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IRADIMED CORP
Awaiting Response
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High
IRADIMED CORP
Response Received
2 company response(s)
High - file number match
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IRADIMED CORP
Response Received
1 company response(s)
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IRADIMED CORP
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2020-08-27
IRADIMED CORP
Summary
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IRADIMED CORP
Awaiting Response
0 company response(s)
Medium
SEC wrote to company
2016-11-03
IRADIMED CORP
Summary
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IRADIMED CORP
Awaiting Response
0 company response(s)
Medium
SEC wrote to company
2016-10-25
IRADIMED CORP
Summary
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IRADIMED CORP
Response Received
2 company response(s)
High - file number match
SEC wrote to company
2015-11-30
IRADIMED CORP
Summary
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Company responded
2015-12-03
IRADIMED CORP
References: November 30, 2015
Summary
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IRADIMED CORP
Response Received
4 company response(s)
Medium - date proximity
SEC wrote to company
2014-06-16
IRADIMED CORP
Summary
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Company responded
2014-06-19
IRADIMED CORP
References: June 2, 2014 | May 22, 2014
Summary
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Company responded
2014-07-09
IRADIMED CORP
References: June 16, 2014
Summary
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Company responded
2014-07-11
IRADIMED CORP
References: July 9, 2014
Summary
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IRADIMED CORP
Awaiting Response
0 company response(s)
Medium
SEC wrote to company
2014-05-22
IRADIMED CORP
Summary
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Summary
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-09-17 | SEC Comment Letter | IRADIMED CORP | DE | 001-36534 | Read Filing View |
| 2025-09-03 | Company Response | IRADIMED CORP | DE | N/A | Read Filing View |
| 2025-08-20 | SEC Comment Letter | IRADIMED CORP | DE | 001-36534 | Read Filing View |
| 2024-05-06 | Company Response | IRADIMED CORP | DE | N/A | Read Filing View |
| 2024-04-11 | SEC Comment Letter | IRADIMED CORP | DE | 333-278487 | Read Filing View |
| 2020-09-02 | Company Response | IRADIMED CORP | DE | N/A | Read Filing View |
| 2020-08-27 | SEC Comment Letter | IRADIMED CORP | DE | N/A | Read Filing View |
| 2016-11-03 | SEC Comment Letter | IRADIMED CORP | DE | N/A | Read Filing View |
| 2016-11-02 | Company Response | IRADIMED CORP | DE | N/A | Read Filing View |
| 2016-10-25 | SEC Comment Letter | IRADIMED CORP | DE | N/A | Read Filing View |
| 2015-12-04 | Company Response | IRADIMED CORP | DE | N/A | Read Filing View |
| 2015-12-03 | Company Response | IRADIMED CORP | DE | N/A | Read Filing View |
| 2015-11-30 | SEC Comment Letter | IRADIMED CORP | DE | N/A | Read Filing View |
| 2014-07-11 | Company Response | IRADIMED CORP | DE | N/A | Read Filing View |
| 2014-07-11 | Company Response | IRADIMED CORP | DE | N/A | Read Filing View |
| 2014-07-09 | Company Response | IRADIMED CORP | DE | N/A | Read Filing View |
| 2014-06-19 | Company Response | IRADIMED CORP | DE | N/A | Read Filing View |
| 2014-06-16 | SEC Comment Letter | IRADIMED CORP | DE | N/A | Read Filing View |
| 2014-05-22 | SEC Comment Letter | IRADIMED CORP | DE | N/A | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-09-17 | SEC Comment Letter | IRADIMED CORP | DE | 001-36534 | Read Filing View |
| 2025-08-20 | SEC Comment Letter | IRADIMED CORP | DE | 001-36534 | Read Filing View |
| 2024-04-11 | SEC Comment Letter | IRADIMED CORP | DE | 333-278487 | Read Filing View |
| 2020-08-27 | SEC Comment Letter | IRADIMED CORP | DE | N/A | Read Filing View |
| 2016-11-03 | SEC Comment Letter | IRADIMED CORP | DE | N/A | Read Filing View |
| 2016-10-25 | SEC Comment Letter | IRADIMED CORP | DE | N/A | Read Filing View |
| 2015-11-30 | SEC Comment Letter | IRADIMED CORP | DE | N/A | Read Filing View |
| 2014-06-16 | SEC Comment Letter | IRADIMED CORP | DE | N/A | Read Filing View |
| 2014-05-22 | SEC Comment Letter | IRADIMED CORP | DE | N/A | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-09-03 | Company Response | IRADIMED CORP | DE | N/A | Read Filing View |
| 2024-05-06 | Company Response | IRADIMED CORP | DE | N/A | Read Filing View |
| 2020-09-02 | Company Response | IRADIMED CORP | DE | N/A | Read Filing View |
| 2016-11-02 | Company Response | IRADIMED CORP | DE | N/A | Read Filing View |
| 2015-12-04 | Company Response | IRADIMED CORP | DE | N/A | Read Filing View |
| 2015-12-03 | Company Response | IRADIMED CORP | DE | N/A | Read Filing View |
| 2014-07-11 | Company Response | IRADIMED CORP | DE | N/A | Read Filing View |
| 2014-07-11 | Company Response | IRADIMED CORP | DE | N/A | Read Filing View |
| 2014-07-09 | Company Response | IRADIMED CORP | DE | N/A | Read Filing View |
| 2014-06-19 | Company Response | IRADIMED CORP | DE | N/A | Read Filing View |
2025-09-17 - UPLOAD - IRADIMED CORP File: 001-36534
<DOCUMENT> <TYPE>TEXT-EXTRACT <SEQUENCE>2 <FILENAME>filename2.txt <TEXT> September 17, 2025 John Glenn Chief Financial Officer IRADIMED CORP 1025 Willa Springs Drive Winter Springs, Florida 32708 Re: IRADIMED CORP Form 10-K for the Year Ended December 31, 2024 File No. 001-36534 Dear John Glenn: We have completed our review of your filings. 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. Sincerely, Division of Corporation Finance Office of Industrial Applications and Services </TEXT> </DOCUMENT>
2025-09-03 - CORRESP - IRADIMED CORP
CORRESP 1 filename1.htm September 3, 2025 VIA EDGAR U.S. Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 Attention: Nudrat Salik or Al Pavot Re: Iradimed Corporation Form 10-K for the Period Ended December 31, 2024 File No. 001-36534 Ladies and Gentlemen: Iradimed Corporation (the “ Company ”) is responding to the comment letter, dated August 20, 2025 (the “ Comment Letter ”), from the staff of the Division of Corporation Finance (the “ Staff ”) of the U.S. Securities and Exchange Commission with respect to the above-referenced filings (the “ Form 10-K ”). For your convenience, we have reproduced the Staff’s comments below in bold, followed by the Company’s response. The Company is concurrently filing an amendment to the Annual Report on Form 10-K for the year ended December 31, 2024 (the “ Form 10-K/A ”) with this letter. Form 10-K for the Year Ended December 31, 2024, Exhibit 32.1 1. Comment: “We note that the Section 906 certifications required by Rule 13-a14(b) of the Exchange Act have been omitted from your Form 10-K. Please file an amended Form10-K in its entirety and include the certifications as Exhibits as required by Item 601of Regulation S-K.” Response: The Company respectfully acknowledges the Staff’s comment and advises the Staff that the Company has filed corrected certifications as Exhibit 32.1 with the Form 10-K/A filed concurrently herewith. Warranty, page F-12 2. Comment: “Given the materiality of your extended warranty products to your earnings and total liabilities, it is not clear why the tabular disclosure referenced in ASC 460-10-50-8 has been omitted. Please provide for us a schedule of activity in your warranty reserve covering the 2023 and 2024 annual periods. Also, if your extended warranty products have had a disproportionate impact on your consolidated gross margin then that fact should be disclosed in MD&A. See Item 303(b)(2)(i) of Regulation S-K.” Response: In response to the Staff’s comment, the Company records a warranty reserve, as part of and in connection with its product sales related to the initial one-year manufacturer warranty. This is for the period prior to any extended warranty period for maintenance optionally purchased. The amount of the reserve has remained consistent from period to period as a result of the Company’s limited historical first year warranty claims experience. Warranty claims have been infrequent and insignificant in dollar amount. In evaluating the adequacy of the reserve, management considered the requirements of ASC 460-10, Guarantees , and ASC 450-20, Loss Contingencies . Based on both historical trends, and expected future claims, the Company has determined that the reserve balance is appropriate and that related warranty expense is immaterial to the Company. Given the immateriality of the reserve and the lack of variability in the balance from period to period, management believes the existing disclosures are sufficient and that additional disclosure would not provide meaningful information to investors. Set forth below is the requested tabular warranty reserve schedule of activity for the years ended December 31, 2023 and 2024 as support . Warranty Liability Years Ended December 31, Beginning Balance Additions Charged to Expense Deductions Related to Year 1 Claims Ending Balance 2023 $ (94,030) 211,734 (235,167) $ (117,463) 2024 $ (117,463) 231,944 (232,750) $ (118,269) With respect to optional extended warranty products, the Company offers extended warranty products that provide customers with coverage for maintenance services beyond the standard one-year manufacturer’s warranty period. Revenue from extended warranty contracts is deferred at the time of sale and recognized ratably over the contract term per the requirements of ASC 606-10. The related deferred revenue is recorded as a component of current and long-term liabilities in the Company’s consolidated balance sheets. The extended warranty products have not had a disproportionate impact on the Company’s consolidated gross margin. Revenue recognized and expenses incurred from extended warranty contracts is relatively consistent, year to year, with the revenue recognized representing approximately 3% of the Company’s total revenues for the years ended December 31, 2023, and 2024. The Company expects extended warranty products to continue to have a consistent and proportionate impact on gross margin in future periods. Management considers the disclosure of the Company’s extended warranty products in Management’s Discussion and Analysis of Financial Condition and Results of Operations in the Form 10-K to be consistent with the requirements of Item 303(b)(2)(i) of Regulation S-K. We hope that the foregoing has been responsive to the Staff’s comments. Please do not hesitate to contact me at 407-677-8022 or JGlenn@Iradimed.com, if you have any further questions or require additional information. Sincerely, Iradimed Corporation /s/ John Glenn John Glenn, Chief Financial Officer cc: David A. Bartz, K&L Gates LLP
2025-08-20 - UPLOAD - IRADIMED CORP File: 001-36534
<DOCUMENT> <TYPE>TEXT-EXTRACT <SEQUENCE>2 <FILENAME>filename2.txt <TEXT> August 20, 2025 John Glenn Chief Financial Officer IRADIMED CORP 1025 Willa Springs Drive Winter Springs, Florida 32708 Re: IRADIMED CORP Form 10-K for the Year Ended December 31, 2024 File No. 001-36534 Dear John Glenn: We have reviewed your filing and have the following comments. 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-K for the Year Ended December 31, 2024 Exhibit 32.1 1. We note that the Section 906 certifications required by Rule 13-a14(b) of the Exchange Act have been omitted from your Form 10-K. Please file an amended Form 10-K in its entirety and include the certifications as Exhibits as required by Item 601 of Regulation S-K. Warranty, page F-12 2. Given the materiality of your extended warranty products to your earnings and total liabilities, it is not clear why the tabular disclosure referenced in ASC 460-10-50-8 has been omitted. Please provide for us a schedule of activity in your warranty reserve covering the 2023 and 2024 annual periods. Also, if your extended warranty products have had a disproportionate impact on your consolidated gross margin then that fact should be disclosed in MD&A. See Item 303(b)(2)(i) of Regulation S-K. 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. August 20, 2025 Page 2 Please contact Nudrat Salik at 202-551-3692 or Al Pavot at 202-551-3738 if you have questions regarding comments on the financial statements and related matters. Sincerely, Division of Corporation Finance Office of Industrial Applications and Services </TEXT> </DOCUMENT>
2024-05-06 - CORRESP - IRADIMED CORP
CORRESP
1
filename1.htm
IRADIMED CORPORATION
1025 Willa Springs Drive
Winter Springs, Florida 32708
VIA EDGAR
May 6, 2024
United States Securities and Exchange Commission
Division of Corporation Finance
100 F Street NE
Washington, D.C. 20549
Attn:
Mr. Nicholas O’Leary
Re:
Iradimed Corporation
Registration Statement on Form S-3/A
File No. 333-278487
Acceleration Request
Requested Date:
May 8, 2024
Requested Time:
4:30 p.m. Eastern Time (or as soon thereafter as practicable)
Ladies and Gentlemen:
Pursuant to Rule 461 under the Securities Act of 1933, as amended, IRADIMED CORPORATION, a Delaware corporation (the “Registrant”), hereby requests that the United States Securities and Exchange Commission (the “Commission”) take appropriate action to
cause the above-referenced Registration Statement on Form S-3/A to become effective on May 8, 2024 at 4:30 p.m. Eastern Time, or as soon thereafter as practicable, or at such later time as the Registrant may orally request via telephone call
to the staff of the Commission. The Registrant hereby authorizes K&L Gates LLP, counsel to the Registrant, to orally modify or withdraw this request for acceleration.
