SAN CARLOS, Calif., April 9, 2018 /PRNewswire/ -- BioCardia®, Inc., [OTC: BCDA] a leader in cardiovascular regenerative medicine, today announced the publication of the Phase III CardiAMP Heart Failure Trial design paper in the American Heart Journal.
Titled "The CardiAMP Heart Failure Trial: A Randomized Controlled Pivotal Trial of High Dose Autologous Bone Marrow Mononuclear Cells Using the CardiAMP Cell Therapy System in Patients with Post Myocardial Infarction Heart Failure: Trial Rationale and Study Design," the paper describes the ongoing 260-patient clinical trial being conducted in up to 40 centers in the U.S. It was authored by the team of world-class clinician scientists who comprise the steering committee for the trial.
Amish Raval, MD, associate professor of medicine at the University of Wisconsin School of Medicine and Public Health and lead author on the paper said, "This paper explains the rationale and methods behind the CardiAMP cell therapy pivotal trial, and points in the direction that there is a greater than 90 percent probability of success in meeting the primary endpoint. If indeed successful, the CardiAMP therapy has great potential to be a cost-effective heart failure treatment provided in a standard interventional cardiology setting."
The paper states, "The safety of the treatment approach combined with the improvements in 6MWD (Six Minute Walk Distance) and quality of life observed in the Phase I (TABMMI) and Phase II (TAC-HFT) trials provide compelling evidence to support further study of BM MNC (bone marrow mononuclear stem cell) treatment of patients with chronic heart failure due to ischemic heart disease (IHD)."
The paper points to several novel aspects of this trial. "The use of a Cell Potency Assay (CPA) to select patients who are more likely to yield therapeutic cells, the high effective dose of BM MNCs that will be injected (200 million target dose), and the point of care treatment approach are intended to maximize therapeutic efficacy, limit dose variability and improve treatment efficiency."
In addition, the paper states, "To achieve a high 'effective' cell dose, the CardiAMP study utilizes a helical injection catheter designed to maximize myocardial cell retention. Mitsutake et al. demonstrated acute retention of radiolabeled BM MNC was three-fold higher using the Helix catheter compared to straight needle injections."
The CardiAMP Cell Therapy System for the treatment of ischemic heart failure patients remains investigational and definitive conclusions on safety and efficacy cannot be made at this time.
About BioCardia®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 StatementsThis 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. As a result of these factors, we cannot assure you that the forward-looking statements in this presentation 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 under the caption titled "Risk Factors." BioCardia expressly disclaims any intent or obligation to update these forward-looking statements, except as required by law.
Investor Contact:David McClung, Chief Financial OfficerEmail: [email protected]Phone: 650-226-0120
Media Contact:David Schull / Alex XenakisEmail: [email protected] / [email protected] Phone: (212) 845-4271 / (212) 845-4226
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Titled "The CardiAMP Heart Failure Trial: A Randomized Controlled Pivotal Trial of High Dose Autologous Bone Marrow Mononuclear Cells Using the CardiAMP Cell Therapy System in Patients with Post Myocardial Infarction Heart Failure: Trial Rationale and Study Design," the paper describes the ongoing 260-patient clinical trial being conducted in up to 40 centers in the U.S. It was authored by the team of world-class clinician scientists who comprise the steering committee for the trial.
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Amish Raval, MD, associate professor of medicine at the University of Wisconsin School of Medicine and Public Health and lead author on the paper said, "This paper explains the rationale and methods behind the CardiAMP cell therapy pivotal trial, and points in the direction that there is a greater than 90 percent probability of success in meeting the primary endpoint. If indeed successful, the CardiAMP therapy has great potential to be a cost-effective heart failure treatment provided in a standard interventional cardiology setting."
The paper states, "The safety of the treatment approach combined with the improvements in 6MWD (Six Minute Walk Distance) and quality of life observed in the Phase I (TABMMI) and Phase II (TAC-HFT) trials provide compelling evidence to support further study of BM MNC (bone marrow mononuclear stem cell) treatment of patients with chronic heart failure due to ischemic heart disease (IHD)."
The paper points to several novel aspects of this trial. "The use of a Cell Potency Assay (CPA) to select patients who are more likely to yield therapeutic cells, the high effective dose of BM MNCs that will be injected (200 million target dose), and the point of care treatment approach are intended to maximize therapeutic efficacy, limit dose variability and improve treatment efficiency."
In addition, the paper states, "To achieve a high 'effective' cell dose, the CardiAMP study utilizes a helical injection catheter designed to maximize myocardial cell retention. Mitsutake et al. demonstrated acute retention of radiolabeled BM MNC was three-fold higher using the Helix catheter compared to straight needle injections."
The CardiAMP Cell Therapy System for the treatment of ischemic heart failure patients remains investigational and definitive conclusions on safety and efficacy cannot be made at this time.
About BioCardia®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 StatementsThis 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. As a result of these factors, we cannot assure you that the forward-looking statements in this presentation 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 under the caption titled "Risk Factors." BioCardia expressly disclaims any intent or obligation to update these forward-looking statements, except as required by law.
Investor Contact:David McClung, Chief Financial OfficerEmail: [email protected]Phone: 650-226-0120
Media Contact:David Schull / Alex XenakisEmail: [email protected] / [email protected] Phone: (212) 845-4271 / (212) 845-4226
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SOURCE BioCardia, Inc.
