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SEC Comment Letter for LANGER INC (CIK 0000725460) — Feb 16, 2005

LANGER INC (CIK 0000725460)
Date: Feb. 16, 2005 · CIK: 0000725460 · Accession: 0000000000-05-007811

AI Filing Summary & Sentiment

File numbers found in text: 333-120718

Date
December 23, 2004
Author
Not clearly detected
Form
UPLOAD
Company
LANGER INC (CIK 0000725460)

Letter

December 23, 2004 Andrew H. Meyers Chief Financial Officer Langer, Inc. 450 Commack Road Dear Park, NY 11729-4510

Re: Langer, Inc. Registration Statement on Form S-1 filed November 23, 2004 File No. 333-120718

Dear Mr. Mayers:

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.

Form S-1

Prospectus Summary - Pages 1 to 4 1. The disclosure in the Summary should be a balanced presentation of your business. Please balance the disclosure of your strengths with a brief discussion of the principal challenges or risks associated with your company, many of which are identified in your Risk Factors section. 2. Please provide copies of the industry reports cited throughout the registration statement, clearly marking the relevant sections. For example, you cite unnamed "independent research" projections on pages 2 and 47.

3. Please provide supplemental support for your stated belief that your brand names "represent a high level of quality in the markets in which [you] sell." 4. Please disclose, or estimate if not currently known, the transaction costs associated with the Silipos acquisition. Additionally, please describe and quantify the working capital adjustments to the Silipos acquisition price.

Risk Factors - Pages 8 to 18

There are significant risks associated with our strategy.... - Page 9 5. Please expand your disclosure to address the risk of dilution to new investors associated with your use of stock to finance future acquisitions.

We may face difficulties integrating the operations of Silipos - Page 10 6. Please describe the "various risks" specifically associated with your integration of Silipos` operations. Additionally, please tell us whether you have experienced any such material integration delays or unexpected costs that have resulted in or are expected to result in a materially adverse impact to your business and operations.

We may be adversely affected by legal actions or proceedings commenced against us. - Page 10 7. Please tell us the basis for your belief that Poly-Gel may raise such claims or bring legal action against you. If you are currently aware of Poly-Gel`s intention to pursue such claims against you, please disclose this fact. This risk factor`s heading, and disclosure on page 40, suggest that Poly-Gel has already commenced an action or proceeding. If this is in fact the case, please revise and add appropriate disclosure here and in the Legal Proceedings section of the prospectus.

Our existing purchase arrangements may be adversely affected .... - Page 10 8. Please describe this risk in more concrete terms by disclosing the circumstances under which third-party manufacturers can alter the terms of or be released from your supply agreements. Additionally, please tell us whether any of these agreements, alone or in the aggregate, are material and file all material supply agreements as exhibits. Also, with a view towards disclosure, please tell us the time you would need to replace any key supplier. 9. For the two most recently completed fiscal years, and in the nine months ended September 30, 2004, disclose whether you experienced any such interruptions or delays that resulted in a materially adverse impact to your business and operations, and if so, how the matter was resolved.

We may not be successful in manufacturing the raw material oil based gels.... - Page 11 10. Disclose why you did not renew Silipos` supply agreement with Poly-Gel and opted to begin manufacturing gels on your own.

The nature of our business could subject us to potential product liability...claims. Page 11 11. Please tell us how you determined that your current insurance coverage is adequate and reconcile this statement with your disclosure on page 12 that your existing coverage "may be inadequate to protect [you]" from liabilities you may incur. 12. Additionally, please disclose whether, in the two most recently completed fiscal years, and in the nine months ended September 30, 2004, you experienced any such product liability claims that resulted in a materially adverse impact to your business and operations.

Changes in government and other third-party payor reimbursement levels.... - Page 12 13. Please quantify the portion of your historical revenues comprised of Medicare and Medicaid payments.

Our products may be subject to product recalls.... - Page 14 14. Please describe any past mandatory or voluntary recalls that have had a material adverse effect on your business.

Our business, operating results and financial condition could be adversely affected if we become involved in litigation regarding our ... intellectual property rights - Page 14 15. Please disclose whether you are currently aware of any parties currently intending to pursue such intellectual property claims against you.

