SEC Company Response from Streamex Corp. (STEX) (CIK 0001530766) (STEX) — Sep 11, 2013
Streamex Corp. (STEX) (CIK 0001530766)
Date: Sept. 11, 2013 · CIK: 0001530766 · Accession: 0001185185-13-002015
AI Filing Summary & Sentiment
Reasoning
File numbers found in text: 333-190080
Referenced dates: August 16, 2013
Letter
Re: BioSig Technologies, Inc.
biosigtech-corresp091013.htm
September 11, 2013
VIA EDGAR
Division of Corporation Finance
Securities and Exchange Commission
Washington, D.C. 20549
Attention: Russell Mancuso
Registration Statement on Form S-1
Filed July 22, 2013
File No. 333-190080
Ladies and Gentlemen:
On behalf of BioSig Technologies, Inc. (the “Company”), transmitted herewith for filing is Amendment No. 1 to Form S-1 (“Amendment No. 1”), marked to show changes from the Registration Statement on Form S-1 of the Company (File No. 333-190080), filed with the Securities and Exchange Commission (the “Commission”) on July 22, 2013 (the “Registration Statement”). We acknowledge receipt of the letter of comment dated August 16, 2013 (the “Comment Letter”) from the staff (the “Commission Staff”) of the Division of Corporation Finance of the Commission regarding the Registration Statement. The following are the Company’s responses to the Comment Letter. The Company’s responses are numbered to correspond to the Commission Staff’s comments as numbered in the Comment Letter. For your convenience, each of the Commission Staff’s comments contained in the Comment Letter have been restated below in their entirety, with the Company’s corresponding response set forth immediately under such comment.
Form S-1 Facing Page
1.
We note your reference to recapitalizations in footnote 1. Please revise to reflect the language of Rule 416.
Response:
The Company has made the requested revision by amending footnote 1 on the facing page of Amendment No. 1.
2.
Please identify the subsection of Rule 457 of Regulation C you used to calculate your registration fee, and explain why you have referred to the price at which the shares are being offered as “estimated” when it is fixed.
U.S. Securities and Exchange Commission
September 11, 2013
Page 2
Response:
The Company has revised footnote 2 of the fee table to explain how the proposed maximum offering price per share was determined and how the amount of registration fee was calculated in accordance with Rule 457(o) of Regulation C.
Prospectus
3.
Since you appear to qualify as an “emerging growth company,” as defined in the Jumpstart Our Business Startups Act, please:
·
Disclose that you are an emerging growth company;
·
Describe how and when a company may lose emerging growth company status;
·
Briefly describe the various exemptions that are available to you, such as exemptions from Section 404(b) of the Sarbanes-Oxley Act of 2002 and Section 14A(a) and (b) of the Securities Exchange Act of 1934; and
·
State your election under Section 107(b) of the JOBS Act:
o
If you have elected to opt out of the extended transition period for complying with new or revised accounting standards pursuant to Section 107(b), include a statement that the election is irrevocable; or
o
If you have elected to use the extended transition period for complying with new or revised accounting standards under Section 102(b)(1), provide a risk factor explaining that this election allows you to delay the adoption of new or revised accounting standards that have different effective dates for public and private companies until those standards apply to private companies. Please state in your risk factor that, as a result of this election, your financial statements may not be comparable to companies that comply with public company effective
dates. Include a similar statement in your critical accounting policy disclosures.
In addition, consider describing the extent to which any of these exemptions are available to you as a Smaller Reporting Company.
Please supplementally provide us with copies of all written communications, as defined in Rule 405 under the Securities Act, that you, or anyone authorized to do so on your behalf, present to potential investors in reliance on Section 5(d) of the Securities Act, whether or not they retain copies of the communications. Similarly, please supplementally provide us with any research reports about you that are published or distributed in reliance upon Section 2(a)(3) of the Securities Act of 1933 added by Section 105(a) of the Jumpstart Our Business Startups Act by any broker or dealer that is participating or will participate in your offering.
U.S. Securities and Exchange Commission
September 11, 2013
Page 3
Response:
The Company has added a discussion of its status as an emerging growth company on page 13 of Amendment No. 1.
Attached supplementally as Exhibit A to this letter is a copy of the written communications, as defined in Rule 405 under the Securities Act, that the Company or its placement agent presented to potential investors in reliance on Section 5(d) of the Securities Act. There have been no research reports prepared on behalf of the Company.
4.
