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SUNNYVALE, Calif. - BioCardia Inc. (NASDAQ:BCDA), a company specializing in cellular and cell-derived therapeutics for cardiovascular and pulmonary diseases, announced today that it has been granted a new patent by the Japan Patent Office. The company, currently valued at $12 million in market capitalization, has shown strong momentum with a 20% return year-to-date according to InvestingPro data. The patent, number 7641330, covers the company’s minimally invasive catheter-based delivery systems for cell and gene-based therapies to the heart, with a term extending until at least September 30, 2034.
The newly issued patent describes BioCardia’s helical needle-tipped catheter technology, which is designed to deliver biotherapies directly to targeted sites within the heart. This method is intended to optimize treatment efficacy, minimize off-target effects, and eliminate the need for surgical access to the heart. According to the company, their Helix System is currently the only catheter-based intramyocardial delivery system in active clinical use.
BioCardia’s CEO, Dr. Peter Altman, stated that the performance of their delivery systems significantly enhances their clinical cell therapy candidates for treating ischemic cardiomyopathies. He also emphasized the importance of the Japanese market for these therapies, citing Japan’s commitment to supporting innovative cell therapy solutions and the development of its stem cell industry. InvestingPro analysis reveals that while the company maintains more cash than debt on its balance sheet, it is currently experiencing rapid cash burn - a critical factor for investors monitoring developmental biotech companies. Get access to 8 more exclusive InvestingPro Tips and comprehensive financial analysis through the Pro Research Report.
The company’s portfolio includes a range of issued patents and pending patent applications surrounding cell, exosome, and microRNA biotherapeutic candidates, as well as minimally invasive delivery platforms and advanced cardiac imaging technologies. These developments are part of BioCardia’s mission to create new treatments for patients with cardiovascular disease.
BioCardia’s press release also contained forward-looking statements regarding its investigational product candidates and delivery capabilities. However, the company noted that these statements are not guarantees of future performance and that actual results may differ. According to InvestingPro metrics, analysts anticipate sales decline in the current year, with the company not expected to achieve profitability. The stock currently trades above its Fair Value estimate, suggesting careful consideration is needed for potential investors.
This news is based on a press release statement from BioCardia, Inc. and has not been independently verified.
In other recent news, BioCardia, Inc. announced the completion of its Phase 3 CardiAMP Heart Failure study’s primary outcomes data verification and freezing process. The study, involving 115 randomized patients, is significant for being one of the largest ischemic heart failure of reduced ejection fraction patient cohorts in a randomized trial of autologous cell therapy. The results, which could indicate a meaningful therapeutic benefit, are expected to be presented at the American College of Cardiology 2025 Scientific Sessions. Concurrently, BioCardia has completed enrollment and dosing for the low-dose cohort in its Phase I/II trial of CardiALLO Allogeneic Mesenchymal Cell Therapy. This trial targets patients with ischemic heart failure with reduced ejection fraction and elevated markers of heart stress and systemic inflammation. The study aims to establish the safety and efficacy of this novel cell therapy, with the first independent safety review scheduled for March 2025. BioCardia’s CEO, Peter Altman, expressed confidence in the CardiALLO program, which may lead to pivotal clinical studies in the U.S. and conditional approval in Japan. Both the CardiAMP and CardiALLO programs are part of BioCardia’s efforts to advance its biotherapeutic platforms for cardiovascular diseases.
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