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SEC Company Response from STRATA Skin Sciences, Inc. (SSKN) (CIK 0001051514) (SSKN) — Jul 15, 2005

STRATA Skin Sciences, Inc. (SSKN) (CIK 0001051514)
Date: July 15, 2005 · CIK: 0001051514 · Accession: 0000950123-05-008574

AI Filing Summary & Sentiment

File numbers found in text: 333-125517

Date
July 15, 2005
Author
Not clearly detected
Form
CORRESP
Company
STRATA Skin Sciences, Inc. (SSKN) (CIK 0001051514)

Letter

Re: Electro-Optical Sciences, Inc. Registration Statement on Form S-1 Filed June 3, 2005 File No. 333-125517

<PAGE> (DREIER LLP LOGO) Attorneys at Law

499 Park Avenue Valerie A. Price New York, New York 10022 Direct Dial: (212) 328-6144 Tel: (212) 328-6100 Direct Fax: (212) 652-3789 Facsimile: (212) 328-6101 Partner vprice@dreierllp.com

July 15, 2005

SENT VIA FAX AND FEDERAL EXPRESS

United States Securities and Exchange Commission 100 F Street, N.E. Washington, DC 20549 Attention: Peggy A. Fisher, Assistant Director, Division of Corporation Finance

Ladies and Gentlemen:

On behalf of Electro-Optical Sciences, Inc., a Delaware corporation (the "Company"), and pursuant to the applicable provisions of the Securities Act of 1933, and the rules and regulations promulgated thereunder, we are submitting for filing with the Securities and Exchange Commission Amendment No. 1 to the above-captioned Registration Statement on Form S-1 ("Amendment No. 1"). A copy of Amendment No. 1 to the Registration Statement has been manually signed in accordance with Rule 302 of Regulation S-T and the signature pages thereto will be retained by the Company for a period of five years. The Company has authorized us to respond to the comment letter sent to Joseph V. Gulfo, M.D. of Electro-Optical Sciences, Inc., dated June 30, 2005, from the Staff of the Commission.

For your convenience, we enclose a marked copy of Amendment No. 1 marked to show changes to the Registration Statement, as originally filed with the Commission on June 3, 2005.

We have referenced the appropriate page number of the prospectus contained in Amendment No. 1 in our responses contained herein. The numbered paragraphs below set forth the Staff's comments, together with our responses. Unless otherwise indicated, capitalized terms used herein have the meanings assigned to them in Amendment No. 1. <PAGE> Prospectus Inside Front Cover Page

1. We note your disclosure that you "do not make any representation as to the accuracy" of the industry data and forecasts and market research included in your prospectus. Please note that it is inappropriate to suggest that you do not have responsibility for the accuracy of disclosure in the registration statement. Please revise your disclosure accordingly.

Response: In response to Comment 1, we deleted the above-referenced language. See the inside front cover page.

2. Please provide us with copies of the industry reports and market data cited throughout the registration statement, clearly marking the relevant sections, and identify any reports prepared specifically for your use.

Response: Attached as Annex A are copies of the industry reports and market data cited throughout the Registration Statement, together with pages of the Registration Statement marked to cross-reference the relevant sections to the appropriate industry report or market data.

Prospectus Summary, page 1

3. Please expand the summary to clarify that you currently do not have any commercialized product or significant source of revenue and that your revenues to date were derived from the DIFOTI product, which was recently discontinued.

Response: We have provided additional disclosure on pages 1 and 44 in response to Comment 3.

4. Also clarify your anticipated timeframe for commercialization of MelaFind, assuming you receive premarket approval for MelaFind in 2007, as you currently anticipate. Also disclose the length of time it may take to obtain Medicare coverage.

Response: We have provided additional disclosure on pages 3 and 46 in response to Comment 4.