The Registrant requests that it be notified of such effectiveness by a telephone call to our counsel, K&L Gates LLP, by
calling Mr. David A. Bartz at (615) 780-6743.
Sincerely,
IRADIMED CORPORATION
By:
/s/ Roger Susi
Roger Susi
President, Chief Executive Officer and Chairman
of the Board of Directors
cc:
David A. Bartz, K&L Gates LLP
Leib Orlanski, K&L Gates LLP
Zidong Liu, K&L Gates LLP
2024-04-11 - UPLOAD - IRADIMED CORP File: 333-278487
United States securities and exchange commission logo
April 11, 2024
Roger Susi
President, Chief Executive Officer,
Iradimed Corporation
1025 Willa Springs Drive
Winter Springs, Florida 32708
Re:Iradimed Corporation
Registration Statement on Form S-3
Filed April 3, 2024
File No. 333-278487
Dear Roger Susi:
This is to advise you that we have not reviewed and will not review your registration
statement.
Please refer to Rules 460 and 461 regarding requests for acceleration. 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 Nicholas O'Leary at 202-551-4451 with any questions.
Sincerely,
Division of Corporation Finance
Office of Industrial Applications and
Services
cc: David A. Bartz, Esq.
2020-09-02 - CORRESP - IRADIMED CORP
CORRESP
1
filename1.htm
IRADIMED CORPORATION
1025 Willa Springs Drive
Winter Springs, FL 32708
VIA EDGAR
September 2, 2020
United States Securities and Exchange Commission
Division of Corporation Finance
100 F Street NE
Washington, DC 20549
Attn:
Ms. Margaret Schwartz
Re:
Iradimed Corporation
Registration Statement on Form S-3
File No. 333-248192
Acceleration Request
Requested Date:
September 3, 2020
Requested Time:
4:30 p.m. Eastern Time (or as soon thereafter as practicable)
Ladies and Gentlemen:
Pursuant to Rule 461 under the Securities Act of 1933, as amended, IRADIMED CORPORATION, a Delaware corporation (the “Registrant”), hereby requests that the Securities and Exchange Commission (the “Commission”) take appropriate action to cause the above-referenced Registration Statement on
Form S-3 to become effective on September 3, 2020 at 4:30 p.m. Eastern Time, or as soon thereafter as practicable, or at such later time as the Registrant may orally request via telephone call to the staff of the Commission. The Registrant
hereby authorizes K&L Gates LLP, counsel to the Registrant, to orally modify or withdraw this request for acceleration.
The Registrant requests that it be notified of such effectiveness by a telephone call to our counsel, K&L Gates LLP, by calling
Ms. Jacqulyn Lewis at (949) 623-3568.
Sincerely,
IRADIMED CORPORATION
By:
/s/ Roger Susi
Roger Susi
President, Chief Executive Officer and Chairman
of the Board of Directors
cc:
Leib Orlanski, K&L Gates LLP
Jacqulyn L. Lewis, K&L Gates LLP
2020-08-27 - UPLOAD - IRADIMED CORP
United States securities and exchange commission logo
August 27, 2020
Chris Scott
Chief Financial Officer and Corporate Secretary
IRADIMED CORP
1025 Willa Springs Drive
Winter Springs, Florida 32708
Re:IRADIMED CORP
Registration Statement on Form S-3
Filed August 20, 2020
File No. 333-248192
Dear Mr. Scott:
This is to advise you that we have not reviewed and will not review your registration
statement.
Please refer to Rules 460 and 461 regarding requests for acceleration. 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 Margaret Schwartz at 202-551-7153 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Jacqulyn L. Lewis
2016-11-03 - UPLOAD - IRADIMED CORP
Mail Stop 3030
November 3 , 2016
Via E -mail
Chris Scott
Chief Financial Officer and Secretary
Iradimed Corporation
1025 Willa Springs Drive
Winter Springs, Florida 32708
Re: Iradimed Corporation
Form 10 -K for the Fiscal Year Ended December 31, 2015
Filed March 10, 2016
File No. 001 -36534
Dear Mr. Scott :
We have completed our review of your filings. 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.
