0000000000-19-013879.txt : 20200323 0000000000-19-013879.hdr.sgml : 20200323 20190924111042 ACCESSION NUMBER: 0000000000-19-013879 CONFORMED SUBMISSION TYPE: UPLOAD PUBLIC DOCUMENT COUNT: 2 FILED AS OF DATE: 20190924 FILED FOR: COMPANY DATA: COMPANY CONFORMED NAME: Ra Medical Systems, Inc. CENTRAL INDEX KEY: 0001716621 STANDARD INDUSTRIAL CLASSIFICATION: SURGICAL & MEDICAL INSTRUMENTS & APPARATUS [3841] IRS NUMBER: 383661826 FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: UPLOAD BUSINESS ADDRESS: STREET 1: 2070 LAS PALMAS DRIVE CITY: CARLSBAD STATE: CA ZIP: 92011 BUSINESS PHONE: (760) 804-1648 MAIL ADDRESS: STREET 1: 2070 LAS PALMAS DRIVE CITY: CARLSBAD STATE: CA ZIP: 92011 PUBLIC REFERENCE ACCESSION NUMBER: 0001564590-19-007905 LETTER 1 filename1.pdf begin 644 filename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Form 10-K For the Fiscal Year Ended December 31, 2018 Filed March 15, 2019 Form 8-K filed August 12, 2019 File No. 001-38677 Dear Mr. Jackson: We have limited our review of your filing to the financial statements and related disclosures and have the following comments. In some of our comments, we may ask you to provide us with information so we may better understand your disclosure. Please respond to these comments 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 comments apply to your facts and circumstances, please tell us why in your response. After reviewing your response to these comments, we may have additional comments. Form 8-K filed August 12, 2019 Item 7.01 Regulation FD Disclosure Independent Investigation 1. We see that the Audit Committee of the Board of Directors has commenced an independent investigation into an anonymous complaint. Please clearly describe to us the allegations made in the anonymous complaint, the circumstances which lead to the investigation and the issues being investigated by the Audit Committee. Based on your current understanding of the allegations and the investigation to date, tell us the areas of your accounting or disclosure that could be impacted (e.g., revenues, impairments, contingencies, etc.). In addition, describe to us your considerations to date of your obligations under Item 4.02 of Form 8-K. 2. Please tell us when you intend to file your Form 10-Q for the quarterly period ended June 30, 2019. Andrew Jackson Ra Medical Systems, Inc. September 24, 2019 Page 2 Exhibit 99.1 Manufacturing Update 3. We note you disclose here that you experienced inconsistencies in the DABRA catheter manufacturing process and that it had an adverse impact on revenue during the fourth quarter of 2018 and the first half of 2019. We also note discussions in your Form 10-K and Form 10-Q of production limitations within MD&A. Please address the following: Bridge the gap between these two disclosures and clarify the specific manufacturing issues encountered and, to the extent possible, the specific impact on your financial statements for the referenced periods. Describe how you account for the catheters within your financial statement and clearly articulate your accounting policies for catheter impairment and/or warranty claims. In closing, 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. You may contact Eric Atallah at (202) 551-3663 or Kevin Kuhar, Accounting Branch Chief, at (202) 551-3662 with any questions. FirstName LastNameAndrew Jackson Sincerely, Comapany NameRa Medical Systems, Inc. Division of Corporation Finance September 24, 2019 Page 2 Office of Electronics and Machinery FirstName LastName