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SEC Comment Letter for BioRestorative Therapies, Inc. (BRTX) (CIK 0001505497) (BRTX) — Aug 8, 2011

BioRestorative Therapies, Inc. (BRTX) (CIK 0001505497)
Date: Aug. 8, 2011 · CIK: 0001505497 · Accession: 0000000000-11-047973

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File numbers found in text: 000-54402

Referenced dates: June 6, 2011

Date
August 8, 2011
Author
Not clearly detected
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UPLOAD
Company
BioRestorative Therapies, Inc. (BRTX) (CIK 0001505497)

Letter

August 8, 2011 Via E-Mail Mark Weinreb, Chief Executive Officer Stem Cell Assurance, Inc. 555 Heritage Drive Jupiter, FL 33458

Re: Stem Cell Assurance, Inc. Amendment No. 1 to Form 10 Filed July 11, 2011 File No. 000-54402

Dear Mr. Weinreb: We have reviewed your filing 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 within ten business days by amending your filing, by providing the requested information, or by advi sing us when you will provide the requested response. If you do not believe our comments apply to your fact s and circumstances or do not believe an amendment is appropriate, pl ease tell us why in your response. After reviewing any amendment to your filing and the information you provide in response to these comments, we may have additional comments.

General

Overview, page 1

1. We reissue comment one of our letter dated June 6, 2011. Please provi de a more detailed discussion of your business plan. Clearly disc lose the milestones for each part of your business plan, including the estimated time fr ame for each milestone, the estimated costs and the intended sources of f unding. In response to our pr ior comment you have instead provided very general disclosure of the busin ess plan, rather than the various milestones that are needed to implement each phase of your business plan. 2. While we note the general statement on page one that the implementation of the business plan will require sufficient e quity or debt financing to f und your operations, please revise the disclosure to clearly st ate the intended sour ce(s) of funding, whether you have any

Mark Weinreb Stem Cell Assurance, Inc. August 8, 2011 Page 2

funding sources to date, and the impact on your business plan if you are unable to obtain such funding. In addition, we note the estima ted costs and time frame for implementing parts of your business plan. Given the signi ficant funding needed, please explain how you determined the time frame and discuss whether you currently have the funding for that particular part of your business plan. Strategy, page 1

1. We note your response to comment six of our le tter dated June 6, 2011, and we reissue it. It is unclear why you provide disclosure of a st rategy that is “[s]ubject to the relaxation of strict domestic regulatory restrictions.” Pleas e revise to clarify wh ether you have a basis for believing the regulatory restrictions that prevent you from operating parts of your business in the United States may be changed in the near future. Otherwise this statement and your contingent plans for U.S. locations for your stem cell therapy clinic and other products appear speculative. Brown Adipose (Fat) Program, page 2

2. Please revise to clarify what you mean by “p latform technology that involves the use of brown fat cell-based therapeutic/cosmetic program.” It is unclear if this is a HCT/P that would be subject to FDA regulatio ns as described on page 7. Fu rther, it is unclear if this is a product that has al ready been developed or would be developed by your Jupiter laboratory. Stem Pearls, page 5

3. We note your response to comment nine of our letter dated June 6, 2011, and we reissue it in part. Please revise to clarify what steps the Company has performed in its Stem Pearls line of business. For example, pl ease clarify whether you have developed Stem Pearls products, whether you are in the design phase, whether you have prototype products, etc. Please discuss in greater detail this proposed product. See Item 101(h)(4)(i) of Regulation S-K. Customers, page 6

4. We note that your website www.stemcellassurance.com is operational. Please disclose this website as well. Government Regulation, page 7

5. We note your responses to comments 12 and 13 of our letter dated June 6, 2011 and we reissue them in part. Please revise to clarify why your HCT/P products would be considered “practice of medicine” and exempt from FDA regulation. Also, please clarify

Mark Weinreb Stem Cell Assurance, Inc. August 8, 2011 Page 3

whether any of your competitors with simila r products and services are subject to FDA regulation. Also, please revise this section to provide de tails, timing, and cost of receiving FDA approval for your products.

