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Glucotrack, Inc.
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2011-10-07
Glucotrack, Inc.
References: September 16, 2011
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Company responded
2011-10-26
Glucotrack, Inc.
References: October 24, 2011 | September 16, 2011
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Company responded
2011-11-10
Glucotrack, Inc.
References: November 9, 2011
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Glucotrack, Inc.
Awaiting Response
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2011-11-10
Glucotrack, Inc.
Summary
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Glucotrack, Inc.
Awaiting Response
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SEC wrote to company
2011-10-24
Glucotrack, Inc.
Summary
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Summary
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2026-01-27 | SEC Comment Letter | Glucotrack, Inc. | DE | 333-292695 | Read Filing View |
| 2026-01-23 | Company Response | Glucotrack, Inc. | DE | N/A | Read Filing View |
| 2024-11-12 | Company Response | Glucotrack, Inc. | DE | N/A | Read Filing View |
| 2024-11-12 | Company Response | Glucotrack, Inc. | DE | N/A | Read Filing View |
| 2024-10-01 | Company Response | Glucotrack, Inc. | DE | N/A | Read Filing View |
| 2024-09-27 | SEC Comment Letter | Glucotrack, Inc. | DE | 333-282297 | Read Filing View |
| 2021-09-23 | SEC Comment Letter | Glucotrack, Inc. | DE | N/A | Read Filing View |
| 2021-09-23 | Company Response | Glucotrack, Inc. | DE | N/A | Read Filing View |
| 2017-12-21 | Company Response | Glucotrack, Inc. | DE | N/A | Read Filing View |
| 2017-12-08 | Company Response | Glucotrack, Inc. | DE | N/A | Read Filing View |
| 2017-11-29 | SEC Comment Letter | Glucotrack, Inc. | DE | N/A | Read Filing View |
| 2011-11-10 | Company Response | Glucotrack, Inc. | DE | N/A | Read Filing View |
| 2011-11-10 | SEC Comment Letter | Glucotrack, Inc. | DE | N/A | Read Filing View |
| 2011-11-10 | Company Response | Glucotrack, Inc. | DE | N/A | Read Filing View |
| 2011-10-26 | Company Response | Glucotrack, Inc. | DE | N/A | Read Filing View |
| 2011-10-24 | SEC Comment Letter | Glucotrack, Inc. | DE | N/A | Read Filing View |
| 2011-10-07 | Company Response | Glucotrack, Inc. | DE | N/A | Read Filing View |
| 2011-09-16 | SEC Comment Letter | Glucotrack, Inc. | DE | N/A | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2026-01-27 | SEC Comment Letter | Glucotrack, Inc. | DE | 333-292695 | Read Filing View |
| 2024-09-27 | SEC Comment Letter | Glucotrack, Inc. | DE | 333-282297 | Read Filing View |
| 2021-09-23 | SEC Comment Letter | Glucotrack, Inc. | DE | N/A | Read Filing View |
| 2017-11-29 | SEC Comment Letter | Glucotrack, Inc. | DE | N/A | Read Filing View |
| 2011-11-10 | SEC Comment Letter | Glucotrack, Inc. | DE | N/A | Read Filing View |
| 2011-10-24 | SEC Comment Letter | Glucotrack, Inc. | DE | N/A | Read Filing View |
| 2011-09-16 | SEC Comment Letter | Glucotrack, Inc. | DE | N/A | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2026-01-23 | Company Response | Glucotrack, Inc. | DE | N/A | Read Filing View |
| 2024-11-12 | Company Response | Glucotrack, Inc. | DE | N/A | Read Filing View |
| 2024-11-12 | Company Response | Glucotrack, Inc. | DE | N/A | Read Filing View |
| 2024-10-01 | Company Response | Glucotrack, Inc. | DE | N/A | Read Filing View |
| 2021-09-23 | Company Response | Glucotrack, Inc. | DE | N/A | Read Filing View |
| 2017-12-21 | Company Response | Glucotrack, Inc. | DE | N/A | Read Filing View |
| 2017-12-08 | Company Response | Glucotrack, Inc. | DE | N/A | Read Filing View |
| 2011-11-10 | Company Response | Glucotrack, Inc. | DE | N/A | Read Filing View |
| 2011-11-10 | Company Response | Glucotrack, Inc. | DE | N/A | Read Filing View |
| 2011-10-26 | Company Response | Glucotrack, Inc. | DE | N/A | Read Filing View |
| 2011-10-07 | Company Response | Glucotrack, Inc. | DE | N/A | Read Filing View |
2026-01-27 - UPLOAD - Glucotrack, Inc. File: 333-292695
January 20, 2026
Paul Goode
Chief Executive Officer
Glucotrack, Inc.
301 Rte. 17 North, Ste. 800,
Rutherford, NJ 07070
Re:Glucotrack, Inc.
Registration Statement on Form S-3
Filed January 13, 2026
File No. 333-292695
Dear Paul Goode:
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 Mannheim, Esq.
2026-01-23 - CORRESP - Glucotrack, Inc.
CORRESP
1
filename1.htm
Glucotrack,
Inc.
301
Rte. 17 North, Ste. 800,
Rutherford,
NJ 07070
(201)
842-7715
January
23, 2026
VIA
EDGAR
United
States Securities and Exchange Commission
Division
of Corporation Finance
Office
of Industrial Applications and Services
100
F Street, NE
Washington,
DC 20549
Attention:
Nicholas
O’Leary
Re:
Glucotrack,
Inc. (the “Company”)
Registration
Statement on Form S-3
(File
No. 333-292695) (the “Registration Statement”)
Ladies
and Gentlemen,
The
Company hereby requests, pursuant to Rule 461 promulgated under the Securities Act of 1933, as amended, acceleration of effectiveness
of the Registration Statement so that such Registration Statement will become effective as of 4:05 p.m. on Tuesday, January 27, 2026,
or as soon thereafter as practicable.
Should
you have any questions concerning this request, please contact our counsel, W. David Mannheim at Nelson Mullins Riley & Scarborough
LLP at (919) 329-3804.
Very
truly yours,
Glucotrack,
Inc.
By:
/s/
Paul Goode
Name:
Paul
Goode
Title:
Chief
Executive Officer
2024-11-12 - CORRESP - Glucotrack, Inc.
CORRESP
1
filename1.htm
Glucotrack,
Inc.
301
Rte. 17 North, Ste. 800,
Rutherford,
NJ 07070
(201)
842-7715
November
12, 2024
VIA
EDGAR
United
States Securities and Exchange Commission
Division
of Corporation Finance
Office
of Industrial Applications and Services
100
F Street, NE
Washington,
DC 20549
Attention:
Juan Grana
Re:
Glucotrack,
Inc. (the “Company”)
Registration Statement on Form S-1
(File
No. 333-282158) (the “Registration Statement”)
Ladies
and Gentlemen,
The
Company hereby requests, pursuant to Rule 461 promulgated under the Securities Act of 1933, as amended, acceleration of effectiveness
of the Registration Statement so that such Registration Statement will become effective as of 4:30 p.m. on Tuesday, November 12, 2024,
or as soon thereafter as practicable.
Should
you have any questions concerning this request, please contact our counsel, Howard Hirsch at Nelson Mullins Riley & Scarborough LLP
at (404) 217-5359.
Very
truly yours,
Glucotrack,
Inc.
By:
/s/
Paul Goode
Name:
Paul
Goode
Title:
Chief
Executive Officer
2024-11-12 - CORRESP - Glucotrack, Inc.
CORRESP 1 filename1.htm DAWSON JAMES SECURITIES INC. 101 North Federal Highway Suite 600 Boca Raton, Fl 33432 November 12, 2024 VIA EDGAR Division of Corporation Finance Office of Industrial Applications and Services U.S. Securities & Exchange Commission 100 F Street, NE Washington, D.C. 20549-3628 Attn: Mr. Juan Grana RE: Glucotrack, Inc. (the “Company”) Registration Statement on Form S-1 (File No. 333-282158) (the “Registration Statement”) Dear Mr. Grana: Dawson James Securities Inc., the placement agent in the offering contemplated in the Registration Statement, hereby requests, pursuant to Rule 461 promulgated under the Securities Act of 1933, as amended, acceleration of effectiveness of the Registration Statement so that such Registration Statement will become effective as of 4:30 P.M. Eastern Time on Tuesday, November 12, 2024, or as soon thereafter as practicable. Once the Registration Statement has been declared effective, please orally confirm that event with Howard Hirsch of Nelson Mullins Riley & Scarborough LLP, counsel to the Company, at (404) 322-6226. Very truly yours, DAWSON JAMES SECURITIES INC. By: /s/ Robert D. Keyser, Jr. Name: Robert D. Keyser, Jr. Title: Chief Executive Officer
2024-10-01 - CORRESP - Glucotrack, Inc.
