BioCardia Receives Two New U.S. Patents - Patents Cover Methods of Preparing Mesenchymal Stem Cell Therapy to Treat Heart Failure and Transradial Delivery of Biotherapeutic Agents to the Heart
September 14, 2018
SAN CARLOS, Calif. – BioCardia®, Inc. [OTC: BCDA], a leader in the development of comprehensive solutions for cardiovascular regenerative therapies, today announced the issuance of two United States patents.
U.S. Patent No. 10,035,982 relates to methods of preparing culture-expanded cells for the treatment of heart failure. The patent has broad claims on an approach for expanding mesenchymal stem cells in media derived from the blood of the same donor who has provided the source cells for culture expansion. In the patented method, a single donor provides the source cells for expansion of the targeted stem cells and blood over time to produce a donor-specific culture medium. The claimed method may provide a solution to the risks and potential immune reactions associated with cells manufactured utilizing culture media derived from animal and human sources.
As the second issued patent, U.S Patent No. 10,071,226 describes a system for delivery of biotherapeutic agents to the heart. The patent claims a catheter system which may be used to achieve heart access from the radial artery in a patient’s wrist and then advanced into a chamber of the heart to directly deliver biologic therapies. Such an approach may offer patients in the future the opportunity to receive cardiac cell therapy in an outpatient setting and return home immediately following the procedure with only a small bandage on their wrist. This system could reduce the cost of such therapies to the healthcare system and appeal to patients, physicians, hospital administrators and payors alike. In the future it could be integrated into the Company’s investigational CardiAMP and CardiALLO cell therapies, as well as other biologic agents in development with partners.
BioCardia remains active in securing patent protection and rights around its therapeutic development activities. In addition to the protection from its intellectual property portfolio, the Company has extensive nonexclusive patent rights related to BioCardia technology improvement inventions from collaborations.
"These two new patents contribute to our important intellectual property estate, and I congratulate the BioCardia staff and their collaborators on their inventions,” said BioCardia CEO Peter Altman, PhD. “Based on the positive early data from our ongoing pivotal CardiAMP Heart Failure Trial and previous data sets, we at BioCardia are optimistic that we may be the first to have an approved cardiac cell therapy in the United States. This potential therapy and other valuable therapeutic products being built on our many inventions may help millions of people. I thank all of those who enable us to work towards this mission each day.”
BioCardia, Inc., headquartered in San Carlos, California, is developing regenerative biologic therapies to treat cardiovascular disease. CardiAMP and CardiALLO cell therapies are the Company’s biotherapeutic product candidates in clinical development. The Company's current products include the Helix™ transendocardial delivery system and the Morph® steerable guide and sheath catheter portfolio. BioCardia also partners with other biotherapeutic companies to provide its Helix systems and clinical support to their programs studying therapies for the treatment of heart failure, chronic myocardial ischemia and acute myocardial infarction.
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, the efficacy and safety of our products and therapies, statements regarding our intentions, beliefs, projections, outlook, analyses or current expectations. Such factors include, among others, the inherent uncertainties associated with developing new products or technologies, regulatory approvals, unexpected expenditures, the ability to raise the additional funding needed to continue to pursue BioCardia’s business and product development plans and overall market conditions. We may find it difficult to enroll patients in our clinical trials, which could delay or prevent development of our therapeutic candidates. 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, and the development of the industry in which we operate may differ materially from the forward-looking statements contained in this presentation. Because 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 16, 2018, including those14 under the caption titled “Risk Factors.” BioCardia expressly disclaims any intent or obligation to update these forward-looking statements, except as required by law.
David McClung, Chief Financial Officer
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