Sincerely,
/s/ Brian Cascio
Brian Cascio
Accounting Branch Chief
Office of Electronics and Machinery
2016-11-02 - CORRESP - IRADIMED CORP
CORRESP 1 filename1.htm K&L GATES LLP 10100 SANTA MONICA BOULEVARD EIGHTH FLOOR LOS ANGELES, CA 90067 T +1 310 552 5000 F +1 310 552 5001 klgates.com November 1, 2016 Via E-mail, US Mail, and EDGAR Brian Cascio Accounting Branch Chief Office of Electronics and Machinery United States Securities and Exchange Commission Division of Corporation Finance 100 F Street NE Washington, DC 20549 Re: IRADIMED CORPORATION Form 10-K for the Fiscal Year Ended December 31, 2015 Filed March 10, 2016 File No. 001-36534 Dear Mr. Cascio: On behalf of IRADIMED CORPORATION, a Delaware corporation (the “Company”, “we”, “us”, “our”), the undersigned is hereby providing the Company’s responses to the Securities and Exchange Commission (the “Commission”) comment letter dated October 25, 2016. The Company’s responses to the Commission’s comment letter, below, are in identical numerical sequence to the Commission comment letter, and each comment is repeated verbatim with the Company’s response immediately following. Enclosed are courtesy copies of (i) Amendment No. 1 to our Annual Report on Form 10-K for the Fiscal Year ended December 31, 2015, (ii) Amendment No. 1 to our Quarterly Report on Form 10-Q for the period ended March 31, 2016, and (iii) Amendment No. 1 to our Quarterly Report on Form 10-Q for the period ended June 30, 2016, each filed with the Commission on the date hereof. Exhibit 31.1 and 31.2 Certifications: 1. Comment: “We note that the officer certifications do not include the language referring to internal control over financial reporting that should appear in the introductory sentence of paragraph 4 and paragraph 4(b). Please refer to Exchange Act Rule 13a-14(a) and Item 601(b)(31) of Regulation S-K and amend the filings to include the correct certifications. You may file an abbreviated amendment that includes a cover page, explanatory note, signature page and paragraphs 1, 2, 4 and 5 of the certification. This comment also applies to your Forms 10-Q for the quarterly periods ended March 31 and June 30, 2016.” Response: We respectfully note your comment and have filed Amendment No. 1 to our Form 10-K for the Fiscal Year ended December 31, 2015 to amend these certifications. We also filed Amendments No. 1 to our Forms 10-Q for the periods ended March 31, 2016 and June 30, 2016. Per the Commission’s instructions, we have filed these as abbreviated amendments including only a cover page, explanatory note, signature page and paragraphs 1, 2, 4 and 5 of the certifications. Should you have any questions or require any additional information, please contact K&L Gates LLP, attention Leib Orlanski, Esq., by phone at (310) 552-5044, by facsimile at (310) 552-5001, or by e-mail at leib.orlanski@klgates.com. Sincerely, K&L Gates LLP /s/Leib Orlanski Leib Orlanski, Esq. cc: Brian Cascio, Commission Li Xiao, Commission Roger Susi, Chief Executive Officer, IRADIMED CORPORATION Chris Scott, Chief Financial Officer, IRADIMED CORPORATION Mark L. Hammes, K&L Gates LLP 2
2016-10-25 - UPLOAD - IRADIMED CORP
Mail Stop 3030
October 25, 2016
Via E -mail
Chris Scott
Chief Financial Officer and Secretary
Iradimed Corporation
1025 Willa Springs Drive
Winter Springs, Florida 32708
Re: Iradimed Corporation
Form 10 -K for the Fiscal Year Ended December 31, 2015
Filed March 10, 2016
File No. 001 -36534
Dear Mr. Scott :
We have limited our review of your filing to the financial statements and related
disclosures and have the following comment. 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 comment within ten busine ss days by providing the requested
information or advis e us as soon as possible when you will respond. If you do not believe our
comment appl ies to your facts and circumstances, please tell us why in your response.
After reviewing your response to this comment, we may have additional comments.
Form 10-K for the Fiscal Year ended December 31, 2015
Exhibit 31.1 and 31.2 Certifications
1. We note that the officer certifications do not include the language referring to internal
control over financial reporting that should appear in the introductory sentence of
paragraph 4 and paragraph 4(b). Please refer to Exchange Act Rule 13a -14(a) and Item
601(b)(31) of Regulation S -K and amend the filing s to include the correct certifications.
You may file an abbreviated amendment that includes a cover page, e xplanatory note,
signature page and paragraphs 1, 2, 4 and 5 of the certification. This comment also
applies to your Form s 10-Q for the quarterly period s ended March 31 and June 30, 2016 .
We remind you that the company and its management are responsible f or the accuracy
and adequacy of their disclosures, notwithstanding any review, comments, action or absence of
action by the staff.
Chris Scott
Iradimed Corporation
October 25 , 2016
Page 2
You may contact Li Xiao at (202) 551 -4391 , or Julie Sherman, Senior Accountant , at
(202) 551 -3640 with any questions. You may also reach me at (202) 551 -3676.
