ophthalmic_international_-diligence_review by xiaopangnv


									Snowdon & Associates Management Consultants

             Ophthalmic International:
          Summary & Diligence Review

                           Prepared by:

                      Dr. Linda Allison, PhD

                     Snowdon & Associates

                         March 30, 2009

               3074 Spencer Place, West Vancouver, BC
                        CANADA V7V 3C9
  Phone: (604) 926-9111   Fax: (604) 926-9101 Cell: (604) 803-2505
Ophthalmic International – Diligence Review
March 30, 2009
Ophthalmic International – Diligence Review
March 30, 2009

                                    Table of Contents

OPHTHALMIC INTERNATIONAL – SUMMARY . . . . . . . . . . . . . . . . 1

 1.1 GLAUCOMA – A MAJOR CAUSE OF VISION LOSS . . . . . . . . . . . . . 2

 1.2 APPROVED TREATMENTS FOR GLAUCOMA . . . . . . . . . . . . . . . . . . 3


 1.4 PNT - MANUFACTURING PROCESS & COSTS . . . . . . . . . . . . . . . . . 7

 1.5 PNT - PATENTS & INTELLECTUAL PROPERTY . . . . . . . . . . . . . . . . . 8

 2.1 MEDICAL DEVICES TO TREAT GLAUCOMA . . . . . . . . . . . . . . . . . . . 9

 2.2 MARKETING STRATEGY & ANTICIPATED SALES . . . . . . . . . . . . . 12

 2.3 REGULATORY APPROVAL OF PNT . . . . . . . . . . . . . . . . . . . . . . . . . 14

 2.4 CLINICAL STUDIES OF PNT TECHNOLOGY . . . . . . . . . . . . . . . . . . 15

 2.5 REIMBURSEMENT FOR PNT TREATMENT. . . . . . . . . . . . . . . . . . . . 16

 2.6 REVENUE PROJECTIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17

SECTION 3: COMPANY INFORMATION . . . . . . . . . . . . . . . . . . . 19
  3.1 CORPORATE STRUCTURE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19

 3.2 MANAGEMENT & ADVISORS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20


Ophthalmic International – Diligence Review
March 30, 2009


APPENDIX 1: Companies with Medical Devices to Treat Glaucoma

APPENDIX 2: Clinical Studies Conducted on PNT

APPENDIX 3: Glossary of Medical Terms & Acronyms

APPENDIX 4: Selected References

APPENDIX 5: CV - Dr. Linda Allison, Snowdon & Associates
Ophthalmic International – Diligence Review
March 30, 2009

 Snowdon & Associates was retained to conduct a diligence review on Ophthalmic
 International, Inc. (“OI” or “the Company”). This report summarizes our review and provides
 an assessment of the market opportunity for its proprietary medical device technology.
 The Company: OI is a subsidiary of CYTTA Corp. (OTC: BB) and has its head office and
 manufacturing facility located in Arizona, US, with a European office in Rome, Italy. The
 Company has developed a proprietary medical device known as PNT (Pneumatic
 Trabeculoplasty) for treating glaucoma and OH (Ocular Hypertension).
 The Technology: PNT uses a plastic suction ring that is placed on the surface of the eye
 and then a controlled vacuum is applied for about 1 minute. This reduces the IOP (Intra-
 Ocular Pressure) caused by glaucoma that damages the retina. PNT treatment takes ~2
 minutes, is repeated every few months and can reduce IOP in ~75% of glaucoma patients.
 Advantages Compared tor Existing Treatments: PNT has demonstrated a benign safety
 profile with minimal side effects. This treatment for glaucoma avoids the side-effects of
 pharmaceutical drugs and the potential risks associated with surgery and/or laser therapy.
 Glaucoma Market Potential: The global glaucoma market is estimated to be in excess of
 US$4 billion and is projected to grow to over US$7 billion by 2009.
 Manufacturing: OI has a facility in Arizona to manufacture the PNT vacuum controllers, and
 to inspect the PNT suction rings that are produced by a FDA approved vendor. OI has
 obtained ISO 13485 certification for production of these medical devices.
 Regulatory Approval: Clinical studies have been conducted in the EU and the PNT
 equipment has obtained a 2a CE mark, which certifies that is has met the EU requirements
 to ensure consumer safety. The CE Mark was also accepted by Health Canada. Approvals
 will be obtained in other countries or regions in the future.
 Marketing & Distribution: OI has marketing and distribution agreements in place with
 distributors in the EU, Turkey, Dominican Republic and China. Agreements with other
 countries are in discussion. The Company intends to market directly in Canada and the US
 once the required approvals and reimbursement codes have been obtained.
 Proprietary Protection: Patents on PNT have been issued in North America, Europe,
 Japan, Australia and China, with additional patents to be filed in the future. PNT appears to
 be the only proven, non-surgical, drug-free treatment for glaucoma.
 Financing: To date, OI has invested nearly US$9 million in R&D, patents, clinical trials,
 regulatory approvals and market development. Its distributors have invested US$6.3 million
 for market development. The Company is now seeking additional financing to support
 expanded international marketing activities and to conduct clinical studies in Canada to
 support reimbursement for this therapy.

