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
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(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.
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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.
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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>
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Term Page Reference
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<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>
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<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.
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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.
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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