In an appropriate section of your prospectus, please describe the various factors considered in determining the $2.09 offering price as required by Regulation S-K Item 505.
Response:
The Company has added a section entitled “Determination of Offering Price” on page 15 of Amendment No. 1 to describe the various factors considered in determining the $2.09 offering price.
5.
In an appropriate section of your prospectus, please disclose clearly your net tangible book value per share. See Regulation S-K Item 506.
Response:
The Company has disclosed its net tangible book value on page 15 of Amendment No. 1.
Prospectus Cover
6.
It is unclear what you mean by “until a market develops” in the first sentence of the second paragraph. We note your reference to the OTC Bulletin Board later in that paragraph. If you mean that the selling shareholders will sell at a price of $2.09 per share until your shares are quoted on the OTC Bulletin Board and thereafter at prevailing market prices or privately negotiated prices, please revise to clarify. Please also revise your “Offering Price” disclosure on page 1 and “Plan of Distribution” disclosure beginning on page 51 accordingly.
Response:
The Company has revised its disclosure on the Prospectus Cover, in the “Offering Price” section on page 1 of Amendment No. 1 and in the “Plan of Distribution” section on page 54 of Amendment No. 1 to clarify that the selling stockholders will sell at a fixed price until the Company’s shares are quoted on the OTC Bulletin Board and thereafter at prevailing market prices or privately negotiated prices.
U.S. Securities and Exchange Commission
September 11, 2013
Page 4
Risk Factors, page 2
7.
Please tell us whether you intend to register you common stock under Section 12(g) of the Exchange Act before this Form S-1 is effective. If you do not intend to register your common stock under Section 12(g), please add a risk factor to explain the effect of the automatic reporting suspension in Section 15(d) of the Exchange Act as well as the inapplicability of the proxy rules and Section 16 of the Exchange Act.
Response:
The Company does not intend to register its common stock under Section 12(g) of the Exchange Act before its Form S-1 is effective. The Company has added an applicable risk factor relating to its lack of intent to register its common stock under Section 12(g) of the Exchange Act on page 12 of Amendment No. 1.
8.
Please add a risk factor to explain clearly the effect on common stockholders of the anti-dilution provisions in your other outstanding securities. Highlight in the risk factor the extent to which you historically have reduced the original conversion or exercise prices of outstanding securities.
Response:
The Company has added a risk factor describing the effect on common stockholders of the anti-dilution provisions in our other securities on page 14 of Amendment No. 1.
Special Note, page 14
9.
Please clarify your statement that your disclosure “may not be accurate indications . . .” You should not include disclosure in your filing that you do not believe is accurate.
Response:
The Company has revised its disclosure regarding forward looking statements on page 14 of Amendment No. 1 to delete any indications that aspects of its disclosure may not be accurate.
Use of Proceeds, page 15
10.
Because you have not registered the exercise of the warrants, please relocate your discussion of the use of the exercise proceeds from here and your prospectus cover to remove any implication that those funds are proceeds from the registered offering.
U.S. Securities and Exchange Commission
September 11, 2013
Page 5
Response:
The Company has relocated its discussion of the use of the exercise proceeds to the “Description of Securities” section on page 46 of Amendment No. 1.
Results of Operations, page 17
11.
Please explain the costs associated with the “beneficial conversion feature” of your Series C Preferred Stock described in the third paragraph on page 18.
Response:
The Company has explained the costs associated with the “beneficial conversion feature” of its Series C Preferred Stock on page 18 of Amendment No. 1. Also, the Company has updated the “Results of Operations” section and the “Liquidity and Capital Resources” section for the six month period ended June 30, 2013.
General and Administrative Expenses, page 18
12.
Your discussion of the change in general and administrative expenses does not explain a significant portion of the increase. Please provide a more complete discussion.
Response:
The Company has expanded its discussion of the change in its general and administrative expenses on page 18 of Amendment No. 1 to more fully explain the increase in such expenses.
Liquidity and Capital Resources, page 19
13.
Please include a discussion of the effect on your liquidity of your obligations to the holders of your Series C Preferred stock.
Response:
The Company has included a discussion of the effect on its liquidity of its obligations to the holders of its Series C Preferred Stock on page 20 of Amendment No. 1.
Overview, page 21
14.
Please file the consent of the representatives mentioned in the last sentence of the first paragraph on page 22 to your use of their opinion regarding the “positive results” in this prospectus.
