SEC Comment Letter for Ivivi Technologies, Inc. (CIK 0001316925) — Mar 28, 2005
Ivivi Technologies, Inc. (CIK 0001316925)
Date: March 28, 2005 · CIK: 0001316925 · Accession: 0000000000-05-014260
AI Filing Summary & Sentiment
File numbers found in text: 333-122768
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March 11, 2005
Mail Stop 0306
Andre DiMino, Chairman
Ivivi Technologies, Inc.
224-S Pegasus Avenue
Northvale, NJ 07647
Re: Ivivi Technologies, Inc.
Registration Statement on Form SB-2
Filed February 11, 2005
Amendment No. 1 to Registration Statement on Form SB-2
Filed March 3, 2005
File No. 333-122768
Dear Mr. DiMino:
We have reviewed your filing and have the following
comments.
Where indicated, we think you should revise your document in
response
to these comments. If you disagree, we will consider your
explanation as to why our comment is inapplicable or a revision is
unnecessary. Please be as detailed as necessary in your
explanation.
In some of our comments, we may ask you to provide us with
supplemental information so we may better understand your
disclosure.
After reviewing this information, we may or may not raise
additional
comments.
Please understand that the purpose of our review process is
to
assist you in your compliance with the applicable disclosure
requirements and to enhance the overall disclosure in your filing.
We look forward to working with you in these respects. We welcome
any questions you may have about our comments or on any other
aspect
of our review. Feel free to call us at the telephone numbers
listed
at the end of this letter.
General
1. Please revise your disclosure to make the meanings of all
technical, medical and industry-specific terms clear from the
context
of your discussion. For example, we note the references to "Stage
III and Stage IV" ulcers, "venous stasis" and "angiogenesis" on
pages
1-2, and "objectively-measured" blood flow on page 42. Please
also
describe such terms where they first appear.
2. Please provide the definitions of all Internal Revenue Code
terms
contained in the prospectus. We note, for example, "parachute
payments" on page 65, and "Outside Directors" and "Incentive
Options"
on page 67.
3. The financial statements should be updated, as necessary, to
comply with Item 310(g) of Regulation S-B at the effective date.
Additionally, when filing the first amendment to your registration
statement, please ensure that corresponding updates are made
throughout the prospectus to reflect the financial results for the
quarter ended December 31, 2004. We note, for example, that your
accumulated deficit disclosure on page 7 and your Dilution
disclosure
on page 24 are as of September 30, 2004.
4. Please include an updated and signed consent from your
independent
auditors with any amendment filed.
Registration Statement Cover Page
5. Please add and check the Rule 415 box to the cover page of the
registration statement. Refer to Item D.36 in the main volume of
our
Manual of Publicly Available Telephone Interpretations, which is
available on our website at
http://www.sec.gov/interps/telephone.shtml.
Prospectus Cover Page
6. Supplementally confirm to us that the selling shareholders will
not sell any of the shares being registered for resale until your
shares are quoted on the Nasdaq SmallCap Market. Alternatively,
disclose on the cover page of the prospectus and in your plan of
distribution section that the selling shareholders will sell at a
fixed price per share until your shares are quoted, and identify
the
fixed price at which the selling shareholders will sell until a
trading market is established.
Prospectus Inside Front Cover Page - Page i
7. We note your disclosure that you "do not make any
representation
as to the accuracy" of the market and clinical data and other data
and forecasts 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.
8. Please supplementally provide us with copies of the industry
reports and market data cited throughout the registration
statement,
clearly marking the relevant sections, and identify the reports
prepared specifically for your use. Please also supplementally
provide us with copies of consents from the sources of the citied
statistics consenting to the use of their names and/or data in the
prospectus.
9. Please also revise to clarify when cited statistics are the
result
of sponsored research and when cited statistics are the result of
studies conducted and findings made by your key employees or
affiliates.
Prospectus Summary - Page 1
10. The disclosure in the summary should be a balanced
presentation
of your business. Please balance the disclosure of your potential
market prospects with a brief discussion of the principal
challenges
or risks associated with your company and business opportunities,
many of which are identified in your Risk Factors section. You
should specifically highlight the fact that since inception you
have
generated only limited revenues and incurred significant losses.
11. We note your disclosure on page 4 that, pursuant to an
agreement
with ADM Tronics, "all future technologies and products utilizing
non-invasive electrotherapeutic technologies will be developed and
commercialized by [you] and not ADM Tronics." Please file this
agreement as an exhibit to the registration statement.
