SEC Company Response from SURGILIGHT INC (CIK 0001070289) — Nov 16, 2005
SURGILIGHT INC (CIK 0001070289)
Date: Nov. 16, 2005 · CIK: 0001070289 · Accession: 0001070289-05-000015
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File numbers found in text: 000-24897
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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
DIVISION OF
CORPORATION FINANCE
Mail Stop 6010
November 16, 2005
Mr. Stuart Michelson
Chief Financial Officer
SurgiLight, Inc.
12001 Science Drive, Suite 140
Orlando, Florida 32826
Re: SurgiLight, Inc.
Form 10-KSB for the Year Ended December 31, 2004
Form 10-QSB for the Quarter Ended March 31, 2005
File No. 000-24897
Dear Mr. Michelson:
We have reviewed your filings and have the following comments. We have
limited our review to only your financial statements and related disclosures
and will make no further review of your documents. 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 information so we
may better understand your disclosure. After reviewing, this information, we
may 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 filings. 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.
RESPONSE: IN SUMMARY
The Company agrees that several of the SEC comments provide appropriate
guidance and result in additional or revised disclosures that make the
Company's financial statement presentation more meaningful. To that extent,
many revisions have already been included in the Company's most recent filing.
However, the Company believes that in the aggregate, the comments contained in
this letter do not rise to the level of requiring the Company to revise its
past filings and will use its best efforts to ensure all subsequent filings
take all applicable comments into consideration.
Form 10-KSB for the Year Ended December 31, 2004
Item 1. Business -Sales and Marketing
1. You state that sales are made as part of the clinical trial process and
expand once a country has cleared the product through its Ministry of
Health. Also, these sales are distributed through an international
distribution network. In this regard, tell us and expand this section to
clarify the following:
Describe to the reader the products you are selling internationally.
RESPONSE:
The SurgiLight OptiVision is a compact, solid-state Erbium:YAG laser that
produces a discreet wavelength of 2940 nm. This wavelength is on one of the
major peaks of water absorption and is absorbed by the histologic water in
biologic matter (human tissue). The laser energy is delivered to tissue via a
flexible fiber optic that is connected to a contact tip for ease of control and
precise interaction with the scleral tissue. This is the only product that
the Company currently markets.
The Company markets only the OptiVision Er:YAG Laser System for laser
presbyopia reversal (LAPR) and other ophthalmic applications worldwide through
approximately 10 international distributors in approximately 15 countries. The
product is currently cleared by the Ministry of Health in most countries with
the notable exceptions of the United States, Canada and Japan, which require
additional clinical trials. In particular, SurgiLight has received the CE mark
for both the OptiVision and, in February 2005, for the LAPR procedure allowing
SurgiLight to market in all of Europe and many other countries around the world
that recognize the CE mark.
Identify those foreign countries where your product has been cleared by
its Ministry of Health.
RESPONSE:
SurgiLight has received ANNEX III and ANNEX IV CE approval to market the
OptiVision for Laser Assisted Presbyopia Reversal (LAPR). These approvals will
allow the Company to market the OptiVision to any country that recognizes the
CE Mark which includes the entire EU and many countries throughout the world.
Indicate the number of distributors that sell your product. If you rely
on one particular distributor, please tell investors.
RESPONSE:
The Company does not rely on one distributor although we did report a
concentration of sales to one distributor in 2004.
The Company sells and markets through distributors internationally. The
distributor receives a discounted price on the laser that is adjusted for
volume purchases. The distributor conducts courses, provides literature and
attends local shows to market the product. A distributor can also sell in a
region that has not been exclusively assigned to another distributor. The
Company does not sell in the U.S. except if and when the FDA expands our
clinical trial for LAPR, which we hope will occur again in the near future.
Revise to discuss separately your sales and marketing activities in
domestic and foreign markets.
RESPONSE:
The Company is currently in a Phase II clinical trial in the US and is able to
market the OptiVision to those countries that recognize the CE Mark which
includes the EU and many other countries throughout the world. The Company
anticipates its trials in the US expanding from the current two (2) sites to
eight (8) sites in the near future. The Company is currently focusing and will
continue to focus its markets and sales activities in those countries that
recognize the CE Mark.
