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BioCardia Announces United States Patent Issuance on Intramyocardial Delivery of Cell Aggregates to the Heart Including Minimally Invasive Radial Artery Approach

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BioCardia announces the issuance of a new U.S. patent for its radial and transendocardial delivery catheter, Patent No. 11,986,611, which will expire in 2036.

This patent pertains to methods and systems for delivering substances to the heart via the radial artery, enabling minimally invasive procedures.

The radial artery approach allows patients to leave the hospital soon after the procedure and significantly reduces overall healthcare costs.

BioCardia's Helix system, used in ongoing clinical trials, is the only known system capable of radial transendocardial biotherapeutic delivery and the new patent enhances its protection and value.

Therapeutic cell aggregates have potential advantages over single cell suspensions but also carry risks like strokes if they leak into the ventricular chamber.

BioCardia's delivery systems are designed to mitigate these risks by preventing leakage during the delivery process.

According to CEO Dr. Peter Altman, the patent issuance strengthens the company's technology and product offerings, benefiting both shareholders and patients.

Positive
  • Issued new U.S. patent No. 11,986,611 for radial and transendocardial delivery catheter, enhancing IP protection until 2036.
  • Radial artery delivery approach reduces hospital stays and healthcare costs, benefiting patients and healthcare providers.
  • BioCardia's Helix system is the only system capable of radial transendocardial biotherapeutic delivery, enhancing its market position.
  • Patent issuance protects and adds value to BioCardia's therapeutic programs and those of its partners.
  • The Helix platform supports ongoing clinical trials, advancing cell and gene-based therapies for cardiovascular diseases.
  • Stable and safe engagement design of BioCardia’s delivery systems aims to minimize risks of leakage and strokes during cell delivery.
Negative
  • Therapeutic cell aggregates carry a risk of potentially life-threatening strokes if leaked into the ventricular chamber.
  • The delivery of cell aggregates involves a 20% risk of obstruction in cerebral arteries, posing significant health risks.

BioCardia's new patent on the radial and transendocardial delivery catheter marks a significant milestone for the company. The radial artery approach for cardiac procedures is particularly noteworthy for its patient-friendly benefits. Patients can expect fewer complications and faster recovery times, which are critical factors in patient care and hospital efficiency.

This new patent not only reinforces BioCardia's intellectual property portfolio but also highlights their focus on innovative delivery methods for biotherapeutic agents. The patent's emphasis on cell aggregate delivery could lead to more effective treatments with higher retention rates in heart tissues, enhancing therapeutic outcomes for patients with cardiovascular diseases.

However, the potential risks associated with cell aggregates, such as life-threatening strokes, cannot be overlooked. It’s essential that BioCardia provides robust clinical data to ensure the safety and efficacy of their delivery systems. Investors should monitor the progress of these trials, as regulatory approval will hinge on demonstrating that the benefits outweigh the risks.

From a financial perspective, the issuance of this patent could positively impact BioCardia's valuation. Patents like these are valuable assets that can provide a competitive edge by safeguarding proprietary technology. This particular patent strengthens BioCardia’s position in the growing market of cellular and cell-derived therapeutics for cardiovascular diseases.

In the short term, the news may boost investor confidence and stock prices, given the added value and protection of their unique technology. In the long term, the financial benefits will largely depend on the commercial success of the Helix system and associated therapies. Successful clinical trials and subsequent market adoption will be key drivers of sustained revenue growth.

However, investors should be mindful of the costs associated with prolonged clinical trials and potential delays in commercialization. While the patent adds to the company’s intellectual property strength, realizing financial returns will depend on overcoming regulatory hurdles and establishing strong market demand.

SUNNYVALE, Calif., June 07, 2024 (GLOBE NEWSWIRE) -- BioCardia®, Inc. [Nasdaq: BCDA], a company focused on cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today announces that the Unites States Patent Office has granted Patent No: 11,986,611 titled “Radial and Transendocardial Delivery Catheter,” with a patent term that will expire in 2036.  