CORRESP 1 filename1.htm Glucotrack, Inc. 301 Rte. 17 North, Ste. 800 Rutherford, NJ 07070 (201) 842-7715 October 1, 2024 VIA EDGAR Securities and Exchange Commission Division of Corporation Finance Office of Industrial Applications and Services Attn: Mr. Juan Grana 100 F. Street NE Washington, D.C. 20549 Re: Glucotrack, Inc. (the “Registrant”) Registration Statement on Form S-3 (File No. 333-282297) Dear Mr. Grana: Pursuant to Rule 461 under the Securities Act of 1933, as amended (the “Securities Act”), the Registrant hereby requests that the effective date for the above-referenced Registration Statement be accelerated so that it will be declared effective under the Securities Act at 4:30 p.m., Eastern Time, on Thursday, October 3, 2024, or as soon as practicable thereafter. In this regard, the Registrant is aware of its obligations under the Securities Act. Please contact W. David Mannheim of Nelson Mullins Riley & Scarborough LLP, the Registrant’s legal counsel, at (919) 329-3804 with any questions or comments. Sincerely, Glucotrack, Inc. By: /s/ Paul Goode Name: Paul Goode Title: Chief Executive Officer
2024-09-27 - UPLOAD - Glucotrack, Inc. File: 333-282297
September 27, 2024
Paul Goode
Chief Executive Officer
Glucotrack, Inc.
301 Rte. 17 North, Ste. 800,
Rutherford, NJ 07070
Re:Glucotrack, Inc.
Registration Statement on Form S-3
Filed September 23, 2024
File No. 333-282297
Dear Paul Goode:
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 Juan Grana at 202-551-6034 with any questions.
Sincerely,
Division of Corporation Finance
Office of Industrial Applications and
Services
cc:Howard Hirsch, Esq.
2021-09-23 - UPLOAD - Glucotrack, Inc.
United States securities and exchange commission logo
September 22, 2021
Shimon Rapps
Audit Committee Chair
Integrity Applications, Inc.
8 Ariel Sharon Street
Or Yehuda 6037607
Israel
Re:Integrity Applications, Inc.
Registration Statement on Form S-3
Filed September 20, 2021
File No. 333-259664
Dear Shimon Rapps:
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 Michael Davis at 202-551-4385 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Jolie Kahn, Esq.
2021-09-23 - CORRESP - Glucotrack, Inc.
CORRESP
1
filename1.htm
INTEGRITY
APPLICATIONS, INC.
8
Ariel Sharon Street
Or
Yehuda 6037607
Israel
September
23, 2021
VIA
EDGAR
U.S.
Securities and Exchange Commission
Division
of Corporation Finance
100
F Street N.E.
Washington,
D.C. 20549
Re:
Integrity
Applications, Inc.
Registration
Statement on Form S-3
File
No. 333-259664
REQUEST
FOR ACCELERATION OF EFFECTIVENESS
Gentlepersons:
Pursuant
to Rule 461 promulgated under the Securities Act of 1933, as amended, Integrity Applications, Inc. (the “Registrant”) hereby
respectfully requests acceleration of the effective date of its Registration Statement on Form S-3 (File No. 333-259664), as amended
(the “Registration Statement”), so that it may become effective at 5:00 p.m. Eastern Time on Monday, September 27, 2021,
or as soon as practicable thereafter.
The
Registrant hereby authorizes Jolie Kahn, Esq., to orally modify or withdraw this request for acceleration.
We
respectfully request that we be notified of such effectiveness by a telephone call to Ms. Kahn at (516) 217-6379.
Very
truly yours,
INTEGRITY
APPLICATIONS, INC.
/s/
Shimon Rapps
Shimon
Rapps
Director
and Chair of the Audit Committee
2017-12-21 - CORRESP - Glucotrack, Inc.
CORRESP 1 filename1.htm Integrity Applications, Inc. 19 Ha’Yahalomim St. PO Box 12143 Ashdod L3 7760049, Israel December 21, 2017 VIA EDGAR Division of Corporation Finance Securities and Exchange Commission 100 F. Street, N.E Washington, D.C. 20549-4631 Attn: Caleb French Re: Integrity Applications, Inc. Registration Statement on Form S-1 File No. 333-221384 Acceleration Request Requested Date: December 26, 2017 Requested Time: 5:15 P.M. Eastern Standard Time Dear Mr. French, Pursuant to Rule 461 under the Securities Act of 1933, as amended, Integrity Applications, Inc. (the “Company”) hereby requests that the above-referenced Registration Statement on Form S-1 (File No. 333-221384) (the “Registration Statement”) be declared effective at the “Requested Date” and “Requested Time” set forth above or at such later time as the Company or its counsel may orally request via telephone call to the staff (the “Staff”) of the Division of Corporation Finance of the Securities and Exchange Commission (the “Commission”). In connection with the acceleration request, the Company hereby 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 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. Thank you for your attention to this matter. Sincerely, Integrity Applications, Inc. /s/ John Graham John Graham Chief Executive Officer cc: Mitchell Lampert, Esq. Robinson & Cole LLP 1055 Washington Boulevard Stamford, CT 06901
2017-12-08 - CORRESP - Glucotrack, Inc.
CORRESP 1 filename1.htm Integrity Applications, Inc. 19 Ha’Yahalomim St. PO Box 12143 Ashdod L3 7760049, Israel December 8, 2017 VIA EDGAR Division of Corporation Finance Securities and Exchange Commission 100 F. Street, N.E Washington, D.C. 20549-4631 Attn: Caleb French Re: Integrity Applications, Inc. Registration Statement on Form S-1 File No. 333-221384 Acceleration Request Requested Date: December 12, 2017 Requested Time: 5:15 P.M. Eastern Standard Time Dear Mr. French, Pursuant to Rule 461 under the Securities Act of 1933, as amended, Integrity Applications, Inc. (the “Company”) hereby requests that the above-referenced Registration Statement on Form S-1 (File No. 333-221384) (the “Registration Statement”) be declared effective at the “Requested Date” and “Requested Time” set forth above or at such later time as the Company or its counsel may orally request via telephone call to the staff (the “Staff”) of the Division of Corporation Finance of the Securities and Exchange Commission (the “Commission”). In connection with the acceleration request, the Company hereby 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 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. Thank you for your attention to this matter. Sincerely, Integrity Applications, Inc. /s/ John Graham John Graham Chief Executive Officer cc: Mitchell Lampert, Esq. Robinson & Cole LLP 1055 Washington Boulevard Stamford, CT 06901
2017-11-29 - UPLOAD - Glucotrack, Inc.
Mail Stop 3030 November 2 9, 2017 Via E -mail John Graham Chief Executive Officer Integrity Applications, Inc. 19 Ha’Yahalomim St. PO Box 12143 Ashdod L3 7760049, Israel Re: Integrity Applications, Inc. Registration Statement on Form S-1 Filed November 7, 2017 File No. 333-221384 Dear Mr. Graham : 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 Caleb French at (202) 551 -6947 with any questions. Sincerely, /s/ Caleb French for Amanda Ravitz Assistant Director Office of Electronics and Machinery cc: Mitchell L. Lampert, Esq. Robinson & Cole LLP
2011-11-10 - CORRESP - Glucotrack, Inc.
CORRESP
1
filename1.htm
Unassociated Document
INTEGRITY APPLICATIONS, INC.
102 Ha’Avoda Street
P.O. Box 432
Ashkelon L3 78100
Israel
November 10, 2011
VIA EDGAR AND FEDERAL EXPRESS
Securities and Exchange Commission
100 F. Street, N.E.
Washington, DC 20549
Attn: Daniel Morris
Re:
Integrity Applications, Inc.
Amendment No. 2 to Registration Statement on Form S-1
Filed October 27, 2011
File No. 333-176415
Dear Mr. Morris:
On behalf of Integrity Applications, Inc., a Delaware corporation (the “Company”), I am writing to respond to the comments of the staff (the “Staff”) of the United States Securities and Exchange Commission (the “SEC”) contained in its letter to the Company, dated November 9, 2011, regarding Amendment No. 2, filed with the SEC on October 27, 2011 (“Amendment No. 2”), to the Company’s Registration Statement on Form S-1 (File No. 333-176415) originally filed with the SEC on August 22, 2011 (the “Registration Statement”).
