SecProbe.io

Filing text and metadata
Intelligence Terminal Search Probe Scores Topics IPO Watchlist Monthly Activity About API

SEC Comment Letter for ClearPoint Neuro, Inc. (CLPT) (CIK 0001285550) (CLPT) — Jan 24, 2012

ClearPoint Neuro, Inc. (CLPT) (CIK 0001285550)
Date: Jan. 24, 2012 · CIK: 0001285550 · Accession: 0000000000-12-003936

Revenue Recognition Regulatory Compliance Financial Reporting

AI Filing Summary & Sentiment

Sentiment
Urgency
Document Type
Confidence
SEC Posture
Company Posture

Summary

Reasoning

File numbers found in text: 000-54575

Date
January 24, 2012
Author
Baker, Donelson, Bearman, Caldwell & Berkowitz, PC
Form
UPLOAD
Company
ClearPoint Neuro, Inc. (CLPT) (CIK 0001285550)

Letter

January 24, 2012 Via E-mail Kimble L. Jenkins Chief Executive Officer MRI Interventions, Inc. One Commerce Square, Suite 2550 Memphis, TN 38103 Re: MRI Interventions, Inc. Registration Statement on Form 10 Filed December 28, 2011 File No. 000-54575

Dear Mr. Jenkins: 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 within te n business days by amending your registration statement, by providing the requested informati on or by advising us when you will provide the requested response. If you do not believe our comments apply to your facts and circumstances or do not believe the amendment is appropr iate, 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.

General

1. Please note that this filing will become eff ective automatically 60 days after the date you initially filed it. If this filing was made voluntarily, you should consider withdrawing it prior to the effective date if comments rema in outstanding. You could then refile when you are prepared to resolve the comments. Please tell us whether you intend to file a request for withdrawal before the automatic effectiveness date of this registration statement if comments remain outstanding. 2. Consideration should be given on an ongoing ba sis to the updating re quirements of Rule 8-08 of Regulation S-X.

Kimble L. Jenkins MRI Interventions, Inc. January 24, 2012 Page 2

Explanatory Note, page 2

3. We note your disclosure in the last paragr aph of market data and other statistical information provided in the registration statemen t. Please provide us with copies of the sources of this data, clearly marking the rele vant sections of the reports that support the data you have included in your disclosure. Item 1. Business, page 3

4. Since your ClearTrace System has not been approved fo r commercialization, please revise throughout to qualify statements a bout its use, capabili ties and results as anticipatory in nature. 5. Please revise to remove disclosure related to Siemens’ market pos ition, or provide us information about the measure of leadersh ip and why the disclosure enhances an investor’s unde rstanding of your business.

6. We note your disclosure on page 9 and else where that your ClearPo int System is not FDA approved for use in specific neurological procedures. If you are not presently seeking to have such indications included in your 510(k) clearance, please revise your disclosure to more clearly e xplain why a discussion of these procedures and the health conditions addressed thereby enhances an investor’s understanding of your business.

Regulatory Status, page 12

7. Please provide an anticipated timeline fo r submission of your ClearTrace product for regulatory approval, or i ndicate that you are not able to estimate the time. Boston Scientific, page 14

8. We note your disclosure in the first paragra ph on page F-47 regardi ng potential payments to Boston Scientific Corporation in the event that specified milestones are not achieved by December 31, 2012 and your disclosure in th e last paragraph on page F-53 regarding the one-time option to terminate the BSC Cardi ac Agreement. Please revise this section as appropriate to discuss the material terms of your license and development agreements. Please also consider risk factor disclosure, to the extent these represent material risks. Sales and Marketing, page 16

9. We note that your revenue model is focuse d on high margin disposable components. Please address here or elsewhere as appr opriate whether you believe your disposable components are sufficiently protected by existing intellectual property rights.

Kimble L. Jenkins MRI Interventions, Inc. January 24, 2012 Page 3

Item 1A. Risk Factors, page 31

We will need additional funding . . . , page 40

10. Please revise this risk factor to quantify the “substantial futu re capital” you anticipate that you will require for your business. Management’s Discussion and Analysis . . . , page 55

11. We note your disclosure in the first pa ragraph on page F-36 regarding your prior intellectual property litigation and legal settlement . Consider disclosure in this section to the extent the proceeding or settlement represents one of the primary drivers of material changes to your selling, general, and admi nistrative expenses or cash flows for the periods disclosed and to the extent that the legal settlement represen ts a known, material demand or commitment that will result in or that is reasonably likely to result in your liquidity decreasing in any material way.

