BioCardia Successfully Meets Nasdaq Compliance Standards

BioCardia Meets Nasdaq Compliance Standards

BioCardia, Inc. (NASDAQ: BCDA), recognized for its groundbreaking cellular and cell-derived therapeutics for cardiovascular and pulmonary diseases, has exciting news to share. The company announced that it has regained full compliance with the Nasdaq Capital Market's listing requirements after a thorough review by the Hearing Panel.

Details on the Compliance Announcement

On a recent date, BioCardia received an official notice from Nasdaq, confirming that it has adhered to the Listing Rule 5550(b)(1), also known as the Equity Rule. This monumental step ensures the continued listing of the Company’s securities on the Nasdaq Stock Market, allowing them to operate without any interruptions.

Recent Achievements and Developments

BioCardia's compliance announcement follows a series of successful efforts aimed at strengthening its financial position. The company raised new capital to support ongoing development projects for its therapeutic candidates and enhance its already approved products. These initiatives reflect a commitment to innovation and patient care in the medical field.

FDA Approvals and Clinical Trials

Recently, the company has achieved significant milestones, including the approval of the CardiAMP Cell Therapy Heart Failure II protocol amendment. This allows the use of their proprietary Cell Population Analysis screening method, which customizes each patient's treatment plan. Additionally, the University of Wisconsin has treated the last participant in the CardiAMP Cell Therapy Chronic Myocardial Ischemia Trial.

Collaborations and Future Plans

BioCardia is also bolstered by its partnerships, such as with Helix™ partner CellProthera, which has received favorable feedback from the FDA during a pre-IND meeting regarding their cell therapy for acute myocardial infarction. Furthermore, the company has obtained FDA market clearance for its Morph® DNA™ product line, marking a major step in its product offerings.

The Vision of BioCardia

Peter Altman, PhD, the President and CEO of BioCardia, expressed enthusiasm about the progress. He emphasized their dedication to developing innovative therapies for treating cardiovascular and pulmonary diseases. The company’s near-term objectives include finalizing the CardiAMP HF I trial data for regulatory review and initiating the randomization of patients in the confirmatory pivotal CardiAMP HF II trial.

About BioCardia

Headquartered in Sunnyvale, California, BioCardia is at the forefront of cellular and cell-derived therapeutic solutions. Their CardiAMP® autologous and CardiALLO™ allogeneic cell therapies represent cutting-edge biotherapeutic platforms currently in clinical development. These innovative therapies not only highlight BioCardia's commitment to pushing medical boundaries but also its dedication to patient-centric care.

Frequently Asked Questions

What does it mean for BioCardia to regain compliance with Nasdaq?

Regaining compliance means that BioCardia has met Nasdaq’s listing requirements, allowing it to continue trading its shares on the exchange without any disruptions.

What regulatory approvals has BioCardia received recently?

BioCardia has recently received approval for the CardiAMP Cell Therapy Heart Failure II protocol amendment and market clearance for the Morph® DNA™ product family.

What are BioCardia's main products?

BioCardia's main products include CardiAMP® and CardiALLO™ cell therapies for cardiovascular and pulmonary conditions, as well as the Morph® vascular navigation product platforms.

How is BioCardia planning to use its recent capital raise?

The raised capital will help BioCardia advance the development of its current therapeutic candidates and support its approved products in the marketplace.

Who can I contact for more information about BioCardia?

For media inquiries, contact Miranda Peto at 650-226-0120 or email mpeto@BioCardia.com. For investor-related questions, reach out to David McClung at the same number or email investors@BioCardia.com.

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