BioCardia Announces United States Patent Issuance on Morph DNA Multi-Directional Steerable Catheter Transseptal Application

Rhea-AI Summary

BioCardia, Inc. [Nasdaq: BCDA] has been granted U.S. Patent No. 12,036,371 for its Morph DNA multi-directional steerable catheter transseptal application. The patent, expiring in 2035, covers medical methods for transseptal access to the heart using steerable introducers based on BioCardia's Morph DNA technology. This innovation enhances shareholder value by protecting current and future products in the transseptal access systems market, which was valued at $941.3 million in 2022 and is projected to reach $2.1 billion by 2033.

The Morph DNA design allows for consistent catheter performance in any direction, preventing sudden jumps or 'whip' during procedures. BioCardia aims to provide or partner this solution for approximately 500,000 transseptal procedures performed annually in the United States, as well as other vascular access markets.

Positive

• Granted U.S. Patent No. 12,036,371 for Morph DNA multi-directional steerable catheter
• Patent protection extends until 2035
• Enhances shareholder value by protecting current and future products
• Targets transseptal access systems market projected to reach $2.1 billion by 2033
• Technology applicable to ~500,000 annual transseptal procedures in the U.S.

Negative

• None.

Medical Research Analyst

The issuance of a new patent for BioCardia's multi-directional steerable catheter technology is a significant milestone, particularly in the field of cardiovascular interventions. This multi-directional steerable catheter is designed to improve transseptal access to the heart, which is important for a variety of cardiac procedures such as atrial fibrillation ablation and percutaneous mitral valve repair. The technology's design to prevent 'whip' and provide consistent catheter performance in any direction can enhance procedural outcomes and patient safety.

From a medical research perspective, the patent protection until 2035 allows BioCardia to maintain a competitive edge and potentially leverage this specialty technology in broader applications beyond transseptal access. This could lead to new partnerships and collaborations, bolstering the company's research and development pipeline.

The potential impact on patient outcomes and procedural efficiency could also attract attention from leading cardiac centers, further validating the technology.

Financial Analyst

The announcement of BioCardia's patent issuance aligns well with the company's strategic objectives and could serve as a catalyst for increased investor interest. The exclusivity provided by the patent until 2035 ensures that BioCardia can capitalize on its innovative catheter technology without immediate competition, potentially leading to significant revenue streams.

Considering the current market for transseptal access systems, which was valued at $941.3 million in 2022 and is expected to grow at a CAGR of 7.3%, reaching $2.1 billion by 2033, BioCardia stands to benefit from this expanding market. Moreover, the company's assertion that all biotherapeutic interventions for conditions like heart failure and myocardial infarction will utilize this platform suggests a clear path for future product developments and revenue diversification.

Importantly, this patent strengthens BioCardia's intellectual property portfolio, potentially enhancing its market valuation and appeal to investors.

Market Research Analyst

The new patent for BioCardia’s Morph DNA multi-directional steerable catheter technology opens a broader market opportunity. The estimate that the global transseptal access systems market will grow to $2.1 billion by 2033 highlights the lucrative potential for BioCardia. Given the advanced features of the Morph DNA technology that address long-standing technical challenges in cardiac procedures, BioCardia is well-positioned to capture a significant market share.

Additionally, the inclusion of procedures such as atrial fibrillation ablation and PFO repair within the scope of this technology indicates a wide array of clinical applications. The company's intention to leverage this technology in other vascular access markets underscores its potential for cross-market utility and further revenue growth.

For investors, the patent signifies a robust entry barrier for competitors, ensuring that BioCardia remains a key player in the transseptal access and broader cardiovascular intervention markets. This strategic positioning can translate to sustained returns over the long term.

SUNNYVALE, Calif., July 17, 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: 12,036,371 titled “Method of Accessing the Left Atrium with a Multi-Directional Steerable Catheter,” with a patent term that will expire in 2035.

The present invention relates to medical methods for transseptal access to the heart using steerable introducers based on the Company’s Morph DNA technology. This additional patent protection for BioCardia’s current and future products in this important existing market enhances shareholder value.

Procedures that leverage transseptal delivery include atrial fibrillation ablation, patent foramen ovale (PFO) and atrial septal defect (ASD) repair, percutaneous mitral valve repair, left atrial appendage closure, and percutaneous left ventricular assist device placement, among others. Worldwide revenue from the transseptal access systems market was $941.3 million in 2022, with the global market estimated to expand at a Compound Annual Growth Rate of 7.3%, reaching $2.1 billion by the end of 2033⁽¹⁾.

Morph DNA designs enable the tensioning elements in the catheter to rotate around the catheter shaft, allowing consistent catheter performance in any direction. The DNA name reflects this design, as these tensioning elements appear as a double helix like that in a strand of DNA. This design is intended to enable smooth navigation and prevent “whip,” when the build-up of mechanical forces in the device causes a catheter to suddenly jump from one orientation to another.

“All of the biotherapeutic interventions we support for treatment of heart failure, refractory angina, and acute myocardial infarction going forward are expected to utilize this same introducer technology platform,” said Peter Altman, PhD, BioCardia’s President and Chief Executive Officer. “This is an elegant solution to a long-standing technical issue. The solution enhances the level of physician control in our procedures, and BioCardia is working to provide or partner this solution for the roughly five hundred thousand transseptal procedures performed in the United States each year, and for other vascular access markets that can benefit from the advantages our patented solution provides.”

About BioCardia^®

BioCardia, Inc., headquartered in Sunnyvale, California, is developing 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.

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 advantages of the Morph DNA design, and the potential transseptal access delivery vascular market for the Morph DNA steerable introducer product Family. 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.

(1) Persistence Market Research (2022). “Transseptal Access Systems Market Outlook (2023-2033).” New York, NY. Persistence Market Research Pvt. Ltd.

FAQ

What is the new patent granted to BioCardia (BCDA) for?

BioCardia (BCDA) has been granted U.S. Patent No. 12,036,371 for its Morph DNA multi-directional steerable catheter transseptal application, covering medical methods for transseptal access to the heart using steerable introducers based on the company's Morph DNA technology.

When does BioCardia's (BCDA) new patent expire?

BioCardia's (BCDA) new patent for the Morph DNA multi-directional steerable catheter transseptal application will expire in 2035.

What is the projected market size for transseptal access systems by 2033?

The global transseptal access systems market is projected to reach $2.1 billion by the end of 2033, growing at a Compound Annual Growth Rate of 7.3% from $941.3 million in 2022.

How many transseptal procedures are performed annually in the United States that BioCardia (BCDA) is targeting?

BioCardia (BCDA) is targeting approximately 500,000 transseptal procedures performed annually in the United States with its Morph DNA technology.