U.S. Securities and Exchange Commission
September 11, 2013
Page 6
Response:
The Company has deleted the sentence that discloses that the representatives confirmed the positive results on page 22 of Amendment No. 1.
15.
Please reconcile your statement in the second paragraph on page 22 that ablation is becoming the first line of therapy for patients with arrhythmias with your statement in the second paragraph on page 24 that many physicians do not perform ablations because it has not been accepted as standard procedure.
Response:
The Company has clarified the status of the use of ablation as therapy for arrhythmia on page 24 of Amendment No. 1.
16.
Please describe the material terms of the relationships mentioned in the first paragraph on page 22, the last bullet point on page 22, and under the caption “Strategic Alliances” on page 27. Include the material obligations of the parties, the nature of the collaboration, when the relationship began, when the agreements expire, material termination provisions, and material compensation arrangements. Also clarify whether the relationships are continuous and ongoing. File the agreements governing the relationships as exhibits to your registration statement.
Response:
The Company has explained its relationships with the physicians affiliated with the institutions mentioned in the “Strategic Alliances” section on pages 27 and 28 of Amendment No. 1. The Company has filed the relevant consulting agreements as Exhibits 10.16, 10.17 and 10.18 to Amendment No. 1.
Our Industry, page 23
17.
Please tell us how you determined that you have included the most recent data in your prospectus. We note for example your reference to 1999 and 2002 data at the top of page 24. Also tell us whether you commissioned any of the data disclosed in this section or elsewhere in your prospectus.
Response:
The Company has updated the information to reflect more recent data in the “Our Industry” section on pages 23 and 24 of Amendment No. 1. None of the data was commissioned. All information is publicly available on the internet from the American Heart Association, Heart Rhythm Society, Centers for Disease Control and market research reports.
U.S. Securities and Exchange Commission
September 11, 2013
Page 7
Our Products, page 25
18.
Please clarify whether your proposed product is intended to be used in addition to existing hardware and software or as a replacement for existing hardware and software. If a replacement, please clarify what it is intended to replace and how you have or will obtain rights to the required intellectual property to perform the functions of the products that will be replaced.
Response:
The Company has explained that its proposed product is intended to be used in addition to existing hardware and software in the “Our Products” section on page 25 of Amendment No. 1.
Initial Analysis, page 26
19.
Please clarify what you mean by “baseline wander” and “notch filter.”
Response:
The Company has explained the terms “baseline wander” and “notch filter” in the “Our Products – Initial Analysis” section on page 26 of Amendment No. 1.
20.
Disclose the criteria that you used to determine that the change was “significant” as you mention in the second paragraph.
Response:
The Company has removed the word “significant” as disclosed in the “Our Products – Initial Analysis” section on page 26 of Amendment No. 1.
21.
Refer to the first picture on page 26. Please tell us whether the recording from the “competitive” system represents the typical recording that current systems provide. Also, clarify what you mean by “ABLd.”
Response:
The Company has explained the term “ABLd” in the caption of the first picture in the “Our Products – Initial Analysis” section on page 26 of Amendment No. 1.
22.
Please clarify how the last picture on page 26 demonstrates “confidence indexes.”
U.S. Securities and Exchange Commission
September 11, 2013
Page 8
Response:
The Company has revised the caption to the last picture on page 26 of Amendment No. 1 to explain that the picture illustrates the PURE EP System analyzing data.
Competition, page 27
23.
Please provide us support for your statement about the “main reasons” in the paragraph following the list of bullet points in this section.
Response:
The Company has provided support for the “main” reasons on page 28 of Amendment No. 1
Suppliers, page 28
24.
We note your disclosure that you are building your proposed product from supplies that are available from others. However, in the last paragraph on page 25, you disclose that your system involves proprietary hardware, software and algorithms. Please clarify what is proprietary about your proposed product and how your supply arrangements are consistent with the claimed proprietary nature of the proposed product.
Response:
The Company has clarified and revised the Suppliers section on page 29 of Amendment No. 1
Intellectual Property, page 28
25.
With a view toward clarified disclosure regarding your rights to the potential product you describe, please tell us who conceived of the proprietary elements of your proposed product, when this occurred, and how you have rights to that person’s concepts.
Response:
The Company’s co-founder and Chief Technology Officer, Budimir S. Drakulic, Ph.D., conceived the proprietary elements of the PURE EP System during 2009-2010. As modules are reduced to practice and patented, all patents will be assigned to the Company.
