20000,"japan_patients_estimated":300000,"reimbursement_per_procedure":124000}},"quotedText":"We believe these milestones create a compelling opportunity for value creation, particularly considering public market precedents for companies with similar clinical profiles and regulatory positioning.","namedEntities":{"people":[{"name":"Peter Altman","role":"Chief Executive Officer"},{"name":"Miranda Peto","role":"Investor Relations"},{"name":"David McClung","role":"Chief Financial Officer"}],"products":["CardiAMP Cell Therapy","Helix Transendocardial Delivery Catheter","Heart3D","CardiALLO","Morph"],"companies":[{"name":"BioCardia, Inc.","ticker":"BCDA"},{"name":"Pharmaceutical and Medical Device Agency (PMDA)","relationship":"regulatory agency"},{"name":"U.S. Food and Drug Administration","relationship":"regulatory agency"}],"dollarAmounts":[{"amount":"$124,000","context":"reimbursement per procedure for previous cardiac cell therapies in Japan"}]},"materialImpact":{"score":2,"reasoning":"Strategic shareholder letter outlining 2026 priorities and potential market opportunity in Japan. While the guidance regarding the CardiAMP submission and reimbursement rates is positive, the update lacks concrete financial results or finalized regulatory approvals, relying heavily on forward-looking statements."},"tickerRelevance":{"others":[],"primary":"BCDA"},"globalImportance":15,"audienceRelevance":15,"eventTypeSecondary":["guidance_update"],"importanceComponents":{"tickerTier":"small-cap","eventGravity":"strategic_letter","sectorWeight":"health_care","retailFavoriteBoost":false}},"event_type":"operations_update","event_type_secondary":["guidance_update"],"sentiment":"bullish","material_impact_score":2,"narrative":"BioCardia's CEO outlined 2026 strategic priorities, targeting a Q4 submission to Japan's PMDA for CardiAMP Cell Therapy to treat ischemic heart failure with a potential initial market of 20,000 patients.\n\nThe company noted that previous therapies in Japan have achieved reimbursement of $124,000 per procedure and that approval there could expedite registrations in other regions via the MDSAP.\n\nManagement also confirmed progress on the U.S. CardiAMP HF II trial and is advancing its Helix delivery platform and MSC therapy pipeline through strategic partnerships, supported by a recent capital raise.","key_figures":{"customDimensions":{"submission_target":"Q4 2026","pipeline_discussions":8,"japan_initial_subgroup":20000,"japan_patients_estimated":300000,"reimbursement_per_procedure":124000}},"named_entities":{"people":[{"name":"Peter Altman","role":"Chief Executive Officer"},{"name":"Miranda Peto","role":"Investor Relations"},{"name":"David McClung","role":"Chief Financial Officer"}],"products":["CardiAMP Cell Therapy","Helix Transendocardial Delivery Catheter","Heart3D","CardiALLO","Morph"],"companies":[{"name":"BioCardia, Inc.","ticker":"BCDA"},{"name":"Pharmaceutical and Medical Device Agency (PMDA)","relationship":"regulatory agency"},{"name":"U.S. Food and Drug Administration","relationship":"regulatory agency"}],"dollarAmounts":[{"amount":"$124,000","context":"reimbursement per procedure for previous cardiac cell therapies in Japan"}]},"model_name":"qwen3_6_27b_awq","prompt_hash":"sha256:727b4b9429a443af","schema_hash":"sha256:05005c02d9cffac9","created_at":"2026-06-18T12:10:26.689Z","global_importance":15,"audience_relevance":15,"importance_components":{"tickerTier":"small-cap","eventGravity":"strategic_letter","sectorWeight":"health_care","retailFavoriteBoost":false}},"durationMs":null,"modelName":"george-droid-qwen-72b"}}