5. We note your disclosure in the second paragraph on page 1 that you have entered into a binding Protocol Agreement with the FDA to conduct a pivotal trial. Please also disclose that such a trial was initiated in 2004, but that you experienced technical operational issues which require refinement to your hardware systems. We refer you to your disclosure in last paragraph on page 46 of the prospectus.

Response: We have provided additional disclosure on pages 1 and 44 in response to Comment 5.

<PAGE> 6. Please tell us when you anticipate the completion of the websites mentioned on page 3 of the prospectus.

Response: The websites mentioned on page 3 of the prospectus are now complete.

The Market Opportunity, page 1

7. Revise the first few sentences to provide industry data regarding the incidence of melanoma, which appears to be a more relevant statistic than the incidence of all skin cancers.

Response: We have provided additional disclosure on pages 1 and 45 in response to Comment 7.

Risk Factors, page 7

8. Please eliminate the last two sentences of the introductory paragraph and revise as necessary to include a discussion of all material risks in the Risk Factors section.

Response: In response to Comment 8, we deleted the above-referenced language. See page 7.

Dilution, page 32

9. Please expand your disclosure to include the further dilution to new investors assuming your underwriters' over-allotment is exercised in full, if material.

Response: In response to Comment 9, we have revised the disclosure on page 33.

Our Business, page 43

10. Throughout the filing, please define or explain medical and regulatory terms, such as "dermatohistopathological" review on page 47, "spectrophotometric intercutaneous" analysis on page 53, and references to "QSR" and "ISO 9000 series" standards.

Response: We have added definitions of the medical, regulatory and statistical terms listed below at appropriate places in the Registration Statement.

<TABLE> <CAPTION> Term Page Reference ---- -------------- <S> <C> Nodular melanomas See pages 8 and 52 Dermatohistopathological (changed to histological) See page 10

Histopathological (changed to histological) See page 10

Confocal microscopy See page 11 </TABLE>

<PAGE> <TABLE> <S> <C> Spectroscopy See page 11

QSR See page 17

Statistically significant greater specificity See page 48

Exact binomial lower confidence bound (changed to lower See page 48 confidence bound)

Spectrophotometric intercutaneous analysis See page 55

Medi-Spas See page 54

Spectrophotometer See page 56

Breslow thickness See page 57

Shell See page 59

ISO 9000 See page 64 </TABLE>

MelaFind(R) Product Description, page 45

11. Please explain in greater detail the "appropriate limits" as it pertains to the MelaFind's functionality. We refer you to your disclosure in the penultimate paragraph on page 46.

Response: We have provided additional disclosure on page 48 in response to Comment 11.

MelaFind(R) Regulatory Status, page 46

12. Explain statistical terms used, such as "binomia1 1ower confidence bound," and quantify the "statistically significant greater specificity" needed to rule out melanoma. Also explain the difference between a "pilot" trial and a "pivotal" trial and update us as to the status of the pilot trial. We refer you to your disclosure in the last sentence on page 46.

Response: With respect to statistical terms, see our response to comment 10. We have revised the disclosure on page 48 in response to Comment 12.

<PAGE> Results of Training Studies and Blinded Tests, page 48

13. It is unclear what, if any, conclusions can be gleaned from the cumulative results of your training studies and blinded tests regarding the effectiveness of your product. The results appear to show that MelaFind's effectiveness varies greatly when compared to the results of study dermatologists. Please revise and expand your disclosure to include a conclusion as to how the latest iteration of your product compares with the effectiveness of expert dermatologists.