Government Regulation, page 28
26.
Please clarify the basis for your believe that your proposed product will be classified as a Class II device. Disclose the implications for the length of the regulatory clearance process and the nature and extent of required studies if your beli
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CORRESP
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filename1.htm
biosigtech-corresp091013.htm
September 11, 2013
VIA EDGAR
Division of Corporation Finance
Securities and Exchange Commission
Washington, D.C. 20549
Attention: Russell Mancuso
Re: BioSig Technologies, Inc.
Registration Statement on Form S-1
Filed July 22, 2013
File No. 333-190080
Ladies and Gentlemen:
On behalf of BioSig Technologies, Inc. (the “Company”), transmitted herewith for filing is Amendment No. 1 to Form S-1 (“Amendment No. 1”), marked to show changes from the Registration Statement on Form S-1 of the Company (File No. 333-190080), filed with the Securities and Exchange Commission (the “Commission”) on July 22, 2013 (the “Registration Statement”). We acknowledge receipt of the letter of comment dated August 16, 2013 (the “Comment Letter”) from the staff (the “Commission Staff”) of the Division of Corporation Finance of the Commission regarding the Registration Statement. The following are the Company’s responses to the Comment Letter. The Company’s responses are numbered to correspond to the Commission Staff’s comments as numbered in the Comment Letter. For your convenience, each of the Commission Staff’s comments contained in the Comment Letter have been restated below in their entirety, with the Company’s corresponding response set forth immediately under such comment.
Form S-1 Facing Page
1.
We note your reference to recapitalizations in footnote 1. Please revise to reflect the language of Rule 416.
Response:
The Company has made the requested revision by amending footnote 1 on the facing page of Amendment No. 1.
2.
Please identify the subsection of Rule 457 of Regulation C you used to calculate your registration fee, and explain why you have referred to the price at which the shares are being offered as “estimated” when it is fixed.
U.S. Securities and Exchange Commission
September 11, 2013
Page 2
Response:
The Company has revised footnote 2 of the fee table to explain how the proposed maximum offering price per share was determined and how the amount of registration fee was calculated in accordance with Rule 457(o) of Regulation C.
Prospectus
3.
Since you appear to qualify as an “emerging growth company,” as defined in the Jumpstart Our Business Startups Act, please:
·
Disclose that you are an emerging growth company;
·
Describe how and when a company may lose emerging growth company status;
·
Briefly describe the various exemptions that are available to you, such as exemptions from Section 404(b) of the Sarbanes-Oxley Act of 2002 and Section 14A(a) and (b) of the Securities Exchange Act of 1934; and
·
State your election under Section 107(b) of the JOBS Act:
o
If you have elected to opt out of the extended transition period for complying with new or revised accounting standards pursuant to Section 107(b), include a statement that the election is irrevocable; or
o
If you have elected to use the extended transition period for complying with new or revised accounting standards under Section 102(b)(1), provide a risk factor explaining that this election allows you to delay the adoption of new or revised accounting standards that have different effective dates for public and private companies until those standards apply to private companies. Please state in your risk factor that, as a result of this election, your financial statements may not be comparable to companies that comply with public company effective
dates. Include a similar statement in your critical accounting policy disclosures.
In addition, consider describing the extent to which any of these exemptions are available to you as a Smaller Reporting Company.
Please supplementally provide us with copies of all written communications, as defined in Rule 405 under the Securities Act, that you, or anyone authorized to do so on your behalf, present to potential investors in reliance on Section 5(d) of the Securities Act, whether or not they retain copies of the communications. Similarly, please supplementally provide us with any research reports about you that are published or distributed in reliance upon Section 2(a)(3) of the Securities Act of 1933 added by Section 105(a) of the Jumpstart Our Business Startups Act by any broker or dealer that is participating or will participate in your offering.
U.S. Securities and Exchange Commission
September 11, 2013
Page 3
Response:
The Company has added a discussion of its status as an emerging growth company on page 13 of Amendment No. 1.
Attached supplementally as Exhibit A to this letter is a copy of the written communications, as defined in Rule 405 under the Securities Act, that the Company or its placement agent presented to potential investors in reliance on Section 5(d) of the Securities Act. There have been no research reports prepared on behalf of the Company.
4.
In an appropriate section of your prospectus, please describe the various factors considered in determining the $2.09 offering price as required by Regulation S-K Item 505.