Concurrently with this response, the Company is also filing Amendment No. 3 to the Registration Statement (“Amendment No. 3”) incorporating the revisions to the Registration Statement described herein. To expedite your review, we have enclosed with this letter a marked copy of Amendment No. 3 to the Registration Statement showing all changes from Amendment No. 2.
For your convenience, we have set forth the text of each of the Staff’s comments in bold, followed in each case by the Company’s response thereto.
Liquidity and Capital Resources, page 32
1.
We note your response to prior comment 7. Please disclose the Israeli Consumer Price Index on the date the loan was made and on the most recent date practicable.
In response to the Staff’s comment, the Company has revised the Registration Statement to disclose the Israeli Consumer Price Index on the date each loan was made and as of November 10, 2011. Please see pages 22, 32 and 67 of Amendment No. 3.
Principal and Selling Shareholders, page 55
2.
Revise the prospectus to state, as disclosed in your response to prior comment 12, that the tax ruling by the Israeli Tax Authorities will not have any effect on any selling shareholder's ability to sell shares pursuant to the registration statement because the ruling did not apply to the shares to be sold.
In response to the Staff’s comment, the Company has revised the Registration Statement to disclose that the tax ruling by the Israeli Tax Authorities will not have any effect on any selling shareholder's ability to sell shares pursuant to the registration statement because the ruling did not apply to the shares to be sold. Please see pages 2, 27 and 33 of Amendment No. 3.
3.
We note your response to prior comment 13. Please disclose, if true, that at the time of the purchase of the securities to be resold, each seller had no agreements or understandings, directly or indirectly, with any person to distribute the securities.
In response to the Staff’s comment, the Company has revised the Registration Statement to disclose that, none of the selling shareholders was party to any agreement or understanding, directly or indirectly, with any person to distribute the shares of the Company’s common stock to be resold by such selling shareholder under the Registration Statement. Please see page 55 of Amendment No. 3.
Item 16. Exhibits, page II-3
4.
Regarding your response to prior comment 14, it appears that the exhibits include only the form of agreement. We therefore reissue our comment.
The Company respectfully advises the Staff that the subscription agreements entered into between the Company and each of the approximately 100 investors in the seven closings of the Company’s recently completed private placement were identical in all respects except for the date of the agreement, the name of the investor, and the number of shares purchased by such investor. As a result, the Company has filed only the form of such agreement as an exhibit to the Registration Statement and has not filed all of the individual subscription agreements.
5.
Please note that we may have further comments after you file the enclosures you mention in response to prior comment 18.
The Company acknowledges the Staff’s comment. Please see Exhibit 10.16, as re-filed with Amendment No. 3 on the date hereof, which includes the previously omitted enclosures.
* * * * *
We thank you in advance for your consideration of this response. If you have any questions regarding this response, please call the Company’s outside counsel, Robert L. Grossman, Esq. of Greenberg Traurig, P.A. at (305) 579-0756.
Sincerely,
/s/ Avner Gal
Chief Executive Officer
cc:
Robert L. Grossman, Esq.,
Greenberg Traurig, P.A.
2011-11-10 - UPLOAD - Glucotrack, Inc.
November 9, 2011 Via E-mail Avner Gal Chief Executive Officer Integrity Applications Inc. P.O. Box 432 Ashkelon 78100, Israel Re: Integrity Applications, Inc. Amendment No. 2 to Registrati on Statement on Form S-1 Filed October 27, 2011 File No. 333-176415 Dear Mr. Gal: We have reviewed your registration statem ent and have the following comments. In some of our comments, we may ask you to provi de 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 re gistration statement and the information you provide in response to these comments, we may have additional comments. Liquidity and Capital Resources, page 32 1. We note your response to prior comment 7. Pl ease disclose the Is raeli Consumer Price Index on the date the loan was made a nd on the most recent date practicable. Principal and Selling Shareholders, page 55 2. Revise the prospectus to state, as disclose d in your response to prior comment 12, that the tax ruling by the Israeli Tax Authorities will not have any effect on any selling shareholder’s ability to sell shares pursuant to the registration statement because the ruling did not apply to th e shares to be sold. 3. We note your response to prior comment 13. Please disclose, if true, that at the time of the purchase of the securities to be resold, each seller had no agreements or understandings, directly or i ndirectly, with any person to distribute the securities. Avner Gal Integrity Applications, Inc. November 9, 2011 Page 2 Item 16. Exhibits, page II-3 4. Regarding your response to prior comment 14, it appears that the e xhibits include only the form of agreement. We therefore reissue our comment. 5. Please note that we may have further comme nts after you file the enclosures you mention in response to prior comment 18. We urge all persons who are responsible for th e accuracy and adequacy of the disclosure in the filing to be certain that the filing incl udes the information the Securities Act of 1933 and all applicable Securities Act rules require. Since the company and its management are in possession of all facts relating to a company’s disc losure, 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 pr ovide a written statement from the company acknowledging that: should the Commission or the staff, acting purs uant to delegated authority, declare the filing effective, it does not foreclose the Co mmission 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 a nd 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 re quests for acceleration. We will consider a written request for acceleration of the effective date of the regi stration statement as confirmation of the fact that those reques ting acceleration are aware of thei r respective responsibilities under the Securities Act of 1933 and the Securities Excha nge Act of 1934 as they relate to the proposed public offering of the securities specified in th e above registration stat ement. Please allow adequate time for us to review any amendment prior to the requested effective date of the registration statement. Avner Gal Integrity Applications, Inc. November 9, 2011 Page 3 You may contact Julie Sherman at (202) 551-3640 or Jay Webb, the accounting reviewer, at (202) 551-3603 if you have ques tions regarding the financial st atements and related matters. Please contact Gabriel Eckstein at (202) 551-3286 or Daniel Morri s, Special Counsel, at (202) 551-3314 with any other questions. Sincerely, /s/ Daniel Morris for Amanda Ravitz Assistant Director cc (via E-mail): Robert L. Grossman, Esq. Greenberg Traurig, P.A.
2011-11-10 - CORRESP - Glucotrack, Inc.
CORRESP
1
filename1.htm
Unassociated Document
INTEGRITY APPLICATIONS, INC.
102 Ha’Avoda Street
P.O. Box 432
Ashkelon L3 78100
Israel
Securities and Exchange Commission
Division of Corporation Finance
100 F. Street, N.E.
Washington, DC 20549
Attn: Daniel Morris
Re:
Integrity Applications, Inc.
Registration Statement on Form S-1
File No. 333-176415
Ladies and Gentlemen:
In accordance with Rule 461 under the Securities Act of 1933, as amended, Integrity Applications, Inc. hereby requests acceleration of the effective date of the above-referenced Registration Statement so that such Registration Statement shall become effective at 4:00 p.m. (EST), on Monday, November 14, 2011, or as soon thereafter as practicable.
The Company hereby acknowledges that:
· should the Securities and Exchange Commission (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 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.
Respectfully yours,
INTEGRITY APPLICATIONS, INC.
By:
/s/ Avner Gal
Name: Avner Gal
Title: Chief Executive Officer
2011-10-26 - CORRESP - Glucotrack, Inc.
CORRESP
1
filename1.htm
Unassociated Document
INTEGRITY APPLICATIONS, INC.
102 Ha’Avoda Street
P.O. Box 432
Ashkelon L3 78100
Israel
October 26, 2011
VIA EDGAR AND FEDERAL EXPRESS
Securities and Exchange Commission
100 F. Street, N.E.
Washington, DC 20549
Attn: Daniel Morris
Re:
Integrity Applications, Inc.
Amendment No. 1 to Registration Statement on Form S-1
Filed October 7, 2011
File No. 333-176415
Dear Mr. Morris:
On behalf of Integrity Applications, Inc., a Delaware corporation (the “Company”), I am writing to respond to the comments of the staff (the “Staff”) of the United States Securities and Exchange Commission (the “SEC”) contained in its letter to the Company, dated October 24, 2011, regarding Amendment No. 1, filed with the SEC on October 7, 2011 (“Amendment No. 1”), to the Company’s Registration Statement on Form S-1 (File No. 333-176415) originally filed with the SEC on August 22, 2011 (the “Registration Statement”).
