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SEC Company Response from OccuLogix, Inc. (CIK 0001299139) — Oct 7, 2004

OccuLogix, Inc. (CIK 0001299139)
Date: Oct. 7, 2004 · CIK: 0001299139 · Accession: 0000909567-04-001376

AI Filing Summary & Sentiment

File numbers found in text: 333-118204

Date
October 7, 2004
Author
Not clearly detected
Form
CORRESP
Company
OccuLogix, Inc. (CIK 0001299139)

Letter

RE: OCCULOGIX, INC. REGISTRATION STATEMENT ON FORM S-1 COMMISSION FILE NO. 333-118204 FILED ON AUGUST 13, 2004

<PAGE> TORYS LLP NEW YORK TORONTO Suite 3000 79 Wellington St. W. Box 270, TD Centre Andrew Beck Toronto, Ontario Direct Tel. 212.880.6010 M5K 1N2 Canada abeck@torys.com

TEL 416.865.0040 FAX 416.865.7380

www.torys.com

October 7, 2004

Securities and Exchange Commission 450 Fifth Street, NW Washington, DC 20549

Attention: Ms. Peggy Fisher

On behalf of our client, OccuLogix, Inc. (the "Company"), we transmit for your review Amendment No. 1 to the Registration Statement on Form S-1 (the "Amended Form S-1") of the Company, which amends the Registration Statement on Form S-1 (File No. 333-118204) (the "Form S-1") of the Company filed on August 13, 2004.

The Amended Form S-1 reflects changes made in response to the comment letter received from the Staff of the Securities and Exchange Commission (the "Commission"), dated September 13, 2004 (the "Comment Letter"). The page numbers referenced in the responses included in this letter refer to the enclosed marked EDGAR submission of the Amended Form S-1. This letter provides responses and supplemental information in response to the comments of the Staff and is keyed to the headings and comment numbers contained in the Comment Letter.

GENERAL

1. PLEASE CONFIRM THAT ANY PRELIMINARY PROSPECTUS YOU CIRCULATE WILL INCLUDE ALL NON-RULE 430A INFORMATION. THIS INCLUDES THE PRICE RANGE AND RELATED INFORMATION BASED ON A BONA FIDE ESTIMATE OF THE PUBLIC OFFERING WITHIN THAT RANGE. ALSO NOTE THAT WE MAY HAVE ADDITIONAL COMMENTS AFTER YOU INCLUDE THIS INFORMATION.

The Company confirms that any preliminary prospectus that is circulated to potential purchasers will include all non-Rule 430A information. The Company notes the Staff's comment that it may have additional comments after it has included this information.

<PAGE> - 2 -

2. PLEASE FILL IN THE BLANKS IN YOUR DOCUMENTS SO THAT WE MAY CONTINUE OUR REVIEW.

In response to the Staff's comment, the Company has completed as many blanks in the Amended Form S-1 as is possible at this time. As indicated in the response to the Staff's comment number 1, the Company will complete all non-Rule 430A information in the version of the preliminary prospectus that will be circulated to potential purchasers.

3. IF YOU INTEND TO INCLUDE ANY GRAPHICS IN THE PROSPECTUS, PLEASE SUBMIT THEM FOR OUR REVIEW.

The Company notes the Staff's comment and will be submitting the graphics it proposes to include in the prospectus shortly for the Staff's review, and in any event prior to the insertion of the graphics in the preliminary prospectus that will be circulated to potential purchasers.

4. PLEASE MINIMIZE THE USE OF TECHNICAL MEDICAL TERMINOLOGY OR OTHER WORDS OR PHRASES THAT MAY BE UNFAMILIAR TO THE AVERAGE INVESTOR IN THE SUMMARY AND RISK FACTORS SECTION. SEE UPDATED STAFF LEGAL BULLETIN NO. 7 (CF). IN ADDITION, IF YOU INCLUDE TECHNICAL TERMS IN THE BODY OF YOUR PROSPECTUS, PLEASE

<PAGE> - 3 -

CONCISELY EXPLAIN THESE TERMS WHERE YOU FIRST USE THEM IN DISCUSSION. FOR EXAMPLE, WE NOTE TERMS SUCH AS RHEOPHERESIS, APHERESIS, BCVA, FRCSC, MORPHOMETRY, AND ELECTROPHYSIOLOGICAL FUNCTION.

In response to the Staff's comment, the Company has revised the disclosure throughout the Amended Form S-1.