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Ophthalmic International – Diligence Review
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    Glaucoma includes a number of eye diseases that damage the optic nerve, resulting in
    gradual loss of vision. Glaucoma is the second most common cause of blindness
    worldwide. Recent medical studies estimate that nearly 70 million people worldwide are
    affected by glaucoma and this is expected to increase to over 80 million by 2020. Almost
    50% of patients with glaucoma are undiagnosed until damage to the eye has already
    occurred, with blurred vision, eye pain, headaches or haloes round lights often being the
    first symptoms. Left untreated, glaucoma can lead to blindness.

  Diagram of the Structure of the Eye (left) and Damage from Glaucoma (Right)

    The medical device technology developed by Ophthalmic International has been shown
    in clinical studies to be effective in treating both Primary Open-Angle Glaucoma (POAG),
    the most common type of glaucoma, and Ocular Hypertension (OH), which is higher
    than normal pressure in the eye and a significant risk factor for developing glaucoma.
    Primary Open-Angle Glaucoma (POAG)
    The most common type of glaucoma is POAG (Primary Open-Angle Glaucoma) in which
    the fluid within the eye, known as “aqueous humour”, does not drain properly through the
    “trabecular meshwork” (see diagram above). Normally the excess fluid drains through
    this tissue to return to the bloodstream. The result is increased internal pressure in the
    eye, known as IOP (Intra-Ocular Pressure). This puts pressure on the inside of the eye
    and gradually damages the optic nerve and gradually causes loss in vision. If left
    untreated, glaucoma can result in complete blindness.

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    POAG accounts for approximately 90% of all glaucoma cases. Since it is symptomless
    in its early stages, up to 40% of useful eyesight can be lost before an individual seeks
    medical treatment. The objective of treating this disorder is to reduce the abnormal
    internal pressure, thereby reducing or halting the damage to the optic nerve.
    In the last few decades, the incidence of glaucoma has been increasing due to a number
    of factors, including:
    o   Changing Demography: Aging is a recognized risk factor for glaucoma and it is
        also more prevalent in persons of African descent. With the world population aging
        and the percentage of people with African descent increasing in both the EU and the
        US, the number of reported cases of glaucoma is increasing.
    o   Obesity & Diabetes: Diabetes is also associated with a higher incidence of
        glaucoma. The increasing obesity rates in both the EU and US is leading to a higher
        prevalence of Type 2 diabetes and, therefore, to an increasing number of persons
        being diagnosed with glaucoma.
    o   Regular Testing: Most ophthalmologists are aware of glaucoma and regularly check
        patients for symptoms. This increases the number of cases of glaucoma that are
        detected and allows treatment to start earlier before major damage occurs.
    o   Low Compliance with Pharmaceutical Therapies: The side-effects from many
        glaucoma medications can be significant and this discourages patients from
        continuing with the drugs, which leads to further damage to the eye.
    All of the above factors have resulted in a growing number of cases of glaucoma and
    emphasize the need for improved treatments that are both effective and well tolerated.
    Ocular Hypertension (OH)
    OH is intraocular pressure higher than normal in the absence of damage to the optic
    nerve or loss of vision. This is the most important risk factor for glaucoma and often the
    first symptom of the disease developing. Once detected, this should be treated to reduce
    the likelihood that it will develop into glaucoma and result in further loss of vision.

    Currently approved treatments for glaucoma include a number of pharmaceutical drugs,
    laser therapies and surgical procedures. Each of these approaches to treating this
    disease has both side-effects and risks:
    o   Pharmaceuticals (usually formulated as eye-drops): Glaucoma is often treated
        initially with medicated eye-drops that lower IOP by increasing the outflow or
        reducing the inflow of fluids in the eye. However, many patients experience
        significant side-effects with these drugs, which results in poor compliance. There are
        a number of categories of glaucoma drugs on the market and others in development,

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March 30, 2009

        but over 50% of glaucoma patients are non-compliant within 6 months of use,
        primarily due to side effects.
    o   Laser Surgery: “Laser Trabeculoplasty” is an established treatment for glaucoma
        that uses a high-energy laser beam to open the clogged drainage canals in the eye,
        thereby allowing the aqueous humour to drain more readily. However, improvements
        in drainage may take a few weeks to become apparent and eventually the intraocular
        pressure will increase again as the drainage channels become blocked again. This
        procedure usually can only be done 2 times in each eye.
    o   Filtering Surgery: This is a surgical technique also known as “Trabulectomy” that
        can is used to create a new opening in the sclera (i.e. the “white” of the eye) by
        removing a small piece of the trabecular network. This permits the aqueous humour
        to drain more normally and thus lowers the eye pressure. This procedure usually
        remains effective for 2-5 years, but complications can occur.
    o   Drainage Implants: Drainage implant surgery installs a shunt or other device in the
        eye to create a new drain for fluids in the trabecular meshwork. There are a number
        of these devices available on the market, but they may cause infection, swelling
        and/or bleeding since a pathway is created from the inside of the eye to the outside.
    Many of the current drugs for glaucoma have low patient compliance due to side-effects,
    while laser and surgical procedures have a relatively high (reported >30%) rate of failure
    or complications. The ideal treatment for glaucoma would be a non-invasive therapy that
    could reduce IOP without the need for either drugs or surgery.
    DILIGENCE COMMENTS: Based on Snowdon’s review of current medical literature on
    glaucoma and available therapies, it is apparent that new and improved treatments for
    glaucoma and ocular hypertension are urgently needed. Many of the current drugs can
    cause side-effects, some severe enough that patients discontinue using their
    pharmaceutical treatments. In addition, current surgical and laser therapies may only be
    effective for a few months or years. Some of these approved treatments cannot be
    repeated more than a few times, if at all.
    Ophthalmic International’s proprietary PNT technology is a simple-to-use, non-invasive
    treatment that has been tested in clinical studies conducted at ophthalmic research
    centres in North American and the EU. The published results from these studies support
    the Company’s claim that PNT can lower the Intra-Ocular Pressure caused by
    glaucoma, although the treatments need to be repeated every few months. Based on
    studies completed to date, the risk profile of PNT appears to be relatively low when
    compared to the existing approved treatments. However, additional independent clinical
    studies will be required to support and strengthen the claims made for PNT in treating
    glaucoma, as well as to verify what side-effects can be anticipated.