A portion of our revenues and expenditures is subject to exchange rate fluctuations that could adversely affect our reported results of operations. - Page 16 16. Please demonstrate this risk by quantifying any material reductions in sales and profitability recently experienced due to foreign currency fluctuations.

Our quarterly results are subject to fluctuations. - Page 16 17. Please briefly explain why orthotic device sales have historically been higher in North America in the warmer months and why you may expect this trend to continue in the future.

One stockholder has the ability to significantly influence .... - Page 17 18. Please expand your disclosure to include the fact that 3 of your current 6 directors are affiliated with your largest shareholder, and that the entire board was designated in 2001 by the investor group led by your largest shareholder. Also tell us whether you currently have any procedures in place for resolving actual or perceived conflicts of interest between your principal shareholders and your other shareholders. 19. Additionally, please disclose the voting agreement between Langer Partners and Oracle, and include in your disclosure the percentage of your common stock beneficially owned by Oracle prior and subsequent to this offering.

The price of our common stock has been and is expected to continue to be volatile, which could affect a stockholder`s return on investment. - Page 17 20. Please discuss, under separate heading, the risks associated with the thin trading level of your stock and the relatively low public float. We have a significant amount of convertible indebtedness.... - Page 21. Please quantify the dilution effect to new shareholders of conversion of the subordinated notes.

Our certificate of incorporation, our bylaws and Delaware law.... - Page 18 22. Please define "interested shareholder" pursuant to Delaware General Corporation Law.

New investors in our common stock will experience immediate and substantial dilution. - Page 18 23. Please include the dilution effects of the conversion of the subordinated notes.

Use of Proceeds - Page 20 24. Please revise your disclosure to more specifically identify the purposes for which the balance of the net proceeds not being used to repay indebtedness is expected to be used and quantify the amount intended to be allocated to each purpose; it is not appropriate nor helpful disclosure to investors to aggregate those purposes under a generic category such as " other general corporate purposes." Alternatively, please discuss the principal reasons for conducting your offering at this time. 25. Your capitalization table on page 22 appears to indicate that a portion of the proceeds will be used to pay the $2.5 million obligation under the Silipos, Inc. purchase agreement. Please supplementally clarify our understanding of your use of proceeds and revise the filing on this page, page 22 or elsewhere, if necessary, based on our concerns.

Capitalization - Page 22 26. Please remove the cash and cash equivalent caption from this table.

Unaudited Pro Forma Condensed Consolidated Financial Statements - Pages 26-30 27. Tell us why you did not include pro forma adjustments to reflect charges that would have been incurred had the employment agreement with W. Gray Hudkins been entered into at the beginning of the periods presented. Does Article 11-02(b)(6) of Regulation S-X require you to include adjustments for the referenced agreement? Revise the filing to include any required additional pro forma adjustments.

Dilution - Page 24 28. Please expand your disclosure to include the further dilution to new investors assuming the exercise of outstanding options and warrants and the conversion of convertible debt. Please also disclose the dilution effects of the exercise of the over- allotment option.

Management`s Discussion & Analysis - Pages 31 to 45

General 29. When a description of known material trends, events, demands and commitments is set forth, expand your discussion to include both the intermediate effects of those matters and the reasons underlying those intermediate effects. For example: how did you lower your labor costs and manufacturing overhead and is the resulting increase in gross profit margins sustainable; how were 2003 custom orthotics sales increased in the U.K.; what factors were responsible for the increased U.K. labor costs; what material efficiencies were realized through the integration of Benefoot and the leverage of your infrastructure and are such efficiencies sustainable; what factors were responsible for the increase in 2002 sales volume? Please apply this comment throughout your MD&A. Please refer to SEC Release No. 33-8350 for additional guidance. 30. Please describe in greater detail the measures taken to strengthen your infrastructure. We note this disclosure in several places within MD&A. Results of Operations - Pages 34 to 38 31. We note that you have provided explanations by segment of your net sales variances for all periods presented. Please revise your analysis of cost of sales (and gross profit) and other charges, if applicable, to also discuss variances by segment for all periods presented in accordance with Item 303(a) of Regulation S-K. 32. Revise your results of operations discussion for all periods presented to be more specific about the reasons for changes in your financial statement line items and to quantify the reasons for the changes, whenever possible. Please describe and quantify costs where you have used phrases such as "increases in certain product costs", "an increase in sales volume", or "due to a change in product mix". How much were the increases or decreases? Which products were affected, specifically? Quantify the portion of changes in financial statement line items related to the acquisitions of Benefoot and Bi- Op, so that it is apparent to the reader how those acquisitions have affected results of operations for the periods presented.