Additionally,
as this agreement relates to "future" technologies, please clarify
whether ADM Tronics is free to compete with your current SofPulse
technology products and the other products you are currently
developing. We note further your disclosure that ADM Tronics
currently has its own "non-invasive medical devices." Also
disclose
whether you have non-competition agreements with ADM Tronics and
its
employees.
12. Please describe in greater detail the joint note offerings
mentioned on page 4. Clarify how the proceeds from these
offerings
where allocated between you and ADM Tronics and the purposes for
which those proceeds were used. We note your disclosure on page
33
that net proceeds from the private placements "were being held by
ADM
Tronics."
Risk Factors - Page 7
General
13. Please describe, under appropriate heading, the risks
associated
with the fact that you did not have sufficient independent and
disinterested directors to approve or ratify the transactions
referenced in the Certain Relationships and Related Transactions
section of the prospects.
14. Please add a risk factor addressing the risks associated with
engaging an underwriter with limited experience, some of which are
listed on page 83.
We have a limited operating history on which to evaluate our
potential.... - Page 7
15. The descriptions in the bulleted lists are too vague and
generic.
Please revise to clarify how each is specific to your business and
operations.
We have a history of significant and continued operating
losses.... -
Page 7
16. Disclose how long you expect to incur additional operating
losses
and negative cash flows from operations. For example, do you
intend
to incur such losses for the foreseeable future?
17. Please address the risks associated with your expectation that
your auditors will raise substantial doubt regarding your ability
to
continue as a going concern. You should address, for example, the
adverse effects that the auditor`s going concern opinion may have
on
your ability to secure additional financing.
Our revenues are currently dependent on our products which utilize
PEMF.... - Page 8
18. In an appropriate section of the prospectus, please expand
your
description of the "perceived issues relating to the quality and
safety" of your products.
19. We refer you to the second paragraph under this risk factor
heading. Under separate and appropriate headings, please expand
your
disclosure to highlight: (i) the risks associated with seeking
regulatory clearance and approval of new products or technologies;
and (ii) the risks associated with your ability to market, sell
and
commercialize new products.
20. Additionally, the bullet point list is generic and does not
indicate how these risks specifically impact your business and
operations. Please revise to use examples that demonstrate the
risk
to your business.
If we are unable to receive reimbursement from third parties.... -
Page 9
21. Please quantify the portion of your historical revenues
comprised
of Medicare payments.
The loss of any of our executive officers or key personnel.... -
Page
13
22. Please confirm that you will file as exhibits to the
registration
statement your employment and consulting agreements with your key
personnel.
23. We also note that your employment agreement with Mr. DiMino
will
not require him to devote his full time and attention to your
company. Please expand your risk factor disclosure to discuss the
risks this may present to your investors.
We depend on a limited number of suppliers.... - Page 13
24. With a view toward disclosure, tell us how much time you would
need to replace a key supplier.
Risks Related to Our Common Stock - Page 17
Executive officers, directors and entities affiliated with
them.... -
Page 17
25. Please revise your disclosure of the percentage of your common
stock beneficially owned by your directors, officers, principal
shareholders and affiliates of the same to reflect the exercise of
all "in the money" options and warrants based on the assumed
initial
public offering price.
Our stock price after the offering could be below the offering
price.
- Page 18
26. Please explain how your stated belief that the valuation
metrics
often attributed to medical device technology companies are less
than
those attributed to biotechnology companies impacts the risk that
your stock price after the offering may be less than the offering
price.
Sales of substantial amounts of our common stock may occur.... -
Page
18
27. It is unclear whether the shares offered by the selling
shareholders and registered pursuant to this registration
statement
are also subject to a lock-up agreement. Please clarify here and
elsewhere where appropriate throughout this prospectus and in the
alternate prospectus. We may have further comment.
Special Note Regarding Forward-Looking Statements - Page 21
28. Please delete the second sentence of this paragraph as it is
inappropriate to disclaim responsibility for the accuracy and
completeness of statements that appear in your prospectus.
Dilution - Page 24
29. Please expand your disclosure to include the further dilution
to
new investors assuming exercise of the outstanding stock options
and
warrants if the exercise prices will be significantly less than
the
IPO price.
