BioCardia Regains Full Compliance with Nasdaq Listing Requirements
BioCardia, Inc. [Nasdaq: BCDA] has regained full compliance with Nasdaq Capital Market's Listing Requirements, as confirmed by Nasdaq on September 17, 2024. This follows the company's successful efforts to improve its balance sheet, including raising new capital. Recent developments include:
1. FDA approval of CardiAMP® Cell Therapy Heart Failure II protocol amendment
2. Completion of the last roll-in patient in the CardiAMP Cell Therapy Chronic Myocardial Ischemia Trial
3. Positive pre-IND meeting for Helix™ partner CellProthera's cell therapy
4. FDA market clearance for Morph® DNA™ product family
5. Closing of a $7.2M financing
BioCardia's focus remains on developing therapies for cardiovascular and pulmonary diseases, with near-term priorities including finalizing CardiAMP HF I trial data for Japan PMDA and FDA, and randomizing first patients in the CardiAMP HF II trial.
BioCardia, Inc. [Nasdaq: BCDA] ha ripristinato la piena conformità con i requisiti di quotazione del Nasdaq Capital Market, come confermato dal Nasdaq il 17 settembre 2024. Questo segue gli sforzi della società per migliorare il proprio bilancio, inclusa la raccolta di nuovo capitale. Gli sviluppi recenti includono:
1. Approvazione da parte della FDA della modifica del protocollo CardiAMP® Cell Therapy Heart Failure II
2. Completamento dell'ultimo paziente arruolato nello studio CardiAMP Cell Therapy Chronic Myocardial Ischemia
3. Incontro pre-IND positivo per la terapia cellulare Helix™ partner CellProthera
4. Autorizzazione al mercato da parte della FDA per la famiglia di prodotti Morph® DNA™
5. Chiusura di un finanziamento di 7,2 milioni di dollari
Il focus di BioCardia rimane sullo sviluppo di terapie per le malattie cardiovascolari e polmonari, con priorità a breve termine che includono il completamento dei dati dello studio CardiAMP HF I per la PMDA giapponese e la FDA, e la randomizzazione dei primi pazienti nello studio CardiAMP HF II.
BioCardia, Inc. [Nasdaq: BCDA] ha recuperado la plena conformidad con los requisitos de cotización del Nasdaq Capital Market, según lo confirmado por Nasdaq el 17 de septiembre de 2024. Esto sigue los esfuerzos exitosos de la compañía para mejorar su balance, incluyendo la recaudación de nuevo capital. Los desarrollos recientes incluyen:
1. Aprobación por parte de la FDA de la enmienda al protocolo de CardiAMP® Cell Therapy Heart Failure II
2. Finalización del último paciente incorporado en el ensayo CardiAMP Cell Therapy Chronic Myocardial Ischemia
3. Reunión pre-IND positiva para la terapia celular de Helix™ socio CellProthera
4. Autorización de la FDA para la familia de productos Morph® DNA™
5. Cierre de un financiamiento de 7.2 millones de dólares
El enfoque de BioCardia sigue siendo el desarrollo de terapias para enfermedades cardiovasculares y pulmonares, con prioridades a corto plazo que incluyen la finalización de los datos del ensayo CardiAMP HF I para PMDA Japón y FDA, y la aleatorización de los primeros pacientes en el ensayo CardiAMP HF II.
BioCardia, Inc. [Nasdaq: BCDA]는 2024년 9월 17일 Nasdaq에 의해 확인된 바와 같이 Nasdaq 자본 시장의 상장 요건을 완전히 준수하게 되었습니다. 이는 회사가 재무 상태를 개선하기 위해 새로운 자본을 조달하는 등 성공적으로 노력한 결과입니다. 최근 발전 사항은 다음과 같습니다:
1. CardiAMP® 세포 요법 심부전 II 프로토콜 수정에 대한 FDA 승인
2. CardiAMP 세포 요법 만성 심근 허혈 시험에서 마지막 환자 등록 완료
3. Helix™ 파트너 CellProthera의 세포 요법에 대한 긍정적인 사전 IND 회의
4. Morph® DNA™ 제품군에 대한 FDA 시장 승인
5. 720만 달러 자금 조달 완료
BioCardia는 심혈관 및 호흡기 질환 치료제 개발에 주력하고 있으며, 단기 우선 사항으로는 일본 PMDA 및 FDA에 대한 CardiAMP HF I 시험 데이터 완성 및 CardiAMP HF II 시험에서 첫 환자의 무작위 배정을 포함하고 있습니다.
BioCardia, Inc. [Nasdaq: BCDA] a retrouvé sa pleine conformité aux exigences de cotation du Nasdaq Capital Market, comme confirmé par Nasdaq le 17 septembre 2024. Cela fait suite aux efforts réussis de l'entreprise pour améliorer son bilan, y compris la levée de nouveaux capitaux. Les développements récents comprennent :
1. Approbation de la FDA pour la modification du protocole CardiAMP® Cell Therapy Heart Failure II
2. Achèvement du dernier patient intégré dans l'essai CardiAMP Cell Therapy Chronic Myocardial Ischemia
3. Réunion pré-IND positive pour la thérapie cellulaire Helix™ du partenaire CellProthera
4. Autorisation de mise sur le marché par la FDA pour la famille de produits Morph® DNA™
5. Clôture d'un financement de 7,2 millions de dollars
Le focus de BioCardia demeure sur le développement de thérapies pour les maladies cardiovasculaires et pulmonaires, avec des priorités à court terme comprenant la finalisation des données de l'essai CardiAMP HF I pour la PMDA japonaise et la FDA, et le randomisation des premiers patients dans l'essai CardiAMP HF II.