Nine Months Ended September 30, 2003 and 2004 - Pages 35 to 33. We note your disclosure on page 35 that the podiatric customer base for your custom foot orthotics, which comprises a large part of your custom orthotics business, is a mature segment. Please describe how this fact effects your revenues, business and results of operations. Liquidity and Capital Resources - Pages 39 to 42 34. Revise your operating cash flows discussion for all periods to focus on cash payments or collections, rather than merely stating changes in balance sheet accounts, and quantify amounts if possible. For example, instead of "...offset by increased accounts receivable levels", disclose specific reasons for the changes. Also, discuss the reasons for material changes in your current asset, liability and other asset accounts between the presented balance sheet dates.

Contractual Obligations - Page 40 35. We note your disclosure of the Put Option to purchase Poly- Gel`s assets or shares at a purchase price of 1.5 times Poly-Gel`s revenues over the 12 month period prior to the exercise of the Put Option. Please quantify this obligation based on Poly-Gel`s prior 12 month revenue as of the most recent practical date here and in the "Use of Proceeds" section. 36. Additionally, please explain more clearly and in greater detail the Poly-Gen put option and the $1-1.5 million obligation that depends on whether Poly-Gel asserts certain claims. Are these potential "claims" the same potential Poly-Gel legal action and proceedings discussed in the Risk Factors section? If so, please tell us how you have determined your liability pursuant to potential claims that Poly-Gel has yet to make. Capital Resources - Page 42 37. Please also discuss your ability to meet your cash obligations for at least the next 12 months without the proceeds of this offering.

Quarterly Results of Operations (unaudited) - Page 43 38. Please revise this section to include all the quarterly data required (the two most recent fiscal years and any subsequent interim period for which financial statements are included) by Item 302 (a)(1) of Regulation S-K.

Business - Pages 46 to 59

Acquisition History - Page 46 39. Explain in more detail the February 2001 acquisition, including the consideration paid and the equity interests and other benefits received in return. Disclose amounts on an aggregate and per- share basis. 40. We note your disclosure that you are obligated to pay "up to" $2.5 million under the Silipos purchase agreement. However, disclosure on page 40 suggests that your obligation pursuant to this agreement could exceed $2.5 million if the Put Option is exercised and depending on the amount of liabilities and damages incurred by you and SSL. Please revise or advise. 41. Please briefly describe the liabilities assumed in the Benefoot acquisition. 42. Additionally, we note on pages F-15 and F-38 that, in connection with the Benefoot acquisition, the Company also entered into a medical consulting agreement with Sheldon Langer. Please disclose the nature of all material relationships Mr. Langer has had with Langer, Inc. and tell us why you have not disclosed the agreement, as amended, in the Certain Relationships and Related Party Transactions section of the prospectus.

Manufacturing and Sourcing - Page 51 43. Please consider adding disclosure in the Risk Factors section of the prospectus describing the risks associated with obtaining PPT from a single supplier.

Competition - Pages 51 to 52 44. If known or reasonably available, please also provide your competitive position relative to your competitors.

Patents and Trademarks - Page 52 45. Please discuss the duration, importance and effect of all material patents, trademarks and licenses held. Please refer to Item 101(c)(1)(iv) of Regulation S-K. Properties - Page 52 46. We note your disclosure that the lease for the Dear Park, NY facilities expires in July 2005. Do you plan to renew this lease, and if so, do you anticipate any material cost increases?

Government Regulation - Pages 53 to 59

Medical Device Regulation - Pages 53 to 55 47. If any of your products have been subject to a recall by international

Show Raw Text
<DOCUMENT>
<TYPE>LETTER
<SEQUENCE>1
<FILENAME>filename1.txt
<TEXT>

December 23, 2004

Andrew H. Meyers
Chief Financial Officer
Langer, Inc.
450 Commack Road
Dear Park, NY 11729-4510

Re:	Langer, Inc.
      Registration Statement on Form S-1 filed November 23, 2004
	File No. 333-120718

Dear Mr. Mayers:

      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.