6. In addition, please provide a detailed discussi on of the governmental regulations that will apply to you in the foreign ju risdiction(s) where you plan to begin your operations. This would include the Cayman Islands. See Item 101(h)(4)(viii) and (ix) of Regulation S-K. Foreign Government Regulation, page 14

7. We note your response to comment 15 of our letter dated June 6, 2011 and we reissue it in part. Please revise the disclosure here and in your Medical Tourism section on page nine to clarify whether your Cayman clinic or the licensing of your technology to a third party foreign clinic is a long term project dependent on future financing. If you intend to establish this part of your business in the next 12 mont hs, please provide further disclosure of your anticipated timeline, the funding necessary to esta blish this business, and anticipated source of funding for this bus iness. Also, if a ny clinics will be in operation in the next 12 months, please provide further detail s of the steps necessary to establish this business. We note, for exam ple, you reference licensing your technology, but you previously disclosed that you do not ha ve any proprietary te chnology or patents at this time. Availability of Funds, page 36

8. We note your response to comment 18 of our letter dated June 6, 2011, and we reissue it in part. Please revise to disclose the mate rial terms and conditions of all material debt financing on an i ndividual basis.

Directors and Executive Officers, page 35

9. We reissue comment 22 of our letter dated J une 6, 2011. Please note that the disclosure in the Form 10 is as of the date of filing. Therefore, since Mr. Proodian was an executive officer at the time of the filing of the Form 10, please add back the disclosure regarding Mr. Proodian. In addition, as previously requested, we note the statement that Mr. Proodian has more than 35 years serving as an officer, director and committee member for several public companies. Please di sclose whether Mr. Proodian is currently a director of any public companies. We di rect your attention to Item 401(e)(2) of Regulation S-K. 10. We note your response to comment 23 of our letter dated June 6, 2011. Please provide clear disclosure in the registration statement.

11. We note your response to comment 25 of our letter dated June 6, 2011 regarding “a

Mark Weinreb Stem Cell Assurance, Inc. August 8, 2011 Page 4

pending action” against Mr. Silva. Please revise this section to provide a brief description of the “pending action” (i.e. that it relates to the enforceability of a non- compete agreement with DaVinci Biosciences, LLC). Also, your cross-reference to the risk factors section should include a specific page number to th e relevant risk factor. In addition, as previously request ed, please provide more specifi c disclosure regarding the impact this action may have upon your business. Executive Compensation, page 44

12. We note the shares to be reissu ed to Ms. McConnell as part of the termination agreement. Please explain why the grant date fair value of this award is not included in the summary compensation table. Certain Relationships and Relate d Party Transactions, page 46

13. We note your response to comment 31 of our letter dated June 6, 2011, and we reissue it in part. Please revise to clarify Mr. Berger’s relations hip with Stem Cell Research Company, LLC and why his termination agre ement directed Stem Cell Research to receive $180,000 and why Stem Cell Research agr eed to the voting proxy for its shares in connection with Mr. Be rger’s termination. Recent Sales of Unregistered Securities, page 50

14. We note your response to comment 33 of our letter dated June 6, 2011, and we reissue it in part. Please revise to clarify whether your investors are sophist icated and discuss the scope of the information you provided to i nvestors of your unreg istered securities. 15. We note your response to comment 34 of our le tter dated June 6, 2011, and we reissue it. Please revise to describe the nature of the “consulting services” provi ded for each sale of securities. 16. We note your response to comment 35 of our letter dated June 6, 2011, and we reissue it in part. Please revise your footnote di sclosure to clarify how non-cash dollar amounts were determined or what they represent (i.e . whether the dollar valu es presented for note (5) represents the fair market value of consul ting services provided). Also, for notes (1), (2), (3), and (4), please include a descrip tion of the considerati on that the purchasers provided to receive these shares or the natu re of the transaction and the value of the consideration. Exhibits

17. We note your response to comment 37 of our letter dated June 6, 2011 regarding your amended articles of incorporati on. Your revised Exhibit 3.1 appears to have altered the

Mark Weinreb Stem Cell Assurance, Inc. August 8, 2011 Page 5

original articles of incorpor ation filed with the Nevada S ecretary of State, as it still contains a stamp and notary signature dated June 1997. Since your amendments and revisions occurred after June 1997, please revi se Exhibit 3.1 to provide an appropriate amended and restated artic les of incorporation.

