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IR-Med, Inc.
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IR-Med, Inc.
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IR-Med, Inc.
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IR-Med, Inc.
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4 company response(s)
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SEC wrote to company
2021-06-04
IR-Med, Inc.
Summary
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IR-Med, Inc.
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SEC wrote to company
2021-10-27
IR-Med, Inc.
Summary
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SEC wrote to company
2021-09-09
IR-Med, Inc.
Summary
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| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-05-23 | Company Response | IR-Med, Inc. | NV | N/A | Read Filing View |
| 2025-05-16 | SEC Comment Letter | IR-Med, Inc. | NV | 333-287229 | Read Filing View |
| 2023-05-16 | SEC Comment Letter | IR-Med, Inc. | NV | N/A | Read Filing View |
| 2023-05-11 | Company Response | IR-Med, Inc. | NV | N/A | Read Filing View |
| 2023-04-27 | SEC Comment Letter | IR-Med, Inc. | NV | N/A | Read Filing View |
| 2021-11-05 | Company Response | IR-Med, Inc. | NV | N/A | Read Filing View |
| 2021-10-28 | Company Response | IR-Med, Inc. | NV | N/A | Read Filing View |
| 2021-10-27 | SEC Comment Letter | IR-Med, Inc. | NV | N/A | Read Filing View |
| 2021-10-21 | Company Response | IR-Med, Inc. | NV | N/A | Read Filing View |
| 2021-09-09 | SEC Comment Letter | IR-Med, Inc. | NV | N/A | Read Filing View |
| 2021-08-26 | Company Response | IR-Med, Inc. | NV | N/A | Read Filing View |
| 2021-06-04 | SEC Comment Letter | IR-Med, Inc. | NV | N/A | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-05-16 | SEC Comment Letter | IR-Med, Inc. | NV | 333-287229 | Read Filing View |
| 2023-05-16 | SEC Comment Letter | IR-Med, Inc. | NV | N/A | Read Filing View |
| 2023-04-27 | SEC Comment Letter | IR-Med, Inc. | NV | N/A | Read Filing View |
| 2021-10-27 | SEC Comment Letter | IR-Med, Inc. | NV | N/A | Read Filing View |
| 2021-09-09 | SEC Comment Letter | IR-Med, Inc. | NV | N/A | Read Filing View |
| 2021-06-04 | SEC Comment Letter | IR-Med, Inc. | NV | N/A | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-05-23 | Company Response | IR-Med, Inc. | NV | N/A | Read Filing View |
| 2023-05-11 | Company Response | IR-Med, Inc. | NV | N/A | Read Filing View |
| 2021-11-05 | Company Response | IR-Med, Inc. | NV | N/A | Read Filing View |
| 2021-10-28 | Company Response | IR-Med, Inc. | NV | N/A | Read Filing View |
| 2021-10-21 | Company Response | IR-Med, Inc. | NV | N/A | Read Filing View |
| 2021-08-26 | Company Response | IR-Med, Inc. | NV | N/A | Read Filing View |
2025-05-23 - CORRESP - IR-Med, Inc.
CORRESP 1 filename1.htm IR-Med, Inc. ZHR Industrial Zone Rosh Pina, Israel, 1231400 May 23, 2025 VIA EDGAR U.S. Securities and Exchange Commission Division of Corporation Finance 100 F Street, NE Washington D.C. 20549 RE: IR-Med, Inc. File No. 333-287229 Registration Statement on Form S-1 Ladies and Gentlemen: In accordance with Rule 461 under the Securities Act of 1933, as amended, the undersigned respectfully requests that the effective date of the above-referenced Registration Statement be accelerated so that the same will become effective at 4:05 p.m. Eastern Time on May 27, 2025, or as soon thereafter as is practicable. Sincerely, IR-Med, Inc. By: /s/ Sharon Levkoviz Sharon Levkoviz Chief Financial Officer cc: Ron Ben-Bassat, Sullivan & Worcester LLP
2025-05-16 - UPLOAD - IR-Med, Inc. File: 333-287229
<DOCUMENT> <TYPE>TEXT-EXTRACT <SEQUENCE>2 <FILENAME>filename2.txt <TEXT> May 16, 2025 Ran Ziskand Chief Executive Officer IR-Med, Inc. ZHR Industrial Zone Rosh Pina, Israel, 1231400 Re: IR-Med, Inc. Registration Statement on Form S-1 Filed May 13, 2025 File No. 333-287229 Dear Ran Ziskand: 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 Conlon Danberg at 202-551-4466 with any questions. Sincerely, Division of Corporation Finance Office of Industrial Applications and Services cc: Ron Ben-Bassat, Esq. </TEXT> </DOCUMENT>
2023-05-16 - UPLOAD - IR-Med, Inc.
United States securities and exchange commission logo
May 16, 2023
Sharon Levkoviz
Chief Financial Officer
IR-Med, Inc.