Response: It is important to understand that the data described in the "Our Business - Results of Training and Blinded Tests" include a comprehensive review of the results obtained throughout the development of prototype hardware systems and developmental software and classifiers. The cumulative results are provided to assist the reader in understanding the evolution of the MelaFind(R) system as the Company seeks to meet the performance goals described in the Protocol Agreement. The intention was to provide the reader with the information to come to a conclusion regarding the likelihood of success of our efforts in the final refinements of the hardware, software, and classifiers. The Company believes that through the clinical studies, it has learned a great deal regarding the optimal classifiers and design of hardware. The Company has implemented changes based on its experience such that steady progress toward optimal performance criteria has been demonstrated. The results of the largest study to date in 352 pigmented lesions using prototype systems serve as validation of the Company's development efforts. The Company believes that when using refined pre-commercialization hardware systems and final software and classifiers, the results of the pivotal trial will be similar or superior to the results obtained in the largest study to date, which employed prototype systems. The Company also believes that the results of the pivotal trial will satisfy the Protocol Agreement endpoints of performance relative to study dermatologists.

Consequently, we have provided additional disclosure on page 52 in response to Comment 13.

14. We refer you to the January 2005 Test Results on page 50. Please provide the basis for your belief that your product's sensitivity would have been 96.4% had the device performed within specifications.

Response: Some of the parameters of lesions imaged with the devices used to acquire the data for the January 2005 Test were significantly outside of the range of all the previous data. This led to the realization that several MelaFind(R) systems had fallen out of specifications as well as to the identification of problems with the MelaFind(R) hardware, which provided insight into a new and more robust design for these devices, intended to eliminate such problems in the future. If the results from the devices that were out of specification are removed, the sensitivity of classifiers A-4 and C-4 would have been 96.4%.

Consequently, we have provided additional disclosure on page 52 in response to Comment 14.

<PAGE> Our Reimbursement Strategy, page 51

15. Please expand your disclosure to provide more specific detail as to how you plan to accomplish your reimbursement strategy. For example, tell us how you plan to secure coverage by private payors and Medicaid agencies, particularly in light of the Risk Factors mentioned on page 9 of the registration statement.

Response: We have provided additional disclosure on pages 54 in response to Comment 15.

16. Please explain why you believe physicians might be willing to pay to use MelaFind and not charge patients for its use. We refer you to your disclosure in the first paragraph on page 52.

Response: In a capitated system (i.e., systems where physicians cannot pass costs on to patients, but rather are paid a fixed amount per patient under the plan, whether or not treated), it is possible that physicians will pay to use MelaFind(R) without passing the cost onto the patient since MelaFind(R) is likely to be less costly than other procedures that are currently used to detect and diagnose melanoma, including biopsy. In a non-capitated system, physicians may choose not to pass the cost of MelaFind(R) onto the patients; however, they may recoup the cost of using MelaFind(R) by performing other reimbursed procedures (for example, biopsies) when the information provided by MelaFind(R) indicates these are appropriate. Similarly, they may recoup the cost of using MelaFind(R) from other procedures that they may now have additional time to perform in the event that the MelaFind(R) information contributes to their decision not to perform a biopsy, for example, various cosmetic procedures. These dynamics are not likely to be understood until MelaFind(R) is approved, marketed and evaluated by physicians.

Consequently, we have provided additional disclosure on page 54.

Competition, page 52

17. Please explain the significance of comparing the specificity of dermatologists in DB-Mips studies to the specificity of dermatologists in MelaFind studies. Additionally, please disclose the reported sensitivity of the DB-Mips system and tell us how it compares to that of the MelaFind. We refer you to the last paragraph on page 52.

Response: The text in the Registration Statement on page 55 has been amended to include the reported sensitivity of the DB-Mips system (95% sensitivity in the blinded test) and to compare it to MelaFind(R)'s sensitivity (100% in the blinded test).