Sincerely,
/s/ Brian Cascio
Brian Cascio
Accounting Branch Chief
Office of Electronics and Machinery
2015-12-04 - CORRESP - IRADIMED CORP
CORRESP 1 filename1.htm IRADIMED CORPORATION 1025 Willa Springs Drive Winter Springs, FL 32708 VIA EDGAR December 4, 2015 United States Securities and Exchange Commission Division of Corporation Finance 100 F Street NE Washington, DC 20549 Attn: Ms. Amanda Ravitz Mr. Tim Buchmiller Mr. Brian Soares Re: Iradimed Corporation Registration Statement on Form S-3 File No. 333-207778 Acceleration Request Requested Date: December 7, 2015 Requested Time: 4:30 p.m. Eastern Time Ladies and Gentlemen: Pursuant to Rule 461 under the Securities Act of 1933, as amended, IRADIMED CORPORATION., a Delaware corporation (the “Company”), hereby requests that the Securities and Exchange Commission (the “Commission”) take appropriate action to cause the above-referenced Registration Statement on Form S-3 to become effective on December 7, 2015 at 4:30 p.m. Eastern Time, or as soon thereafter as practicable, or at such later time as the Registrant may orally request via telephone call to the staff (the “Staff”) of the Commission. The Company acknowledges that: · Should the Commission or the Staff, acting pursuant to delegated authority, declare the Registration Statement effective, it does not foreclose the Commission from taking any action with respect to the Registration Statement; · The action of the Commission or the Staff, acting pursuant to delegated authority, in declaring the Registration Statement effective, does not relieve the Company from its full responsibility for the adequacy and accuracy of the disclosure in the Registration Statement; and · The Company may not assert Staff comments or the declaration of the effectiveness as a defense in any proceeding initiated by the Commission or any person under the federal securities laws of the United States. The Registrant requests that it be notified of such effectiveness by a telephone call to our counsel, K&L Gates LLP, by calling Mr. Leib Orlanski at (310) 552-5044. Sincerely, IRADIMED CORPORATION By: /s/ Roger Susi Roger Susi President and Chief Executive Officer cc: Leib Orlanski, K&L Gates LLP Mark L. Hammes, K&L Gates LLP Trevor D. Belton, K&L Gates LLP
2015-12-03 - CORRESP - IRADIMED CORP
CORRESP 1 filename1.htm K&L GATES LLP 10100 SANTA MONICA BOULEVARD EIGHTH FLOOR LOS ANGELES, CA 90067 T +1 310 552 5000 F +1 310 552 5001 klgates.com December 3, 2015 Via EDGAR and Overnight Delivery Amanda Ravitz Assistant Director United States Securities and Exchange Commission Division of Corporation Finance 100 F Street NE Washington, DC 20549 Re: IRADIMED CORPORATION Amendment No. 1 to Registration Statement on Form S-3 Submitted December 3, 2015 CIK No. 00013525618 Dear Ms. Ravitz: On behalf of IRADIMED CORPORATION, a Delaware corporation (the “Company”, “we”, “us”, “our”), the undersigned is hereby providing the Company’s responses to the Securities and Exchange Commission (the “Commission”) comment letter dated November 30, 2015. The Company’s responses to the Staff’s comment letter, below, are in identical numerical sequence to the Commission comment letter, and each comment is repeated verbatim with the Company’s response immediately following. Enclosed are two courtesy copies of Amendment No. 1 to the Registration Statement on Form S-3 filed on the date hereof, in a clean and blacklined version showing changes that were made from the Registration Statement on Form S-3 that was filed with the Commission on November 3, 2015. Fee Table: 1. Comment: “We note that you have provided a dollar amount of securities that you intend to register for resale by the selling shareholders. Please revise this table and your disclosure throughout the prospectus to provide the number of shares that you intend to register for resale by the selling shareholders. Refer to Securities Act Rules Compliance and Disclosure Interpretations Questions 228.03 and 228.04. Also file a revised legal opinion covering that number of shares.” Response: We respectfully note your comment and have revised the fee table and disclosures throughout the prospectus to provide the number of shares that will be registered for resale by the selling shareholder. In addition, Exhibit 5.1 contains a revised legal opinion covering this number of shares. Amanda Ravitz Page 2 of 2 Selling Stockholders, page 5: 2. Comment: “Please revise to describe more specifically the transactions in which the securities were sold to the selling security holders. Refer to Regulation S-K Item 507.” Response: We respectfully note your comment and have revised the disclosures under “Selling Stockholder” on page 5 to provide additional information on the transactions in which the securities were sold to the selling security holder and other information required by Regulation S-K Item 507. Incorporation of Certain Documents by Reference, page 9: 3. Comment: “Please revise to incorporate the description of your common stock from your Form 8-A filed on July 10, 2014, and any amendments thereto. Refer to Item 12(a)(3) of Form S-3.” Response: We respectfully note your comment and have revised our list of documents incorporated by reference. Please see page 9. Should you have any questions or require any additional information, please contact K&L Gates LLP, attention Leib Orlanski, Esq., by phone at (310) 552-55044, by facsimile at (310) 552-5001, or by e-mail at leib.orlanski@klgates.com. Sincerely, K&L Gates LLP /s/Leib Orlanski Leib Orlanski, Esq. cc: Brian Soares, Commission Tim Buchmiller, Commission Roger Susi, Chief Executive Officer, IRADIMED CORPORATION Chris Scott, Chief Financial Officer, IRADIMED CORPORATION Mark L. Hammes, K&L Gates LLP Trevor D. Belton, K&L Gates LLP
2015-11-30 - UPLOAD - IRADIMED CORP
Mail Stop 3030 November 30, 2015 Via E -mail Roger Susi Chief Executive Officer and President Iradimed Corporation 1025 Willa Springs Drive Winter Springs, FL 32708 Re: Iradimed Corporation Registration Statement on Form S-3 Filed November 3, 2015 File No. 333-207778 Dear Mr. Susi : We have limited our review of your registration statement to those issues we have addressed in our 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 amending your registration statement and providing the requested information . If you do not believe our com ments apply to your facts and circumstances or do not believe an amendment is appropriate, please tell us why in your response. After reviewing any amendment to your registration statement and the information you provide in response to these comments, w e may have additional comments. Fee Table 1. We note that you have provided a dollar amount of securities that you intend to register for resale by the selling shareholders. Please revise this table and your disclosure throughout the prospectus to provid e the number of shares that you intend to register for resale by the selling shareholders. Refer to Securities Act Rules Compliance and Disclosure Interpretations Questions 228.03 and 228.04. Also file a revised legal opinion covering that number of shares . Selling