Concurrently with this response, the Company is also filing Amendment No. 2 to the Registration Statement (“Amendment No. 2”) incorporating the revisions to the Registration Statement described herein. To expedite your review, we have enclosed with this letter a marked copy of Amendment No. 2 to the Registration Statement showing all changes from Amendment No. 1.
For your convenience, we have set forth the text of each of the Staff’s comments in bold, followed in each case by the Company’s response thereto.
Fee Table
1.
We note your response to prior comment 1 and the use of the phrase “any other public market.” It is unclear why you cannot simply state that your stock will be offered at a fixed price until quoted on the OTC Bulletin Board, given the disclosure on the prospectus cover page that you intend to have your stock listed on the OTCBB. Please advise or revise throughout your document.
In response to the Staff’s comment, the Company has revised the Registration Statement to delete the references to the phrase “any other public market.” See the cover page and pages 6, 25 and 76 of Amendment No. 2.
Summary, Page 2
2.
We note your response to prior comment 4. Please revise the opening paragraph to disclose your losses for the most recently completed fiscal year and applicable stub period.
In response to the Staff’s comment, the Company has revised the opening paragraph of the “Summary” section of the Registration Statement to disclose its losses for the most recently completed fiscal year and the applicable stub period. See page 2 of Amendment No. 2.
3.
We note your response to prior comment 4. Please disclose the nature of the modifications contemplated and further disclose, if true, that you cannot be sure that the proposed modifications will improve your device’s results.
In response to the Staff’s comment, the Company has revised the Registration Statement to disclose the modifications made and anticipated to be made to the device, and to disclose that the Company cannot be sure that such modifications will improve the device’s results. See pages 2, 33 and 44 of Amendment No. 2.
4.
Regarding your response to prior comment 5, please further revise your document to avoid reliance on defined terms. We note, for example and without limitation, your frequent use of defined terms on pages 47 and 48. You also appear to define terms whose meaning is clear from their context, such as Securities and Exchange Commission. Refer to sample comment 3 in Staff Legal Bulletin No. 7 (June 7, 1999) for guidance.
In response to the Staff’s comment, the Company has further revised the prospectus to limit reliance on defined terms.
Risk Factors, page 7
A former stockholder . . ., page 7
5.
We note your response to prior comment 7. Please update the disclosure to reflect any developments as a result of the October 11, 2011 hearing, including any relief specified, now that an arbitrator has been appointed.
In response to the Staff’s comment, the Company has revised the Registration Statement to disclose the developments resulting from the October 11, 2011 hearing. See pages 3, 7 and 67 of Amendment No. 2.
2
Capitalization, page 26
6.
Please tell us why your pro forma capitalization at June 30, 2011 is less than your historical capitalization on the same date. We note the pro forma capitalization reflects the sale by you of 269,680 shares of common stock in private placements since June 30, 2011.
The capitalization table, as presented in Amendment No. 1, used parentheses to present liabilities and additional paid-in capital. Negative amounts were presented without parentheses. As a result, the capitalization table shows an increase in our pro forma capitalization to 2,771,408 from an amount of 1,306,854 in our historical capitalization. In order to clarify the Company's capitalization, the Company has revised the Capitalization table to properly present all line items in accordance with U.S. accounting practices. See page 26 of Amendment No. 2.
Liquidity and Capital Resources, page 32
7.
Please revise to clarify how interest on the shareholder loans will be calculated.
In response to the Staff’s comment, the Company has revised the Registration Statement to clarify how the amount to be repaid is calculated by reference to changes in the Israeli Consumer Price Index. See pages 22, 32 and 67 of Amendment No. 2.
Business, page 33
Overview, page 33
8.
We note your response to prior comment 10; however, your disclosure in this section is unclear as to what developments took place in the last three years. For example, in the third paragraph, you refer to the year that you were founded and then generally discuss the developments since that date without indicating when they took place. We therefore reissue our comment.
In response to the Staff’s comment, the Company has revised the Registration Statement to provide in the “Overview” section the relevant dates for the development of its product candidate. The Company has also revised the “Overview” section to clarify what developments took place during the past three years. We note that the overview section already discloses the form and year of the Company’s organization, as well as the reorganization transaction completed in July of 2010. See page 33 of Amendment No. 2. All other items required to be disclosed in the description of the Company’s business pursuant to Item 101(h)(4) of Regulation S-K have been disclosed on the following pages of the Registration Statement.
Principal products or services and their markets -- See disclosure on page 33 of Amendment No. 1, as supplemented by the additional disclosure included on page 33 of Amendment No. 2.
Distribution methods of the products or services -- See disclosure under the caption “Sales & Marketing” on page 46 of Amendment No. 1.
3
Status of any publicly announced new product or service -- See pages 38-44 of Amendment No. 1., which discloses the results of recent clinical trials of, and the status of, the GlucoTrack DF-F device.
Competitive business conditions and the smaller reporting company's competitive position in the industry and methods of competition - See disclosure under the caption “Competition” on pages 53-54 of Amendment No. 1.
Sources and availability of raw materials and the names of principal suppliers - See disclosure under the caption “Manufacturing” on page 46 of Amendment No. 1 with respect to the Company’s intended future manufacturing efforts.
Dependence on one or a few major customers - See disclosure under the caption “Sales & Marketing” 46 of Amendment No. 1, which discloses the Company’s plans with respect to its intended future distribution efforts.
Patents, trademarks, licenses, franchises, concessions, royalty agreements or labor contracts, including duration -- See disclosure under the caption “Intellectual Property” on pages 52-53 of Amendment No. 1.
Need for any government approval of principal products or services. If government approval is necessary and the smaller reporting company has not yet received that approval, discuss the status of the approval within the government approval process -- See disclosure under the caption “Government Regulatory” on pages 46-52 of Amendment No. 1. Note that the status of the GlucoTrack DF-F’s FDA and CE Mark approvals are disclosed on the second and third paragraphs, respectively, of page 48 of Amendment No. 1.
Effect of existing or probable governmental regulations on the business -- See disclosure under the caption “Government Regulatory” on pages 46-52 of Amendment No. 1.
Estimate of the amount spent during each of the last two fiscal years on research and development activities, and if applicable, the extent to which the cost of such activities is borne directly by customers -- See disclosure under the caption “Research and Development expenses” on page 31 of Amendment No. 1.
Costs and effects of compliance with environmental laws (federal, state and local) -- Not applicable.
Number of total employees and number of full-time employees -- See disclosure under the caption “Employees” on page 54 of Amendment No. 1.
4
The Product, page 36
9.
We reissue the part of prior comment 18 relating to the purchase price as a barrier to adoption because it is not addressed in your response.
In response to the Staff’s comment, the Company had revised the registration statement to include additional disclosure relating to the purchase price as a barrier to adoption. See pages 5 and 37 of Amendment No. 2.
10.
Please clarify your disclosure in response to prior comment 21 to indicate who recalibrates your products. Also, to the extent that the product must be recalibrated monthly by the user through the use of an invasive device, disclose how this compares to the recalibration requirements of competing products and revise your disclosure to clearly state, if true, that your product must be used in conjunction with an invasive device.
In response to the Staff’s comment, the Company has revised the Registration Statement to disclose who recalibrates the Company’s product. Additional disclosure has also been included to address the extent to which an invasive device is required to be used to recalibrate the device. See pages 5 and 43 of Amendment No. 2.
Regulation of the Design, Manufacture and Distribution…, page 47
11.
We note your response to prior comment 22. Given that you disclose an intention to market your product in countries that do not rely on the CE Mark, please expand your disclosure to identify these markets and discuss the regulatory hurdles you will encounter.
In response to the Staff’s comment, the Company has revised the Registration Statement to disclose the country that does not rely on the CE Mark in which it intends to market its products. See page 48 of Amendment No. 2.
Principal and Selling Stockholders, page 55
12.
We note your response to prior comment 28. Please provide your analysis as to the impact of the tax ruling by the Israeli Tax Authorities on your selling shareholders’ ability to sell shares pursuant to this registration statement. We note, for instance, the two-year restriction discussed elsewhere in the prospectus.