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    Ophthalmic International has developed a medical device for treating glaucoma known
    as PNT (Pneumatic Trabeculoplasty). In contrast to Laser Trabeculoplasty, which uses a
    laser to burn small openings in the trabecular network of the eye to allow the aqueous
    fluid to drain more readily, PNT is totally non-invasive and appears to have very few and
    temporary side-effects
    A number of clinical studies have been conducted by the Company or its distributors that
    provide data on the anticipated benefits of PNT. In these studies, PNT demonstrated
    that it can reduce elevated IOP in patients with Primary Open-Angle Glaucoma (POAG)
    or Ocular Hypertension (OH). In both of these disorders, pressure builds up inside the
    eye and this gradually damages the optic nerve, leading to loss of vision, pain and
    eventual blindness.
    Based on a review of available therapies for glaucoma, PNT appears to be the only
    completely non-invasive, non-surgical, non-laser and non-pharmaceutical treatment that
    has been approved for treating these eye disorders. A series of clinical studies have
    been conducted by the Company and independent research groups that have
    demonstrated that PNT is effective in lowering intra-ocular pressure and has a good
    safety profile. PNT provides a new treatment option for patients with POAG and OH,
    without many of the side-effects or risks associated with existing treatments.
    PNT Medical Device

    The PNT equipment is assembled and tested at the Company’s headquarters in
    Fountain Hills, Arizona, with components manufactured by qualified suppliers of medical
    devices. The PNT equipment consists of two components:
    o   Sterile Disposable Suction Rings: These are sterile, disposable rings that are
        gently placed onto the surface of the eye and then connected to the PNT vacuum
        controller. The vacuum pressure reduced the Intra-Ocular Pressure (IOP), thereby
        allowing better drainage of fluids from the eye. The rings are precision manufactured
        and bar-coded to ensure that they can only be used once and are disposed following
    o   Vacuum Controller: This is an electronic device that generates a precisely
        controlled vacuum in the suction rings which are positioned on the surface of the
        eye. This stretches the surface of the eye and increases the outflow of fluids through
        the trabecular network. The vacuum controller requires that the bar code of the rings
        be scanned prior to treatment and will not operate if a previously used bar code is
        used. This ensures that patients are treated with unused, sterilized suction rings.
        This medical device also incorporates various safety features to ensure patient
        safety and precision control over the vacuum pressure and the length of treatment.

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               PNT Vacuum Controller (left) & Disposable Suction Ring (Right)

    PNT Treatment Protocol
    Each PNT treatment session normally includes two applications of the vacuum, with a
    rest period of ~5 minutes between treatments. Following the first PNT treatment session,
    a second treatment is recommended about one week later and then every 3-4 months
    for long-term control of the intraocular pressure. Clinical studies conducted by the
    Company demonstrated that over 75% of diagnosed glaucoma patients responded
    positively to this treatment and returned for follow-up treatments.
    PNT treatment is conducted by ophthalmologists who have been trained in the use of
    this equipment. Clinical studies conducted by OI and independent research studies have
    demonstrated that this treatment is effective at lowering intraocular pressure for a period
    of weeks or months, depending on the patient and the severity of the glaucoma. In
    addition, up to 50% of patients have been able to reduce their use of glaucoma drugs
    following PNT treatments.
    The only side-effect noted in the clinical trials of PNT completed to date is that some
    patients may experience a transient “grey-out” of vision during a treatment session. This
    usually clears up a few minutes after the vacuum pressure is released. Also, some
    patients may experience mild discomfort following the procedure, which usually resolves
    within a few hours.
    DILIGENCE COMMENTS: Based on the published reports of clinical studies conducted
    to date by Ophthalmic International, it appears the side effects from PNT are relatively
    minor when compared to the risks of laser surgery or the side effects of glaucoma drugs.
    However, most of the data on safety and efficacy gathered to date has been obtained in
    studies conducted by the Company or its distributors. The evaluation of clinical trial
    results and the assessment of the potential side effects could be strengthened by
    conducting completely independent studies.

