BioCardia Receives CE Mark Renewal for Helix Biotherapeutic Delivery Catheter and Morph Guide Catheter Through May 2024
October 08, 2019
SAN CARLOS, Calif. – BioCardia (Nasdaq: BCDA), a leader in the development of comprehensive solutions for cardiovascular regenerative therapies, today announced renewal of the CE Mark for the Helix™ Biotherapeutic Delivery Catheter and Morph® Universal Deflectable Guide Catheter, both used in the delivery of biotherapeutics to the heart. CE Mark renewal enables BioCardia to continue supporting partners conducting biotherapeutic clinical trials outside of the U.S., such as CellProThera and Centro Cardiologico Monzino, as well as commercial sales in the European Union and other countries that recognize the CE Mark through May 2024.
“Renewal of the CE Mark for our innovative biotherapeutic delivery products ensures that we can continue participating in a variety of biotherapeutic research programs with the potential to drive the field forward and respond to very ill patients,” said BioCardia CEO Peter Altman.
“In light of sweeping European regulatory changes associated with the transition from the MDD directive to the new MDR regulation, it has been a challenging time for both notified bodies, who are working to become certified to grant CE Mark under the new system, and for companies, who are trying to meet the new requirements and move their CE Mark applications forward. It is a significant achievement for BioCardia to have received CE Mark renewal in this environment, when many other companies are struggling to do the same or even abandoning the region.”
Published literature has shown that the Helix™ Biotherapeutic Delivery System - which includes the Morph guide product - presents the lowest risk to patients for biotherapeutic delivery compared to other delivery methods evaluated[i], and is three to six times more efficient at delivering cells to the heart muscle than other methods[ii]. The Helix system is currently being evaluated in the U.S. Phase III pivotal CardiAMP™ Heart Failure Trial along with the company’s lead cell therapy candidate (CardiAMP™)[iii], which uses a patient’s own (autologous) bone marrow cells delivered to the heart in a minimally-invasive procedure to potentially stimulate the body’s natural healing response.
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™ Biotherapeutic Delivery System and the Morph® steerable guide and sheath catheter portfolio, including the new AVANCE™ Steerable Introducer family. 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 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. 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 press release will prove to be accurate. Additional factors that could materially affect actual results can be found in BioCardia’s Form 10-Q filed with the Securities and Exchange Commission on August 9, 2019, 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.
[ii] Mitsutake Y, Pyum WB, Rouy D, Wong Po Foo C, Stertzer SH, Altman P, Ikeno F. Improvement of local cell delivery using Helix Transendocardial Delivery Catheter in a porcine heart. Int Heart J. 2017.
[iii] Raval AN, Cook TD, Duckers HJ, Johnston PV, Traverse JH, Abraham WT, Altman PA, Pepine CJ. 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, American Heart Journal 201 (2018) 141–148.
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