We have also added a discussion of the importance of pre-biopsy diagnoses by examining physicians. The

Show Raw Text
<DOCUMENT>
<TYPE>CORRESP
<SEQUENCE>1
<FILENAME>filename1.txt
<TEXT>
<PAGE>
(DREIER LLP LOGO)
Attorneys at Law

499 Park Avenue                                                 Valerie A. Price
New York, New York 10022                             Direct Dial: (212) 328-6144
Tel: (212) 328-6100                                  Direct Fax:  (212) 652-3789
Facsimile: (212) 328-6101                                                Partner
                                                            vprice@dreierllp.com

                                  July 15, 2005

SENT VIA FAX AND FEDERAL EXPRESS

United States Securities and Exchange Commission
100 F Street, N.E.
Washington, DC  20549
Attention: Peggy A. Fisher, Assistant Director, Division of Corporation Finance

         Re:      Electro-Optical Sciences, Inc.
                  Registration Statement on Form S-1
                  Filed June 3, 2005
                  File No. 333-125517

Ladies and Gentlemen:

         On behalf of Electro-Optical Sciences, Inc., a Delaware corporation
(the "Company"), and pursuant to the applicable provisions of the Securities Act
of 1933, and the rules and regulations promulgated thereunder, we are submitting
for filing with the Securities and Exchange Commission Amendment No. 1 to the
above-captioned Registration Statement on Form S-1 ("Amendment No. 1"). A copy
of Amendment No. 1 to the Registration Statement has been manually signed in
accordance with Rule 302 of Regulation S-T and the signature pages thereto will
be retained by the Company for a period of five years. The Company has
authorized us to respond to the comment letter sent to Joseph V. Gulfo, M.D. of
Electro-Optical Sciences, Inc., dated June 30, 2005, from the Staff of the
Commission.

         For your convenience, we enclose a marked copy of Amendment No. 1
marked to show changes to the Registration Statement, as originally filed with
the Commission on June 3, 2005.

         We have referenced the appropriate page number of the prospectus
contained in Amendment No. 1 in our responses contained herein. The numbered
paragraphs below set forth the Staff's comments, together with our responses.
Unless otherwise indicated, capitalized terms used herein have the meanings
assigned to them in Amendment No. 1.
<PAGE>
Prospectus Inside Front Cover Page

1.       We note your disclosure that you "do not make any representation as to
         the accuracy" of the industry data and forecasts and market research
         included in your prospectus. Please note that it is inappropriate to
         suggest that you do not have responsibility for the accuracy of
         disclosure in the registration statement. Please revise your disclosure
         accordingly.

         Response: In response to Comment 1, we deleted the above-referenced
         language. See the inside front cover page.

2.       Please provide us with copies of the industry reports and market data
         cited throughout the registration statement, clearly marking the
         relevant sections, and identify any reports prepared specifically for
         your use.

         Response: Attached as Annex A are copies of the industry reports and
         market data cited throughout the Registration Statement, together with
         pages of the Registration Statement marked to cross-reference the
         relevant sections to the appropriate industry report or market data.

Prospectus Summary, page 1

3.       Please expand the summary to clarify that you currently do not have any
         commercialized product or significant source of revenue and that your
         revenues to date were derived from the DIFOTI product, which was
         recently discontinued.

         Response: We have provided additional disclosure on pages 1 and 44 in
         response to Comment 3.

4.       Also clarify your anticipated timeframe for commercialization of
         MelaFind, assuming you receive premarket approval for MelaFind in 2007,
         as you currently anticipate. Also disclose the length of time it may
         take to obtain Medicare coverage.

         Response: We have provided additional disclosure on pages 3 and 46 in
         response to Comment 4.

5.       We note your disclosure in the second paragraph on page 1 that you have
         entered into a binding Protocol Agreement with the FDA to conduct a
         pivotal trial. Please also disclose that such a trial was initiated in
         2004, but that you experienced technical operational issues which
         require refinement to your hardware systems. We refer you to your
         disclosure in last paragraph on page 46 of the prospectus.

         Response: We have provided additional disclosure on pages 1 and 44 in
         response to Comment 5.

                                       2
<PAGE>
6.       Please tell us when you anticipate the completion of the websites
         mentioned on page 3 of the prospectus.

         Response: The websites mentioned on page 3 of the prospectus are now
         complete.