ZHR Industrial Zone
Rosh Pina, Israel
Re:IR-Med, Inc.
Form 10-K filed March 29, 2023
File No. 000-56492
Dear Sharon Levkoviz :
We have completed our review of your filing. 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
2023-05-11 - CORRESP - IR-Med, Inc.
CORRESP
1
filename1.htm
May
11, 2023
U.S.
Securities and Exchange Commission
Division
of Corporation Finance
Office
of Industrial Applications and Services
100
F Street, N.E.
Washington,
DC 20549
Attn:
Jeanne
Baker
Terence
O’Brien
Re:
IR-Med,
Inc.
Form
10-K filed March 29, 2023
File
No. 000-56492
Dear
Sirs/ Madams:
IR-Med,
Inc., a Nevada corporation (the “Company”), hereby files with the Securities and Exchange Commission (the “Commission”)
an amended Annual Report on Form 10-K (the “Amended Annual Report”) in response to the comments of the staff (the “Staff”),
dated April 27, 2023.
For
the convenience of the Staff, each of the Staff’s comments is included and is followed by the corresponding response of the Company.
Unless the context indicates otherwise, references in this letter to “we,” “us” and “our” refer to
the Company on a consolidated basis.
Form
10-K for the Fiscal Year ended December 31, 2022
Item
9A. Controls and Procedures, page 50
1. You
indicate that as of December 31, 2022, your disclosure controls and procedures (DCP) were
effective. Please explain how you reached this conclusion. In this regard, we note the Item
4 disclosures in your Form 10-Q for the quarter ended September 30, 2022, indicate that the
two material weaknesses identified in your assessment of internal controls over financial
reporting (ICFR) as of December 31, 2021, were still not remediated. In light of this disclosure,
as well as your current disclosure that during the quarter ended December 31, 2022, there
were no changes in your ICFR that have materially affected, or are reasonably likely to materially
affect, your ICFR, it is unclear how the two material weaknesses were sufficiently remediated
in order for you to conclude that your DCP was effective as of December 31, 2022. Please
revise your disclosures accordingly.
Response:
We have indicated in Item 9A of the Amended Annual Report the process and procedures that the Company carried out a remediation plan
during the 2022 fiscal year to address the identified material weaknesses. As provided therein, from the beginning of the
fourth quarter of 2021, management introduced internal control and review procedures including
the retention of a Sarbanes and Oxley (SOX) experienced advisor in order to remediate the material weaknesses in internal controls,
and conducted a thorough review of its internal control systems, including its policies and procedures, as well as the effectiveness
of its control environment. As part of this process, the Company developed and implemented a new process for monitoring and reviewing
its financial transactions, which includes increased documentation and oversight by management. The Company further implemented additional,
new controls relating to the access authorizations to its financial systems, including (among other) improved password management and
multi-factor authentication. At the end of the process during the fourth quarter of 2022 the Company’s internal key controls were
tested by the SOX experienced advisor based on best practices of ICFR testing. Since the Company concluded that it can view its quarterly
controls as effective following two quarters in which the controls were actually applied effectively, the third quarter of 2022 was the
first quarter in which the controls worked effectively, and the 2022 year end fourth quarter was the second such quarter.
Following this process and based on the evaluation of its disclosure controls and procedures, the Company concluded that, as of December
31, 2022, its disclosure controls and procedures were effective. Management believes that due to the foregoing, as of December 31, 2022,
the Company has remediated the material weakness previously identified.
Yahalom
20, Z.H.R Industrial Zone
PO
Box 143, Rosh Pina, Israel 1231400
Tel:
(+972) 04-6555054 Fax: (+972) 04-6104976 www.ir-medical.com
Page
1 of 2
2. You
do not provide a conclusion of the effectiveness of ICFR. With reference to our above concerns
regarding the material weaknesses previously identified, please revise your disclosures to
conclude on the effectiveness of your ICFR.
Response:
We have revised the disclosures in Item 9A of the Amended Annual Report to include the required conclusion as to the effectiveness
of the Company’s ICFR.
3. Your
conclusion regarding the effectiveness of DCP refers to COSO. Please revise this disclosure
as COSO is used for an assessment of ICFR.
Response:
The necessary corrections were made in the Amended Annual Report
4. To
the extent you have remediated your previously identified material weaknesses, please address
the need to revise your disclosures under the caption, Changes in Internal Controls Over
Financial Reporting.
Response:
The necessary corrections were made in the Amended Annual Report.
We
hope the Amended Annual Report on Form 10-K addresses the comments of the Commission. If we can provide any further assistance, please
do not hesitate to contact the undersigned.
Sincerely,
IR-Med,
Inc.
By:
Sharon
Levkoviz
Chief
Financial Officer
Yahalom
20, Z.H.R Industrial Zone
PO
Box 143, Rosh Pina, Israel 1231400
Tel:
(+972) 04-6555054 Fax: (+972) 04-6104976 www.ir-medical.com
Page
2 of 2
2023-04-27 - UPLOAD - IR-Med, Inc.