5. PLEASE PROVIDE AN OBJECTIVE SUPPORT FOR THE FOLLOWING STATEMENTS:

o OUR RHEO SYSTEM IS THE ONLY DRY AMD TREATMENT TO TARGET WHAT WE BELIEVE TO BE THE UNDERLYING CAUSE OF AMD RATHER THAN ITS SYMPTOMS (PAGES 1 AND 38); AND

o RHEO THERAPY IS CURRENTLY THE ONLY DRY AMD THERAPY THAT... APPEARS TO IMPROVE VISION IN SOME PATIENTS (PAGE 2).

In response the Staff's comment, the Company has supplementally provided copies of the articles, Influence of Membrane Differential Filtration of the Natural Course of Age-Related Macular Degeneration and the Annual Meeting of the German Society for Clinical Microcirculation and Hemorheology (attached as

<PAGE> - 4 -

Appendix A) written by Dr. Richard Brunner and published in peer-reviewed scientific journals, which objectively support the statements noted above.

6. WE NOTE THE STATISTICS YOU ATTRIBUTE TO VARIOUS THIRD PARTIES THROUGHOUT THE PROSPECTUS INCLUDING, AMONG OTHERS, THE FOLLOWING:

o DRY AMD AFFLICTS APPROXIMATELY 13.0 TO 13.5 MILLION PEOPLE IN THE UNITED STATES, REPRESENTING APPROXIMATELY 85% TO 90% OF ALL AMD CASES (PAGES 1, 38, AND 40);

o APPROXIMATELY 15 MILLION PEOPLE IN THE UNITED STATES SUFFER FROM AMD (PAGES 2 AND 39);

o THE CATEGORY 3 AND THE CATEGORY 4 DRY AMD POPULATION... REPRESENTS APPROXIMATELY 54% OF THE TOTAL U.S. DRY AMD PATIENTS, OR CURRENTLY 8 MILLION PEOPLE (PAGE 2);

o THE PREVALENCE OF AMD INCREASES SHARPLY WITH AGE, FROM 18% AMONG PEOPLE 65 TO 74 YEARS OF AGE TO 47% AMONG PEOPLE 85 YEARS AND OLDER (PAGE 39); AND

<PAGE> - 5 -

o THE PREVALENCE OF AMD AMONG A SELECTED SAMPLE OF U.S. RESIDENTS AGED 65 AND OLDER WAS 27% IN 1999 (PAGE 39).

PLEASE SUPPLEMENTALLY PROVIDE US WITH COPIES OF THE MATERIALS THAT SUPPORT THE STATISTICS CITED, CLEARLY MARKING THE RELEVANT SECTIONS. IN ADDITION, PLEASE TELL US WHETHER THOSE THIRD PARTIES HAVE CONSENTED TO YOUR USE OF THEIR DATA AND WHETHER ANY OF THE REPORTS WERE PREPARED SPECIFICALLY FOR YOUR USE.

In response to the Staff's comment, the Company has supplementally provided copies of the materials (attached as Appendix B) to support the statistics cited in the Amended Form S-1.

In addition, the Company advises the Staff that the reports cited are public and therefore the Company believes that no third party consents are required. Furthermore, the Company confirms that no reports were prepared specifically for their use.

<PAGE> - 6 -

7. NEWS ARTICLES REPORT THAT YOUR TREATMENT COULD BE LAUNCHED IN THE SECOND HALF OF 2005. SEE E.G. TLC SUBSIDIARY FILES FOR IPO IN CANADA, THE GLOBE AND MAIL, SEP. 1, 2004, AT B11; TLC SPINOFF FILES FOR SHARE OFFERING, THE GLOBE AND MAIL, AUG. 14, 2004, AT B2. THIS APPEARS TO BE INCONSISTENT WITH THE DISCLOSURE IN THE PROSPECTUS THAT YOU WOULD NOT GENERATE SIGNIFICANT REVENUES UNTIL LATE 2006. PLEASE SUPPLEMENTALLY ADVISE IF YOU OR YOUR AFFILIATES PROVIDED SUCH INFORMATION TO THE MARKET OR MEDIA.

Neither the Company nor its affiliates provided such information to the market or media. The Company believes that the writers of the articles obtained the information contained in the articles by reviewing previously published research reports on the Company's affiliate, TLC Vision Corporation.

PROSPECTUS COVER PAGE

8. DISCLOSE THAT YOUR MAJOR SHAREHOLDER, TLC VISION CORPORATION, CURRENTLY HOLDS 65.8% OF YOUR OUTSTANDING SHARES AND PLANS TO SELL _______ SHARES IN THIS OFFERING.