Stockholders, page 5 2. Please revise to describe more specifically the transaction s in which the securities were sold to the selling security holders. Refer to Regulation S -K Item 507 . Roger Susi Iradimed Corporation November 30, 2015 Page 2 Incorporation of Certain Documents by Reference, pa ge 9 3. Please revise to incorporate the description of your common stock from your Form 8-A filed on July 10, 2014, and any amendments thereto. Refer to Item 12(a)(3) of Form S -3. We urge all persons who are responsible for the accuracy and adequacy of the disclosure in the filing to be certain that the filing includes the information the Securities Act of 193 3 and all applicable Securities Act rules require. Since the company and its management are in possession of all facts relating to a company’s disclosure, they are responsible for the accuracy and adequacy of the disclosures they have made. Notwithstanding our comments, in the event you request acceleration of the effective date of the pending registration statement , please provide a written statement from the company acknowledging that: should the Commission or the staff, acting pursuant to delegated authority, declare the filing effective, it does not foreclose the Commiss ion from taking any action with respect to the filing; the action of the Commission or the staff, acting pursuant to delegated authority, in declaring the filing effective, does not relieve the company from its full responsibility for the adequacy and ac curacy of the disclosure in the filing; and the company may not assert staff comments and the declaration of effectiveness as a defense in any proceeding initiated by the Commission or any person under the federal securities laws of the United States. Please refer to Rules 460 and 461 regarding requests for acceleration . We will consider a written request for acceleration of the effective date of the registration statement as confirmation of the fact that those requesting acceleration are aware of thei r respective responsibilities under the Securities Act of 1933 and the Securities Exchange Act of 1934 as they relate to the proposed public offering of the securities specified in the above registration statement. Please allow adequate time for us to rev iew any amendment prior to the requested effective date of the registration statement. Roger Susi Iradimed Corporation November 30, 2015 Page 3 Please contact Brian Soares at (202) 551 -3580 or Tim Buchmiller, Senior Attorney, at (202) 551-3635 with any questions. Sincerely, /s/ Tim Buchmiller for Amanda Ravitz Assistant Director Office of Electronics and Machinery cc: Leib Orlanski, Esq. K&L Gates LLP
2014-07-11 - CORRESP - IRADIMED CORP
CORRESP 1 filename1.htm VIA EDGAR July 11, 2014 Amanda Ravitz Assistant Director United States Securities and Exchange Commission Division of Corporation Finance 100 F Street NE Washington, DC 20549 Re: Iradimed Corporation Registration Statement on Form S-1 File No. 333-196875 Ladies and Gentlemen: Roth Capital Partners, LLC as representative for Monarch Capital Group (the “Underwriters”) respectfully joins the request of Iradimed Corporation (the “Company”), that the Commission accelerate the effective date of the Company’s Registration Statement on Form S-1, File No. 333-196875, as amended, to 4:30 pm Eastern time on Tuesday, July 15, 2014, or as soon thereafter as practicable. In addition, the Underwriters hereby provide the Staff with supplemental information regarding the distribution of the preliminary prospectus dated July 9, 2014 as filed with the Commission on July 9, 2014. The following is supplemental information supplied under Rule 418(a)(7) and Rule 460 under the Securities Act of 1933: (i) Date of preliminary prospectus: July 9, 2014 (ii) Dates of distribution: July 9, 2014 to July 11, 2014 (iii) Number of prospective underwriters and dealers to whom the preliminary prospectus was furnished: 9 (iv) Number of prospectuses distributed to underwriters, dealers and other potential participants in the above-referenced issue: approximately 557 In addition to the foregoing, the undersigned (x) distributed on July 9, 2014, an electronic copy of the preliminary prospectus to each underwriter and dealer participating in the above-referenced issue; and (y) instructed each such dealer to distribute such preliminary prospectus to each of its customers who may participate in the above-referenced issue. The undersigned confirms that they have complied with and will continue to comply with, and they have been informed or will be informed by participating dealers that they have complied with or will comply with, Rule 15c2-8 promulgated under the Securities Exchange Act of 1934, as amended, in connection with the above-referenced issue. Very truly yours, ROTH CAPITAL PARTNERS, LLC By: /s/ Aaron Gurewitz Name: Aaron Gurewitz Title: Head of Equity Capital Markets For itself and as the Representative of the several Underwriters. cc: Mary Beth Breslin, Securities and Exchange Commission Brian Soares, Securities and Exchange Commission Michael J. Kinkelaar, Esq., Procopio, Cory, Hargreaves & Savitch LLP Leib Orlanski, Esq., K&L Gates LLP Anh Q. Tran, Esq., K&L Gates LLP 2
2014-07-11 - CORRESP - IRADIMED CORP
CORRESP 1 filename1.htm July 11, 2014 VIA EDGAR and FACSIMILE Amanda Ravitz Assistant Director United States Securities and Exchange Commission Division of Corporation Finance 100 F Street NE Washington, DC 20549 Re: Iradimed Corporation Registration Statement on Form S-1 File No. 333-196875 Ladies and Gentlemen: Pursuant to Rule 461 of the Securities Act of 1933, as amended, Iradimed Corporation, a Delaware corporation (the “Company”), hereby requests that the Securities and Exchange Commission take appropriate action to cause the above-referenced Registration Statement to become effective at 4:30 p.m., Eastern Time on Tuesday, July 15, 2014, or as soon thereafter as practicable. The Company acknowledges that: · should the Commission or the staff, acting pursuant to delegated authority, declare the filing effective, it does not foreclose the Commission from taking any action with respect to the filing; · the action of the Commission or the staff, acting pursuant to delegated authority, in declaring the filing effective, does not relieve the Company from its full responsibility for the adequacy and accuracy of the disclosure in the filing; and · the Company may not assert staff comments and the declaration of effectiveness as a defense in any proceeding initiated by the Commission or any person under the federal securities laws of the United States. Should you have any questions or require any additional information with respect to this filing, please contact Anh Q. Tran, Esq. at (310) 552-5083 or by facsimile at (310) 552-5007. Thank you for your assistance and cooperation. Best regards, IRADIMED CORPORATION /s/ Roger E. Susi By: Roger E. Susi Title: Chief Executive Officer cc: Mary Beth Breslin, Securities and Exchange Commission Brian Soares, Securities and Exchange Commission Leib Orlanski, Esq., K&L Gates LLP Anh Q. Tran, Esq., K&L Gates LLP