United States securities and exchange commission logo
April 27, 2023
Sharon Levkoviz
Chief Financial Officer
IR-Med, Inc.
ZHR Industrial Zone
Rosh Pina, Israel
Re:IR-Med, Inc.
Form 10-K filed March 29, 2023
File No. 000-56492
Dear Sharon Levkoviz :
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 10-K for the Fiscal Year ended December 31, 2022
Item 9A. Controls and Procedures, page 50
1.You indicate that as of December 31, 2022, your disclosure controls and procedures
(DCP) were effective. Please explain how you reached this conclusion. In this regard, we
note the Item 4 disclosures in your Form 10-Q for the quarter ended September 30, 2022,
indicate that the two material material weaknesses identified in your assessment of
internal controls over financial reporting (ICFR) as of December 31, 2021, were still not
remediated. In light of this disclosure, as well as your current disclosure that during the
quarter ended December 31, 2022, there were no changes in your ICFR that have
materially affected, or are reasonably likely to materially affect, your ICFR, it is unclear
how the two material weaknesses were sufficiently remediated in order for you to
conclude that your DCP was effective as of December 31, 2022. Please revise your
disclosures accordingly.
2.You do not provide a conclusion of the effectiveness of ICFR. With reference to our
FirstName LastNameSharon Levkoviz
Comapany NameIR-Med, Inc.
April 27, 2023 Page 2
FirstName LastName
Sharon Levkoviz
IR-Med, Inc.
April 27, 2023
Page 2
above concerns regarding the material weaknesses previously identified, please revise
your disclosures to conclude on the effectiveness of your ICFR.
3.Your conclusion regarding the effectiveness of DCP refers to COSO. Please revise this
disclosure as COSO is used for an assessment of ICFR.
4.To the extent you have remediated your previously identified material weaknesses, please
address the need to revise your disclosures under the caption, Changes in Internal Controls
Over Financial Reporting.
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 Jeanne Baker at 202-551-3691 or Terence O'Brien at 202-551-
3355 with any questions.
Sincerely,
Division of Corporation Finance
Office of Industrial Applications and
Services
2021-11-05 - CORRESP - IR-Med, Inc.
CORRESP
1
filename1.htm
IR-Med
Inc.
November
5, 2021
VIA
Edgar
Securities
and Exchange Commission
Division
of Corporation Finance
100
F Street, N.E.
Washington,
D.C. 20549
Attention:
Mr.
Jeffrey Gabor
Ms.
Abby Adams
Re:
IR-Med, Inc.
Amendment
No. 3 to Registration Statement on Form S-1
Filed
October 28, 2021
File
No: 333-255894
Ladies
and Gentlemen:
Pursuant
to Rule 461 under the Securities Act of 1933, as amended, IR-Med, Inc. (the “Company”) hereby requests that the effective
date of the above-referenced Registration Statement be accelerated so that it may become effective at 4:00 p.m., Washington, D.C. time,
on November 9, 2021, or as soon as possible thereafter. In this regard, the Company is aware of its obligations under the Securities
Act.
The
Company requests that it be notified of such effectiveness by contacting David Aboudi, the Company’s counsel, at Aboudi Legal Group
PLLC, at (646) 768-4285 or at david@aboudilegal.com.
Sincerely,
/s/
Sharon Levkoviz
Sharon
Levkoviz
Chief
Financial Officer
2021-10-28 - CORRESP - IR-Med, Inc.
CORRESP
1
filename1.htm
October
28, 2021
VIA
EDGAR
United
States Securities and Exchange Commission
Division
of Corporation Finance
100
F Street, N.E.
Washington,
D.C. 20549
Attention:
Mr. Jeffrey Gabor
Ms.
Abby Adams
Re:
IR-Med, Inc.
Amendment
No. 2 to Registration Statement on Form S-1
Filed
October 21, 2021
File
No. 333-255894
Ladies
and Gentlemen:
On
behalf of IR-Med, Inc. (the “Company”), we are hereby filing with the Securities and Exchange Commission (the “Commission”)
Amendment No. 3 to the above-referenced Registration Statement on Form S-1 (the “Amendment No.3”) and this letter in response
to the comment of the Staff of the Commission’s Division of Corporation Finance (the “Staff”) given by letter (the
“Comment Letter”) dated October 27, 2021. The response is numbered to correspond to the comment set forth in the Comment
Letter, which for convenience, we have incorporated into this response letter.
Amendment
No. 2 to Registration Statement on Form S-1 filed on October 21, 2021
Exhibit
23.1 Consent of Independent Registered Public Accounting Firm, page 1
1.
We refer to the auditor’s consent that consents to the consolidated financial statements of IR-Med, Inc., included herein. However,
we note that the consolidated financial statements of IR-Med, Inc. are not included in the amendment to Form S-1. Please file a full
amendment with consolidated financial statements and an updated consent from your auditors.