In response to the Staff’s comment, we have revised the Registration Statement to disclose that the selling shareholders acquired the shares to be sold pursuant to the Registration Statement in the private placement disclosed on page 3 and elsewhere in Amendment No. 1. See the inside front cover page and page 55 of Amendment No. 2. The Company respectfully advises the Staff that the tax ruling by the Israeli Tax Authorities will not have any effect on the selling shareholders’ ability to sell shares pursuant to the Registration Statement because, as disclosed on page 2 and elsewhere in Amendment No. 1, the tax ruling applies with respect to the shares of the Company owned by the former shareholders of Integrity Israel whose shares in Integrity Israel were exchanged for shares in the Company pursuant to the Reorganization completed on July 15, 2010, as described on page 2 and elsewhere in Amendment No. 1. The selling shareholders acquired their shares directly from the Company pursuant to the private placement, which commenced on July 26, 2010 and consisted of seven closings held between December 2010 and July 2011.
5
13.
We also note that your response to prior comment 28 states that two selling shareholders are associated with a broker dealer. Please tell us whether these shareholders are affiliated with a broker dealer, as the term “affiliate” is defined in Rule 405 of the Securities Act.
Based on shareholder questionnaires received from the selling shareholders referenced, the Company believes that each of these two shareholders is an affiliate of a broker dealer. However, each of these shareholders also represented to the Company in his shareholder questionnaire that he purchased his shares in the Company sold in the private placement in the ordinary course of business, and did not, at the time of purchase, have any agreements or understandings, directly or indirectly, with any person to distribute such shares.
14.
Please file or tell us where you filed your material agreements related to the private placements conducted between December 16, 2010 and July 29, 2011.
The Company respectfully advises the Staff that all material agreements related to the private placements have been filed as exhibits to the Registration Statement. Please see Exhibits 10.2 and 10.3, respectfully, for copies of the form of subscription and registration rights agreements entered into between the Company and the investors in the private placements. Please see Exhibits 10.5 and 10.6, respectfully, for a copy of the agreement entered into between the Company and the placement agent for the private placement and an amendment to such agreement.
15.
We note your response to prior comment 29. Please revise the footnotes to clarify the natural persons with voting and dispositive power over the shares held by IRA custodians. In addition, confirm that voting and dispositive power in joint tenancy holdings is held by the persons identified in the table.
In response to the Staff’s comment, the Company has revised the footnotes to clarify the natural persons with voting and dispositive power over the shares held by IRA custodians and to confirm that voting and dispositive power in joint tenancy holdings is held by the persons identified in the table.
Financial Statements, page F-1
Report of Independent Registered Public Accounting Firm, page F-3
6
16.
We note that your auditors changed the date of their opinion regarding your financial statements for the years ended December 31, 2009 and 2010. However, there is no indication in the filing as to the reason for the date change and there are no disclosures in the filing to indicate if any changes were made to the previous audit opinion and/or related financial statements. Please ask your auditors to explain to us why the date of their opinion was changed from August 22, 2011 to October 7, 2011 and to tell us the nature of any additional audit procedures they performed through October 7, 2011. Also, tell us whether any other changes were made to the prior audit report dated August 22, 2011 and/or related financial statements and if so, explain the reason for such changes.
The Company’s auditor has advised us that the date of its opinion was changed from August 22, 2011 to October 7, 2011 as a result of the revisions made to the financial statements in order to reflect the responses of the Company to the Staff’s comments contained in its comment letter dated September 16, 2011. These changes to the financial statements required the auditor to complete additional audit work and procedures, and therefore the date of the original report was changed to the date of completion of the additional work and procedures.
The additiona
2011-10-24 - UPLOAD - Glucotrack, Inc.
October 24, 2011 Via E-mail Avner Gal Chief Executive Officer Integrity Applications Inc. P.O. Box 432 Ashkelon 78100, Israel Re: Integrity Applications, Inc. Amendment No. 1 to Registrati on Statement on Form S-1 Filed October 7, 2011 File No. 333-176415 Dear Mr. Gal: We have reviewed your registration statem ent and have the following comments. In some of our comments, we may ask you to provi de 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 re gistration statement and the information you provide in response to these comments, we may have additional comments. Fee Table 1. We note your response to prior comment 1 a nd the use of the phr ase “any other public market.” It is unclear why you cannot simply state that your stock wi ll be offered at a fixed price until quoted on the OTC Bulletin Board, given the disclosure on the prospectus cover page that you intend to have your stock listed on the OTCBB. Please advise or revise th roughout your document. Summary, page 2 2. We note your response to prior comment 4. Please revise the opening paragraph to disclose your losses for the most recently completed fiscal year and applicable stub period. Avner Gal Integrity Applications, Inc. October 24, 2011 Page 2 3. We note your response to prior comment 4. Please disclose the nature of the modifications contemplated and further disclose , if true, that you ca nnot be sure that the proposed modifications will impr ove your device’s results. 4. Regarding your response to prior comment 5, please further revise your document to avoid reliance on defined terms. We not e, for example and without limitation, your frequent use of defined terms on pages 47 and 48 . You also appear to define terms whose meaning is clear from their context, such as Securities and Exchange Commission. Refer to sample comment 3 in Staff Legal Bulletin No. 7 (June 7, 1999) for guidance. Risk Factors, page 7 A former stockholder…, page 7 5. We note your response to prior comment 7. Pl ease update the disclo sure to reflect any developments as a result of the October 11, 2011 hearing, including any relief specified, now that an arbitrator has been appointed. Capitalization, page 26 6. Please tell us why your pro forma capita lization at June 30, 2011 is less than your historical capitalizati on on the same date. We note th e pro forma capitalization reflects the sale by you of 269,680 shares of common st ock in private placements since June 30, 2011. Liquidity and Capital Resources, page 32 7. Please revise to clarify how interest on the shareholder loans will be calculated. Business, page 33 Overview, page 33 8. We note your response to prior comment 10; how ever, your disclosure in this section is unclear as to what developments took place in the last three years. For example, in the third paragraph, you refer to the year that you were founded and then generally discuss the developments since that date without indi cating when they took place. We therefore reissue our comment. The Product, page 36 9. We reissue the part of prior comment 18 rela ting to the purchase price as a barrier to adoption because it is not addressed in your response. Avner Gal Integrity Applications, Inc. October 24, 2011 Page 3 10. Please clarify your disclosure in respons e to prior comment 21 to indicate who recalibrates your products. Also, to the exte nt that the product must be recalibrated monthly by the user through the us e of an invasive device, disclose how this compares to the recalibration requirements of competing pro ducts and revise your disclosure to clearly state, if true, that your product must be us ed in conjunction with an invasive device. Regulation of the Design, Manufact ure and Distribution…, page 47 11. We note your response to prior comment 22. Gi ven that you disclose an intention to market your product in countries that do not rely on the CE Mark, please expand your disclosure to identify these markets a nd discuss the regulatory hurdles you will encounter. Principal and Selling Stockholders, page 55 12. We note your response to prior comment 28. Pl ease provide your an alysis as to the impact of the tax ruling by the Israeli Tax Authorities on your selling shareholders’ ability to sell shares pursuant to this regi stration statement. We note, for instance, the two-year restriction discussed elsewhere in the prospectus. 13. We also note that your response to prior comm ent 28 states that two selling shareholders are associated with a broker dealer. Pleas e tell us whether these shareholders are affiliated with a broker dealer, as the term “affiliate” is defined in Rule 405 of the Securities Act. 14. Please file or tell us where you filed your ma terial agreements re lated to the private placements conducted between December 16, 2010 and July 29, 2011. 15. We note your response to prior comment 29. Plea se revise the footnotes to clarify the natural persons with voting and dispositive power over the shares held by IRA custodians. In addition, confirm that voti ng and dispositive power in joint tenancy holdings is held by the persons identified in the table. Financial Statements, page F-1 Report of Independent Registered Public Accounting Firm, page F-3 16. We note that your auditors changed the date of their opinion rega rding your financial statements for the years ended Decemb er 31, 2009 and 2010. However, there is no indication in the filing as to the reason for th e date change and there are no disclosures in the filing to indicate if any changes were made to the pr evious audit opinion and/or related financial statements. Please ask your au ditors to explain to us why the date of their opinion was changed from August 22, 2011 to October 7, 2011 and to tell us the nature of any additional audit procedures they performed through October 7, 2011. Also, Avner Gal Integrity Applications, Inc. October 24, 2011 Page 4 tell us whether any other changes were ma de to the prior audit report dated August 22, 2011 and/or related financial statements and if so, explain the reason for such changes. Consolidated Balance Sheets, page F-4 17. Please tell us your consideration of the gui dance at ASC 915-210-45 w ith respect to the current description herein of your accumulated deficit. Item 16. Exhibits, page II-3 18. Please file a complete exhibit 10.16. We not e the exhibit contai ns references to enclosures. 19. Regarding your response to prior comment 40, pl ease tell us which exhi bit pertains to the May 2002 loan described on page 67 of your document. 20. Please file a complete exhibit 10.12. We note th e exhibit contains a reference to exhibit C. We urge all persons who are responsible for th e accuracy and adequacy of the disclosure in the filing to be certain that the filing incl udes the information the Securities Act of 1933 and all applicable Securities Act rules require. Since the company and its management are in possession of all facts relating to a company’s disc losure, 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 pr ovide a written statement from the company acknowledging that: should the Commission or the staff, acting purs uant to delegated authority, declare the filing effective, it does not foreclose the Co mmission 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 a nd 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 re quests for acceleration. We will consider a written request for acceleration of the effective date of the regi stration statement as confirmation Avner Gal Integrity Applications, Inc. October 24, 2011 Page 5 of the fact that those reques ting acceleration are aware of thei r respective responsibilities under the Securities Act of 1933 and the Securities Excha nge Act of 1934 as they relate to the proposed public offering of the securities specified in th e above registration stat ement. Please allow adequate time for us to review any amendment prior to the requested effective date of the registration statement. You may contact Julie Sherman at (202) 551- 3640 or Jay Webb, reviewing accountant, at (202) 551-3603 if you have questions regardi ng comments on the financial statements and related matters. Please contac t Gabriel Eckstein at (202) 55 1-3286 or Daniel Morris, Special Counsel, at (202) 551-3314 w ith any other questions. Sincerely, /s/ Daniel Morris for Amanda Ravitz Assistant Director cc (via E-mail): Robert L. Grossman, Esq. Greenberg Traurig, P.A.