Form S-1

Prospectus Summary - Pages 1 to 4
1. The disclosure in the Summary should be a balanced presentation
of
your business.  Please balance the disclosure of your strengths
with
a brief discussion of the principal challenges or risks associated
with your company, many of which are identified in your Risk
Factors
section.
2. Please provide copies of the industry reports cited throughout
the
registration statement, clearly marking the relevant sections.
For
example, you cite unnamed "independent research" projections on
pages
2 and 47.

3. Please provide supplemental support for your stated belief that
your brand names "represent a high level of quality in the markets
in
which [you] sell."
4. Please disclose, or estimate if not currently known, the
transaction costs associated with the Silipos acquisition.
Additionally, please describe and quantify the working capital
adjustments to the Silipos acquisition price.

Risk Factors - Pages 8 to 18

      There are significant risks associated with our strategy....
-
Page 9
5. Please expand your disclosure to address the risk of dilution
to
new investors associated with your use of stock to finance future
acquisitions.

      We may face difficulties integrating the operations of
Silipos
- Page 10
6. Please describe the "various risks" specifically associated
with
your integration of Silipos` operations.  Additionally, please
tell
us whether you have experienced any such material integration
delays
or unexpected costs that have resulted in or are expected to
result
in a materially adverse impact to your business and operations.

We may be adversely affected by legal actions or proceedings
commenced against us. - Page 10
7. Please tell us the basis for your belief that Poly-Gel may
raise
such claims or bring legal action against you.  If you are
currently
aware of Poly-Gel`s intention to pursue such claims against you,
please disclose this fact.  This risk factor`s heading, and
disclosure on page 40, suggest that Poly-Gel has already commenced
an
action or proceeding.  If this is in fact the case, please revise
and
add appropriate disclosure here and in the Legal Proceedings
section
of the prospectus.

Our existing purchase arrangements may be adversely affected ....
-
Page 10
8. Please describe this risk in more concrete terms by disclosing
the
circumstances under which third-party manufacturers can alter the
terms of or be released from your supply agreements.
Additionally,
please tell us whether any of these agreements, alone or in the
aggregate, are material and file all material supply agreements as
exhibits.  Also, with a view towards disclosure, please tell us
the
time you would need to replace any key supplier.
9. For the two most recently completed fiscal years, and in the
nine
months ended September 30, 2004, disclose whether you experienced
any
such interruptions or delays that resulted in a materially adverse
impact to your business and operations, and if so, how the matter
was
resolved.

We may not be successful in manufacturing the raw material oil
based
gels.... - Page 11
10. Disclose why you did not renew Silipos` supply agreement with
Poly-Gel and opted to begin manufacturing gels on your own.

The nature of our business could subject us to potential product
liability...claims.  Page 11
11. Please tell us how you determined that your current insurance
coverage is adequate and reconcile this statement with your
disclosure on page 12 that your existing coverage "may be
inadequate
to protect [you]" from liabilities you may incur.
12. Additionally, please disclose whether, in the two most
recently
completed fiscal years, and in the nine months ended September 30,
2004, you experienced any such product liability claims that
resulted
in a materially adverse impact to your business and operations.

Changes in government and other third-party payor reimbursement
levels.... - Page 12
13. Please quantify the portion of your historical revenues
comprised
of Medicare and Medicaid payments.

Our products may be subject to product recalls.... - Page 14
14. Please describe any past mandatory or voluntary recalls that
have
had a material adverse effect on your business.

Our business, operating results and financial condition could be
adversely affected if we become involved in litigation regarding
our
... intellectual property rights - Page 14
15. Please disclose whether you are currently aware of any parties
currently intending to pursue such intellectual property claims
against you.

A portion of our revenues and expenditures is subject to exchange
rate fluctuations that could adversely affect our reported results
of
operations.  - Page 16
16. Please demonstrate this risk by quantifying any material
reductions in sales and profitability recently experienced due to
foreign currency fluctuations.