RESPONSE:
The Company has filed a full Amendment No. 3 with consolidated financial statements and an updated consent from the Company’s auditors
(Exhibit 23.1). The Company has also refiled the corrected Amended and Restated Articles of Incorporation (Exhibit 3.4).
We
hope that the above responses address the Staff’s concerns. Please do not hesitate to contact us if we can further assist.
Sincerely,
/s/
Sharon Levkoviz
Chief
Financial Officer
Yahalom
20, Z.H.R Industrial Zone
PO
Box 143, Rosh Pina, Israel 1210002
Confidential
Tel:
(+972) 04-6555054 Fax: (+972) 04-6104976 www.ir-medical.com
Page
1 of 1
2021-10-27 - UPLOAD - IR-Med, Inc.
United States securities and exchange commission logo
October 27, 2021
Sharon Levkoviz
Chief Financial Officer
IR-Med, Inc.
Z.H.R. Industrial Zone
Rosh Pina, Israel
Re:IR-Med, Inc.
Amendment No. 2 to Registration Statement on Form S-1
Filed October 21, 2021
File No. 333-255894
Dear Mr. Levkoviz:
We have reviewed your amended registration statement and have the following
comments. Please respond to this letter by amending your registration statement and providing
the requested information. 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 any amendment to your registration statement and the information
you provide in response to these comments, we may have additional comments.
Amendment No. 2 to Registration Statement on Form S-1 filed on October 21, 2021
Exhibit 23.1 Consent of Independent Registered Public Accounting Firm, page 1
1.We refer to the auditor's consent that consents to the consolidated financial statements of
IR-Med, Inc., included herein. However, we note that the consolidated financial
statements of IR-Med, Inc. are not included in the amendment to Form S-1. Please file a
full amendment with consolidated financial statements and an updated consent from your
auditors.
FirstName LastNameSharon Levkoviz
Comapany NameIR-Med, Inc.
October 27, 2021 Page 2
FirstName LastName
Sharon Levkoviz
IR-Med, Inc.
October 27, 2021
Page 2
You may contact Kristin Lochhead at (202) 551-3664 or Mary Mast (202) 551-3613 if
you have questions regarding our comment on the financial statements and related
matters. Please contact Abby Adams at (202) 551-6902 or Jeff Gabor at (202) 551-2544 with
any other questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: David Aboudi, Esq.
2021-10-21 - CORRESP - IR-Med, Inc.
CORRESP
1
filename1.htm
October
21, 2021
VIA
EDGAR
United
States Securities and Exchange Commission
Division
of Corporation Finance
100
F Street, N.E.
Washington,
D.C. 20549
Attention:
Mr. Jeffrey Gabor
Ms.
Abby Adams
Re:
IR-Med, Inc.
Amendment
No. 1 to Registration Statement on Form S-1
Filed
August 26, 2021
File
No. 333-255894
Ladies
and Gentlemen:
On
behalf of IR-Med, Inc. (the “Company”), we are hereby filing with the Securities and Exchange Commission (the “Commission”)
Amendment No. 2 to the above-referenced Registration Statement on Form S-1 (the “Amendment No.2”) and this letter in response
to the comment of the Staff of the Commission’s Division of Corporation Finance (the “Staff”) given by letter (the
“Comment Letter”) dated September 9, 2021. The response is numbered to correspond to the comment set forth in the Comment
Letter, which for convenience, we have incorporated into this response letter.
Amendment
No. 1 to Registration Statement on Form S-1 filed August 26, 2021
Risks
Related to the Ownership of our Common Stock, Page 32
1.
We
note your response to prior comment 8. Please revise Article XI to clearly state that the forum provision will not apply to any causes
of action arising under the Securities Act or the Exchange Act, consistent with your disclosure on page 38. Alternately, please provide
reasonable assurance that you will make future investors aware of the provision’s limited applicability by including such disclosure
in your future Exchange Act reports.
RESPONSE:
The Company has revised Article XI of its Second Amendment and Restated Articles of Incorporation to specifically except from the forum
provisions any actions arising under the Securities Act or the Exchange Act. At the end of Section 1 of Article XI, the following
sentence was added: “This exclusive forum provision shall not be applicable to any action brought under the Securities Act of 1933,
as amended or The Securities Exchange Act of 1934, as amended.”
We
have filed under cover of Amendment No. 2 a revised corrected Second Amended and Restated Articles of Incorporation with the revised
Article XI.
We
hope that the above responses address the Staff’s concerns. Please do not hesitate to contact us if we can further assist.
Sincerely,
/s/
Sharon Levkoviz
Sharon
Levkoviz
Chief
Financial Officer
Yahalom 20, Z.H.R Industrial Zone
PO Box 143, Rosh Pina, Israel 1210002 Confidential
Tel: (+972) 04-6555054 Fax: (+972) 04-6104976 www.ir-medical.com Page
1 of 1
2021-09-09 - UPLOAD - IR-Med, Inc.