The present invention relates to medical methods and systems suitable for substance delivery to the heart via a radial artery and for the intracardiac delivery of cellular aggregates and other agglomerated materials.

Radial artery delivery is a means by which cardiac catheters are advanced through a blood vessel in a patient’s wrist to treat the heart. This approach has significant advantages for patients, enabling them to leave the hospital soon after the procedure with a band aid on their wrist and their arm in a simple sling, allowing them to immediately return to their active lives. In addition, a radial approach permits hospitals and other care centers to greatly reduce costs by eliminating the need for an overnight stay by the patient. For these reasons, trans-radial access is becoming the default approach in many cardiac centers worldwide. Enabling radial access has enormous potential advantages for biotherapeutic delivery to the heart.  

BioCardia’s Helix system, used in our ongoing clinical trials, is the only known system with patented designs that can enable radial transendocardial biotherapeutic delivery. The issued patent claims further protect this approach and add value to both BioCardia’s therapeutic programs and those of our biotherapeutic delivery partners.

Therapeutic cell aggregates have the potential advantage over single cell suspensions by enhancing retention in the heart to maximize therapeutic benefit. However, the delivery of cell aggregates carries greater risks of potentially life-threatening strokes should they leak into the ventricular chamber. As 20% of the blood in the heart chamber goes to the brain, 20% of any cell or cell aggregates released in the heart are expected to obstruct the first cerebral artery that is too small to allow the cell or cell aggregate to pass. The larger the cell aggregate, the larger the vessel they are capable of obstructing, with greater risk of a significant life-threatening stroke.

BioCardia’s delivery systems are designed to prevent leakage of therapeutic agents into the ventricular chamber by providing stable and safe engagement to the heart tissue during the delivery process. The issued patent claims further protect this design and add value to both BioCardia’s therapeutic programs and those of our biotherapeutic delivery partners.

“Our minimally invasive biotherapeutic delivery platforms enable the successful development of cell and gene-based therapies for the heart,” said Dr. Peter Altman, BioCardia CEO. “The Helix platform underlies BioCardia’s cell therapy clinical programs and this recent patent issuance provides additional protection to our technology and product offerings in the United States for at least another dozen years. This is just one of many patent applications we are advancing to protect our value creation for the benefit of shareholders, which in turn enables these advances to be supported for expected benefit to millions of patients.”

About BioCardia®

BioCardia, Inc., headquartered in Sunnyvale, California, is developing cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases. CardiAMP™ autologous and CardiALLO allogeneic cell therapies are the Company’s biotherapeutic platforms in three clinical stage product candidates in development. BioCardia also partners with other biotherapeutic companies to provide its delivery systems and development support to their programs. For more information visit: www.BioCardia.com.

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 benefits and risks of cell aggregates, the benefits of radial artery access, the level and duration of patent protection that the Company’s patents provide to its product candidates, and the expected safety of BioCardia’s delivery device designs. 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 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.


FAQ

What new patent did BioCardia announce?

BioCardia announced the issuance of U.S. Patent No. 11,986,611 for its radial and transendocardial delivery catheter.

What is the significance of BioCardia's new patent?

The new patent protects BioCardia's radial and transendocardial delivery method, enhancing IP protection and adding value to their therapeutic programs until 2036.

How does BioCardia's radial artery approach benefit patients?

BioCardia's radial artery approach allows patients to leave the hospital soon after the procedure, reducing healthcare costs and enabling a quicker return to daily activities.

What system does BioCardia use for radial transendocardial biotherapeutic delivery?

BioCardia uses the Helix system for radial transendocardial biotherapeutic delivery, which is protected by the new patent.

What are the risks associated with the delivery of cell aggregates?

The delivery of cell aggregates carries risks of potentially life-threatening strokes if they leak into the ventricular chamber.

What measures does BioCardia take to mitigate the risks of cell aggregate delivery?

BioCardia's delivery systems are designed to prevent leakage of therapeutic agents into the ventricular chamber, minimizing stroke risks.

How long will BioCardia's new patent last?

BioCardia's new patent will last until 2036.

BioCardia, Inc.

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