0000000000-21-006591.txt : 20210722 0000000000-21-006591.hdr.sgml : 20210722 20210525173016 ACCESSION NUMBER: 0000000000-21-006591 CONFORMED SUBMISSION TYPE: UPLOAD PUBLIC DOCUMENT COUNT: 2 FILED AS OF DATE: 20210525 FILED FOR: COMPANY DATA: COMPANY CONFORMED NAME: Miromatrix Medical Inc. CENTRAL INDEX KEY: 0001527096 STANDARD INDUSTRIAL CLASSIFICATION: BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES) [2836] IRS NUMBER: 271285782 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: UPLOAD BUSINESS ADDRESS: STREET 1: 10399 WEST 70TH STREET CITY: EDEN PRAIRIE STATE: MN ZIP: 55344 BUSINESS PHONE: (612)202-7026 MAIL ADDRESS: STREET 1: 10399 WEST 70TH STREET CITY: EDEN PRAIRIE STATE: MN ZIP: 55344 LETTER 1 filename1.pdf begin 644 filename1 M)5!$1BTQ+C4*)>+CS],*,2 P(&]B:@H\/"]#;VQO7!E+UA/8FIE8W0O5VED=&@@,30R."],96YG=&@@,S8U+T)I='-097)# M;VUP;VYE;G0@.#X^7M0Q1$1$1$1$1&3"Q\<'QA6_?__&K *98K_? 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Amendment No. 1 to Draft Registration Statement on Form S-1 Submitted May 6, 2021 CIK No. 0001527096 Dear Mr. Ross: We have reviewed your amended draft registration statement 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 this letter by providing the requested information and either submitting an amended draft registration statement or publicly filing your registration statement on EDGAR. If you do not believe our comments apply to your facts and circumstances or do not believe an amendment is appropriate, please tell us why in your response. After reviewing the information you provide in response to these comments and your amended draft registration statement or filed registration statement, we may have additional comments. Amendment No. 1 to Draft Registration Statement on Form S-1 Business Overview of the Decellularization and Recellularization Processes, page 79 1. We note your response to prior comment 13. Please revise your disclosure in the second paragraph on page 80 to reference whether the studies described in your disclosure were conducted using human organ matrices or animal organ matrices. Jeff Ross Miromatrix Medical Inc. May 25, 2021 Page 2 Pursuing an Efficient Regulatory Pathway, page 83 2. We note your revised disclosure in response to prior comment 7. Please revise to indicate whether you have received feedback from FDA staff or other regulators concerning the classification and regulatory pathway. To the extent that you have not received feedback from regulators, please revise your disclosure on page 3 to clarify this point. You may contact Nudrat Salik at 202-551-3692 or Brian Cascio at 202-551-3676 if you have questions regarding comments on the financial statements and related matters. Please contact Alan Campbell at 202-551-4224 or Joe McCann at 202-551-6262 with any other questions. Sincerely, FirstName LastNameJeff Ross Division of Corporation Finance Comapany NameMiromatrix Medical Inc. Office of Life Sciences May 25, 2021 Page 2 cc: Jonathan Zimmerman FirstName LastName