In response to the Staff's comment, the Company has revised the disclosure on the Prospectus cover page.

<PAGE> - 7 -

9. THE UNDERWRITER SHOULD BE AWARE OF THE STAFF'S LONG-STANDING AND UNCHANGED POSITION THAT THE TERM "SOLE BOOK-RUNNER" SHOULD BE REMOVED FROM THE COVER PAGE. PLEASE COMPLY. YOU MAY, HOWEVER, INCLUDE THIS LANGUAGE ON THE BACK COVER PAGE.

In response to the Staff's comment, the Company has removed the term "Sole Book-Runner" from the Prospectus cover page.

<PAGE> - 8 -

PROSPECTUS SUMMARY - PAGE 1

10. PLEASE PROVIDE INDEPENDENT SUPPORT FOR YOUR BELIEF THAT POOR MICROCIRCULATION AND THE GRADUAL BUILD-UP OF CELLULAR WASTE MATERIAL CONTRIBUTE TO THE DEVELOPMENT OF DRY AMD AND FOR THE EFFICACY OF YOUR PROCESS.

In response to the Staff's comment, the Company has supplementally provided a copy of the interim analysis of the MIRA-1 study (attached as Appendix C), which independently supports the efficacy of Rheophoresis and the Company's belief that poor microcirculation and the gradual build-up of cellular waste material contribute to the development of Dry AMD.

11. CLARIFY THAT TO DATE YOU HAVE RECEIVED RESULTS FOR 36 PATIENTS IN THE MIRA-1 CLINICAL TRIAL, ONE THIRD OF WHICH ARE IN THE PLACEBO GROUP.

In response to the Staff's comment, the Company has revised the disclosure on page 1.

<PAGE> - 9 -

12. QUANTIFY WHAT YOU MEAN BY "WORSE THAN LEGAL DRIVING VISION" AND THE DEGREE TO WHICH VISION IMPROVED IN 58% OF THE PATIENTS. DISCUSS THE EXTENT TO WHICH YOU HAVE ESTABLISHED WHETHER IMPROVEMENTS ARE LONG TERM, AS WELL AS SHORT TERM.

In response to the Staff's comment, the Company has revised the disclosure on page 1.

13. BRIEFLY DESCRIBE THE EXTENT OF THE AFFILIATION OF THE REGISTRANT WITH TLC VISION CORPORATION.

In response to the Staff's comment, the Company has revised the disclosure on page 1.

14. IN THE FOREPART, PLEASE BRIEFLY DESCRIBE THE STATUS OF YOUR PRODUCTS' REGULATORY APPROVAL, AND STATE THAT YOU DO NOT EXPECT TO GENERATE REVENUES IN THE UNITED STATES OR MATERIALLY INCREASE SALES IN CANADA UNTIL LATE 2006, AT THE EARLIEST.

In response to the Staff's comment, the Company has revised the disclosure on pages 1, 2 and 29 to include a description of the status of their products'

<PAGE> - 10 -

regulatory approval and the statement that they do not expect to generate revenues in the United States. The Company advises the Staff that they have not, however, included a statement disclosing that they do not expect to increase sales in Canada until late 2006 at the earliest because they have approval to sell their products in Canada and they expect an increase in sales to occur in the near future. The Company has, in fact, signed an agreement with Rheotherapeutics to purchase approximately 8,000 treatment sets with the option to purchase 2,000 additional treatment sets by 2005 as well as an estimated 20 OctoNova pumps. The Company has revised the disclosure on pages 2 and 40 to disclose this purchase.

15. EXPAND THE SECOND PARAGRAPH ON PAGE 2 TO CLARIFY THE EXTENT TO WHICH THERAPIES FOR WET AMD HAVE RECEIVED FDA APPROVAL.

In response to the Staff's comment, the Company has revised the disclosure on page 2.

16. WE NOTE THE ADVANTAGES OF YOUR RHEO SYSTEM DESCRIBED IN "OUR SOLUTION" SUBSECTION. IN ORDER TO PROVIDE A MORE BALANCED DISCLOSURE, PLEASE IDENTIFY THE DISADVANTAGES OF YOUR SYSTEMS INCLUDING THE POSSIBLE SIDE EFFECTS AND BRIEFLY DISCUSS THE SIGNIFICANT RISKS RELATED TO THE INVESTMENT IN YOUR COMPANY.