Liquidity and Capital Resources, page 62

12. We note your disclosure in the second paragraph of this section that the maturity dates of your Boston Scientific loans have been extended through January 16, 2012 and that you are in the process of negotia ting a longer term extension. Please revise to update your disclosure regarding the st atus of these loans and th e present outstanding amount.

13. We note your disclosure in the third paragra ph of this section of 10% senior unsecured convertible notes in the aggregate principa l amount of $4.1 million. We also note your disclosure that holders of $3.4 million in pr incipal amount of the notes have amended their notes. Please revise to clarify the st atus of the remaining $0.7 million in principal amount of these notes. 14. For each convertible instrument, please indi cate the number of shares the holder would receive if conversion occurred today. Item 5. Directors and Executive Officers, page 68

15. Please tell us whether any of your director s were elected or ap pointed based on an arrangement or understanding between you and the director or any other person. We note, in this regard, your disclosure in the fi rst paragraph on page F-52 that an affiliate of Boston Scientific Corporation is a stockholder and has a representative on your board of directors. We also note your disclosure of a Stockholders’ Agr eement in Amendment No. 14 to your Form S-1 filed on August 17, 2010, such as on pages 91-92 and in Exhibit 3.6.

Kimble L. Jenkins MRI Interventions, Inc. January 24, 2012 Page 4 Base Salary, page 74

16. Please revise your disclosure in the first paragraph on page 75 to provide additional discussion of the voluntary reductions in sala ry for your named executive officers. For example, please discuss the amount and durat ion of the temporary reductions for each named executive officer. Long-Term Equity Compensation, page 75

17. Please revise the first paragraph on page 76 to describe the factors of individual performance considered by your compensati on committee in determining stock option award amounts for your named ex ecutive officers for fiscal 2010. Equity Compensation Plan Information, page 88

18. Please revise as appropriate to describe brie fly the material features of each equity compensation plan that was adopted without the approval of security hol ders or to clarify which of your equity compensation plans discus sed elsewhere, such as on pages 81 to 84, were adopted without the appr oval of security holders.

Item 10. Recent Sales of Unregistered Securities, page 88

19. Please identify the purchasers or types of purch asers in the sale discussed in paragraph number 8. Audited Financial Statements as of December 31, 2010 and 2009 and for the years ended December 31, 2010, 2009, and 2008, page F-1 Notes to Financial Statements, page F-8

2. Summary of Significant Acc ounting Policies, page F-8

Revenue Recognition, page F-12

20. We noted from disclosures herein that your ClearPoint system consists of reusable equipment and software. Please tell us and re vise this note to disclose how your revenue recognition accounting policy reflec ts the fact your products sold include software. Your response should include specific references to the authoritative U.S. GAAP that you followed when accounting for sales of products that include software. Also, tell us whether you have any post-shipment obligati ons due to the fact certain of your product include software and discuss the accounting implications of any such obligations. For example, tell us if your custom ers have software upgrade rights.

Kimble L. Jenkins MRI Interventions, Inc. January 24, 2012 Page 5 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 include s the information the Securities Exchange Act of 1934 and all applicable Exchange Act rules requir e. Since the company and its management are in possession of all facts relating to a company’s disclosure, they are responsible for the accuracy and adequacy of the disclosures they have made. In responding to our comments, please provi de a written statement from the company acknowledging that:  the company is responsible for the adequacy an d accuracy of the disclo sure in the filing;

 staff comments or changes to disclosure in response to staff comments do not foreclose the Commission from taking any action with respect to the filing; and

 the company may not assert staff comments as a defense in any proceeding initiated by the Commission or any person under the federal s ecurities laws of the United States. You may contact Dennis Hult at (202) 551-3618 or Jay Webb , Accounting Reviewer, at (202) 551-3603 if you have questions regardi ng comments on the financial statements and related matters. You may contact Aslynn H ogue at (202) 551-3841 or me at (202) 551-3528 with any other questions.