United States securities and exchange commission logo
September 9, 2021
Sharon Levkoviz
Chief Financial Officer
IR-Med, Inc.
Z.H.R. Industrial Zone
Rosh Pina, Israel
Re:IR-Med, Inc.
Amendment No. 1 to Registration Statement on Form S-1
Filed August 26, 2021
File No. 333-255894
Dear Mr. Levkoviz:
We have reviewed your amended registration statement and have the following
comment. Please respond to this letter by amending your registration statement and providing
the requested information. If you do not believe our comment applies 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 our comment, we may have additional comments.
Amendment No. 1 to Registration Statement on Form S-1 filed August 26, 2021
Risks Related to the Ownership of Our Common Stock, page 32
1.We note your response to prior comment 8. Please revise Article XI to clearly state that
the forum provision will not apply to any causes of action arising under the Securities Act
or the Exchange Act, consistent with your disclosure on page 38. Alternately, please
provide reasonable assurance that you will make future investors aware of the provision’s
limited applicability by including such disclosure in your future Exchange Act reports.
FirstName LastNameSharon Levkoviz
Comapany NameIR-Med, Inc.
September 9, 2021 Page 2
FirstName LastName
Sharon Levkoviz
IR-Med, Inc.
September 9, 2021
Page 2
You may contact Kristin Lochhead at (202) 551-3664 or Mary Mast at (202) 551-3613 if
you have questions regarding the financial statements and related matters. Please contact Abby
Adams at (202) 551-6902 or Jeffrey Gabor at (202) 551-2544 with any other questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: David Aboudi, Esq.
2021-08-26 - CORRESP - IR-Med, Inc.
CORRESP
1
filename1.htm
IR-MED,
INC.
ZHR Industrial Zone
Rosh Pina, Israel
August 26, 2021
VIA
EDGAR
United
States Securities and Exchange Commission
Division
of Corporation Finance
100
F Street, N.E.
Washington,
D.C. 20549
Attention:
Mr.
Jeffrey Gabor
Ms.
Abby Adams
Re:
IR-Med, Inc.
Registration
Statement on Form S-1
Filed
May 7, 2021
File
No. 333-255894
Ladies
and Gentlemen:
On
behalf of IR-Med, Inc. (the “Company”), we are hereby filing with the Securities and Exchange Commission (the “Commission”)
Amendment No. 1 to the above-referenced Registration Statement on Form S-1 (the “Amendment”) and this letter in response
to the comment of the Staff of the Commission’s Division of Corporation Finance (the “Staff”) given by letter (the
“Comment Letter”) dated June 4, 2021. Each response is numbered to correspond to the comment set forth in the Comment Letter,
which for convenience, we have incorporated into this response letter.
Registration
Statement on Form S-1 filed May 7, 2021 About This Prospectus, page 3
1. You
state on page 3, “This prospectus contains summaries of certain provisions contained
in some of the documents described herein, but reference is made to the actual documents
for complete information. All of the summaries are qualified in their entirety by the actual
documents.” Investors are entitled to rely on your disclosure. Revise the document
to disclose the material terms of these documents and eliminate this inappropriate disclaimer,
and similar disclaimers throughout your document, including that on page 7.
RESPONSE:
As reflected in the Amendment, the qualifiers have been removed and the material terms of the referred to documents have been disclosed.
Prospectus,
page 4
2. On
page 4 you state that of the 37,973,724 shares being offered by the selling security holders,
28,645,395 are currently issued and outstanding. You note on page 13 that you issued warrants
exercisable for 9,328,329 shares in your 2020 private placement. You list 9,484,569 shares
underlying options in the selling stockholders table, which, by our calculation, totals more
than the number of shares being registered. Please clarify.
RESPONSE:
We inadvertently and incorrectly reflected the warrant shares to two of the investors. As reflected in the Amendment ( the Selling Stockholders
Section) we have corrected the incorrect entries and the aggregate number of shares issuable upon exercise of the warrants is 9,328,329.
1
Prospectus
Summary, page 5
3. As
your medical devices must receive FDA clearance before you are able to commercialize them,
and your products are not yet marketable, revise to clarify references to your product candidates
as “compelling solutions to currently unmet medical needs.” Further clarify the
niche nature of your product candidates in light of your disclosure on pages 60-61 that you
expect each of your product candidates, if successfully developed, to have direct competition.
RESPONSE:
As reflected in the Amendment, we have removed the terminology referring to our product candidates as “compelling solutions to
currently unmet medical needs.” As reflected in the Amendment, we have also clarified the niche nature of our products candidates.
4. At
the bottom of page 5, you briefly reference the “appropriate approvals” needed
before you will be able to market your product candidates. Revise to briefly explain those
approvals and cross-reference a more detailed explanation in the prospectus.