<PAGE> - 11 -

In response to the Staff's comment, the Company has revised the disclosure on page 3.

<PAGE> - 12 -

17. YOU INDICATE THAT YOU ARE "CURRENTLY" IDENTIFYING MULTI-FACILITY HEALTH CARE SERVICE PROVIDERS AND ALSO SEEKING TO ESTABLISH MEDICARE REIMBURSEMENT FOR RHEO THERAPY. IN AN APPROPRIATE SECTION, PLEASE DESCRIBE THE STATUS OF ANY CONTACT OR NEGOTIATION. CONSIDERING THE FACT THAT YOU DO NOT HAVE FDA APPROVAL TO COMMERCIALIZE THE PRODUCT AND THAT SALES IN THE US WILL NOT BEGIN UNTIL LATE 2006, PLEASE DESCRIBE HOW MUCH YOU ARE FOCUSING ON SUCH MARKETING ACTIVITIES.

Prior to obtaining FDA approval, the Company is not permitted to market RHEO Therapy to potential patients or service providers. Thus, until FDA approval has been received, as is currently stated in the Form S-1, the Company's marketing activities have been limited to identifying who they will chose to market to upon obtaining FDA approval. In response to the Staff's comments, the Company has revised its disclosure concerning Medicare reimbursement on pages 4 and 46.

18. YOU STATE THAT MIRA-1 FOLLOWS TEN YEARS OF SUCCESSFUL CLINICAL TRIALS AND STUDIES ON RHEOPHERESIS CONDUCTED OUTSIDE UNITED STATES. PLEASE CLARIFY IF YOUR RHEO SYSTEM HAS BEEN PUT IN CLINICAL TRIAL FOR TEN YEARS OUTSIDE THE UNITED STATES. DISCLOSE IF YOUR SYSTEM HAS BEEN APPROVED IN FOREIGN COUNTRIES FOR COMMERCIAL USE.

<PAGE> - 13 -

In response to the Staff's comment, the Company has revised the disclosure on pages 1, 2, 40 and 41.

19. ON PAGE 3, YOU STATE THAT AMA IN JANUARY 2003 ESTABLISHED AN INSURANCE BILLING CODE THAT ACCURATELY CHARACTERIZES THE RHEO THERAPY PROCEDURE AND THAT MEDICARE CURRENTLY COVERS AND PAYS FOR OTHER FDA-LICENSED SERVICES BILLED WITH THIS CODE ONLY WHEN PERFORMED IN A HOSPITAL OUTPATIENT SETTING. PLEASE CLARIFY WHAT PROCEDURES THE NEW INSURANCE BILLING CODE COVERS, AND DISCLOSE IF THERE IS A THERAPY SIMILAR TO RHEO THAT IS CURRENTLY PERFORMED TO OUTPATIENTS. ALSO, SINCE YOU ARE YEARS AWAY FROM FDA APPROVAL, DELETE MULTIPLE DISCUSSIONS ON MEDICAL REIMBURSEMENT. WE NOTE THE BOTTOM OF PAGE 1.

In response to the Staff's comments, the Company has revised its disclosure concerning Medicare reimbursement on pages 4 and 46. The Company supplementally advises that it deleted references in the "Summary - Our Company" and the "Business - Overview" sections.

20. UNDER THE CAPTION "OUR SOLUTION," BRIEFLY DESCRIBE THE PROCESS YOU USE TO FILTER THE BLOOD. ALSO DISCLOSE WHAT CONSTITUTES "AN INITIAL COURSE OF RHEO THERAPY."

<PAGE> - 14 -

In response to the Staff's comment, the Company has revised the disclosure on pages 2 and 3.

21. IN AN APPROPRIATE SECTION, PLEASE DESCRIBE YOUR BUSINESS IN CANADA. DESCRIBE THE STATUS OF REGULATORY APPROVAL BY THE CANADIAN GOVERNMENT, AND DISCLOSE WHETHER THE PRODUCT AND SERVICES ARE COMMERCIALLY PROVIDED TO AMD PATIENTS.