Sincerely,
/s/ Amanda Ravitz
Amanda Ravitz Assistant Director
cc (via e-mail): Robert J. DelPriore, Esq.
Baker, Donelson, Bearman, Caldwell & Berkowitz, PC

Show Raw Text
January 24, 2012
 Via E-mail

Kimble L. Jenkins Chief Executive Officer MRI Interventions, Inc. One Commerce Square, Suite 2550 Memphis, TN 38103
Re: MRI Interventions, Inc.
Registration Statement on Form 10 Filed December 28, 2011
  File No. 000-54575

Dear Mr. Jenkins:
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 within te n business days by amending your registration
statement, by providing the requested informati on or by advising us when you will provide the
requested response.  If you do not believe our comments apply to your facts and circumstances
or do not believe the amendment is appropr iate, 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.

General

 1. Please note that this filing will become eff ective automatically 60 days after the date you
initially filed it.  If this filing was made voluntarily, you should consider withdrawing it
prior to the effective date if comments rema in outstanding.  You could then refile when
you are prepared to resolve the comments.  Please tell us whether you intend to file a
request for withdrawal before the automatic  effectiveness date of this registration
statement if comments remain outstanding.
2. Consideration should be given on an ongoing ba sis to the updating re quirements of Rule
8-08 of Regulation S-X.

Kimble L. Jenkins MRI Interventions, Inc. January 24, 2012 Page 2

Explanatory Note, page 2

 3. We note your disclosure in the last paragr aph of market data and other statistical
information provided in the registration statemen t.  Please provide us with copies of the
sources of this data, clearly marking the rele vant sections of the reports that support the
data you have included in your disclosure.
 Item 1. Business, page 3

 4. Since your ClearTrace System  has not been approved fo r commercialization, please
revise throughout to qualify statements a bout its use, capabili ties and results as
anticipatory in nature.
5. Please revise to remove disclosure related to Siemens’ market pos ition, or provide us
information about the measure of leadersh ip and why the disclosure enhances an
investor’s unde rstanding of your
 business.

6. We note your disclosure on page 9 and else where that your ClearPo int System is not
FDA approved for use in specific neurological  procedures.  If you are not presently
seeking to have such indications included in your 510(k) clearance, please revise your
disclosure to more clearly e xplain why a discussion of these procedures and the health
conditions addressed thereby enhances an investor’s understanding of your business.

Regulatory Status, page 12

7. Please provide an anticipated timeline fo r submission of your ClearTrace product for
regulatory approval, or i ndicate that you are not able  to estimate the time.
 Boston Scientific, page 14

 8. We note your disclosure in the first paragra ph on page F-47 regardi ng potential payments
to Boston Scientific Corporation in the event that specified milestones are not achieved
by December 31, 2012 and your disclosure in th e last paragraph on page F-53 regarding
the one-time option to terminate the BSC Cardi ac Agreement.  Please revise this section
as appropriate to discuss the material terms of your license and development agreements.
Please also consider risk factor  disclosure, to the extent these represent material risks.
 Sales and Marketing, page 16

9. We note that your revenue model is focuse d on high margin disposable components.
Please address here or elsewhere as appr opriate whether you believe your disposable
components are sufficiently protected by existing intellectual property rights.

Kimble L. Jenkins MRI Interventions, Inc. January 24, 2012 Page 3

Item 1A. Risk Factors, page 31

 We will need additional funding . . . , page 40

 10. Please revise this risk factor to quantify the “substantial futu re capital” you anticipate that
you will require for your business.
Management’s Discussion and Analysis . . . , page 55

 11. We note your disclosure in the first pa ragraph on page F-36 regarding your prior
intellectual property litigation and legal settlement .  Consider disclosure  in this section to
the extent the proceeding or settlement represents one of the primary drivers of material changes to your selling, general, and admi nistrative expenses or cash flows for the
periods disclosed and to the extent that the legal settlement represen ts a known, material
demand or commitment that will result in or that is reasonably likely to result in your
liquidity decreasing in any material way.