2011-10-07 - CORRESP - Glucotrack, Inc.
CORRESP
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filename1.htm
Unassociated Document
INTEGRITY APPLICATIONS, INC.
102 Ha’Avoda Street
P.O. Box 432
Ashkelon L3 78100
Israel
October 7, 2011
VIA EDGAR AND FEDERAL EXPRESS
Securities and Exchange Commission
100 F. Street, N.E.
Washington, DC 20549
Attn: Daniel Morris
Re:
Integrity Applications, Inc.
Registration Statement on Form S-1
Filed August 22, 2011
File No. 333-176415
Dear Mr. Morris:
On behalf of Integrity Applications, Inc., a Delaware corporation (the “Company”), we are writing to respond to the comments of the staff (the “Staff”) of the United States Securities and Exchange Commission (the “SEC”) contained in its letter to the Company, dated September 16, 2011, regarding the Company’s Registration Statement on Form S-1 (File No. 333-176415) filed on August 22, 2011 (the “Registration Statement”).
Concurrently with this response, the Company is also filing Amendment No. 1 to the Registration Statement incorporating the revisions to the Registration Statement described herein. To expedite your review, we have enclosed with this letter a marked copy of Amendment No. 1 to the Registration Statement showing all changes from the original Registration Statement.
For your convenience, we have set forth the text of each of the Staff’s comments in bold, followed in each case by the Company’s response thereto.
Fee Table
1.
We note that there is currently no established market for your shares. Please provide a fixed price on the cover. In addition, please revise footnote (2) and throughout the prospectus, as appropriate, to clarify that shares will be sold at a fixed price until a market develops.
In response to the Staff’s comment, the Company has revised the Registration Statement to clarify on the cover page, and wherever else appropriate, that the shares will be sold at a fixed price until a market develops. See the cover page and pages 6, 25 and 76 of Amendment No. 1.
Prospectus Cover Page
2.
We note that your name is the same as that of Integrity Applications, Incorporated, an engineering and software services company based in Chantilly, Virginia. To eliminate any confusion, please provide the additional disclosure required by Regulation S-K Item 501 (b)( 1) Instruction.
In response to the Staff’s comment, the Company has revised the Registration Statement to include the additional disclosure required by the Instruction to Item 501(b)(1) of Regulation S-K. See the cover page and pages 5 and 33 of Amendment No. 1.
Cautionary Note Regarding Forward-Looking Statements, page 1
3.
Refer to the first sentence in this section. Please remove the inapplicable references to the safe harbor provisions under the Securities and Exchange Acts.
In response to the Staff’s comment, the Company has revised the first sentence of the section of the Registration Statement captioned “Cautionary Note Regarding Forward-Looking Statements” to delete the references to the safe harbor provisions under the Securities and Exchange Acts. See page 1 of Amendment No. 1.
Summary, page 2
4.
Please revise the summary to describe the risks and drawbacks of your product as prominently as your disclosure about the benefits of your product. In addition, please revise to disclose the going concern limitation mentioned in the auditor’s report as well as your current and cumulative losses and lack of revenues.
In response to the Staff’s comment, the Company has revised the section of the Registration Statement captioned “Summary” to describe the risks and drawbacks of the Company’s product as prominently as the benefits of the product. The Company has also revised the “Summary” section to disclose the going concern limitation mentioned in the auditor’s report as well as the Company’s current and cumulative losses. See pages 2 and 4 of Amendment No. 1.
5.
Please revise the prospectus to limit your reliance on defined terms. Risk Factors, page 7
In response to the Staff’s comment, the Company has revised the prospectus to limit reliance on defined terms.
6.
Please include a risk factor that discloses the effects on your business, including your revenues and profits, of your obligation to repay shareholder loans and royalties to OCS.
In response to the Staff’s comment, the Company has revised the Registration Statement to include a risk factor that discloses the effects on its business, including its revenues and profits, of its obligation to repay shareholder loans and royalties to the Office of the Chief Scientist (“OCS”). See page 22 of Amendment No. 1.
A former shareholder of Integrity Israel..., page 7
7.
With a view to disclosure, please more fully describe the equitable remedies and/or monetary damages sought by Mr. Dimri. To the extent that Mr. Dimri seeks anti-dilution shares, please tell us the number of additional shares that you would be required to issue to meet his demands.
In response to the Staff’s comment, the Company has revised the Registration Statement to disclose the fact that, as Mr. Dimri has not yet specified the relief he is seeking, the Company does not know the equitable remedies and/or monetary damages that he is seeking. In accordance with Israeli law, Mr. Dimri was not required to, and he did not, specify in his request for the appointment of an arbitrator the relief to be sought by him in such arbitration. The Company anticipates that Mr. Dimri will specify the relief sought after an arbitrator is appointed.
The Company advises the Staff that, pursuant to the Irrevocable Undertaking of Indemnification (the “Indemnification Agreement”) entered into by the founders of the Company, the founders agreed to indemnify and hold the Company harmless from any adverse consequences (excluding the fees and costs of defending the Company) that result from Mr. Dimri’s, or his successors’ or assigns’, enforcement of the anti-dilution rights granted to Mr. Dimri. Pursuant to the terms of that agreement, the founders’ would be obligated to transfer up to such number of shares of the Company’s common stock that he or she owned as of the date of the reorganization to Dimri or to the Company. Therefore, to the extent that Mr. Dimri seeks (and is awarded) anti-dilution shares, the Company expects that such shares would be transferred by the founders pursuant to the Indemnity Agreement, as opposed to an original issuance by the Company. Please see pages 7 and 66 of Amendment No. 1 for more information regarding the Indemnity Agreement.
Capitalization, page 26
8.
Please remove your line item for cash and cash equivalents since this is not part of your capitalization.
In response to the Staff’s comment, the Company has revised the capitalization table to delete the line for cash and cash equivalents. See page 26 of Amendment No. 1.
Management’s Discussion and Analysis..., page 27 Recent Developments, page 27
9.
We note your statement in the last paragraph in this section that you are required to pay royalties up to 100% of the amount of grants received. Please clarify whether you also owe interest on the grants.
In response to the Staff’s comment, the Company respectfully advises the Staff that, as previously disclosed, the Company is in fact required to pay interest on the grants, in an amount equal to the London Interbank Offered Rate (LIBOR). See page 28 of the Registration Statement, as originally filed on August 22, 2011, and page 28 of Amendment No. 1.
Business, page 33 Overview, page 33
10.
Please include disclosure regarding the development of your business for the last three years. Refer to Regulation S-K Item 101(h).
The Company respectfully advises the Staff that the section of the prospectus captioned “Business” includes the disclosure regarding the development of the Company’s business for the last three years required by Item 101(h) of Regulation S-K.