In response to the

Show Raw Text
<DOCUMENT>
<TYPE>CORRESP
<SEQUENCE>1
<FILENAME>filename1.txt
<TEXT>
<PAGE>
TORYS LLP
NEW YORK TORONTO                   Suite 3000
                                   79 Wellington St. W.
                                   Box 270, TD Centre   Andrew Beck
                                   Toronto, Ontario     Direct Tel. 212.880.6010
                                   M5K 1N2 Canada       abeck@torys.com

                                   TEL 416.865.0040
                                   FAX 416.865.7380

                                   www.torys.com

                                   October 7, 2004

Securities and Exchange Commission
450 Fifth Street, NW
Washington, DC 20549

Attention:        Ms. Peggy Fisher

                  RE:  OCCULOGIX, INC. REGISTRATION STATEMENT ON FORM S-1
                       COMMISSION FILE NO. 333-118204 FILED ON AUGUST 13, 2004

                  On behalf of our client, OccuLogix, Inc. (the "Company"), we
transmit for your review Amendment No. 1 to the Registration Statement on Form
S-1 (the "Amended Form S-1") of the Company, which amends the Registration
Statement on Form S-1 (File No. 333-118204) (the "Form S-1") of the Company
filed on August 13, 2004.

                  The Amended Form S-1 reflects changes made in response to the
comment letter received from the Staff of the Securities and Exchange Commission
(the "Commission"), dated September 13, 2004 (the "Comment Letter"). The page
numbers referenced in the responses included in this letter refer to the
enclosed marked EDGAR submission of the Amended Form S-1. This letter provides
responses and supplemental information in response to the comments of the Staff
and is keyed to the headings and comment numbers contained in the Comment
Letter.

GENERAL

     1.   PLEASE CONFIRM THAT ANY PRELIMINARY PROSPECTUS YOU CIRCULATE WILL
          INCLUDE ALL NON-RULE 430A INFORMATION. THIS INCLUDES THE PRICE RANGE
          AND RELATED INFORMATION BASED ON A BONA FIDE ESTIMATE OF THE PUBLIC
          OFFERING WITHIN THAT RANGE. ALSO NOTE THAT WE MAY HAVE ADDITIONAL
          COMMENTS AFTER YOU INCLUDE THIS INFORMATION.

          The Company confirms that any preliminary prospectus that is
          circulated to potential purchasers will include all non-Rule 430A
          information. The Company notes the Staff's comment that it may have
          additional comments after it has included this information.

<PAGE>
                                     - 2 -

     2.   PLEASE FILL IN THE BLANKS IN YOUR DOCUMENTS SO THAT WE MAY CONTINUE
          OUR REVIEW.

          In response to the Staff's comment, the Company has completed as many
          blanks in the Amended Form S-1 as is possible at this time. As
          indicated in the response to the Staff's comment number 1, the Company
          will complete all non-Rule 430A information in the version of the
          preliminary prospectus that will be circulated to potential
          purchasers.

     3.   IF YOU INTEND TO INCLUDE ANY GRAPHICS IN THE PROSPECTUS, PLEASE SUBMIT
          THEM FOR OUR REVIEW.

          The Company notes the Staff's comment and will be submitting the
          graphics it proposes to include in the prospectus shortly for the
          Staff's review, and in any event prior to the insertion of the
          graphics in the preliminary prospectus that will be circulated to
          potential purchasers.

     4.   PLEASE MINIMIZE THE USE OF TECHNICAL MEDICAL TERMINOLOGY OR OTHER
          WORDS OR PHRASES THAT MAY BE UNFAMILIAR TO THE AVERAGE INVESTOR IN THE
          SUMMARY AND RISK FACTORS SECTION. SEE UPDATED STAFF LEGAL BULLETIN NO.
          7 (CF). IN ADDITION, IF YOU INCLUDE TECHNICAL TERMS IN THE BODY OF
          YOUR PROSPECTUS, PLEASE

<PAGE>
                                     - 3 -

          CONCISELY EXPLAIN THESE TERMS WHERE YOU FIRST USE THEM IN DISCUSSION.
          FOR EXAMPLE, WE NOTE TERMS SUCH AS RHEOPHERESIS, APHERESIS, BCVA,
          FRCSC, MORPHOMETRY, AND ELECTROPHYSIOLOGICAL FUNCTION.

          In response to the Staff's comment, the Company has revised the
          disclosure throughout the Amended Form S-1.

     5.   PLEASE PROVIDE AN OBJECTIVE SUPPORT FOR THE FOLLOWING STATEMENTS:

          o    OUR RHEO SYSTEM IS THE ONLY DRY AMD TREATMENT TO TARGET WHAT WE
               BELIEVE TO BE THE UNDERLYING CAUSE OF AMD RATHER THAN ITS
               SYMPTOMS (PAGES 1 AND 38); AND

          o    RHEO THERAPY IS CURRENTLY THE ONLY DRY AMD THERAPY THAT...
               APPEARS TO IMPROVE VISION IN SOME PATIENTS (PAGE 2).