Our quarterly results are subject to fluctuations. - Page 16
17. Please briefly explain why orthotic device sales have
historically been higher in North America in the warmer months and
why you may expect this trend to continue in the future.

One stockholder has the ability to significantly influence .... -
Page 17
18. Please expand your disclosure to include the fact that 3 of
your
current 6 directors are affiliated with your largest shareholder,
and
that the entire board was designated in 2001 by the investor group
led by your largest shareholder.  Also tell us whether you
currently
have any procedures in place for resolving actual or perceived
conflicts of interest between your principal shareholders and your
other shareholders.
19. Additionally, please disclose the voting agreement between
Langer
Partners and Oracle, and include in your disclosure the percentage
of
your common stock beneficially owned by Oracle prior and
subsequent
to this offering.

The price of our common stock has been and is expected to continue
to
be volatile, which could affect a stockholder`s return on
investment.
- Page 17
20. Please discuss, under separate heading, the risks associated
with
the thin trading level of your stock and the relatively low public
float.
We have a significant amount of convertible indebtedness.... -
Page
17
21. Please quantify the dilution effect to new shareholders of
conversion of the subordinated notes.

Our certificate of incorporation, our bylaws and Delaware law....
-
Page 18
22. Please define "interested shareholder" pursuant to Delaware
General Corporation Law.

New investors in our common stock will experience immediate and
substantial dilution. -
Page 18
23. Please include the dilution effects of the conversion of the
subordinated notes.

Use of Proceeds - Page 20
24. Please revise your disclosure to more specifically identify
the
purposes for which the balance of the net proceeds not being used
to
repay indebtedness is expected to be used and quantify the amount
intended to be allocated to each purpose; it is not appropriate
nor
helpful disclosure to investors to aggregate those purposes under
a
generic category such as " other general corporate purposes."
Alternatively, please discuss the principal reasons for conducting
your offering at this time.
25. Your capitalization table on page 22 appears to indicate that
a
portion of the proceeds will be used to pay the $2.5 million
obligation under the Silipos, Inc. purchase agreement.  Please
supplementally clarify our understanding of your use of proceeds
and
revise the filing on this page, page 22 or elsewhere, if
necessary,
based on our concerns.

Capitalization - Page 22
26. Please remove the cash and cash equivalent caption from this
table.

Unaudited Pro Forma Condensed Consolidated Financial Statements -
Pages 26-30
27. Tell us why you did not include pro forma adjustments to
reflect
charges that would have been incurred had the employment agreement
with W. Gray Hudkins been entered into at the beginning of the
periods presented.  Does Article 11-02(b)(6) of Regulation S-X
require you to include adjustments for the referenced agreement?
Revise the filing to include any required additional pro forma
adjustments.

Dilution - Page 24
28. Please expand your disclosure to include the further dilution
to
new investors assuming the exercise of outstanding options and
warrants and the conversion of convertible debt.  Please also
disclose the dilution effects of the exercise of the over-
allotment
option.

Management`s Discussion & Analysis - Pages 31 to 45

General
29. When a description of known material trends, events, demands
and
commitments is set forth, expand your discussion to include both
the
intermediate effects of those matters and the reasons underlying
those intermediate effects.  For example:  how did you lower your
labor costs and manufacturing overhead and is the resulting
increase
in gross profit margins sustainable; how were 2003 custom
orthotics
sales increased in the U.K.; what factors were responsible for the
increased U.K. labor costs; what material efficiencies were
realized
through the integration of Benefoot and the leverage of your
infrastructure and are such efficiencies sustainable; what factors
were responsible for the increase in 2002 sales volume?  Please
apply
this comment throughout your MD&A.  Please refer to SEC Release
No.
33-8350 for additional guidance.
30. Please describe in greater detail the measures taken to
strengthen your infrastructure.  We note this disclosure in
several
places within MD&A.
Results of Operations - Pages 34 to 38
31. We note that you have provided explanations by segment of your
net sales variances for all periods presented.  Please revise your
analysis of cost of sales (and gross profit) and other charges, if
applicable, to also discuss variances by segment for all periods
presented in accordance with Item 303(a) of Regulation S-K.
32. Revise your results of operations discussion for all periods
presented to be more specific about the reasons for changes in
your
financial statement line items and to quantify the reasons for the
changes, whenever possible.  Please describe and quantify costs
where
you have used phrases such as "increases in certain product
costs",
"an increase in sales volume", or "due to a change in product
mix".
How much were the increases or decreases?  Which products were
affected, specifically?  Quantify the portion of changes in
financial
statement line items related to the acquisitions of Benefoot and
Bi-
Op, so that it is apparent to the reader how those acquisitions
have
affected results of operations for the periods presented.