Liquidity and Capital Resources, page 62

12. We note your disclosure in the second paragraph of this section that the maturity dates of
your Boston Scientific loans have been extended through January 16, 2012 and that you
are in the process of negotia ting a longer term extension.  Please revise to update your
disclosure regarding the st atus of these loans and th e present outstanding amount.

13. We note your disclosure in the third paragra ph of this section of  10% senior unsecured
convertible notes in the aggregate principa l amount of $4.1 million.  We also note your
disclosure that holders of $3.4 million in pr incipal amount of the notes have amended
their notes.  Please revise to clarify the st atus of the remaining $0.7 million in principal
amount of these notes.
14. For each convertible instrument, please indi cate the number of shares the holder would
receive if conversion occurred today.
Item 5. Directors and Executive Officers, page 68

 15. Please tell us whether any of your director s were elected or ap pointed based on an
arrangement or understanding between you and the director or any other person.  We
note, in this regard, your disclosure in the fi rst paragraph on page F-52 that an affiliate of
Boston Scientific Corporation is a stockholder and has a representative on your board of
directors.  We also note your disclosure of a Stockholders’ Agr eement in Amendment
No. 14 to your Form S-1 filed on August 17, 2010, such as on pages 91-92 and in  Exhibit 3.6.

Kimble L. Jenkins MRI Interventions, Inc. January 24, 2012 Page 4
 Base Salary, page 74

 16. Please revise your disclosure in the first paragraph on page 75 to provide additional
discussion of the voluntary reductions in sala ry for your named executive officers.  For
example, please discuss the amount and durat ion of the temporary reductions for each
named executive officer.
 Long-Term Equity Compensation, page 75

 17. Please revise the first paragraph on page 76 to describe the factors of individual
performance considered by your compensati on committee in determining stock option
award amounts for your named ex ecutive officers for fiscal 2010.
 Equity Compensation Plan Information, page 88

 18. Please revise as appropriate to describe brie fly the material features of each equity
compensation plan that was adopted without the approval of security hol ders or to clarify
which of your equity compensation plans discus sed elsewhere, such as on pages 81 to 84,
were adopted without the appr oval of security holders.

Item 10.  Recent Sales of Unregistered Securities, page 88

 19. Please identify the purchasers or types of purch asers in the sale discussed in paragraph
number 8.
Audited Financial Statements  as of December 31, 2010 and 2009 and for the years ended
December 31, 2010, 2009, and 2008, page F-1
 Notes to Financial Statements, page F-8

 2. Summary of Significant Acc ounting Policies, page F-8

 Revenue Recognition, page F-12

 20. We noted from disclosures herein that your ClearPoint system consists of reusable
equipment and software.  Please tell us and re vise this note to disclose how your revenue
recognition accounting policy reflec ts the fact your products sold include software.  Your
response should include specific references to the authoritative U.S. GAAP that you
followed when accounting for sales of products  that include software. Also, tell us
whether you have any post-shipment obligati ons due to the fact certain of your product
include software and discuss the accounting implications of any such obligations. For
example, tell us if your custom ers have software upgrade rights.

Kimble L. Jenkins MRI Interventions, Inc. January 24, 2012 Page 5
 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 include s the information the Securities Exchange Act of
1934 and all applicable Exchange Act rules requir e.  Since the company and its management are
in possession of all facts relating to a company’s disclosure, they are responsible for the accuracy
and adequacy of the disclosures they have made.
 In responding to our comments, please provi de a written statement from the company
acknowledging that:
 the company is responsible for the adequacy an d accuracy of the disclo sure in the filing;

 staff comments or changes to disclosure in response to staff comments do not foreclose
the Commission from taking any action with respect to the filing; and

 the company may not assert staff comments as  a defense in any proceeding initiated by
the Commission or any person under the federal s ecurities laws of the United States.
 You may contact Dennis Hult at (202) 551-3618 or Jay Webb , Accounting Reviewer, at
(202) 551-3603 if you have questions regardi ng comments on the financial statements and
related matters.  You may contact Aslynn H ogue at (202) 551-3841 or me at (202) 551-3528
with any other questions.

Sincerely,

 /s/ Amanda Ravitz
 Amanda Ravitz Assistant Director
  cc (via e-mail):   Robert  J. DelPriore, Esq.
Baker, Donelson, Bearman, Caldwell & Berkowitz, PC