RESPONSE:
As reflected in the Amendment, we have revised the disclosures in the appropriate sections to comply with the Staff’s guidance.
5. Revise
the summary to disclose at what stage you are in the development of each of your potential
products. For example, on page 55, you state that you are “currently in advanced prototype
phase of development” for your PressureSafe device. As you began testing your device
in 2018, clarify what you mean by “advanced prototype phase” and explain what
further development you plan to undertake prior to conducting additional clinical trials.
Briefly explain this information in the summary with additional detail in the business section.
RESPONSE:
as reflected in the Amendment, we have revised the disclosures to conform to the Staff’s guidance.
6. Risk
Factors
We
depend on licenses from third parties for certain technologies that we integrate into our planned products, page 25
Please
provide a summary of the material terms of your license agreements in the Business section and file the agreements as exhibits or tell
us why you do not believe it is required.
RESPONSE:
The Company does not currently utilize, nor does it anticipate so in the future, any third party technology or intellectual property
rights in its current product candidates or the disposables accompanying the PressureSafe device, as only open source software
is utilized. Accordingly, as reflected in the Amendment, we have deleted this risk factor.
7. Risks
Related to the Ownership of Our Common Stock, page 32
Revise
the risk factor on page 35 regarding undiscovered liabilities to further clarify how this problem arises from the acquisition transaction.
RESPONSE:
We have revised the risk factor to further clarify that the Company, through the Acquisition, has assumed the liabilities of IR-Med Ltd.
2
8. We
note that your forum selection provision in Article XI of the amended charter identifies
the Eighth Judicial District Court of Clark County, Nevada as the sole and exclusive forum
for certain litigation, including any “derivative action.” Revise to clearly
and prominently describe the provision in an appropriate section of the prospectus, and also
revise this section to address the associated risks. Please disclose whether this provision
applies to actions arising under the Securities Act or Exchange Act. In that regard, we note
that Section 27 of the Exchange Act creates exclusive federal jurisdiction over all suits
brought to enforce any duty or liability created by the Exchange Act or the rules and regulations
thereunder, and Section 22 of the Securities Act creates concurrent jurisdiction for federal
and state courts over all suits brought to enforce any duty or liability created by the Securities
Act or the rules and regulations thereunder. If the provision applies to Securities Act claims,
please also revise your prospectus to state that there is uncertainty as to whether a court
would enforce such provision and that investors cannot waive compliance with the federal
securities laws and the rules and regulations thereunder. If this provision does not apply
to actions arising under the Securities Act or Exchange Act, please also ensure that the
exclusive forum provision in the governing documents states this clearly, or tell us how
you will inform investors in future filings that the provision does not apply to any actions
arising under the Securities Act or Exchange Act. Finally, please be certain your risk factor
disclosure includes the risks that your exclusive forum provision may result in increased
costs for investors to bring a claim and that the provision can discourage claims or limit
investors’ ability to bring a claim in a judicial forum that they find favorable.
RESPONSE:
As reflected in the Amendment and the Exhibits thereto, the Company filed a Certificate of Amendment with the Secretary of State of the
State of Nevada amending and restating its Articles of Incorporation (the “Articles”), with the amended and restated
Articles being included as an exhibit to Amendment. Based on the Staff’s input, the principal reason for the amendment and restatement
of the Articles was to ensure that the exclusive forum provision set forth in Article XI of the Articles is clearly written so as to
be inapplicable to any action brought under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended.
Accordingly, the Amendment updates Item 16 of the Registration Statement to include the amended and restated Articles with the updated
forum selection clause, which the Company believes addresses the Staff’s comment.
Business
Overview Page 50
9. You
cite to reports for statistical information regarding your industry. Please note that when
an issuer includes an active hyperlink or an inactive URL for a website that could be converted
into an active hyperlink within a document required to be filed or delivered under the federal
securities laws, the issuer assumes responsibility for the information that is accessible
through the hyperlinked website as if it were part of the filing. Refer to Release No. 34-42728
for further guidance regarding the use of hyperlinks in your document.
RESPONSE:
As reflected in the Amendment, we have removed the website reference links.
3
10. Revise
this section to provide further information describing your devices under development. For
example, clarify what type of disposables they require to function. We note disposables addressed
in the discussion of revenue generation on page 61.
RESPONSE:
As reflected in the Amendment, we have made the appropriate disclosures to comply with the Staff’s guidance.
Intellectual
Property, page 60
11. Please
revise your intellectual property disclosure to clearly describe on an individual or patent
family basis the type of patent protection for each product candidate, the expiration year
of each patent held, and the jurisdiction of each patent or application. Please clearly distinguish
between owned patents and patents licensed from third parties. We note the risk factor on
page 25 regarding your reliance on licensed technology.
RESPONSE:
As reflected in the Amendment, we have revised the disclosures to comply with the Staff’s comments. As noted earlier, the Company’s
product candidates do not currently utilize or incorporate any licensed technologies.