Response:
The Company has added a section entitled “Determination of Offering Price” on page 15 of Amendment No. 1 to describe the various factors considered in determining the $2.09 offering price.
5.
In an appropriate section of your prospectus, please disclose clearly your net tangible book value per share. See Regulation S-K Item 506.
Response:
The Company has disclosed its net tangible book value on page 15 of Amendment No. 1.
Prospectus Cover
6.
It is unclear what you mean by “until a market develops” in the first sentence of the second paragraph. We note your reference to the OTC Bulletin Board later in that paragraph. If you mean that the selling shareholders will sell at a price of $2.09 per share until your shares are quoted on the OTC Bulletin Board and thereafter at prevailing market prices or privately negotiated prices, please revise to clarify. Please also revise your “Offering Price” disclosure on page 1 and “Plan of Distribution” disclosure beginning on page 51 accordingly.
Response:
The Company has revised its disclosure on the Prospectus Cover, in the “Offering Price” section on page 1 of Amendment No. 1 and in the “Plan of Distribution” section on page 54 of Amendment No. 1 to clarify that the selling stockholders will sell at a fixed price until the Company’s shares are quoted on the OTC Bulletin Board and thereafter at prevailing market prices or privately negotiated prices.
U.S. Securities and Exchange Commission
September 11, 2013
Page 4
Risk Factors, page 2
7.
Please tell us whether you intend to register you common stock under Section 12(g) of the Exchange Act before this Form S-1 is effective. If you do not intend to register your common stock under Section 12(g), please add a risk factor to explain the effect of the automatic reporting suspension in Section 15(d) of the Exchange Act as well as the inapplicability of the proxy rules and Section 16 of the Exchange Act.
Response:
The Company does not intend to register its common stock under Section 12(g) of the Exchange Act before its Form S-1 is effective. The Company has added an applicable risk factor relating to its lack of intent to register its common stock under Section 12(g) of the Exchange Act on page 12 of Amendment No. 1.
8.
Please add a risk factor to explain clearly the effect on common stockholders of the anti-dilution provisions in your other outstanding securities. Highlight in the risk factor the extent to which you historically have reduced the original conversion or exercise prices of outstanding securities.
Response:
The Company has added a risk factor describing the effect on common stockholders of the anti-dilution provisions in our other securities on page 14 of Amendment No. 1.
Special Note, page 14
9.
Please clarify your statement that your disclosure “may not be accurate indications . . .” You should not include disclosure in your filing that you do not believe is accurate.
Response:
The Company has revised its disclosure regarding forward looking statements on page 14 of Amendment No. 1 to delete any indications that aspects of its disclosure may not be accurate.
Use of Proceeds, page 15
10.
Because you have not registered the exercise of the warrants, please relocate your discussion of the use of the exercise proceeds from here and your prospectus cover to remove any implication that those funds are proceeds from the registered offering.
U.S. Securities and Exchange Commission
September 11, 2013
Page 5
Response:
The Company has relocated its discussion of the use of the exercise proceeds to the “Description of Securities” section on page 46 of Amendment No. 1.
Results of Operations, page 17
11.
Please explain the costs associated with the “beneficial conversion feature” of your Series C Preferred Stock described in the third paragraph on page 18.
Response:
The Company has explained the costs associated with the “beneficial conversion feature” of its Series C Preferred Stock on page 18 of Amendment No. 1. Also, the Company has updated the “Results of Operations” section and the “Liquidity and Capital Resources” section for the six month period ended June 30, 2013.
General and Administrative Expenses, page 18
12.
Your discussion of the change in general and administrative expenses does not explain a significant portion of the increase. Please provide a more complete discussion.
Response:
The Company has expanded its discussion of the change in its general and administrative expenses on page 18 of Amendment No. 1 to more fully explain the increase in such expenses.
Liquidity and Capital Resources, page 19
13.
Please include a discussion of the effect on your liquidity of your obligations to the holders of your Series C Preferred stock.
Response:
The Company has included a discussion of the effect on its liquidity of its obligations to the holders of its Series C Preferred Stock on page 20 of Amendment No. 1.
Overview, page 21
14.
Please file the consent of the representatives mentioned in the last sentence of the first paragraph on page 22 to your use of their opinion regarding the “positive results” in this prospectus.
U.S. Securities and Exchange Commission
September 11, 2013
Page 6
Response:
The Company has deleted the sentence that discloses that the representatives confirmed the positive results on page 22 of Amendment No. 1.
15.