BioCardia, Inc. [Nasdaq: BCDA] hat die volle Konformität mit den Zulassungsanforderungen des Nasdaq Capital Markets wiederhergestellt, wie Nasdaq am 17. September 2024 bestätigte. Dies folgt den erfolgreichen Bemühungen des Unternehmens, seine Bilanz zu verbessern, einschließlich der Beschaffung neuer Mittel. Zu den aktuellen Entwicklungen gehören:
1. FDA-Zulassung der Protokolländerung für die CardiAMP® Zelltherapie Herzinsuffizienz II
2. Abschluss des letzten Patienten in der CardiAMP Zelltherapie chronische Myokardischämie-Studie
3. Positives Pre-IND-Meeting für die Zelltherapie Helix™ Partner CellProthera
4. FDA-Marktzulassung für die Morph® DNA™ Produktfamilie
5. Abschluss einer Finanzierung über 7,2 Millionen Dollar
BioCardias Fokus liegt weiterhin auf der Entwicklung von Therapien für kardiovaskuläre und pulmonale Erkrankungen, wobei kurzfristige Prioritäten die Fertigstellung der Studienergebnisse der CardiAMP HF I-Studie für die japanische PMDA und die FDA sowie die Randomisierung der ersten Patienten in der CardiAMP HF II-Studie umfassen.
- Regained full compliance with Nasdaq Capital Market's Listing Requirements
- FDA approval of CardiAMP® Cell Therapy Heart Failure II protocol amendment
- Completion of last roll-in patient in CardiAMP Cell Therapy Chronic Myocardial Ischemia Trial
- FDA market clearance for Morph® DNA™ product family
- Successful $7.2M financing to support ongoing efforts
- None.
Insights
BioCardia's regaining of Nasdaq compliance is a positive development for the company's financial stability and investor confidence. The successful capital raise of
However, investors should note that while compliance is maintained, the company's financial position may still be precarious. The need for additional capital raises in the future is likely, given the ongoing clinical trials and product development efforts. The company's ability to continue meeting Nasdaq requirements will depend on its success in commercializing products and advancing its pipeline.
BioCardia's recent progress across multiple fronts is noteworthy. The FDA approval for the CardiAMP® Cell Therapy Heart Failure II protocol amendment, incorporating proprietary Cell Population Analysis screening, could potentially improve patient outcomes and trial success rates. The completion of patient enrollment in the Chronic Myocardial Ischemia Trial is also a significant milestone.
The positive pre-IND meeting for CellProthera's acute myocardial infarction therapy and FDA market clearance for the Morph® DNA™ product family demonstrate momentum in BioCardia's pipeline and partnerships. These advancements position the company well in the competitive cardiovascular and pulmonary therapeutics market. However, investors should remain cautious as clinical trial success and regulatory approvals are never guaranteed in this high-risk, high-reward sector.
SUNNYVALE, Calif., Sept. 18, 2024 (GLOBE NEWSWIRE) -- BioCardia, Inc. [Nasdaq: BCDA], a global leader in cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, announced today that the Company has regained full compliance with the Nasdaq Capital Market’s Listing Requirements as required by the Hearing Panel’s (the “Panel”) decision on May 13, 2024.
On September 17, 2024, BioCardia received notice from Nasdaq confirming that the Company has demonstrated compliance with Listing Rule 5550(b)(1) (the “Equity Rule”) of The Nasdaq Stock Market. Accordingly, the Panel has determined to continue the listing of the Company’s securities on the Nasdaq Stock Market and is closing this matter.
This confirmation follows the Company’s successful efforts to improve its balance sheet, including raising new capital to continue development of its therapeutic candidates and advance its approved products.
“It has been a busy past few weeks, with the FDA approving the CardiAMP® Cell Therapy Heart Failure II protocol amendment to use our proprietary Cell Population Analysis screening to define each patient’s treatment plan, the University of Wisconsin treating our last roll-in patient in the CardiAMP Cell Therapy Chronic Myocardial Ischemia Trial, Helix™ partner CellProthera having a positive pre-IND meeting with the FDA for their cell therapy in acute myocardial infarction, our securing FDA market clearance for our Morph® DNA™ product family, and our closing a
About BioCardia:
BioCardia, Inc., headquartered in Sunnyvale, California, is a global leader in cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary disease. 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.
Forward Looking Statements
This press release contains forward-looking statements that are subject to many risks and uncertainties. Forward-looking statements include, among other things, references to the Company’s investigational product candidates, the potential benefits of CardiAMP cell therapy for patients, enrollment in our clinical trials, future regulatory submissions and approvals, whether Helix partner CellProthera will advance their therapeutic development with BioCardia, and the potential market for the Company’s approved products. These forward-looking statements are made as of the date of this press release, and BioCardia assumes no obligation to update the forward-looking statements.
We may use terms such as “believes,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” “approximately” or other words that convey the uncertainty of future events or outcomes to identify these forward-looking statements. Although we believe that we have a reasonable basis for each forward-looking statement contained herein, we caution you that forward-looking statements are not guarantees of future performance and that our actual results may differ materially from the forward-looking statements contained in this press release as a result of one or more risk factors. As a result of these factors, we cannot assure you that the forward-looking statements in this press release will prove to be accurate. Additional factors that could materially affect actual results can be found in BioCardia’s Form 10-K filed with the Securities and Exchange Commission on March 27, 2024, under the caption titled “Risk Factors” and in its subsequently filed Quarterly Reports on Form 10-Q. BioCardia expressly disclaims any intent or obligation to update these forward-looking statements, except as required by law.
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