BioCardia Announces FDA Market Clearance of Morph® DNA™ Steerable Introducer Product Family

BioCardia Announces FDA Market Clearance of Morph® DNA™ Steerable Introducer Product Family

August 29, 2024

BioCardia, Inc. [Nasdaq: BCDA], a global leader in cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, announced today that the Food and Drug Administration (FDA) has cleared BioCardia to market the Morph DNA Steerable Introducer product family, subject to the general controls provisions of the Federal Food, Drug, and Cosmetic Act.

The patented Morph® DNA™ Steerable Introducer product family now has FDA market clearance to provide a pathway through which medical instruments, such as balloon dilatation catheters, guidewires, or other therapeutic devices, may be introduced into the peripheral vasculature or chambers and coronary vasculature of the heart. The clearance covers sixteen products in lengths of 30, 45, 71, and 90 centimeters in 5, 6, 7, and 8 French introducer sheath equivalent diameters.

These products are expected to cover most clinical applications in interventional cardiology, interventional radiology, cardiac electrophysiology, and vascular surgery. The product solution is also expected to enhance some of the most common and advanced procedures performed in the United States, including peripheral vascular intervention for contralateral access, renal denervation for the treatment of high blood pressure, endovascular aortic repair, carotid artery stenting, treating perivalvular leaks in structural heart procedures, and enabling left heart access for the mapping and ablation of atrial fibrillation.

"BioCardia's previous Morph product in a single diameter has already been used in each of these various clinical indications, totaling approximately 12,000 commercial procedures," said Peter Altman PhD, President and CEO. He continued, "We are looking forward to introducing the more advanced Morph DNA products to our valued physician customers and earning their business. Over time, I expect this product family to provide value to physicians and their patients. We estimate that more than a million procedures performed per year in the United States may benefit from these products, which are expected to have a list price starting at $1,000."

"We developed this product initially to address our own needs for enhanced control navigating inside the left ventricle of the heart to perform our CardiAMP® and CardiALLO™ cell therapy procedures, and this Morph DNA product family is the outcome of our belief that there are additional advanced interventional procedures where the Morph DNA platform could provide physicians with improved access and control, resulting in reduced procedure times, access to new or difficult to reach anatomies, and predictable and reliable performance for their patients," said Edward Gillis, BioCardia's Senior Vice President of Devices.

The Morph DNA steerable introducer family has bidirectional steering, a proprietary layup for torque response, ergonomic actuation, an adjustable brake for fine control, and a swiveling side port in its hemostasis valve to solve tangling issues and enhance procedures. Morph DNA designs contain tensioning elements in the catheter that rotate around the catheter shaft, allowing consistent catheter performance in any direction. The DNA name reflects this design, as these tensioning elements resemble the double helix 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.

About BioCardia

BioCardia, Inc., headquartered in Sunnyvale, California, is a global leader in 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.

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 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 one or more risk factors. 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.

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