The Company sells and markets through distributors internationally. The
distributor receives a discounted price on the laser that is adjusted for
volume purchases. The distributor conducts courses, provides literature and
attends local shows to market the product. A distributor can also sell in a
region that has not been exclusively assigned to another distributor. The
Company does not sell in the U.S. except if and when the FDA expands our
clinical trial for LAPR, which we hope will occur again in the near future.
2. You state that sales contracts are made primarily through attendance at
a few trade shows throughout the year. Revise to indicate the percentage
of these sales made in the United States and in foreign countries.
Discuss any material differences in the terms of your domestic and
foreign sales contracts.
RESPONSE:
The Company does attend several large regional trade shows in the U.S. and
other countries and receives the majority of its leads from these
conferences. These leads are passed on to the distributors as we have
chosen not to sell in the United States except for clinical trials. The
Company's investigators and doctors also publish papers on the procedure.
Government Regulation
3. We note that you were subject to inspections by the FDA in 2003 and in
January 2004 and received Form 483 notices and warning letters resulting
in your inability to ship products to certain countries around the
world. However, it is unclear to us which Form 483 notices and warning
letters have been resolved to date.
Tell us and revise this section and MD&A to include a discussion of the
current status of the open violations with the FDA as a result of their
inspections.
Explain how you are resolving the issues and address the impact of these
violations on your current and future results of operations.
RESPONSE:
We continue to wait for any response from the FDA to our responses to the
Warning letters and Form 483 notices, which were submitted to the FDA more
than a year ago. We continue to believe (in some cases with the concurrence
of the FDA) that most of the issues in our Form 483s and Warning Letters
were misunderstandings resulting from the FDA believing that we our
manufacturing the OptiVision laser instead of having purchased them from
Premier Laser Systems. The clinical issues in the Warning Letter have been
resolved through mutually agreed upon changes in the protocol. The greatest
impact of these violations has been the delay in expansion of the clinical
trials in the United States, however, since we do not rely on sales from the
U.S., the impact is more intangible as it affects the worldwide perception
of SurgiLight. To date, the warning letters have not affected our clinical
trials elsewhere in the world or our shipments during the last year. We
cannot predict the affect that it may have in future years or when they will
be resolved.
The FDA frowns on us giving our opinion of the Warning Letters, time to
resolution, or any detailed discussion of current status. Therefore, we
have chosen to report the existence of the Warning Letters and Form 483s,
but not to project any resolution. We have also reported that it may impact
our sales to certain countries.
Item 6. Management's Discussion and Analysis of Financial Condition and Results
of Operations
Critical Accounting Policies
4. In addition to identifying your significant estimates in Note 1 to the
financial statements, revise to include a critical accounting policies
section in your MD&A that discusses those critical accounting estimates
and assumptions involved in the application of GAAP.
Describe the methodology used by management in determining these
particular estimates; the significant assumptions you use; and the
likelihood that materially different amounts would be reported under
different conditions or using different methods. It would appear that
discussions relating to those estimates involved in your accounting for
your allowance of doubtful accounts, inventory obsolescence, warranty
obligations, valuing of investments, and legal contingences may be
required. Refer to the guidance provided in FR-72.
RESPONSE:
Critical Accounting Policies, Estimates and Judgments
We follow accounting principles generally accepted in the United States
("GAAP") in preparing our financial statements. As part of this work, we must
make estimates and judgments about future events. These affect the value of
the assets and liabilities, contingent assets and liabilities, and revenues and
expenses reported in our financial statements. We believe these estimates and
judgments are reasonable and we make them in accordance with our accounting
policies based on information available at the time. However, actual results
could differ from our estimates and could require us to record adjustments to
expenses or revenues material to our financial position and results of
operations in future periods. We believe our most critical accounting
policies, estimates and judgments include the following:
Revenue Recognition
Our revenue recognition policy is described in Note 1 to our Financial
Statements. We are also required to ensure that collectibility is reasonably
assured before we recognize revenue. Accordingly, we evaluate our customers
for credit worthiness and only recognize revenue if we believe that we have
reasonable assurance that amounts will be collected within the next operating
cycle. Where we are unable to assess with reasonable assurance that amounts
will be collected during that period, we defer revenue recognition until the
payments are received.
