SUNNYVALE, Calif. - BioCardia, Inc. (NASDAQ:BCDA), a biotechnology firm specializing in therapies for cardiovascular and pulmonary conditions, announced today the issuance of a new patent by the United States Patent Office. The patent, numbered 11,986,611 and titled "Radial and Transendocardial Delivery Catheter," is set to expire in 2036.
This new patent covers medical methods and systems for delivering substances to the heart through the radial artery, a technique that involves threading cardiac catheters through a blood vessel in the wrist. This approach is gaining favor in cardiac centers globally due to its potential benefits, including reduced hospital stays and lower costs, as it typically allows patients to leave the hospital sooner with minimal aftercare.
The patent specifically relates to BioCardia's Helix system, currently the only known system with patented designs that can enable radial transendocardial biotherapeutic delivery. The system is used in ongoing clinical trials and is designed to deliver cellular aggregates to the heart. These aggregates are believed to have a therapeutic advantage due to enhanced retention, maximizing potential benefits.
However, the delivery of cell aggregates also poses risks, including the possibility of life-threatening strokes if they enter the ventricular chamber and travel to the brain. BioCardia's delivery systems aim to mitigate these risks by ensuring stable and secure engagement with heart tissue during the delivery process.
Dr. Peter Altman, CEO of BioCardia, stated that the Helix platform is fundamental to the company's cell therapy clinical programs and that the patent provides additional protection for their technology in the U.S. market. He emphasized the importance of this protection for the company's value creation and its potential to benefit millions of patients.
BioCardia's product candidates, including CardiAMP autologous and CardiALLO allogeneic cell therapies, are currently in clinical development. The company also partners with other biotherapeutic companies to provide its delivery systems and development support.
In other recent news, BioCardia, Inc. has announced its intention to execute a reverse stock split to meet Nasdaq's minimum bid price condition for continued listing. The reverse stock split, approved by stockholders and the Board of Directors, is set to be effective with a ratio of 1 post-split share for every 15 pre-split shares. This decision was taken as a strategic move to elevate the company's stock price above Nasdaq's minimum requirement.
In addition to the stock split, BioCardia has reported a mixed financial performance for Q1 2024, with revenue of $55,000 and a net loss of $2.3 million. However, the company's CardiAMP autologous cell therapy trials have shown significant risk reductions in heart failure-related events, which is promising news for the company's future.
BioCardia is also in discussions with Japanese regulatory authorities and potential partners for commercializing its therapies in Japan. The anticipated final results from clinical trials are expected to be ready for presentation and regulatory submission by Q4 2024.
InvestingPro Insights
As BioCardia, Inc. (NASDAQ:BCDA) continues to innovate in the field of cardiovascular and pulmonary therapies, recent data and analysis from InvestingPro provide a window into the company's financial health and market performance. According to InvestingPro, BioCardia is currently experiencing significant challenges, with a market capitalization of just 7.97 million USD. This underscores the scale of the company in the highly competitive biotech sector.
The company's financial metrics reveal a troubling picture, with a negative P/E ratio of -0.62, indicating that investors are concerned about the company's ability to generate future earnings. This is further highlighted by a negative Price/Book ratio of -3.5, suggesting that the market values the company at less than the net value of its assets. Additionally, BioCardia has seen a substantial revenue decline over the last twelve months as of Q1 2024, with a decrease of 65.49%, reflecting potential challenges in its operations or market demand.
InvestingPro Tips highlight several areas of concern for BioCardia, including a quick burn through cash and weak gross profit margins. The company also suffers from short term obligations exceeding liquid assets, which could pose liquidity risks. Analysts do not anticipate the company will be profitable this year, and the stock has taken a significant hit over the last six months, declining by 55.84%. Moreover, BioCardia does not pay a dividend to shareholders, which may limit its appeal to income-focused investors.
For those considering an investment in BioCardia or seeking a deeper analysis of the company's prospects, InvestingPro offers additional insights. There are currently 12 more InvestingPro Tips available for BioCardia, which can be accessed at: https://www.investing.com/pro/BCDA. These tips may provide valuable guidance for investors looking to make an informed decision. Additionally, users can take advantage of an exclusive offer by using the coupon code PRONEWS24 to get an additional 10% off a yearly or biyearly Pro and Pro+ subscription.
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