BioCardia, Inc 8-K, filed Dec 1, 2020
BioCardia, Inc. (BCDA)
About this 8-K
BioCardia, Inc filed this 8-K on December 1, 2020.
Items reported
- Item 7.01: Regulation FD disclosure
- 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): December 1, 2020
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BIOCARDIA, INC. |
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(Exact name of registrant as specified in its charter) |
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Delaware |
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0-21419 |
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23-2753988 |
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(State or other jurisdiction of incorporation) |
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(Commission File Number) |
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(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) |
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Registrant’s telephone number, including area code: (650) 226-0120
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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:
☐ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
☐ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
☐ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
☐ 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 |
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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 7.01 | Regulation FD Disclosure. |
Today, December 1, 2020, BioCardia, Inc. (the “Company”) has issued a press release announcing that the Company’s proprietary Helix Biotherapeutic Delivery System demonstrated the best safety profile among clinical transendocardial catheter injection systems used for cardiac cell therapy delivered in an in-press corrected proof published in the journal, Cardiovascular Revascularization Medicine. The Helix system is being used in the pivotal Phase III CardiAMP Heart Failure Trial currently enrolling nationwide for infusion of BioCardia’s CardiAMP cell therapy to the Myocardium. A copy of the press release is attached as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated by reference herein.
The information furnished pursuant to this Item 7.01, including Exhibit 99.1 hereto, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities under that section, nor shall it be deemed to be incorporated by reference in any filing made by the Company under the Securities Act of 1933, as amended, or the Exchange Act, except as otherwise expressly set forth by specific reference in such filing.
| Item 9.01. | Financial Statements and Exhibits. |
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(d) Exhibits |
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Exhibit No. |
Exhibit Description |
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99.1 |
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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: December 1, 2020 |
Exhibit 99.1
For Immediate Release
Published Study Shows Helix Biotherapeutic Delivery System used in CardiAMP Phase III Heart Failure Trial has Fewest Adverse Events Among Competitive Delivery Systems
SAN CARLOS, Calif. – December 01, 2020 - BioCardia®, Inc. [Nasdaq: BCDA] today announced that the Company’s proprietary Helix Biotherapeutic Delivery System (the Helix System) demonstrated the best safety profile among clinical transendocardial catheter injection systems used for cardiac cell therapy delivery in an in-press corrected proof published in the journal, Cardiovascular Revascularization Medicine. The Helix System is being used in the pivotal Phase III CardiAMP Heart Failure Trial currently enrolling nationwide for infusion of BioCardia’s CardiAMP cell therapy to the myocardium.
The study, which can be accessed here1, analyzed clinical trials encompassing 1,789 patients that underwent transendocardial injections using either a helical needle (BioCardia’s Helix System), or one of three other clinical use designs developed by BioCardia competitors: an electro-anatomically tracked straight needle, a straight needle without tracking elements, or a curved needle. The paper titled, “Clinical safety profile of transendocardial catheter injection systems: a plea for uniform reporting,”1 was authored by Amish N. Raval, MD, of the University of Wisconsin and Carl J. Pepine, MD, of the University of Florida.
The article reported the combined transendocardial injection-associated serious adverse event (SAE) rate was 3.4% across all four catheters, with the Helix System demonstrating the lowest SAE rate of only 1.1%. The next-closest delivery system had three times as many reported adverse events as the Helix System, with one system having 8.3 times as many adverse events as the Helix System.
In the paper, the authors concluded,“the helical needle designed catheter is associated with a particularly low reported rate of death, myocardial infarction, stroke, cardiac perforation causing death or requiring surgical or percutaneous evacuation, serious arrhythmia, and vascular complications.”
“This rigorous, independent review of the scientific literature follows earlier data showing that Helix has the lowest risk to patients2 and most efficient cell delivery3 compared to other leading delivery routes evaluated. Having the safest and highest performance delivery platform enhances the probability that our clinical cell therapy programs will become valuable therapies for millions of patients suffering from cardiac disease,” said BioCardia Chief Executive Officer Peter Altman.
About BioCardia®
BioCardia, Inc., headquartered in San Carlos, California, is developing autologous and allogenic cell-based therapies to treat cardiovascular disease. CardiAMP™ and CardiALLO™ cell therapies are the Company’s biotherapeutic product candidates in clinical development. The Company has also developed a portfolio of approved enabling products that optimize delivery of its cell therapies.
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 safety and efficiency of cell delivery using the Company’s delivery systems.
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 our documents filed with the SEC, including our recent filings on Form 8-K, Form 10-K and Form 10-Q, particularly any statements under the caption entitled “Risk Factors” Therein.” BioCardia expressly disclaims any intent or obligation to update these forward-looking statements, except as required by law.
References
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1. |
Raval AN, Pepine CJ. Clinical safety profile of transendocardial catheter injection systems: A plea for uniform reporting. Cardiovascular Revascularization Medicine https://www.sciencedirect.com/science/article/pii/S1553838920304164?via%3Dihub. |
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2. |
Duckers HJ, et al. Performance of Helix transendocardial biotherapeutic delivery system after 300 cases, Transcatheter Therapeutics, San Diego 2018. |
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3. |
Mitsutake Y, et al. Improvement of local cell delivery using Helix Transendocardial Delivery Catheter in a porcine heart. Int Heart J. 2017. |
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Media Contact:
Michelle McAdam, Chronic Communications, Inc.
Email: michelle@chronic-comm.com
Phone: 310-902-1274
Investor Contact:
David McClung, Chief Financial Officer
Email: investors@BioCardia.com
Phone: 650-226-0120