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    The French distributor of PNT has funded an independent clinical study in France at two
    highly respected ophthalmology hospitals for the purpose of obtaining reimbursement
    approval. When the results from this study are available, they could provide additional
    supporting data for the benefits of PNT, as well as identify and quantify any potential
    side effects. The Italian distributor is planning a similar independent clinical study in Italy
    and OI intends to conduct a study in Canada. The data from these studies will be used
    to support reimbursement and to provide further supportive data for the efficacy of PNT.
    The Company also plans to conduct FDA approved clinical trials in the US either after
    securing sufficient financing to support these costs or after appointing a US distributor
    who would conduct these trials. The results from all of these independent studies will be
    an important component in the acceptance of PNT by ophthalmologists for treating both
    Primary Open-Angle Glaucoma and Ocular Hypertension, as well as for securing
    reimbursement approval. Similar studies will need to be conducted in other countries
    where the product will be distributed.

    Ophthalmic International is an ISO 13485 certified medical device manufacturer qualified
    in design, research and product development, as well as assembly and manufacturing.
    ISO (International Organization for Standardization) defines the requirements for a
    comprehensive management system for design and manufacture of medical devices.
    As required under this certification, the Company follows the guidelines of GMP (Good
    Manufacturing Processes) as specified by the FDA (Food & Drug Administration),
    including providing traceability and accountability for all materials, parts and products
    used in the manufacturing of the PNT equipment and rings.
    The Vacuum Controller devices are manufactured, tested and inspected in-house. The
    current manufacturing facility is located in Fountain Hills, Arizona and has the capacity to
    produce up to 350 units each week. Although some of the components are custom
    made, OI has secured backup vendors to ensure that production is not interrupted.
    The Company owns the molds for the vacuum suction rings, which are manufactured at
    an independent certified facility and delivered to OI for final inspection. The production
    equipment is capable of manufacturing up to 200,000 suction rings per day, which are
    then sent to a local clean-room facility that packages and seals them in individual
    pouches with bar code identification.
    OI has indicated that the current costs of manufacturing the vacuum rings and vacuum
    controller provide a profitable return to the Company from sales of these devices to
    distributors. The rings and controllers are currently being sold at approximately US$22
    and US$3,200 respectively, which provides a substantial margin to the Company. The
    Company also believes that the manufacturing costs can likely be reduced further once
    sales volumes increase.

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    DILIGENCE COMMENTS: The Company has secured registration under ISO 13485 to
    manufacture medical devices and it has also implemented GMP (Good Manufacturing
    Procedures) to insure the safety and accountability of the PNT equipment. Compliance
    with ISO 13485 is required prior to receiving an approval from the European regulatory
    agency to market a new medical device. OI has secured the EU approval for marketing
    PNT and this was also accepted by Health Canada. By using an independent, certified
    facility to manufacture the Suction Rings, OI is able to produce these disposable devices
    the required quality standards at a price that provides a good profile margin. The
    Vacuum Controllers are manufactured by the Company, which permits OI to retain
    control over production of this key component. Snowdon has not visited the
    manufacturing facility, but has relied on information provided by OI on the assembly and
    testing procedures for these devices.

    Patents have been issued on the PNT technology in the United States, EU, China, Hong
    Kong, Japan and Mexico. The US patent expires in 2014 and the others in 2017, but OI
    anticipates new patent filings before these dates based on improvements in the device
    technology. All of the existing patents are based on the same claims, which include a
    detailed description of the PNT equipment and its use. A preliminary search of the US
    Patent Office site for other glaucoma device patents identified a number of medical
    devices that could be considered “comparable”. However, there were only two other
    medical devices that claimed to be non-invasive. Both of these technologies use “high
    frequency electronic pulses” and “laser beams”, which present other safety concerns.

    DILIGENCE COMMENTS: Snowdon reviewed the issued OI patent, which provides a
    description of the PNT device and its applications. However, we do not have expertise in
    patent law and cannot comment on the strength of this patent against challenges from
    competitive products nor to identify any weaknesses in the current patent. Since the US
    patent expires in 2014, the Company should be monitoring patents for other glaucoma
    devices on a regular basis and compiling data on potential enhancements or
    modification to the PNT technology in preparation for future patent filings.
    Based on the large international market for glaucoma treatments, OI has the potential to
    market the PNT technology worldwide. The Company already has distributors in regions
    not covered by the current patents (e.g. Turkey and the Dominican Republic) and
    anticipates other distributors in the near future. Therefore, OI should be planning for new
    patent filings on enhancements or revisions to the PNT technology, as well as expanding
    its patent coverage to other parts of the world. It is critical that the Company protects its
    technology in all international markets of interest. These activities should be a high
    priority and the proposed use of funds should include a sufficient allocation for both new
    product developments and associated patenting activities.

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    The total worldwide sales of all categories of products used to diagnose or treat
    glaucoma (i.e. pharmaceuticals, laser therapy, surgery and other devices), was reported
    at US$4.2 billion in 2008, with pharmaceuticals accounting for the majority of these
    revenues. Worldwide sales of medical devices to diagnose and/or treat glaucoma were
    reported at US$362 million in 2007 and are projected to grow to US$470 million by 2012
    (“Comprehensive Report on the Global Glaucoma Device Market.” 2008).
    The market for glaucoma treatments has grown rapidly in the last decade, based on
    both the increasing number of people with glaucoma and the introduction of new
    treatments. The global ophthalmic pharmaceutical market projects a compound annual
    growth rate of greater than 11% between 2008 and 2012, driven primarily by an aging
    population. There are four categories of medical devices for treating glaucoma: Surgical
    Systems and Instruments, Lasers, Single Use Surgical Devices (SUSD), and Glaucoma
    Drainage Devices (GDD).
    The GDD sector is the most rapidly growing sector of the glaucoma device market, with
    sales estimated to reach over US$80 million by 2013. PNT would be included in the
    GDD category. Since PNT is also the only non-invasive device in this category on the
    market, this could provide a very positive differentiation.