11.
Please disclose the number of shares held by the stockholders you mention in the last sentence of the second paragraph.
In response to the Staff’s comment, the Company has revised the last sentence of the second paragraph under the caption “Business--Overview,” and wherever else appropriate in the Registration Statement, to disclose the number of shares held by the shareholders of the Company referenced therein. See pages 2, 27 and 33 of Amendment No. 1.
12.
Refer to the third paragraph. Please disclose what you mean by “benign effect.”
In response to the Staff’s comment, the Company has revised the Registration Statement to replace the term “benign effect,” as used in the third paragraph under the caption “Business--Overview,” with a more descriptive term. In addition, the Company refers the Staff to Figure G contained in Amendment No. 1, which includes a definition of the risk described as “benign” under Zone B of the Clarke Error Grid. See pages 33 and 41 of Amendment No. 1.
13.
Please disclose what you are comparing your product against when you disclose in the last sentence of the fourth paragraph on page 34 that your product is less expensive.
In response to the Staff’s comment, the Company has revised the Registration Statement to clarify that the Company’s product is expected to be less expensive as compared to traditional invasive measurement devices, such as spot finger stick devices. See page [__] of Amendment No. 1.
Market Opportunity, page 34
14.
Regarding the industry data that you cite in your document, please tell us whether you obtained the information from sources that are generally publicly available for no or nominal fee. If not, please file a consent pursuant to Rule 436 of the Securities Act of 1933. Also, please tell us how you confirmed that you have used the most current data.
In response to the Staff’s comment, the Company has updated the disclosure in the Registration Statement to reflect the most current data available. The industry data cited in the prospectus, as revised in Amendment No. 1, was generally obtained from reports issued by, and available without cost on the websites of, the sources cited. The data has been updated to reflect the most recent reports displayed on those websites, and, to the Company’s knowledge, no more recent data is publicly available.
15.
Please provide us with independent support, including relevant articles and reports, for your statements in the prospectus regarding your market opportunity. Please mark the supporting materials so that they are tied to the disclosure.
In response to the Staff’s comment, the Company is attaching (supplementally) as Exhibit A to this response letter the relevant articles and reports that support the statements in the prospectus regarding the Company’s market opportunity.
Glucose Monitoring, page 35
16.
Please identify in your document the “industry sources” that you refer to in the last sentence of the second paragraph on page 35.
In response to the Staff’s comment, the Company has revised the Registration Statement to clarify this statistic and to identify the source thereof. See page 35 of Amendment No. 1.
The Product, page 36
17.
With a view to disclosure, please tell us the basis for your statement that cost and pain are two of the most significant barriers to frequent blood monitoring.
In response to the Staff’s comment, the Company has revised the Registration Statement to qualify this statement by the Company’s belief. See page 36 of Amendment No. 1. The basis for the Company’s belief are several articles and publications supporting this conclusion, copies of which have been attached (supplementally) as Exhibit B to this response letter.
18.
Please clarify the second bullet point on page 36 to disclose the significant initial purchase price of your product when compared to a conventional monitoring system and how this may present a barrier to adoption.
In response to the Staff’s comment, the Company has revised the second bullet to disclose the significant initial purchase price of the product. See page 36 of Amendment No. 1.
19.
We note that several of your trials and/or studies appear to involve a limited number of participants. We also note your second risk factor on page 10. Please balance your disclosure by describing the inherent shortcomings, if any, of relying on limited studies.
In response to the Staff’s comment, the Company has revised the Registration Statement to disclose the inherent shortcomings of relying on limited studies. See pages 2, 10, 27 and 33 of Amendment No. 1.
20.
In the first paragraph on page 43 you disclose that trials indicate that recalibration is necessary every few months. Please reconcile this disclosure with your disclosure on page 5 where you indicate that your product will require monthly calibration.
In response to the Staff’s comment, the Company has revised the Registration Statement to reconcile the statements regarding the frequency with which the Company’s product is expected to require recalibration. See pages 5 and 43 of Amendment No. 1.
21.
Please disclose how your product is recalibrated and whether this entails a cost to the patient. To the extent that there is a recalibration cost, please confirm that this has been disclosed in Figure B on page 37.
In response to the Staff’s comment, the Company has revised the Registration Statement to disclose (1) how the product is recalibrated, (2) that the cost of recalibration to the patient is expected to be minimal, (3) that Figure B excludes recalibration costs and (4) an estimate of such costs over the period reflected in Figure B. See page 37 of Amendment No. 1.
Regulation of the Design, manufacture and Distribution of Medical Devices, page 47
22.
With a view to disclosure, please tell us whether you intend to limit your sales outside the United States to countries that rely on the CE Mark.
The Company respectfully advises the Staff that it does not intend to limit sales outside the United States to countries that rely on the CE Mark. In response to the Staff’s comment, the Company has revised the Registration Statement to disclose this fact. See page 48 of Amendment No. 1.
Reimbursement, page 49
23.
Please include disclosure regarding possible cuts in government spending programs, such as Medicare, due to deficit reductions efforts and its effects on your business.
In response to the Staff’s comment, the Company has revised the Registration Statement to include disclosure regarding possible cuts in government spending programs, such as Medicare, due to deficit reductions efforts, and its effects on the Company’s business. See pages 15 and 50 of Amendment No. 1.
Intellectual Property, page 52
24.
Please disclose the duration of your significant patents. Competition, page 53.
In response to the Staff’s comment, the Company has revised the Registration Statement to include disclosure regarding the duration of its significant patent. See page 52 of Amendment No. 1.
25.
Please remove the images of your competitors’ products from the table marked “Figure J” on page 54. In addition, please revise this section to include descriptions of the competing technologies identified in the table.
In response to the Staff’s comment, the Company has revised “Figure J” to remove the images of its competitors’ products and to include descriptions of the competing technologies identified therein. See page 54 of Amendment No. 1.
Principal and Selling Shareholders, page 55
26.
Given the nature of the transaction being registered, please advise the staff of the company’s basis for determining that the transaction is appropriately characterized as a transaction that is eligible to be made on a shelf basis under Rule 415(a)( 1 )(i).
Rule 415(a)(1)(i) allows securities to be registered for an offering to be made on a continuous or delayed basis in the future, provided that the registration statement pertains only to “[s]ecurities which are to be offered or sold solely by or on behalf of a person or persons other than the registrant, a
2011-09-16 - UPLOAD - Glucotrack, Inc.