Questions may be directed to Edwin S. Ki m at (202) 551-3297 or Pam Howell, Special Counsel, at (202) 551-3357. Sincerely, / s / P a m e l a H o w e l l f o r John Reynolds Assistant Director

Show Raw Text
August 8, 2011
Via E-Mail
Mark Weinreb, Chief Executive Officer Stem Cell Assurance, Inc.  555 Heritage Drive Jupiter, FL 33458

Re: Stem Cell Assurance, Inc.
Amendment No. 1 to Form 10 Filed July 11, 2011 File No. 000-54402

Dear Mr. Weinreb:
We have reviewed your filing 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 within ten business days by amending your filing, by
providing the requested information, or by advi sing us when you will provide the requested
response.  If you do not believe our comments apply to your fact s and circumstances or do not
believe an amendment is appropriate, pl ease tell us why in your response.
 After reviewing any amendment to your filing and the information you provide in
response to these comments, we may have additional comments.

General

 Overview, page 1

 1. We reissue comment one of our letter dated June 6, 2011.  Please provi de a more detailed
discussion of your business plan.  Clearly disc lose the milestones for each part of your
business plan, including the estimated time fr ame for each milestone, the estimated costs
and the intended sources of f unding.  In response to our pr ior comment you have instead
provided very general disclosure of the busin ess plan, rather than the various milestones
that are needed to implement each phase of your business plan.
 2. While we note the general statement on page one that the implementation of the business
plan will require sufficient e quity or debt financing to f und your operations, please revise
the disclosure to clearly st ate the intended sour ce(s) of funding, whether you have any

Mark Weinreb
Stem Cell Assurance, Inc.  August 8, 2011 Page 2

 funding sources to date, and the impact on your  business plan if you are unable to obtain
such funding.  In addition, we note the estima ted costs and time frame for implementing
parts of your business plan.  Given the signi ficant funding needed, please explain how
you determined the time frame and discuss whether you currently have the funding for
that particular part of your business plan.
 Strategy, page 1

 1. We note your response to comment six of our le tter dated June 6, 2011, and we reissue it.
It is unclear why you provide disclosure of a st rategy that is “[s]ubject to the relaxation of
strict domestic regulatory restrictions.”  Pleas e revise to clarify wh ether you have a basis
for believing the regulatory restrictions that prevent you from operating parts of your
business in the United States may be changed in  the near future.  Otherwise this statement
and your contingent plans for U.S. locations for your stem cell therapy clinic and other
products appear speculative.
 Brown Adipose (Fat) Program, page 2

 2. Please revise to clarify what you mean by “p latform technology that involves the use of
brown fat cell-based therapeutic/cosmetic program.”   It is unclear if this is a HCT/P that
would be subject to FDA regulatio ns as described on page 7.  Fu rther, it is unclear if this
is a product that has al ready been developed or  would be developed by your Jupiter
laboratory.
 Stem Pearls, page 5

 3. We note your response to comment nine of our  letter dated June 6, 2011, and we reissue
it in part.  Please revise to clarify what steps the Company has performed in its Stem
Pearls line of business.  For example, pl ease clarify whether you have developed Stem
Pearls products, whether you are in the design phase, whether you have prototype
products, etc.  Please discuss in greater detail this proposed product.  See Item
101(h)(4)(i) of Regulation S-K.
 Customers, page 6

 4. We note that your website www.stemcellassurance.com
 is operational.  Please disclose
this website as well.
 Government Regulation, page 7

 5. We note your responses to comments 12 and 13 of our letter dated June 6, 2011 and we
reissue them in part.  Please revise to  clarify why your HCT/P products would be
considered “practice of medicine” and exempt  from FDA regulation.  Also, please clarify

Mark Weinreb
Stem Cell Assurance, Inc.  August 8, 2011 Page 3

 whether any of your competitors with simila r products and services are subject to FDA
regulation.  Also, please revise  this section to provide de tails, timing, and cost of
receiving FDA approval for your products.

