BioCardia, Inc 8-K, filed Jul 15, 2021
BioCardia, Inc. (BCDA)
About this 8-K
BioCardia, Inc filed this 8-K on July 15, 2021.
Items reported
- Item 8.01: Other events
- Item 9.01: Financial statements and exhibits
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 OR 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): July 15, 2021
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BIOCARDIA, INC. |
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(Exact name of registrant as specified in its charter) |
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Delaware |
0-21419 |
23-2753988 |
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(State or other jurisdiction of incorporation) |
(Commission File Number) |
(IRS Employer Identification No.) |
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125 Shoreway Road, Suite B |
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(Address of principal executive offices and zip code) |
Registrant’s telephone number, including area code: (650) 226-0120
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
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☐ |
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
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Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities registered pursuant to Section 12(b) of the Act:
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Title of each class |
Trading Symbol(s) |
Name of each exchange on which registered |
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Common Stock, par value $0.001 |
BCDA |
The Nasdaq Capital Market |
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Warrant to Purchase Common Stock |
BCDAW |
The Nasdaq Capital Market |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (17 CFR §230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR §240.12b-2 of this chapter) ☐
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item 8.01 Other Events.
On July 15, 2021, BioCardia, Inc. (the “Company”) issued a press release announcing that the Japan patent office has granted Patent No. 6887216 titled “Target Site Selection, Entry, and Update With Automatic Remote Image Annotation” with a patent term that will expire on January 8, 2034. The patent claims a system for fluoroscopic imaging of a patient’s heart and means for registering and transposing a three-dimensional image of the heart onto two orthogonal, two-dimensional images, which can be marked to show anatomical details as well as treatment planning information in the preoperative three-dimensional image. This new patent is anticipated to strengthen the protection of BioCardia efforts with respect to its cardiovascular therapeutic approaches already afforded by issued patents. A copy of the press release is attached hereto as Exhibit 99.1 to this current report on Form 8-K and is incorporated herein by reference.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
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Exhibit No. |
Description |
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99.1 |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
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BIOCARDIA, INC. |
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/s/ Peter Altman, Ph.D. |
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Peter Altman, Ph.D. |
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President and Chief Executive Officer |
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Date: July 15, 2021 |
Exhibit 99.1
FOR IMMEDIATE RELEASE
BioCardia Announces Japanese Patent on Imaging System for Targeting Cardiac Therapies
July 15, 2021
SAN CARLOS, Calif. – 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 Japan Patent Office has granted Patent No: 6887216 titled, “Target Site Selection, Entry, and Update With Automatic Remote Image Annotation” with a patent term that will expire on January 8, 2034.
“This patent describes advances for image guided delivery of treatments for the heart, describing how procedures using interventional biotherapeutic delivery technologies to deliver biologics to specific target sites in the heart may be expected to be performed in the near future. The patented imaging system is designed to enable physicians to bring a previously obtained three-dimensional image of a patient’s heart from either MRI or CT scan into a procedure, predefine target sites and annotate the heart images to prepare for therapeutic intervention, and then deliver therapy to these target sites in a controlled fashion,” said Dr. Peter Altman, BioCardia CEO.
The patent claims a system for fluoroscopic imaging of a patient’s heart and means for registering and transposing a three-dimensional image of the heart onto two orthogonal, two-dimensional images which can be marked to show anatomical details as well as treatment planning information in the preoperative three-dimensional image. This new patent is anticipated to strengthen the protection of BioCardia efforts with respect to its cardiovascular therapeutic approaches already afforded by issued patents.
“This patent is a continued demonstration of our ongoing innovation in cardiovascular therapeutic development. We believe the imaging product described by this new patent, our transendocardial biotherapeutic delivery products, and our steerable vascular access technologies have significant value for physicians, patients, and partners in their own right as well as for enabling and enhancing our therapeutics under development,” added Dr. Altman.
BioCardia’s cardiac biotherapeutics under development include (1) the CardiAMP® autologous cell therapy in ischemic heart failure that has just had a positive independent data safety monitoring board review and randomized its 102nd patient, (2) the CardiAMP autologous cell therapy in chronic myocardial ischemia that has consented its first patient, and (3) the CardiALLO™ Neurokinin 1 receptor positive allogenic cell therapy which is awaiting final test results from its manufacturing validation runs.
About BioCardia®
BioCardia, Inc., headquartered in San Carlos, California, is developing cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary disease. CardiAMP™ autologous and NK1R+ allogeneic cell therapies are the Company’s biotherapeutic product candidates in clinical development. The Company's current products include the Helix™ transendocardial delivery system, the Morph® steerable guide and sheath catheter portfolio and the AVANCE™ steerable introducer family. BioCardia also partners with other biotherapeutic companies to provide its Helix systems and development 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, references to the protection provided by BioCardia patent applications and patents, enrollment in our pivotal trials, and the availability and use of new imaging technologies to enhance cardiovascular intervention. 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 30, 2021, under the caption titled “Risk Factors.” BioCardia expressly disclaims any intent or obligation to update these forward-looking statements, except as required by law.
Media Contact:
Anne Laluc, Marketing
Email: alaluc@biocardia.com
Phone: 650-226-0120
Investor Contact:
David McClung, Chief Financial Officer
Email: investors@BioCardia.com
Phone: 650-226-0120