Facilities,
page 62
12. We
note your lease more than doubled, retroactive to January 2021. File the lease agreement
as an exhibit pursuant to Item 601(b)(10)(ii)(D) of Regulation S-K
RESPONSE:
IR. Med Ltd. entered into a lease with an entity controlled by two of our directors for use of shared office space facilities in Rosh
Pina Israel. During 2020, commencing in February 2020, IR Med Ltd paid the equivalent of approximately $1,300 per month. With
the growth of the research and development activities in 2020, IR. Med Ltd. acquired additional office services to support its growth
and, hence, the consequent increase in lease payments to the equivalent of approximately $3,115 per month. A translation of the
Office lease has been attached as an Exhibit to the Amendment.
Employees
& Consultants, page 67
13. Revise
to quantify your full-time and part-time employees. Clarify whether the individuals disclosed
here include the five consultants disclosed on page 60. Refer to Item 101(h)(4)(xii) of Regulation
S-K.
RESPONSE:
As reflected in the Amendment, IR. Med Ltd currently engages, on a full time basis, four employees and one service providers and,
on a part-time basis, two employees and seven service providers for a total of 14 employees and service providers as of August 2021.
Security
Ownership of Certain Beneficial Owners and Management, page 86
14. We
note that Mr. Bashan is the controlling shareholder of Med2BWell, Ltd, which beneficially
owns 13.33% of the company’s shares, yet the table does not list him as a director
individually or reflect any shares beneficially owned by him. Similarly, we note that Mr.
Levy is a director and also a selling shareholder, yet he is only listed in the footnote
as a control person related to the holdings of Liat Electronics Ltd., and his beneficial
ownership as a director is not reported. Revise this table to disclose the beneficial ownership
of each officer and director, as required by Item 403(b) of Regulation S-K, following Instruction
2 to Item 403 in determining beneficial ownership.
RESPONSE:
As reflected in the Amendment, we have revised the table and the accompanying shareholdings to comply with the Staff comments and consistent
with Item 430(b) of Regulation S-K. Please note that David Levy is a director of the Company’s subsidiary.
We
hope that the above responses address the Staff’s concerns. Please do not hesitate to contact me or our attorney
David Aboudi, Esq. if we can further assist.
Sincerely,
/s/
Sharon Levkoviz
Sharon
Levkoviz
Chief
Financial Officer
4
2021-06-04 - UPLOAD - IR-Med, Inc.
United States securities and exchange commission logo
June 4, 2021
Sharon Levkoviz
Chief Financial Officer
IR-Med, Inc.
Z.H.R. Industrial Zone
Rosh Pina, Israel
Re:IR-Med, Inc.
Registration Statement on Form S-1
Filed May 7, 2021
File No. 333-255894
Dear Mr. Levkoviz:
We have reviewed your 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 amending your registration statement and providing the
requested information. 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 any amendment to your registration statement and the information you
provide in response to these comments, we may have additional comments.
Registration Statement on Form S-1 filed May 7, 2021
About This Prpspectus, page 3
1.You state on page 3, "This prospectus contains summaries of certain provisions contained
in some of the documents described herein, but reference is made to the actual documents
for complete information. All of the summaries are qualified in their entirety by the actual
documents." Investors are entitled to rely on your disclosure. Revise the document to
disclose the material terms of these documents and eliminate this inappropriate disclaimer,
and similar disclaimers throughout your document, including that on page 7.
Prospectus, page 4
2.On page 4 you state that of the 37,973,724 shares being offered by the selling security
holders, 28,645,395 are currently issued and outstanding. You note on page 13 that you
FirstName LastNameSharon Levkoviz
Comapany NameIR-Med, Inc.
June 4, 2021 Page 2
FirstName LastNameSharon Levkoviz
IR-Med, Inc.
June 4, 2021
Page 2
issued warrants exercisable for 9,328,329 shares in your 2020 private placement. You list
9,484,569 shares underlying options in the selling stockholders table, which, by our
calculation, totals more than the number of shares being registered. Please clarify.
Prospectus Summary, page 5
3.As your medical devices must receive FDA clearance before you are able to
commercialize them, and your products are not yet marketable, revise to clarify references
to your product candidates as "compelling solutions to currently unmet medical needs."
Further clarify the niche nature of your product candidates in light of your disclosure on
pages 60-61 that you expect each of your product candidates, if successfully developed, to
have direct competition.
4.At the bottom of page 5, you briefly reference the "appropriate approvals" needed before
you will be able to market your product candidates. Revise to briefly explain those
approvals and cross-reference a more detailed explanation in the prospectus.
5.Revise the summary to disclose at what stage you are in the development of each of your
potential products. For example, on page 55, you state that you are "currently in advanced
prototype phase of development" for your PressureSafe device. As you began testing your
device in 2018, clarify what you mean by "advanced prototype phase" and explain what
further development you plan to undertake prior to conducting additional clinical trials.