          In response the Staff's comment, the Company has supplementally
          provided copies of the articles, Influence of Membrane Differential
          Filtration of the Natural Course of Age-Related Macular Degeneration
          and the Annual Meeting of the German Society for Clinical
          Microcirculation and Hemorheology (attached as

<PAGE>
                                     - 4 -

          Appendix A) written by Dr. Richard Brunner and published in
          peer-reviewed scientific journals, which objectively support the
          statements noted above.

     6.   WE NOTE THE STATISTICS YOU ATTRIBUTE TO VARIOUS THIRD PARTIES
          THROUGHOUT THE PROSPECTUS INCLUDING, AMONG OTHERS, THE FOLLOWING:

          o    DRY AMD AFFLICTS APPROXIMATELY 13.0 TO 13.5 MILLION PEOPLE IN THE
               UNITED STATES, REPRESENTING APPROXIMATELY 85% TO 90% OF ALL AMD
               CASES (PAGES 1, 38, AND 40);

          o    APPROXIMATELY 15 MILLION PEOPLE IN THE UNITED STATES SUFFER FROM
               AMD (PAGES 2 AND 39);

          o    THE CATEGORY 3 AND THE CATEGORY 4 DRY AMD POPULATION...
               REPRESENTS APPROXIMATELY 54% OF THE TOTAL U.S. DRY AMD PATIENTS,
               OR CURRENTLY 8 MILLION PEOPLE (PAGE 2);

          o    THE PREVALENCE OF AMD INCREASES SHARPLY WITH AGE, FROM 18% AMONG
               PEOPLE 65 TO 74 YEARS OF AGE TO 47% AMONG PEOPLE 85 YEARS AND
               OLDER (PAGE 39); AND

<PAGE>
                                     - 5 -

          o    THE PREVALENCE OF AMD AMONG A SELECTED SAMPLE OF U.S. RESIDENTS
               AGED 65 AND OLDER WAS 27% IN 1999 (PAGE 39).

          PLEASE SUPPLEMENTALLY PROVIDE US WITH COPIES OF THE MATERIALS THAT
          SUPPORT THE STATISTICS CITED, CLEARLY MARKING THE RELEVANT SECTIONS.
          IN ADDITION, PLEASE TELL US WHETHER THOSE THIRD PARTIES HAVE CONSENTED
          TO YOUR USE OF THEIR DATA AND WHETHER ANY OF THE REPORTS WERE PREPARED
          SPECIFICALLY FOR YOUR USE.

          In response to the Staff's comment, the Company has supplementally
          provided copies of the materials (attached as Appendix B) to support
          the statistics cited in the Amended Form S-1.

          In addition, the Company advises the Staff that the reports cited are
          public and therefore the Company believes that no third party consents
          are required. Furthermore, the Company confirms that no reports were
          prepared specifically for their use.

<PAGE>
                                     - 6 -

     7.   NEWS ARTICLES REPORT THAT YOUR TREATMENT COULD BE LAUNCHED IN THE
          SECOND HALF OF 2005. SEE E.G. TLC SUBSIDIARY FILES FOR IPO IN CANADA,
          THE GLOBE AND MAIL, SEP. 1, 2004, AT B11; TLC SPINOFF FILES FOR SHARE
          OFFERING, THE GLOBE AND MAIL, AUG. 14, 2004, AT B2. THIS APPEARS TO BE
          INCONSISTENT WITH THE DISCLOSURE IN THE PROSPECTUS THAT YOU WOULD NOT
          GENERATE SIGNIFICANT REVENUES UNTIL LATE 2006. PLEASE SUPPLEMENTALLY
          ADVISE IF YOU OR YOUR AFFILIATES PROVIDED SUCH INFORMATION TO THE
          MARKET OR MEDIA.

          Neither the Company nor its affiliates provided such information to
          the market or media. The Company believes that the writers of the
          articles obtained the information contained in the articles by
          reviewing previously published research reports on the Company's
          affiliate, TLC Vision Corporation.

PROSPECTUS COVER PAGE

     8.   DISCLOSE THAT YOUR MAJOR SHAREHOLDER, TLC VISION CORPORATION,
          CURRENTLY HOLDS 65.8% OF YOUR OUTSTANDING SHARES AND PLANS TO SELL
          _______ SHARES IN THIS OFFERING.