2014-07-09 - CORRESP - IRADIMED CORP
CORRESP 1 filename1.htm July 9, 2014 Via EDGAR Amanda Ravitz Assistant Director United States Securities and Exchange Commission Division of Corporation Finance 100 F Street NE Washington, DC 20549 Re: iRadimed Corporation Amendment No. 1 to Registration Statement on Form S-1 (File No. 333-196875) Filed July 9, 2014 CIK No. 00013525618 Dear Ms. Ravitz: On behalf of iRadimed Corporation, a Delaware corporation (the “Company”, “we”, “us”, “our”), the undersigned is hereby providing the Company’s response to the Securities and Exchange Commission’s (the “Commission”) oral comment provided by Mr. Brian Soares on behalf of the Commission Staff on June 24, 2014 during a telephone conference with Mr. Anh Tran of K&L Gates LLP. The oral comment noted that that revisions to the Company’s Registration Statement filed with the Commission on June 18, 2014 in response to Comment No. 2 in the Commission’s letter dated June 16, 2014 were made in the Use of Proceeds section starting on page 32 but were not made to the Prospectus Summary section starting on page 1. We respectfully note the comment and have revised the disclosures in the Prospectus Summary to conform to the disclosures in the Use of Proceeds section. Should you have any questions or require any additional information, please contact K&L Gates LLP, attention Anh Q. Tran, Esq., by phone at (310) 552-5083, by facsimile at (310) 552-5007, or by e-mail at anh.tran@klgates.com. Sincerely, K&L Gates LLP /s/ Anh Q. Tran, Esq. Anh Q. Tran, Esq. cc: Brian Soares, Commission Roger Susi, Chief Executive Officer, Iradimed Corporation Chris Scott, Chief Financial Officer, Iradimed Corporation Leib Orlanski, K&L Gates LLP
2014-06-19 - CORRESP - IRADIMED CORP
CORRESP 1 filename1.htm June 19, 2014 Via EDGAR and Courier Amanda Ravitz Assistant Director United States Securities and Exchange Commission Division of Corporation Finance 100 F Street NE Washington, DC 20549 Re: iRadimed Corporation Registration Statement on Form S-1 Submitted June 18, 2014 CIK No. 00013525618 Dear Ms. Ravitz: On behalf of iRadimed Corporation, a Delaware corporation (the “Company”, “we”, “us”, “our”), the undersigned is hereby providing an update to one of the Company’s responses to the Securities and Exchange Commission (the “Commission”) comment letter dated May 22, 2014 (the “SEC Letter”). Comment No. 5 of the SEC Letter requested, in part, “Also, please supplementally provide us with copies of all written communications, as defined in Rule 405 under the Securities Act, that you, or anyone authorized to do so on your behalf, present to potential investors in reliance on Section 5(d) of the Securities Act, whether or not they retain copies of the communications.” In Company’s response letter dated June 2, 2014, the Company indicated that, “to the extent the Company presents any written communications to potential investors in reliance on Section 5(d) of the Securities Act …, it will supplementally provide the Staff with copies of such written communication ….” The Company, concurrently with this letter, will supplementally provide the Staff with the written communications that the Company presented to certain qualified institutional buyers and institutional accredited investors in reliance on Section 5(d) of the Securities Act. The Company advises the Staff that these potential investors were not permitted to retain copies of such written communications. Should you have any questions or require any additional information, please contact K&L Gates LLP, attention Anh Q. Tran, Esq., by phone at (310) 552-5083, by facsimile at (310) 552-5007, or by e-mail at anh.tran@klgates.com. Sincerely, K&L Gates LLP /s/ Anh Q. Tran, Esq. Anh Q. Tran, Esq. cc: Julie Sherman, Commission Brian Soares, Commission Roger Susi, Chief Executive Officer, Iradimed Corporation Chris Scott, Chief Financial Officer, Iradimed Corporation Leib Orlanski, K&L Gates LLP
2014-06-16 - UPLOAD - IRADIMED CORP
June 16, 2014 Via E -mail Roger Susi Chief Executive Officer and President iRadimed Corporation 7457 Aloma Avenue Winter Park, FL 32792 Re: iRadimed Corporation Amendment No. 1 to Draft Registration Statement on Form S -1 Submitted June 2, 2014 CIK No. 0001325618 Dear Mr. Susi : 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 registra tion statement or filed registration statement, we may have additional comments. Prospectus Summary, page 1 1. We note your response to prior comment 1. Please clarify where you have revised the disclosure to state that your pump systems require the use of your proprietary disposable IV sets. If necessary, please revise accordingly. Offering Summary, page 7 2. We note your revisions in response to prior comment 2 and that you have set forth intended uses for your proceeds. Here and in your disclosure on page 32, please revise to quantify the approximate amount intended to be used for each purpose, per Item 504 of Regulation S -K. Further, with respect to the funds to be used toward research and development of product candidates, please also disclose the a mount and sources of Roger Susi iRadimed Corporation June 16, 2014 Page 2 additional funds that may be needed to bring the product candidates to market. Refer to Instruction 3 to Item 504. Intellectual Property, page 67 3. We note your response to prior comment 10. Please file as an exhibit to your filed registration statement the agreement pursuant to which your CEO assigned to you the intellectual property discussed in this section, or tell us why you do not believe the agreement is required to be filed. Note 5 – Capital Stock, page F -15 4. We note your res ponse to prior comment 12. Please provide us with a more thorough explanation of why your current presentation complies with US GAAP and SEC rules and regulations, or revise the financial statements as appropriate. General If you intend to respond to these comments with an amended draft registration statement, please submit it and any associated correspondence in accordance with the guidance we provide in the Division’s October 11 , 2012 announcement on the SEC website at http://www.sec.gov/divisions/corpfin/cfannouncements/drsfilingprocedures101512.htm . You may contact Julie Sherman at (202) 551 -3640 or Kaitlin Tillan, at (202) 551 -3604 if you have questions regarding comments on the financial statements and related matters. Please contact Brian Soares at (202) 551 -3580 or me at (202) 551 -3625 with any other questions. Sincerely, /s/ Mary Beth Breslin for Amanda Ravitz Assistant Director cc (via e -mail): Leib Orlanski, Esq. K&L Gates LLP
2014-05-22 - UPLOAD - IRADIMED CORP