Please reconcile your statement in the second paragraph on page 22 that ablation is becoming the first line of therapy for patients with arrhythmias with your statement in the second paragraph on page 24 that many physicians do not perform ablations because it has not been accepted as standard procedure.
Response:
The Company has clarified the status of the use of ablation as therapy for arrhythmia on page 24 of Amendment No. 1.
16.
Please describe the material terms of the relationships mentioned in the first paragraph on page 22, the last bullet point on page 22, and under the caption “Strategic Alliances” on page 27. Include the material obligations of the parties, the nature of the collaboration, when the relationship began, when the agreements expire, material termination provisions, and material compensation arrangements. Also clarify whether the relationships are continuous and ongoing. File the agreements governing the relationships as exhibits to your registration statement.
Response:
The Company has explained its relationships with the physicians affiliated with the institutions mentioned in the “Strategic Alliances” section on pages 27 and 28 of Amendment No. 1. The Company has filed the relevant consulting agreements as Exhibits 10.16, 10.17 and 10.18 to Amendment No. 1.
Our Industry, page 23
17.
Please tell us how you determined that you have included the most recent data in your prospectus. We note for example your reference to 1999 and 2002 data at the top of page 24. Also tell us whether you commissioned any of the data disclosed in this section or elsewhere in your prospectus.
Response:
The Company has updated the information to reflect more recent data in the “Our Industry” section on pages 23 and 24 of Amendment No. 1. None of the data was commissioned. All information is publicly available on the internet from the American Heart Association, Heart Rhythm Society, Centers for Disease Control and market research reports.
U.S. Securities and Exchange Commission
September 11, 2013
Page 7
Our Products, page 25
18.
Please clarify whether your proposed product is intended to be used in addition to existing hardware and software or as a replacement for existing hardware and software. If a replacement, please clarify what it is intended to replace and how you have or will obtain rights to the required intellectual property to perform the functions of the products that will be replaced.
Response:
The Company has explained that its proposed product is intended to be used in addition to existing hardware and software in the “Our Products” section on page 25 of Amendment No. 1.
Initial Analysis, page 26
19.
Please clarify what you mean by “baseline wander” and “notch filter.”
Response:
The Company has explained the terms “baseline wander” and “notch filter” in the “Our Products – Initial Analysis” section on page 26 of Amendment No. 1.
20.
Disclose the criteria that you used to determine that the change was “significant” as you mention in the second paragraph.
Response:
The Company has removed the word “significant” as disclosed in the “Our Products – Initial Analysis” section on page 26 of Amendment No. 1.
21.
Refer to the first picture on page 26. Please tell us whether the recording from the “competitive” system represents the typical recording that current systems provide. Also, clarify what you mean by “ABLd.”
Response:
The Company has explained the term “ABLd” in the caption of the first picture in the “Our Products – Initial Analysis” section on page 26 of Amendment No. 1.
22.
Please clarify how the last picture on page 26 demonstrates “confidence indexes.”
U.S. Securities and Exchange Commission
September 11, 2013
Page 8
Response:
The Company has revised the caption to the last picture on page 26 of Amendment No. 1 to explain that the picture illustrates the PURE EP System analyzing data.
Competition, page 27
23.
Please provide us support for your statement about the “main reasons” in the paragraph following the list of bullet points in this section.
Response:
The Company has provided support for the “main” reasons on page 28 of Amendment No. 1
Suppliers, page 28
24.
We note your disclosure that you are building your proposed product from supplies that are available from others. However, in the last paragraph on page 25, you disclose that your system involves proprietary hardware, software and algorithms. Please clarify what is proprietary about your proposed product and how your supply arrangements are consistent with the claimed proprietary nature of the proposed product.
Response:
The Company has clarified and revised the Suppliers section on page 29 of Amendment No. 1
Intellectual Property, page 28
25.
With a view toward clarified disclosure regarding your rights to the potential product you describe, please tell us who conceived of the proprietary elements of your proposed product, when this occurred, and how you have rights to that person’s concepts.
Response:
The Company’s co-founder and Chief Technology Officer, Budimir S. Drakulic, Ph.D., conceived the proprietary elements of the PURE EP System during 2009-2010. As modules are reduced to practice and patented, all patents will be assigned to the Company.
Government Regulation, page 28
26.
Please clarify the basis for your believe that your proposed product will be classified as a Class II device. Disclose the implications for the length of the regulatory clearance process and the nature and extent of required studies if your beli