                    Global Glaucoma Device Market (2008 - 2013)
           (From “The Comprehensive Report on Glaucoma Device Market”, 2008)

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    The SUSD (Single Use Surgical Devices) category includes stents and implants, but
    these require invasive surgery. The GDD (Glaucoma Drainage Devices) sector is
    projected to increase substantially in the next 5-10 years, based on an aging population
    in the developed world, an increasing number of glaucoma patients in under-developed
    countries and concerns with the side-effects of many glaucoma drugs. The potential
    risks associated with laser treatments and implanted devices further supports PNT as a
    very attractive alternative for glaucoma patients.
    PNT Market Positioning
    Ophthalmic International indicated that it intends to market the PNT technology for two
    major sectors of the glaucoma market:
      1. An alternative to existing surgical treatments, and
      2. An adjunct therapy to glaucoma eye drops.
    The Company believes that PNT could become an adjunct to glaucoma eye drops based
    on studies that showed that PNT has no significant adverse effects. In contrast, most
    other current therapies have both potential side effects and risks. The table below lists
    the most common side-effects associated with glaucoma treatments currently being
    marketed, as well as indicates the current size of the US market for each category.

               Comparison of Current Categories of Glaucoma Therapy
                          (From “Preserving Human Vision”, Solx, 2008)

  Glaucoma Drugs            Laser Surgery   Filtration Surgery           Ocular Implant
  (All Categories)        (Trabeculoplasty) (Trabeculectomy)              (Tube Shunt)

  • Multiple side         • Can only be done a • Multiple medical       • Considered as
    effects.                few times (2 or 3) in check-ups after         procedure of last
                            each eye.             the procedure.          resort.
  • Inconvenient.
                          • ~50% failure rate.   • High rate of         • Complications
  • Less effective over
                                                   complications.         include Infection,
                                                 • Typically              swelling, bleeding
  • Costly ($1-3k/yr).                                                    and loss of vision.
                                                   effective only for
  • Poor compliance.                               2-5 years.

  ~175,000 new             ~260,000 laser         ~106,000 surgical      ~15,000 implant
  patient starts/year      procedures/year        procedures/year        procedures/year

    Ophthalmic International’s PNT treatment for glaucoma could provide the first effective
    therapy that does not have major risks or significant side-effects. This would position the
    Company with the only approved medical device therapy for POAG that is completely
    non-invasive and can be repeated on a regular basis to maintain normal IOP. However,

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    further clinical studies will be needed to support these claims and provide evidence for
    long-term benefits.
    DILIGENCE COMMENTS: Our review of the glaucoma treatment market has confirmed
    that GDD (Glaucoma Drainage Devices) is the product sector with the largest projected
    growth in the next 5 years. Since this is the category in which PNT would be classified, it
    suggests that there could be a substantial marketing opportunity for PNT, since it is
    completely non-invasive. In contrast, the majority of other devices in this category are
    stents or shunts that require a surgical process to install them into the eye.
    Snowdon conducted an on-line search to locate competitive technologies and/or
    methods for treating glaucoma. This analysis identified 25 companies (including OI) with
    devices for treating glaucoma (see Appendix 1). The majority of these were invasive
    drainage devices, surgical devices and laser treatments. Some of these devices require
    a permanent shunt between the interior of the eye and the outside to allow effective
    drainage of aqueous fluid from the interior of the eye. However, this treatment could
    potentially lead to infections of the eye that could further degrade the patient’s vision.
    Laser therapies also carry risks and may not be able to be repeated more than twice.
    Snowdon did not identify any other non-invasive devices for treating intraocular pressure
    in glaucoma, but this does not confirm that there are none on the market or being
    development. OI should continue to monitor the world market for comparable devices. In
    addition, the Company should review the current PNT technology to identify if there are
    any enhancements or new technologies that could justify additional patent filings,
    particularly in those countries where future marketing activities are planned.
    OI and its distributors should continue to conduct clinical studies both to demonstrate the
    benefits of PNT and also to ensure that ophthalmologists are aware its advantages to
    their patients. Although PNT treatment is relatively simple, data on the benefits of this
    treatment and also on any anticipated side-effects should be verified by independent
    ophthalmologists in each country or region where it is being marketed. If possible, these
    studies should be published in international peer-reviewed ophthalmology journals,
    which could further support adoption of this treatment on an international basis.
    The Company indicated that clinical studies are planned in the near future in France,
    Italy and Canada. These studies could provide further supportive data for marketing
    activities (i.e. regulatory and/or reimbursement approvals), as well as published data to
    educate ophthalmologists on this new treatment option. Once the Company has secured
    some additional funding, it should consider funding several independent studies to
    compare the benefits and side-effects of PNT with several other market-leading GDDs to
    obtain unbiased and conclusive data on the benefits of this new technology. These
    publications would communicate the benefits of PNT treatment of glaucoma to the
    medical sector and complement marketing activities.

