SEC Comment Letter for BioCardia, Inc. (BCDA) (CIK 0000925741) (BCDA) — Nov 25, 2019
BioCardia, Inc. (BCDA) (CIK 0000925741)
Date: Nov. 25, 2019 · CIK: 0000925741 · Accession: 0000000000-19-015835
AI Filing Summary & Sentiment
Reasoning
File numbers found in text: 000-21419
Letter
November 25, 2019 David McClung Chief Financial Officer BioCardia, Inc. 125 Shoreway Road, Suite B San Carlos, California 94070 Re:BioCardia, Inc. Form 10-K for the Fiscal Year Ended December 31, 2018 Filed April 2, 2019 File No. 000-21419 Dear Mr. McClung: We have reviewed your filing and have the following comment. In our comment, we may ask you to provide us with information so we may better understand your disclosure. Please respond to the comment within ten business days by providing the requested information or advise us as soon as possible when you will respond. If you do not believe our comment applies to your facts and circumstances, please tell us why in your response. After reviewing your response to the comment, we may have additional comments. Form 10-K for the Fiscal Year Ended December 31, 2018 ITEM 1. BUSINESS Cell Processing and Cell Delivery Product Platforms, page 6 1.You disclose that you "believe the Helix biotherapeutic delivery system is the world's safest and most efficient platform for cardiac therapeutic delivery." Although you disclose the Helix system has received regulatory approval for commercial use in Europe, it has only received FDA approval for investigational use in the United States. Because the Helix system has not received marketing approval from the FDA, it is premature to suggest or imply that it is safe or effective. Please provide to us draft disclosure for future periodic filings revising this or other similar statements accordingly. We remind you that the company and its management are responsible for the accuracy and adequacy of their disclosures, notwithstanding any review, comments, action or absence of action by the staff.
FirstName LastNameDavid McClung Comapany NameBioCardia, Inc. November 25, 2019 Page 2 FirstName LastName David McClung BioCardia, Inc. November 25, 2019 Page 2 You may contact Rolf Sundwall at 202-551-3105 or Sasha Parikh at 202-551-3627 if you have questions. Sincerely, Division of Corporation Finance Office of Life Sciences
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November 25, 2019
David McClung
Chief Financial Officer
BioCardia, Inc.
125 Shoreway Road, Suite B
San Carlos, California 94070
Re:BioCardia, Inc.
Form 10-K for the Fiscal Year Ended December 31, 2018
Filed April 2, 2019
File No. 000-21419
Dear Mr. McClung:
We have reviewed your filing and have the following comment. In our comment, we
may ask you to provide us with information so we may better understand your disclosure.
Please respond to the comment within ten business days by providing the requested
information or advise us as soon as possible when you will respond. If you do not believe our
comment applies to your facts and circumstances, please tell us why in your response.
After reviewing your response to the comment, we may have additional comments.
Form 10-K for the Fiscal Year Ended December 31, 2018
ITEM 1. BUSINESS
Cell Processing and Cell Delivery Product Platforms, page 6
1.You disclose that you "believe the Helix biotherapeutic delivery system is the world's
safest and most efficient platform for cardiac therapeutic delivery." Although you
disclose the Helix system has received regulatory approval for commercial use in Europe,
it has only received FDA approval for investigational use in the United States. Because
the Helix system has not received marketing approval from the FDA, it is premature to
suggest or imply that it is safe or effective. Please provide to us draft disclosure for future
periodic filings revising this or other similar statements accordingly.
We remind you that the company and its management are responsible for the accuracy
and adequacy of their disclosures, notwithstanding any review, comments, action or absence of
action by the staff.
FirstName LastNameDavid McClung
Comapany NameBioCardia, Inc.
November 25, 2019 Page 2
FirstName LastName
David McClung
BioCardia, Inc.
November 25, 2019
Page 2
You may contact Rolf Sundwall at 202-551-3105 or Sasha Parikh at 202-551-3627 if you
have questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences