0000000000-24-013331.txt : 20250226 0000000000-24-013331.hdr.sgml : 20250226 20241203173606 ACCESSION NUMBER: 0000000000-24-013331 CONFORMED SUBMISSION TYPE: UPLOAD PUBLIC DOCUMENT COUNT: 2 FILED AS OF DATE: 20241203 FILED FOR: COMPANY DATA: COMPANY CONFORMED NAME: EBR Systems, Inc. CENTRAL INDEX KEY: 0001347123 STANDARD INDUSTRIAL CLASSIFICATION: SURGICAL & MEDICAL INSTRUMENTS & APPARATUS [3841] ORGANIZATION NAME: 08 Industrial Applications and Services IRS NUMBER: 571164669 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: UPLOAD SEC FILE NUMBER: 000-56671 BUSINESS ADDRESS: STREET 1: 480 OAKMEAD PARKWAY CITY: SUNNYVALE STATE: CA ZIP: 94085 BUSINESS PHONE: 408 720-1906 MAIL ADDRESS: STREET 1: 480 OAKMEAD PARKWAY CITY: SUNNYVALE STATE: CA ZIP: 94085 FORMER COMPANY: FORMER CONFORMED NAME: EBR Systems Inc DATE OF NAME CHANGE: 20051216 PUBLIC REFERENCE ACCESSION NUMBER: 0001214659-24-013104 LETTER 1 filename1.pdf begin 644 filename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filename2.txt December 3, 2024 John McCutcheon Chief Executive Officer EBR Systems, Inc. 480 Oakmead Parkway Sunnyvale, CA 94085 Re: EBR Systems, Inc. Amendment No. 3 to Registration Statement on Form 10-12G Filed November 21, 2024 File No. 000-56671 Dear John McCutcheon: We have reviewed your filing and have the following comment. Please respond to this letter 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 a comment applies to your facts and circumstances, please tell us why in your response. After reviewing your response to this letter, we may have additional comments. Form 10-12G/A No. 3 filed November 21, 2024 Interim Financial Statements Pre-launch inventory, page F-37 1. We note that during the three months ended September 30, 2024 you have begun to capitalize certain pre-launch inventory. Please expand your disclosure herein, or within your Critical Accounting Estimates on page 75, to provide the following additional disclosures: Specifically identify the point during the FDA approval process that you determined a probable future benefit existed and the status of the FDA s consideration of the safety and efficacy of the system and evaluation of the manufacturing process at that point. Identify the risks and uncertainties surrounding market acceptance of the system once approved and how this will affect the realization of the asset. December 3, 2024 Page 2 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. Please contact Tayyaba Shafique at 202-551-2110 or Jeanne Baker at 202-551-3691 if you have questions regarding comments on the financial statements and related matters. Please contact Nicholas O'Leary at 202-551-4451 or Lauren Nguyen at 202-551- 3642 with any other questions. Sincerely, Division of Corporation Finance Office of Industrial Applications and Services cc: John Sellers, Esq.