September 16, 2011 Via E-mail Avner Gal Chief Executive Officer Integrity Applications Inc. P.O. Box 432 Ashkelon 78100, Israel Re: Integrity Applications, Inc. Registration Statement on Form S-1 Filed August 22, 2011 File No. 333-176415 Dear Mr. Gal: We have reviewed your registration statem ent and have the following comments. In some of our comments, we may ask you to provi de 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 re gistration statement and the information you provide in response to these comments, we may have additional comments. Fee Table 1. We note that there is currently no established market for your shares. Please provide a fixed price on the cover. In addition, pl ease revise footnote (2 ) and throughout the prospectus, as appropriate, to clarify that shares will be sold at a fixed price until a market develops. Prospectus Cover Page 2. We note that your name is the same as that of Integrity Applicati ons, Incorporated, an engineering and software services company ba sed in Chantilly, Virginia. To eliminate any confusion, please provide the additional disclosure required by Regulation S-K Item 501(b)(1) Instruction. Avner Gal Integrity Applications, Inc. September 16, 2011 Page 2 Cautionary Note Regarding Forw ard-Looking Statements, page 1 3. Refer to the first sentence in this section. Please remove the inapplicable references to the safe harbor provisions under th e Securities and Exchange Acts. Summary, page 2 4. Please revise the summary to describe th e risks and drawbacks of your product as prominently as your disclosure about the be nefits of your product. In addition, please revise to disclose the going c oncern limitation mentioned in th e auditor’s report as well as your current and cumulative lo sses and lack of revenues. 5. Please revise the prospectus to lim it your reliance on defined terms. Risk Factors, page 7 6. Please include a risk factor that disclose s the effects on your business, including your revenues and profits, of your oblig ation to repay shareholder lo ans and royalties to OCS. A former stockholder of In tegrity Israel…, page 7 7. With a view to disclosure, please more fully describe the equitable remedies and/or monetary damages sought by Mr. Dimri. To th e extent that Mr. Dimri seeks anti-dilution shares, please tell us the number of additiona l shares that you would be required to issue to meet his demands. Capitalization, page 26 8. Please remove your line item for cash and cash e quivalents since this is not part of your capitalization. Management’s Discussion and Analysis…, page 27 Recent Developments, page 27 9. We note your statement in the last paragraph in this section that you are required to pay royalties up to 100% of the amount of grants received. Please cl arify whether you also owe interest on the grants. Avner Gal Integrity Applications, Inc. September 16, 2011 Page 3 Business, page 33 Overview, page 33 10. Please include disclosure regarding the deve lopment of your business for the last three years. Refer to Regulation S-K Item 101(h). 11. Please disclose the number of shares held by the stockholders you me ntion in the last sentence of the second paragraph. 12. Refer to the third paragraph. Please disc lose what you mean by “benign effect.” 13. Please disclose what you are comparing your product against when you disclose in the last sentence of the fourth paragraph on page 34 that your product is less expensive. Market Opportunity, page 34 14. Regarding the industry data th at you cite in your document, please tell us whether you obtained the information from sources that are generally publicly available for no or nominal fee. If not, please file a consent pur suant to Rule 436 of the Securities Act of 1933. Also, please tell us how you confirmed th at you have used the most current data. 15. Please provide us with independent support, including relevant artic les and reports, for your statements in the prospectus regardi ng your market opportunity. Please mark the supporting materials so that they are tied to the disclosure. Glucose Monitoring, page 35 16. Please identify in your document the “industry sources” that you refe r to in the last sentence of the second paragraph on page 35. The Product, page 36 17. With a view to disclosure, pleas e tell us the basis for your stat ement that cost and pain are two of the most significant barrie rs to frequent blood monitoring. 18. Please clarify the second bulle t point on page 36 to disclo se the significant initial purchase price of your product when compared to a conventional monitoring system and how this may present a barrier to adoption. 19. We note that several of your trials and/or st udies appear to involve a limited number of participants. We also note your second risk factor on pa ge 10. Please balance your disclosure by describing the inherent shortc omings, if any, of relying on limited studies. Avner Gal Integrity Applications, Inc. September 16, 2011 Page 4 20. In the first paragraph on page 43 you disclose th at trials indicate th at recalibration is necessary every few months. Please reconcil e this disclosure w ith your disclosure on page 5 where you indicate that your pr oduct will require monthly calibration. 21. Please disclose how your product is recalibrate d and whether this entails a cost to the patient. To the extent that there is a recalib ration cost, please confir m that this has been disclosed in Figure B on page 37. Regulation of the Design, manufacture and Di stribution of Medical Devices, page 47 22. With a view to disclosure, please tell us whether you intend to limit your sales outside the United States to countries that rely on the CE Mark. Reimbursement, page 49 23. Please include disclosure regarding possible cuts in government spending programs, such as Medicare, due to deficit reductions e fforts and its effects on your business. Intellectual Property, page 52 24. Please disclose the duration of your significant patents. Competition, page 53 25. Please remove the images of your competitors’ products from the table marked “Figure J” on page 54. In addition, please revise th is section to include descriptions of the competing technologies iden tified in the table. Principal and Selling Shareholders, page 55 26. Given the nature of the transaction being registered, please advise the staff of the company’s basis for determining that the transaction is appr opriately characterized as a transaction that is eligible to be made on a shelf basis under Rule 415(a)(1)(i). 27. We note your disclosure in the table on page 55 that you have five executive officers and directors. Please reconcile this disclosure with your disclosure under “Management” on page 61. 28. Please tell us whether any selling shareholde r is a broker-dealer or affiliated with a broker-dealer. 29. Please disclose the individuals that have voting and/or investment authority for each entity included in your tables. Avner Gal Integrity Applications, Inc. September 16, 2011 Page 5 Management, page 61 Directors and Executive Officers, page 61 30. Please provide the information required by Regulation S-K Item 401(e) regarding the qualifications of your director s. Also, disclose Dr. Fisc hell’s term as a director. Executive Compensation, page 63 Outstanding Equity Awards…, page 63 31. We note your reference to the “Options Awards” column in your summary compensation table. Please revise your tabl e to include this disclosure. Avner Gal, page 64 32. Please disclose the options received by Messrs. Gal and Malka in your Summary Compensation Table and in the table required by Item 402(p) or tell us why disclosure is not required. Financial Statements, page F-1 33. Please update your financial stat ements as necessary to comp ly with the requirements of Rule 8-08 of Regulation S-X. Also, all am endments should contai n a currently dated accountant’s consent. Consolidated Statements of Operations, page F-5 34. Please revise to present loss per share amounts rounded to the nearest cent in order not to imply a greater degree of precision than exists. Consolidated Statements of Cash Flows, page F-11 35. Please tell us and revise the filing to disclose what your lin e item ‘Linkage difference on principal of loans from stockholders’ in the operating activitie s section of this statement represents. Note 3 – Other Current Assets, page F-18 36. Please tell us and revise the filing to disclose the nature of the government institution assets. Avner Gal Integrity Applications, Inc. September 16, 2011 Page 6 Note 9 – Commitments and Contingent Liabilities, page F-20 37. We noted your discussion in Section A that approximately $93,000 in grants are subject to repayment as of June 30, 2011. Please ex plain the terms upon which these amounts would be required to be repa id, explain the period through which the contingency extends through and revise to explain you r accounting for the contingency. 38. We noted your discussion of the actions brought about by Mr. Dimri. If no liabilities have been recorded or if there is at least a reas onable possibility that a loss exceeding liability amounts already recognized may have been in curred with regards to Mr. Dimri’s claims, please revise to either disclose an estimate (or, if true, state that the estimate is immaterial in lieu of providing quantified amounts) of the additional loss or range of loss, or state that such an estimate cannot be made. Please refer to ASC 450-20-50. If you conclude that you cannot estimate the reasonably possible addi tional loss or range of loss, please supplementally: (1) expl ain to us the procedures you undertake on a quarterly basis to attempt to develop a range of reasonably possibl e loss for disclosure and (2) for each material matter, what specif ic factors are causing the inability to estimate and when you expect those fact ors to be alleviated. We r ecognize that there are a number of uncertainties and po tential outcomes associated with loss contingencies. Nonetheless, an effort should be made to develop estim ates for purposes of disclosure, including determining which of the potential outcom es are reasonably possible and what the reasonably possible range of losses would be for those reasonably possible outcomes. Please include your proposed di sclosures in your response. Item 16. Exhibits, page II-3 39. Please file copies of the royalty agreements with the Office of the Chief Scientist. 40. Please file copies of any agreements relate d to your credit facilities and loans from shareholders, including the loans mentioned in the last paragraph on page 67. Also, please revise your “Liquidity and Capita l Resources” discussion in Management’s Discussion and Analysis to disclose th e material terms of these agreements. 41. Please file the agreement with the leading chain of private diab etes clinics that you mention on page 46. Exhibit 5.1 42. Please revise to clarify that Delaware law in cludes applicable provi sions of the Delaware constitution and reported j udicial interpretations. Avner Gal Integrity Applications, Inc. September 16, 2011 Page 7 We urge all persons who are responsible for th e accuracy and adequacy of the disclosure in the filing to be certain that the filing incl udes the information the Securities Act of 1933 and all applicable Securities Act rules require. Since the company and its management are in possession of all facts relating to a company’s disc losure, 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 pr ovide a written statement from the company acknowledging that: should the Commission or the staff, acting purs uant to delegated authority, declare the filing effective, it does not foreclose the Co mmission 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 a nd 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 re quests for acceleration. We will consider a written request for acceleration of the effective date of the regi stration statement as confirmation of the fact that those reques ting acceleration are aware of thei r respective responsibilities under the Securities Act of 1933 and the Securities Excha nge Act of 1934 as they relate to the proposed public offering of the securities specified in th e above registration stat ement. Please allow adequate time for us to review any amendment prior to the requested effective date of the registration statement. You may contact Julie Sherman at (202) 551- 3640 or Jay Webb, reviewing accountant, at (202) 551-3603 if you have questions regardi ng comments on the financial statements and related matters. Please contac t Gabriel Eckstein at (202) 55 1-3286 or Daniel Morris, Special Counsel, at (202) 551-3314 w ith any other questions. Sincerely, /s/ Daniel Morris for Amanda Ravitz Assistant Director cc (via E-mail): Robert L. Grossman, Esq. Greenberg Traurig, P.A.