Briefly explain this information in the summary with additional detail in the business
section.
Risk Factors
We depend on licenses from third parties for certain technologies that we integrate into our
planned products, page 25
6.Please provide a summary of the material terms of your license agreements in
the Business section and file the agreements as exhibits or tell us why you do not believe
it is required.
Risks Related to the Ownership of Our Common Stock, page 32
7.Revise the risk factor on page 35 regarding undiscovered liabilities to further clarify how
this problem arises from the acquisition transaction.
8.We note that your forum selection provision in Article XI of the amended charter
identifies the Eighth Judicial District Court of Clark County, Nevada as the sole and
exclusive forum for certain litigation, including any “derivative action.” Revise to clearly
and prominently describe the provision in an appropriate section of the prospectus, and
also revise this section to address the associated risks. Please disclose whether this
provision applies to actions arising under the Securities Act or Exchange Act. In that
regard, we note that Section 27 of the Exchange Act creates exclusive federal jurisdiction
over all suits brought to enforce any duty or liability created by the Exchange Act or the
FirstName LastNameSharon Levkoviz
Comapany NameIR-Med, Inc.
June 4, 2021 Page 3
FirstName LastName
Sharon Levkoviz
IR-Med, Inc.
June 4, 2021
Page 3
rules and regulations thereunder, and Section 22 of the Securities Act creates concurrent
jurisdiction for federal and state courts over all suits brought to enforce any duty or
liability created by the Securities Act or the rules and regulations thereunder. If the
provision applies to Securities Act claims, please also revise your prospectus to state that
there is uncertainty as to whether a court would enforce such provision and that investors
cannot waive compliance with the federal securities laws and the rules and regulations
thereunder. If this provision does not apply to actions arising under the Securities Act or
Exchange Act, please also ensure that the exclusive forum provision in the governing
documents states this clearly, or tell us how you will inform investors in future filings that
the provision does not apply to any actions arising under the Securities Act or Exchange
Act. Finally, please be certain your risk factor disclosure includes the risks that your
exclusive forum provision may result in increased costs for investors to bring a claim
and that the provision can discourage claims or limit investors' ability to bring a claim in a
judicial forum that they find favorable.
Business
Overview, page 50
9.You cite to reports for statistical information regarding your industry. Please note that
when an issuer includes an active hyperlink or an inactive URL for a website that could be
converted into an active hyperlink within a document required to be filed or delivered
under the federal securities laws, the issuer assumes responsibility for the information that
is accessible through the hyperlinked website as if it were part of the filing. Refer to
Release No. 34-42728 for further guidance regarding the use of hyperlinks in your
document.
10.Revise this section to provide further information describing your devices under
development. For example, clarify what type of disposables they require to function. We
note disposables addressed in the discussion of revenue generation on page 61.
Intellectual Property, page 60
11.Please revise your intellectual property disclosure to clearly describe on an individual or
patent family basis the type of patent protection for each product candidate, the expiration
year of each patent held, and the jurisdiction of each patent or application. Please clearly
distinguish between owned patents and patents licensed from third parties. We note the
risk factor on page 25 regarding your reliance on licensed technology.
Facilities, page 62
12.We note your lease more than doubled, retroactive to January 2021. File the lease
agreement as an exhibit pursuant to Item 601(b)(10)(ii)(D) of Regulation S-K.
FirstName LastNameSharon Levkoviz
Comapany NameIR-Med, Inc.
June 4, 2021 Page 4
FirstName LastName
Sharon Levkoviz
IR-Med, Inc.
June 4, 2021
Page 4
Employees & Consultants, page 67
13.Revise to quantify your full-time and part-time employees. Clarify whether the
individuals disclosed here include the five consultants disclosed on page 60. Refer to Item
101(h)(4)(xii) of Regulation S-K.
Security Ownership of Certain Beneficial Owners and Management, page 86
14.We note that Mr. Bashan is the controlling shareholder of Med2BWell, Ltd, which
beneficially owns 13.33% of the company's shares, yet the table does not list him as a
director individually or reflect any shares beneficially owned by him. Similarly, we note
that Mr. Levy is a director and also a selling shareholder, yet he is only listed in the
footnote as a control person related to the holdings of Liat Electronics Ltd., and his
beneficial ownership as a director is not reported. Revise this table to disclose the
beneficial ownership of each officer and director, as required by Item 403(b) of
Regulation S-K, following Instruction 2 to Item 403 in determining beneficial ownership.
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.
Refer to Rules 460 and 461 regarding requests for acceleration. Please allow adequate
time for us to review any amendment prior to the requested effective date of the registration
statement.
You may contact Kristin Lochhead at (202) 551-3664 or Mary Mast at (202) 551-3613 if
you have questions regarding comments on the financial statements and related matters. Please
contact Abby Adams at (202) 551-6902 or Jeffrey Gabor at (202) 551-2544 with any other
questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: David Aboudi, Esq.