The Market Opportunity, page 1

7.       Revise the first few sentences to provide industry data regarding the
         incidence of melanoma, which appears to be a more relevant statistic
         than the incidence of all skin cancers.

         Response: We have provided additional disclosure on pages 1 and 45 in
         response to Comment 7.

Risk Factors, page 7

8.       Please eliminate the last two sentences of the introductory paragraph
         and revise as necessary to include a discussion of all material risks
         in the Risk Factors section.

         Response: In response to Comment 8, we deleted the above-referenced
         language. See page 7.

Dilution, page 32

9.       Please expand your disclosure to include the further dilution to new
         investors assuming your underwriters' over-allotment is exercised in
         full, if material.

         Response: In response to Comment 9, we have revised the disclosure on
         page 33.

Our Business, page 43

         10. Throughout the filing, please define or explain medical and
regulatory terms, such as "dermatohistopathological" review on page 47,
"spectrophotometric intercutaneous" analysis on page 53, and references to "QSR"
and "ISO 9000 series" standards.

         Response: We have added definitions of the medical, regulatory and
         statistical terms listed below at appropriate places in the
         Registration Statement.

<TABLE>
<CAPTION>
                  Term                                                                      Page Reference
                  ----                                                                      --------------
                  <S>                                                                     <C>
                  Nodular melanomas                                                       See pages 8 and 52
                  Dermatohistopathological (changed to histological)                         See page 10

                  Histopathological (changed to histological)                                See page 10

                  Confocal microscopy                                                        See page 11
</TABLE>

                                       3
<PAGE>
<TABLE>
                  <S>                                                                     <C>
                  Spectroscopy                                                               See page 11

                  QSR                                                                        See page 17

                  Statistically significant greater specificity                              See page 48

                  Exact binomial lower confidence bound (changed to lower                    See page 48
                  confidence bound)

                  Spectrophotometric intercutaneous analysis                                 See page 55

                  Medi-Spas                                                                  See page 54

                  Spectrophotometer                                                          See page 56

                  Breslow thickness                                                          See page 57

                  Shell                                                                      See page 59

                  ISO 9000                                                                   See page 64
</TABLE>

MelaFind(R) Product Description, page 45

11.      Please explain in greater detail the "appropriate limits" as it
         pertains to the MelaFind's functionality. We refer you to your
         disclosure in the penultimate paragraph on page 46.

         Response: We have provided additional disclosure on page 48 in response
         to Comment 11.

MelaFind(R) Regulatory Status, page 46

12.      Explain statistical terms used, such as "binomia1 1ower confidence
         bound," and quantify the "statistically significant greater
         specificity" needed to rule out melanoma. Also explain the difference
         between a "pilot" trial and a "pivotal" trial and update us as to the
         status of the pilot trial. We refer you to your disclosure in the last
         sentence on page 46.

         Response: With respect to statistical terms, see our response to
         comment 10. We have revised the disclosure on page 48 in response to
         Comment 12.

                                       4
<PAGE>
Results of Training Studies and Blinded Tests, page 48

13.      It is unclear what, if any, conclusions can be gleaned from the
         cumulative results of your training studies and blinded tests regarding
         the effectiveness of your product. The results appear to show that
         MelaFind's effectiveness varies greatly when compared to the results of
         study dermatologists. Please revise and expand your disclosure to
         include a conclusion as to how the latest iteration of your product
         compares with the effectiveness of expert dermatologists.