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    Ophthalmic International plans to markets the PNT equipment in most countries through
    qualified medical distributors, although it is considering marketing the product directly in
    Canada and the US. To date, the Company has appointed distributors for PNT in a
    number of countries in the EU, the Middle East, the Dominican Republic and China.
    Expansion into other countries and regions is anticipated in the near future.
    The current PNT distributors in are listed in the table below, along with the number of
    Vacuum Controller units sold to date. Future expansion into other regions of the world is
    anticipated in the near future, once the required regulatory approvals have been
    obtained in each region and qualified distributors identified.

        Current Distributors of PNT Equipment & Number of Vacuum Units Sold

                                                                  Date of  Units
              Territory                Distributor
                                                                 Agreement Sold
      Canada                  Ophthalmic International               Internal         0

      France                  Laboratories DOLIAGE                  April 2006      34

      Italy                   Go Tech Medical Device                Mar 2008       198
                              Beijing Vision World Trading
      China                                                         Mar 2006          7
      Poland                  Medithermy                            May 2005          4

      Portugal                Izasa, Lda                          In Negotiation    11

      Spain                   Izasa, S.A                          In Negotiation    22

      Germany                 Vision-Consulting                   In Negotiation      4
      Bulgaria, Croatia,
                              IPSAF Ltda (Bulgaria)                 Nov 2007          2
      Greece                  ERGHANI SA                            July 2007         8
      Denmark, Norway,
                              AMWO ApS (Denmark)                  In Negotiation      0
      Sweden, Finland
      Turkey                   Afiyet Medical                       July 2007         0

      Dominican Republic      s3g Investment Ltd. (Dubai)          Feb 2009           2

    Those countries with zero sales numbers in the above table are new distributors that
    have not yet initiated marketing activities and/or are in the process of securing regulatory
    or reimbursement approvals for PNT.

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    To date, OI distributors have purchased a total of 38,000 suction rings and nearly 300
    vacuum controllers. These numbers are anticipated to increase dramatically as
    reimbursement approvals are obtained in each region and more ophthalmologists learn
    about the benefits of using this non-invasive treatment for glaucoma.
    The distributors are medical device companies who are currently marketing other
    products to the ophthalmology market. The Company is currently in discussion with
    other potential distributors and is evaluating the market potential in South America, the
    Middle East, Africa and other parts of Asia. The current priorities are is to obtain
    reimbursement approval for PNT in the EU and in Canada and to identify “Key Opinion
    Leaders” (KOI’s) in the ophthalmology sector to support wider use of PNT treatment for
    glaucoma. These persons will be involved in such tasks as training ophthalmologists on
    PNT, monitoring clinical studies and speaking at conferences.
    Dr. Francesco Aspes has been appointed Head of European Operations for the
    Company. He supports product development, clinical studies and marketing activities in
    the EU and is actively involved in establishing PNT as a standard treatment for
    glaucoma in Italy. Dr. Aspes was formerly Vice President Europe for Novartis and brings
    in-depth experience in marketing and sales of ophthalmic products.
    Over the next several years, OI expects to sign contracts with additional companies.
    Discussions are in progress in South America, the Middle East, Asia and Africa. Already
    existing distributors are expressing interest in expanding into new territories based on
    the global prevalence of glaucoma.
    DILIGENCE COMMENTS: The Italian and French distributors have sold the most PNT
    devices to date as they were the first territories to obtain regulatory approval. All of the
    marketing agreements signed to date are relatively recent, as it requires time for any
    new medical device technology to establish credibility, as well as secure reimbursement
    approvals. The Company anticipates that sales will increased once reimbursement has
    been obtained in each territory and more ophthalmologists are aware of the benefits of
    PNT as an alternative or adjunct to other treatments for glaucoma.
    OI has indicated that it plans to add a number of new distributors for PNT in the next
    several years, which could significantly increase sales revenues. To date, Italy has sold
    the largest number of vacuum control units, but it was also the first territory to secure
    regulatory approval for PNT treatment. Once PNT has secured both regulatory and
    reimbursement approval in multiple countries and ophthalmologists are being educated
    about the benefits of this therapy, sales revenues are likely to grow much more rapidly.
    Securing the required regulatory approvals is essential to permit ophthalmologists to
    adopt this new technology. Once patients can also obtain reimbursement for PNT
    therapy, the sales of these devices is likely to expand even more rapidly.