6. In addition, please provide a detailed discussi on of the governmental regulations that will
apply to you in the foreign ju risdiction(s) where you plan to begin your operations.  This
would include the Cayman Islands.  See Item  101(h)(4)(viii) and (ix)  of Regulation S-K.
 Foreign Government Regulation, page 14

 7. We note your response to comment 15 of our letter dated June 6, 2011 and we reissue it
in part.  Please revise the disclosure here  and in your Medical Tourism section on page
nine to clarify whether your Cayman clinic or the licensing of your technology to a third
party foreign clinic is  a long term project dependent on future financing.  If you intend to
establish this part of your business in the next 12 mont hs, please provide further
disclosure of your anticipated timeline, the funding necessary to esta blish this business,
and anticipated source of funding for this bus iness.  Also, if a ny clinics will be in
operation in the next 12 months, please provide further detail s of the steps necessary to
establish this business.  We note, for exam ple, you reference licensing your technology,
but you previously disclosed that you do not ha ve any proprietary te chnology or patents
at this time.
 Availability of Funds, page 36

 8. We note your response to comment 18 of our letter dated June 6, 2011, and we reissue it
in part.  Please revise to disclose the mate rial terms and conditions of all material debt
financing on an i ndividual basis.

Directors and Executive Officers, page 35

 9. We reissue comment 22 of our letter dated J une 6, 2011.  Please note that the disclosure
in the Form 10 is as of the date of filing.  Therefore, since Mr. Proodian was an executive
officer at the time of the filing of the Form  10, please add back the disclosure regarding
Mr. Proodian.  In addition, as previously requested, we note the statement that Mr.
Proodian has more than 35 years serving as an officer, director and committee member for several public companies.  Please di sclose whether Mr. Proodian is currently a
director of any public companies.  We di rect your attention to  Item 401(e)(2) of
Regulation S-K.
 10. We note your response to comment 23 of our letter dated June 6, 2011.  Please provide
clear disclosure in the registration statement.

11. We note your response to comment 25 of our  letter dated June 6, 2011 regarding “a

Mark Weinreb
Stem Cell Assurance, Inc.  August 8, 2011 Page 4

 pending action” against Mr. Silva.  Please revise this section to provide a brief
description of the “pending action” (i.e. that  it relates to the enforceability of a non-
compete agreement with DaVinci Biosciences,  LLC).  Also, your cross-reference to the
risk factors section should include  a specific page number to th e relevant risk factor.  In
addition, as previously request ed, please provide more specifi c disclosure regarding the
impact this action may have upon your business.
 Executive Compensation, page 44

12. We note the shares to be reissu ed to Ms. McConnell as part of the termination agreement.
Please explain why the grant date fair value of this award is not included in the summary compensation table.
 Certain Relationships and Relate d Party Transactions, page 46

 13. We note your response to comment 31 of our letter dated June 6, 2011, and we reissue it
in part.  Please revise to clarify Mr. Berger’s relations hip with Stem Cell Research
Company, LLC and why his termination agre ement directed Stem Cell Research to
receive $180,000 and why Stem Cell Research agr eed to the voting proxy for its shares in
connection with Mr. Be rger’s termination.
 Recent Sales of Unregistered Securities, page 50

 14. We note your response to comment 33 of our letter dated June 6, 2011, and we reissue it
in part.  Please revise to clarify whether your investors are sophist icated and discuss the
scope of the information you provided to i nvestors of your unreg istered securities.
 15. We note your response to comment 34 of our le tter dated June 6, 2011, and we reissue it.
Please revise to describe the nature of the “consulting services” provi ded for each sale of
securities.
 16. We note your response to comment 35 of our letter dated June 6, 2011, and we reissue it
in part.  Please revise your footnote di sclosure to clarify how non-cash dollar amounts
were determined or what they represent (i.e . whether the dollar valu es presented for note
(5) represents the fair market value of consul ting services provided).  Also, for notes (1),
(2), (3), and (4), please include a descrip tion of the considerati on that the purchasers
provided to receive these shares or the natu re of the transaction and the value of the
consideration.
 Exhibits

 17. We note your response to comment 37 of our  letter dated June 6, 2011 regarding your
amended articles of incorporati on.  Your revised Exhibit 3.1 appears to have altered the

Mark Weinreb
Stem Cell Assurance, Inc.  August 8, 2011 Page 5

 original articles of incorpor ation filed with the Nevada S ecretary of State, as it still
contains a stamp and notary signature dated June 1997.  Since your amendments and revisions occurred after June 1997, please revi se Exhibit 3.1 to provide an appropriate
amended and restated artic les of incorporation.

Questions may be directed to Edwin S. Ki m at (202) 551-3297 or Pam Howell, Special
Counsel, at (202) 551-3357.
Sincerely,
         / s /  P a m e l a  H o w e l l          f o r           John Reynolds
Assistant Director