          In response to the Staff's comment, the Company has revised the
          disclosure on the Prospectus cover page.

<PAGE>
                                     - 7 -

     9.   THE UNDERWRITER SHOULD BE AWARE OF THE STAFF'S LONG-STANDING AND
          UNCHANGED POSITION THAT THE TERM "SOLE BOOK-RUNNER" SHOULD BE REMOVED
          FROM THE COVER PAGE. PLEASE COMPLY. YOU MAY, HOWEVER, INCLUDE THIS
          LANGUAGE ON THE BACK COVER PAGE.

          In response to the Staff's comment, the Company has removed the term
          "Sole Book-Runner" from the Prospectus cover page.

<PAGE>
                                     - 8 -

PROSPECTUS SUMMARY - PAGE 1

     10.  PLEASE PROVIDE INDEPENDENT SUPPORT FOR YOUR BELIEF THAT POOR
          MICROCIRCULATION AND THE GRADUAL BUILD-UP OF CELLULAR WASTE MATERIAL
          CONTRIBUTE TO THE DEVELOPMENT OF DRY AMD AND FOR THE EFFICACY OF YOUR
          PROCESS.

          In response to the Staff's comment, the Company has supplementally
          provided a copy of the interim analysis of the MIRA-1 study (attached
          as Appendix C), which independently supports the efficacy of
          Rheophoresis and the Company's belief that poor microcirculation and
          the gradual build-up of cellular waste material contribute to the
          development of Dry AMD.

     11.  CLARIFY THAT TO DATE YOU HAVE RECEIVED RESULTS FOR 36 PATIENTS IN THE
          MIRA-1 CLINICAL TRIAL, ONE THIRD OF WHICH ARE IN THE PLACEBO GROUP.

          In response to the Staff's comment, the Company has revised the
          disclosure on page 1.

<PAGE>
                                     - 9 -

     12.  QUANTIFY WHAT YOU MEAN BY "WORSE THAN LEGAL DRIVING VISION" AND THE
          DEGREE TO WHICH VISION IMPROVED IN 58% OF THE PATIENTS. DISCUSS THE
          EXTENT TO WHICH YOU HAVE ESTABLISHED WHETHER IMPROVEMENTS ARE LONG
          TERM, AS WELL AS SHORT TERM.

          In response to the Staff's comment, the Company has revised the
          disclosure on page 1.

     13.  BRIEFLY DESCRIBE THE EXTENT OF THE AFFILIATION OF THE REGISTRANT WITH
          TLC VISION CORPORATION.

          In response to the Staff's comment, the Company has revised the
          disclosure on page 1.

     14.  IN THE FOREPART, PLEASE BRIEFLY DESCRIBE THE STATUS OF YOUR PRODUCTS'
          REGULATORY APPROVAL, AND STATE THAT YOU DO NOT EXPECT TO GENERATE
          REVENUES IN THE UNITED STATES OR MATERIALLY INCREASE SALES IN CANADA
          UNTIL LATE 2006, AT THE EARLIEST.

          In response to the Staff's comment, the Company has revised the
          disclosure on pages 1, 2 and 29 to include a description of the status
          of their products'

<PAGE>
                                     - 10 -

          regulatory approval and the statement that they do not expect to
          generate revenues in the United States. The Company advises the Staff
          that they have not, however, included a statement disclosing that they
          do not expect to increase sales in Canada until late 2006 at the
          earliest because they have approval to sell their products in Canada
          and they expect an increase in sales to occur in the near future. The
          Company has, in fact, signed an agreement with Rheotherapeutics to
          purchase approximately 8,000 treatment sets with the option to
          purchase 2,000 additional treatment sets by 2005 as well as an
          estimated 20 OctoNova pumps. The Company has revised the disclosure on
          pages 2 and 40 to disclose this purchase.

     15.  EXPAND THE SECOND PARAGRAPH ON PAGE 2 TO CLARIFY THE EXTENT TO WHICH
          THERAPIES FOR WET AMD HAVE RECEIVED FDA APPROVAL.

          In response to the Staff's comment, the Company has revised the
          disclosure on page 2.

     16.  WE NOTE THE ADVANTAGES OF YOUR RHEO SYSTEM DESCRIBED IN "OUR SOLUTION"
          SUBSECTION. IN ORDER TO PROVIDE A MORE BALANCED DISCLOSURE, PLEASE
          IDENTIFY THE DISADVANTAGES OF YOUR SYSTEMS INCLUDING THE POSSIBLE SIDE
          EFFECTS AND BRIEFLY DISCUSS THE SIGNIFICANT RISKS RELATED TO THE
          INVESTMENT IN YOUR COMPANY.