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     Ophthalmic International has obtained the regulatory approvals required to market the
     PNT device in the EU and has received a 2A CE mark that covers both the automated
     vacuum controller and disposable rings. CE Marking is required for many products sold
     in the EU and certifies that the product has met consumer safety and health
     requirements. This certification allows the Company to promote and market its products
     freely in all EU countries. This certification was also submitted by OI to Health Canada,
     which accepted it for marketing approval of PNT in Canada.
     The Company’s distributors are responsible for monitoring any local or regional
     changes in the regulatory approval process and also to prepare any additional filings
     needed to maintain these approvals. With new distributors being appointed in other
     regions of the world, the Company needs to ensure that it understands the regulatory
     guidelines of each county. Although it could rely on its distributors to handle many of
     these tasks, it is important for Ophthalmic International to maintain close control of
     product regulatory requirements and related tasks.
     This is particularly important now that the Company has distribution agreements for
     other regions of the world (e.g. China, Turkey, Dominican Republic), as any problems
     with regulatory approvals would significantly slow or could potentially prevent securing
     the required approvals for marketing the PNT devices.
     SNOWDON DILIGENCE COMMENTS: As new distributors are added in other parts of
     the world, the Company will need to work closely with them to secure the required
     regulatory approvals in those regions. Some countries will accept regulatory approvals
     from other major agencies. For example, Canada accepts documents from the US FDA
     (Food & Drug Administration) and the European Medicines Agency (EMEA). Other
     countries and regions of the world have different regulatory agencies and regulations,
     which makes this a critical component in the product marketing planning.
     There are many differences between the guidelines and monitoring programs used by
     different regulatory agencies and even within an agency (e.g. the EU has variations in
     medical device regulation in different member states). Ophthalmic International has
     agreed that, once funding has been obtained, it should retain a qualified regulatory
     group with international experience in medical devices to guide the Company in
     obtaining the necessary approvals in all countries, as well as monitoring any changes in
     regulations that could affect the PNT technology. This strategy would ensure that OI
     has qualified regulatory expertise on a worldwide basis and also that the Company and
     its distributors would be advised by the regulatory group of any changes to regulatory
     regulations that affect this category of products.

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     A number of clinical studies have been conducted on PNT that have demonstrated its
     ability to reduce elevated IOP (IntraOcular Pressure) in POAG (Primary Open-Angle
     Glaucoma). To date, studies have been conducted in the US and EU. The following is a
     summary of the key studies completed to date:
      o PNT Device for Treating POAG and Ocular Hypertension (US – Published
        1997): This study was conducted at the Arizona Glaucoma Institute to provide data
        for submission to the FDA (Food & Drug Administration) in the US. The protocol
        was approved by the IRB (Institutional Review Board) of the New York Eye Surgery
        Center. However, the study was discontinued in 1998 at the request of the FDA,
        based on a disagreement regarding the trial protocol. OI intends to conduct a US
        clinical trial in the next several years to secure US marketing approval.
      o PNT – Efficacy Trial (Mexico & US – Published 2004): This study was an analysis
        of patients using PNT in conjunction with other treatments for glaucoma. It included
        a “feasibility study” with 177 patients (conducted at an ophthalmology clinic in
        Guadalajara, Mexico) and an “efficacy study” on 317 patients (conducted at the
        Arizona Glaucoma Institute). The conclusion was that PNT was a safe procedure to
        reduce IOP and it may allow patients to reduce the dosage of other medications.
      o Pilot Study to Evaluate Efficacy and Safety of PNT in Glaucoma and Ocular
        Hypertensives (Italy – Published 2005): This was a pilot study on 37 patients
        conducted in Rome, Italy at two ophthalmic clinics. This study evaluated PNT
        combined with existing glaucoma medications to determine its efficacy and safety in
        lowering IOP. This study showed that PNT was effective, although 34 patients had
        mild side effects that resolved within a few days.
      o Clinical Trial to Evaluate the Effects of PNT in Ocular Hypertension and
        Glaucoma Subjects (Italian University Eye Clinics – Published 2008): This was
        a multicentre clinical study at 4 Italian University ophthalmology clinics that
        assessed the effects of PNT on 64 glaucoma patients. Each patient was treated
        twice, a week apart, and then followed for 6 months. This study confirmed that PNT
        was most effective in the first 3 months, then gradually lost efficacy. Longer-term
        data is needed to define the duration of PNT efficacy, how often to repeat
        treatments and which glaucoma patients would benefit most from PNT.
    Additional clinical studies are being planned in France, Italy and Canada to provide
    further information on the efficacy of the PNT treatment for glaucoma, and to secure
    reimbursement approval. Other clinical studies will be undertaken in the future as
    required to expand marketing into other regions of the world.
    DILIGENCE COMMENTS: The Company has conducted, either on its own or in
    collaboration with distributors, the clinical studies summarized above in order to verify

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    the safety and the efficacy of PNT in treating glaucoma. Unfortunately, the first study
    conducted in the US in the 1990’s was discontinued at the request of the FDA. The
    Company intends to design another US clinic trial in the next several years and to
    support an application to the FDA for approval to market the PNT technology in the US.
    With new distribution agreements being signed in other countries and regions of the
    world, OI will need to provide guidance on the regulatory requirements in each territory.
    It would be prudent for the Company to use a regulatory expert with international
    medical device expertise to assist in this process, so that these critical procedures are
    properly monitored and the clinical studies are conducted according to the current
    guidelines in each region (see related comments in regulatory section above). Although
    the distributors may be responsible for the costs of these studies, it is essential that OI
    manages the process to ensure that all clinical trials are conducted according to the
    current regulatory guidelines in each region so that the results can be used to obtain the
    required approvals to market the PNT technology.