May 22 , 2014 Via E -mail Roger Susi Chief Executive Officer and President iRadimed Corporation 7457 Aloma Avenue Winter Park, FL 32792 Re: iRadimed Corporation Draft Registration Statement on Form S -1 Submitted April 25, 2014 CIK No. 00013525618 Dear Mr. Susi: We have reviewed your 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 i s 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. Prospectus Summary, page 1 1. We note your disclosure that in addition to the sale of your pump systems, you generate revenue by the sale of disposable IV sets us ed during every patient infusion . Revise to clarify whether your pump systems require the use of disposabl e IV sets that only you sell, or whether another manufacturer’s disposable IV sets can be used in your devices. 2. We note your disclosure in the third paragraph regarding your revenue growth from 2011 – 2013 and your operating income and operating margins in fiscal year 2013. Please also disclose your operating income for the fiscal years 2011 and 2012, as well as your net income (or loss) for all periods. With respect to your operating margin disclosure, please clarify if the number cited is a blended f igure representing your margins across all product types you sell, and if so, please provide separate disclosure of your margins for your pump systems and disposable IV sets. Roger Susi iRadimed Corporation May 22 , 2014 Page 2 3. Please balance your disclosure regarding the potential competitive opportunity you believe you have, given the recall of a competitor’s product, with a brief discussion of your recall noted on page 73 . Also describe the impact this recall may have on your ability to capitalize on the potential opportunity described here. 4. Please revise the last paragraph on this page to clarify that your competitor does not intend to remove its pumps from the market until June 2015, as you state on pages 55 and throughou t your prospectus. Implications of Being an Emerging Growth Company, page 5 5. Please consider describing the extent to which any of the exemptions that are available to you as an “emerging growth company” are also available to you as a Smaller Reporting Company. Also, p lease supplementally provide us with copies of all written communications, as defined in Rule 405 under the Securities Act, that you , or anyone authorized to do so on your behalf , present to potential investors in reliance on Section 5(d) of the Securities Act, whether or not they retain copies of the communications. Similarly, please supplementally provide us with any research reports about you that are published or distributed in reliance upon Section 2(a)(3) of the Securities Act of 1933 added by Section 105(a) of the Jumpstart Our Business Startups Act by any broker or dealer that is participating or will participate in your offering . Offering Summary , page 6 6. We note your disclosure here and on page 31 that while you have identified cer tain uses for the offering proceeds, you “cannot specify with certainty all of the particular uses for the net proceeds to be received upon completion of the offering.” Please revise to state explicitly that you have no current specific plan for the offer ing proceeds and discuss the principal reasons why you are conducting the offering at this time. We... are required to comply with FDA regulations, page 18 7. It appears that you are discussing separate and distinct risks in the two paragraphs of this risk factor. Please revise to highlight each risk separately. Robert Susi... owns a significant percentage of our stock, page 25 8. We note your disclosure indicating that your largest shareholder beneficially own s 83% of your outstanding stock. Accordingly, please tell us, if known, whether you will qualify as a “controlled company” under NASDAQ’s listing requirements . If so, please revise to explain the exemptions available to you as a “controlled company” under the exchange’s listing standards. Roger Susi iRadimed Corporation May 22 , 2014 Page 3 Capitalization, page 33 9. Please remove your line item for cash and cash equivalents and investments since this is not part of your capita lization . Intellectual Property, page 64 10. Please revise to clarify how you obtained the intellectual property rights described in this section. From your disclosure on pages 53 – 54, it is unclear what rights the person or persons who developed your pum p system may have . Product Recalls, page 73 11. We note the last sentence of the last paragraph beginning on page 73. Please expand to describe the remainder of the observations cited by the FDA in the Form 483 issued on April 16, 2014. Financial Stateme nts, page F -1 Note 5 – Capital Stock, page F -15 12. We note the discussion of your reincorporation in Delaware on April 14, 2014. Please respond to the following: Given the terms of conversion of your preferred stock as disclosed on page F -16, please tell us why you disclose that upon the effective date of your initial public offering all of your New Series A Preferred Stock will be automatically converted into common stock. Please explain why you believe it is appropriate to include the conversion of the preferred stock that you expect to occur upon the effective date of the IPO as a part of the recapitalization and account for it as a stock split and retroactively restate your financial statements for all periods presented. Note 6 – Stock -Based Compensation, page F -17 13. Please tell us the estimated IPO price range. To the extent that there is a significant difference between the estimated grant -date fair values of your common stock during the past twelve months and the estimated IPO price, please tell us each significant factor contributing to the difference. 14. We see your disclosure here and on pages 44 – 46 that you used a third party valuation specialist to determine the fair value of your common stock. Please tell us the nature an d extent of the third party valuation specialist’s involvement and management’s reliance on the work of the third party. Please refer to Question 141.02 of the Compliance and Roger Susi iRadimed Corporation May 22 , 2014 Page 4 Disclosure Interpretations on Securities Act Sections, which can be found at http://www.sec.gov/divisions/corpfin/guidance/sasinterp.htm . General If you intend to respond to these comments with an amended draft registration statement , please submit it and any associated correspondence in accordance with the guidance we provide in the Division’s October 11, 2012 announcement on the SEC website at http://www.sec.gov/divisions/corpfin/cfannouncements/drsfilingprocedures101512.htm . Please keep in mind that we may publicly post filing review correspondence in accordance with our December 1, 2011 policy (http://www.sec.gov/divisions/corpfin/cfannouncements/edgarcorrespondence.htm ). If you intend to use Rule 83 (17 CFR 200.83) to request confidential treatment of information in the correspondence you submit on EDGAR, please properly mark that information in each of your confidential submissions to us so we do not repeat or refer to that information in our comment letters to you. You may contact Julie Sherman at (202) 551 -3640 or Kaitlin Tillan, Assistant Chief Accountant, at (202) 551 -3604 if you have questions regarding comments on the financial statements and related matters. Please contact Brian Soares at (202) 551 -3580 or Mary Beth Breslin, Senior Attorney, at (202) 551 -3625 with any other questions. Sincerely, /s/ Mary Beth Breslin for Amanda Ravitz Assistant Director cc (via e -mail): Leib Orlanski, Esq. K&L Gates LLP