         Response: It is important to understand that the data described in the
         "Our Business - Results of Training and Blinded Tests" include a
         comprehensive review of the results obtained throughout the development
         of prototype hardware systems and developmental software and
         classifiers. The cumulative results are provided to assist the reader
         in understanding the evolution of the MelaFind(R) system as the Company
         seeks to meet the performance goals described in the Protocol
         Agreement. The intention was to provide the reader with the information
         to come to a conclusion regarding the likelihood of success of our
         efforts in the final refinements of the hardware, software, and
         classifiers. The Company believes that through the clinical studies, it
         has learned a great deal regarding the optimal classifiers and design
         of hardware. The Company has implemented changes based on its
         experience such that steady progress toward optimal performance
         criteria has been demonstrated. The results of the largest study to
         date in 352 pigmented lesions using prototype systems serve as
         validation of the Company's development efforts. The Company believes
         that when using refined pre-commercialization hardware systems and
         final software and classifiers, the results of the pivotal trial will
         be similar or superior to the results obtained in the largest study to
         date, which employed prototype systems. The Company also believes that
         the results of the pivotal trial will satisfy the Protocol Agreement
         endpoints of performance relative to study dermatologists.

         Consequently, we have provided additional disclosure on page 52 in
         response to Comment 13.

14.      We refer you to the January 2005 Test Results on page 50. Please
         provide the basis for your belief that your product's sensitivity would
         have been 96.4% had the device performed within specifications.

         Response: Some of the parameters of lesions imaged with the devices
         used to acquire the data for the January 2005 Test were significantly
         outside of the range of all the previous data. This led to the
         realization that several MelaFind(R) systems had fallen out of
         specifications as well as to the identification of problems with the
         MelaFind(R) hardware, which provided insight into a new and more robust
         design for these devices, intended to eliminate such problems in the
         future. If the results from the devices that were out of specification
         are removed, the sensitivity of classifiers A-4 and C-4 would have been
         96.4%.

         Consequently, we have provided additional disclosure on page 52 in
         response to Comment 14.

                                       5
<PAGE>
Our Reimbursement Strategy, page 51

15.      Please expand your disclosure to provide more specific detail as to how
         you plan to accomplish your reimbursement strategy. For example, tell
         us how you plan to secure coverage by private payors and Medicaid
         agencies, particularly in light of the Risk Factors mentioned on page 9
         of the registration statement.

         Response: We have provided additional disclosure on pages 54 in
         response to Comment 15.

16.      Please explain why you believe physicians might be willing to pay to
         use MelaFind and not charge patients for its use. We refer you to your
         disclosure in the first paragraph on page 52.

         Response: In a capitated system (i.e., systems where physicians cannot
         pass costs on to patients, but rather are paid a fixed amount per
         patient under the plan, whether or not treated), it is possible that
         physicians will pay to use MelaFind(R) without passing the cost onto
         the patient since MelaFind(R) is likely to be less costly than other
         procedures that are currently used to detect and diagnose melanoma,
         including biopsy. In a non-capitated system, physicians may choose not
         to pass the cost of MelaFind(R) onto the patients; however, they may
         recoup the cost of using MelaFind(R) by performing other reimbursed
         procedures (for example, biopsies) when the information provided by
         MelaFind(R) indicates these are appropriate. Similarly, they may recoup
         the cost of using MelaFind(R) from other procedures that they may now
         have additional time to perform in the event that the MelaFind(R)
         information contributes to their decision not to perform a biopsy, for
         example, various cosmetic procedures. These dynamics are not likely to
         be understood until MelaFind(R) is approved, marketed and evaluated by
         physicians.

         Consequently, we have provided additional disclosure on page 54.

Competition, page 52

17.      Please explain the significance of comparing the specificity of
         dermatologists in DB-Mips studies to the specificity of dermatologists
         in MelaFind studies. Additionally, please disclose the reported
         sensitivity of the DB-Mips system and tell us how it compares to that
         of the MelaFind. We refer you to the last paragraph on page 52.

         Response: The text in the Registration Statement on page 55 has been
         amended to include the reported sensitivity of the DB-Mips system (95%
         sensitivity in the blinded test) and to compare it to MelaFind(R)'s
         sensitivity (100% in the blinded test).

         We have also added a discussion of the importance of pre-biopsy
         diagnoses by examining physicians. The