Accounts Receivable
At the end of each accounting period, we estimate the reserve necessary for
accounts receivables that will ultimately not be collected from customers. To
develop this estimate, we review all receivables and identify those accounts
with problems. For these problem accounts, we estimate individual, specific
reserves based on our analysis of the payment history, operations and finances
of each account. Unexpected deterioration in the health of either a large
customer or a national economy could lead to a material adverse impact on the
collectibility of our accounts receivable and our future operating results.
Inventories
Adjustments to the carrying value of inventory for excess and obsolete items
are based, in part, on our estimate of demand over the following 12 months.
This estimate, though based on our historical experience and consideration of
other relevant factors, such as the current economic climate, is subject to
some uncertainty. Amounts charged to income for excess and obsolete inventory
for the years ending December 31, 2004 and 2003 as a percentage of total
revenues in 2004 and 2003 were 0.0%. To date, our estimates have been
materially accurate and subject to any major changes in our business model, our
operating environment or the economy, and taking consideration of the ongoing
development of our technology, we do not expect either our methodology or the
accuracy of our estimates to change significantly in the future.
Legal Contingencies
At the end of each accounting period, we review all outstanding legal matters.
If we believe it is probable that we will incur a loss as a result of the
resolution of a legal matter and we can reasonably estimate the amount of the
loss, we accrue our best estimate of the potential loss. It is very difficult
to predict the future results of complex legal matters. New developments in
legal matters can cause changes in previous estimates and result in significant
changes in loss accruals. Currently we are not aware of any pending or
threatened legal actions against us that we believe could materially adversely
affect our business, financial condition or results of operations. However, we
could in the future be subject to litigation claims that could cause us to
incur significant expenses and put our business, financial position, and
results of operations at material risk.
Product Warranty Costs
At the time we recognize revenue for each unit, we also record a charge of $400
that estimates our liability for future service costs over the twelve-month
warranty period. At the end of each accounting period, we review the
outstanding balance and adjust the balance to match the remaining months
remaining in our warranty period. To date, our estimates have been materially
accurate and subject to any major changes in our business model, our operating
environment or the economy, and taking consideration of the ongoing development
of our technology, we do not expect either our methodology or the accuracy of
our estimates to change significantly in the future.
Revenues
5 You state that revenue from equipment sales were $1,705,000 in 2004 as
compared to$1,157,240 in 2003. Please revise to address the following.
Clearly explain what you mean by "equipment sales." Briefly describe
the products that you sell.
Indicate how much revenue you earned from domestic and foreign sales
in each period.
Describe the items included in cost of revenues
Identify the factors that contributed to the significant margins you
recorded on your sales.
RESPONSE:
As previously mentioned, the Company markets only the OptiVision Er:YAG
Laser System for laser presbyopia reversal (LAPR) and other ophthalmic
applications worldwide through approximately 10 international
distributors in approximately 15 countries. That product constitutes our
sole revenue source of "equipment sales."
The following summarizes the equipment sales for the years ended 2004 and
2003:
2004 2003
---- ----
Domestic Sales $ 180,000 11% $ 248,000 21%
International Sales 1,525,000 89% 909,240 79%
Total $ 1,705,000 $ 1,157,240
Due to the purchase of the inventory from Premier Laser Systems in 2000
and 2001, the Company has been able to maintain a fixed cost of goods
sold per unit. The Company has adequate inventory to maintain the
current cost levels for an estimated additional three years, at which
time additional units can be manufactured from existing inventories of
raw materials. At that time, it is possible that the Company's per unit
cost may vary from the current level due to the assembly and testing
costs to be incurred. Cost of goods sold includes the fixed cost of the
un