<PAGE>
                                     - 11 -

          In response to the Staff's comment, the Company has revised the
          disclosure on page 3.

<PAGE>
                                     - 12 -

     17.  YOU INDICATE THAT YOU ARE "CURRENTLY" IDENTIFYING MULTI-FACILITY
          HEALTH CARE SERVICE PROVIDERS AND ALSO SEEKING TO ESTABLISH MEDICARE
          REIMBURSEMENT FOR RHEO THERAPY. IN AN APPROPRIATE SECTION, PLEASE
          DESCRIBE THE STATUS OF ANY CONTACT OR NEGOTIATION. CONSIDERING THE
          FACT THAT YOU DO NOT HAVE FDA APPROVAL TO COMMERCIALIZE THE PRODUCT
          AND THAT SALES IN THE US WILL NOT BEGIN UNTIL LATE 2006, PLEASE
          DESCRIBE HOW MUCH YOU ARE FOCUSING ON SUCH MARKETING ACTIVITIES.

          Prior to obtaining FDA approval, the Company is not permitted to
          market RHEO Therapy to potential patients or service providers. Thus,
          until FDA approval has been received, as is currently stated in the
          Form S-1, the Company's marketing activities have been limited to
          identifying who they will chose to market to upon obtaining FDA
          approval. In response to the Staff's comments, the Company has revised
          its disclosure concerning Medicare reimbursement on pages 4 and 46.

     18.  YOU STATE THAT MIRA-1 FOLLOWS TEN YEARS OF SUCCESSFUL CLINICAL TRIALS
          AND STUDIES ON RHEOPHERESIS CONDUCTED OUTSIDE UNITED STATES. PLEASE
          CLARIFY IF YOUR RHEO SYSTEM HAS BEEN PUT IN CLINICAL TRIAL FOR TEN
          YEARS OUTSIDE THE UNITED STATES. DISCLOSE IF YOUR SYSTEM HAS BEEN
          APPROVED IN FOREIGN COUNTRIES FOR COMMERCIAL USE.

<PAGE>
                                     - 13 -

          In response to the Staff's comment, the Company has revised the
          disclosure on pages 1, 2, 40 and 41.

     19.  ON PAGE 3, YOU STATE THAT AMA IN JANUARY 2003 ESTABLISHED AN INSURANCE
          BILLING CODE THAT ACCURATELY CHARACTERIZES THE RHEO THERAPY PROCEDURE
          AND THAT MEDICARE CURRENTLY COVERS AND PAYS FOR OTHER FDA-LICENSED
          SERVICES BILLED WITH THIS CODE ONLY WHEN PERFORMED IN A HOSPITAL
          OUTPATIENT SETTING. PLEASE CLARIFY WHAT PROCEDURES THE NEW INSURANCE
          BILLING CODE COVERS, AND DISCLOSE IF THERE IS A THERAPY SIMILAR TO
          RHEO THAT IS CURRENTLY PERFORMED TO OUTPATIENTS. ALSO, SINCE YOU ARE
          YEARS AWAY FROM FDA APPROVAL, DELETE MULTIPLE DISCUSSIONS ON MEDICAL
          REIMBURSEMENT. WE NOTE THE BOTTOM OF PAGE 1.

          In response to the Staff's comments, the Company has revised its
          disclosure concerning Medicare reimbursement on pages 4 and 46. The
          Company supplementally advises that it deleted references in the
          "Summary - Our Company" and the "Business - Overview" sections.

     20.  UNDER THE CAPTION "OUR SOLUTION," BRIEFLY DESCRIBE THE PROCESS YOU USE
          TO FILTER THE BLOOD. ALSO DISCLOSE WHAT CONSTITUTES "AN INITIAL COURSE
          OF RHEO THERAPY."

<PAGE>
                                     - 14 -

          In response to the Staff's comment, the Company has revised the
          disclosure on pages 2 and 3.

     21.  IN AN APPROPRIATE SECTION, PLEASE DESCRIBE YOUR BUSINESS IN CANADA.
          DESCRIBE THE STATUS OF REGULATORY APPROVAL BY THE CANADIAN GOVERNMENT,
          AND DISCLOSE WHETHER THE PRODUCT AND SERVICES ARE COMMERCIALLY
          PROVIDED TO AMD PATIENTS.

          In response to the