30. Please also quantify the dilution to new investors assuming
your
underwriters` over-allotment is exercised in full.
Selected Financial Information - Page 27
31. Please supplementally clarify what is meant by the phrase
"qualified in its entirety by" as it relates to the audited
financial
statements.
Management`s Discussion and Analysis of Financial Condition and
Results of Operation - Page 28
Results of Operations - Page 31
Six months ended September 30, 2004 compared to six months ended
September 30, 2003 - Page 31
Rental Income - Page 31
32. Revise to quantify each of the significant factors cited, such
as
increased marketing activities and sales of products, in
explaining
the changes in your rental income. In addition, each significant
factor that contributed to the significant variances in expense
amounts each period, such as increases in salaries and consulting
fees in your selling, general and administrative expenses, should
also be quantified and discussed. Please apply throughout MD&A to
the extent practicable.
33. Please explain how sales of your products increased your
rental
income.
Income Taxes - Page 32
34. Please tell us whether this offering will qualify as a "change
of
control" for purposes of determining loss carryforwards.
Liquidity and Capital Resources - Page 33
35. Please revise your discussion of liquidity to describe more
fully
your overall financial structure, with particular emphasis on your
agreements with ADM and subsidiaries. Transactions, arrangements
and
relationships with unconsolidated entities that are reasonably
likely
to affect liquidity should be fully disclosed as well.
36. Please make more specific disclosure about covenants
associated
with your borrowings. For example, quantify the financial
covenants
to the extent practicable.
37. Additionally, please describe in greater detail the "certain
covenants" that may result in an increase in the number of shares
of
common stock underlying the notes and warrants. Also quantify the
potential increase in the number of underlying shares.
38. Please revise to disclose, if true, that you are currently in
compliance with the covenants contained in the notes.
Additionally,
to the extent that these existing debt covenants may substantially
restrict your ability to operate your business, provide
appropriate
risk factor disclosure.
39. Please tell us why ADM Tronics was holding the proceeds from
your
private placement. We note your disclosure on page 33.
Other
40. When you make changes to the financial statements included in
the
Form SB-2 in responding to our financial statement comments,
revise
Management`s Discussion and Analysis where necessary to reflect
those
changes.
Business - Page 36
Business Overview - Page 36
41. We note your disclosure that the SofPulse device has been used
in
over 600,000 treatments. Please expand your disclosure to define
"treatment" as the term is used in this context. For example,
does
"treatment" refer to a single patient or a single session?
42. Please describe the material terms of your three third-party
distribution agreements and tell us why you have not filed these
agreements as exhibits to the registration statement.
Market Overview - Page 37
43. We note your disclosure that you are currently researching and
clinically testing potential applications for your SofPulse device
and exploring the possibility of utilizing PEMF technology for the
treatment of edema. Please expand your disclosure to discuss the
research and testing costs and time needed to make such
applications
of your products viable.
Future Markets - Page 38
44. If you elect to retain projections regarding potential future
markets in your prospectus, please balance this disclosure with a
description of the challenges, costs, and time needed to develop
and
commercialize products to be introduced into those markets.
Other Markets and Applications - Page 45
45. Please update your disclosure regarding the status of your
regulatory clearance application for the pain relief product and
tell
us whether you still anticipate obtaining clearance by the end of
2005.
Our Strategy - Page 39
Expand the use of SofPulse for Angiogenesis and Vascularization
....
- Page 40
46. Please briefly describe the material terms of your sponsored
research agreements with Montefiore Medical Center and disclose
whether any payments were made with securities.
Current Applications - Page 41
47. We note your disclosure on page 42 that you are re-introducing
the SofPulse device into the chronic wound market. Please expand
your disclosure to discuss the impact of competing products and
technologies developed by your competitors since 1997, the last
time
your SofPulse device had a significant presence in this market.
Plastic Surgery - Page 43
48. Please disclose the meaning of acronyms such as "ASAPS" where
they first appear in the prospectus. Also, please disclose any
material relationships between you and this particular
organization.
49. Please describe briefly the "issues of compliance" mentioned
in
the last paragraph on page 43.
Manufacturer and Suppliers - Page 48
Manufacturer - Page 48
50. From the disclosure of the terms of your manufacturing
agreement,
it appears that you are charged twice for the same materials used
to
manufacture your products, once when you purchase and provide ADM
Tronics with these materials (as disclosed on page 50), and again
when ADM