	Nine Months Ended September 30, 2003 and 2004 - Pages 35 to
36
33. We note your disclosure on page 35 that the podiatric customer
base for your custom foot orthotics, which comprises a large part
of
your custom orthotics business, is a mature segment.  Please
describe
how this fact effects your revenues, business and results of
operations.
	Liquidity and Capital Resources - Pages 39 to 42
34. Revise your operating cash flows discussion for all periods to
focus on cash payments or collections, rather than merely stating
changes in balance sheet accounts, and quantify amounts if
possible.
For example, instead of "...offset by increased accounts
receivable
levels", disclose specific reasons for the changes.  Also, discuss
the reasons for material changes in your current asset, liability
and
other asset accounts between the presented balance sheet dates.

	Contractual Obligations - Page 40
35. We note your disclosure of the Put Option to purchase Poly-
Gel`s
assets or shares at a purchase price of 1.5 times Poly-Gel`s
revenues
over the 12 month period prior to the exercise of the Put Option.
Please quantify this obligation based on Poly-Gel`s prior 12 month
revenue as of the most recent practical date here and in the "Use
of
Proceeds" section.
36. Additionally, please explain more clearly and in greater
detail
the Poly-Gen put option and the $1-1.5 million obligation that
depends on whether Poly-Gel asserts certain claims.  Are these
potential "claims" the same potential Poly-Gel legal action and
proceedings discussed in the Risk Factors section?  If so, please
tell us how you have determined your liability pursuant to
potential
claims that Poly-Gel has yet to make.
Capital Resources - Page 42
37. Please also discuss your ability to meet your cash obligations
for at least the next 12 months without the proceeds of this
offering.

      Quarterly Results of Operations (unaudited) - Page 43
38. Please revise this section to include all the quarterly data
required (the two most recent fiscal years and any subsequent
interim
period for which financial statements are included) by Item 302
(a)(1) of Regulation S-K.

Business - Pages 46 to 59

	Acquisition History - Page 46
39. Explain in more detail the February 2001 acquisition,
including
the consideration paid and the equity interests and other benefits
received in return.  Disclose amounts on an aggregate and per-
share
basis.
40. We note your disclosure that you are obligated to pay "up to"
$2.5 million under the Silipos purchase agreement.  However,
disclosure on page 40 suggests that your obligation pursuant to
this
agreement could exceed $2.5 million if the Put Option is exercised
and depending on the amount of liabilities and damages incurred by
you and SSL.  Please revise or advise.
41. Please briefly describe the liabilities assumed in the
Benefoot
acquisition.
42. Additionally, we note on pages F-15 and F-38 that, in
connection
with the Benefoot acquisition, the Company also entered into a
medical consulting agreement with Sheldon Langer.  Please disclose
the nature of all material relationships Mr. Langer has had with
Langer, Inc. and tell us why you have not disclosed the agreement,
as
amended, in the Certain Relationships and Related Party
Transactions
section of the prospectus.

Manufacturing and Sourcing - Page 51
43. Please consider adding disclosure in the Risk Factors section
of
the prospectus describing the risks associated with obtaining PPT
from a single supplier.

Competition - Pages 51 to 52
44. If known or reasonably available, please also provide your
competitive position relative to your competitors.

Patents and Trademarks - Page 52
45. Please discuss the duration, importance and effect of all
material patents, trademarks and licenses held.  Please refer to
Item
101(c)(1)(iv) of Regulation S-K.
Properties - Page 52
46. We note your disclosure that the lease for the Dear Park, NY
facilities expires in July 2005.  Do you plan to renew this lease,
and if so, do you anticipate any material cost increases?

Government Regulation - Pages 53 to 59

Medical Device Regulation - Pages 53 to 55
47. If any of your products have been subject to a recall by
international