    The Company recognizes that reimbursement for PNT is essential to its commercial
    success since this treatment needs to be repeated on a regular basis. As noted in the
    section above, the distributors in each country or region will need to conduct clinical
    studies in order to collect sufficient information for submission to local health authorities
    to secure reimbursement approval. Without this approval, patients have to pay for all
    costs associated with the PNT treatment.
    The current status of reimbursement for PNT is as follows:
    o   Italy – Reimbursement Granted in Rome Region: Clinical trials have been
        conducted in Italy during the last 5 years and the results were submitted to the
        Ministry of Health. Reimbursement approval has been granted in the Rome area at
        111€ per treatment. National reimbursement will require individual submissions in
        each of Italy’s 24 regions and support from KOLs (“Key Opinion Leaders”) in
        ophthalmology. This reimbursement study is currently in the planning stage.
    o   France – Reimbursement Studies in Process: The French distributor has
        completed 3 years of clinical studies which were submitted to the French Health
        Ministry. One additional study of 200 patients over a 6-month period is required and
        this is scheduled to start in April 2009 at hospitals in Paris and Lyon. This study is
        being designed to provide the information needed for reimbursement in France.
    o   Other EU Countries – Reimbursement Approval Not Secured: Once
        reimbursement has been secured in the Italy and France, then approvals in other EU
        countries should be easier to obtain. However, the EU reimbursement policies can

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        differ between countries and each region will need to assess the local protocols and
        the specific data requirements.
    o   Canada – Reimbursement Studies Not Started: Reimbursement in Canada is
        established at the provincial level. The plan is to conduct a 150 patient 6-month
        clinical trial in each province and use KOLs (“Key Opinion Leaders”) in Canada to
        establish marketing support and reimbursement approval. Since OI already has
        marketing approval from Health Canada, it believes that it may be able to start
        marketing PNT midway through this study. No dates have been provided as yet for
        these studies.
     Additional clinical studies will need to be conducted to secure reimbursement approvals
     in other countries and regions in which PNT will be marketed.
     DILIGENCE COMMENTS: Obtaining reimbursement for medical devices is a key
     component in its financial success. Without reimbursement approval, PNT will not
     secure a large market share, especially compared to alternative therapies that are
     approved for reimbursement. The Company must ensure that all its distributors are
     knowledgeable about the reimbursement process and have sufficient funding to
     conduct these studies. As noted earlier, OI should consider requiring its distributors to
     use the services of a single regulatory group with international experience with medical
     devices. This would ensure that these studies and the submissions are conducted to a
     consistent standard and meets the requirements of each country or region.

     Ophthalmic International prepared the following revenue projections of anticipated sales
     of PNT devices and estimated gross profits.
                      Sales Projections for 5- year Period 2010-2014
                            (Dollar amounts in Thousands of $US)

                     2010           2011           2012          2013              2014

  Countries *           4           11             20              20               20

  % of Market         3%          4.7%            7.4%           11.5%            18.1%

                  $6,605,000    $17,863,000 $38,692,000        $68,840,000 $107,850,000

  Cost of Goods     $680,000     $1,426,000      $3,993,000     $7,654,000     $15,211,000

  Gross Profit    $5,926,000    $16,410,000 $34,699,000        $61,186,000     $92,639,000

 * Number of countries with regulatory approval to market PNT.

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    These projections assume that:
     1. OI appoints distributors and secures the required regulatory approvals in the
        projected number of countries each year,
     2. The distributors are able to secure both regulatory and reimbursement approval for
        PNT treatment, and
    PNT technology is accepted by a sufficient percentage of ophthalmologists in each
    territory to generate the anticipated revenues.
    Ophthalmic International’s revenue projections for 2010-2014 are based on data that
    suggests 2.0-2.5% of the population in the EU and US has glaucoma. However, since
    only 50% of these cases have been diagnosed, the incidence of active glaucoma in
    actually around 1%. The Company discounted these numbers by 40%, since not all
    glaucoma patients will benefit from PNT, and then estimated the percentage of the
    market that might be obtained in each year. Additional countries will be added as
    regulatory and reimbursement approval is received in each region.
    The Company anticipates appointing new distributors in the US, South America, Africa
    and the Asia-Pacific regions during this 5-year time period. However, the projected sales
    and profits will also depend on the Company attracting qualified and aggressive
    distributors to market the product. In addition, the Company’s ability to attract Key
    Opinion Leaders in each region and to secure sufficient funding to support marketing
    activities are both important factors in achieving these projected sales.
    DILIGENCE COMMENTS: As noted earlier in this report, worldwide sales of medical
    devices to diagnose and/or treat glaucoma were reported at US$362 million in 2007 and
    are projected to grow to US$470 million by 2012 (based on data from “The
    Comprehensive Report on Glaucoma Device Market”, 2008). Ophthalmic International
    has projected that it will obtain revenues of ~$39 million in 2012, which equates to ~8%
    of the world market, which is an aggressive objective.
    However, until the PNT has received reimbursement in several EU markets and
    marketing activities are underway in other regions of the world, there is no quantitative
    basis on which to evaluate these projections. If PNT can provide the benefits anticipated
    for glaucoma patients, then it has the potential to capture a significant portion of the
    market for treating this disease. If that occurs, then future sales of the PNT could easily
    attain the revenues projected by the Company.
    In summary, until Ophthalmic International has obtained reimbursement approval for
    PNT in the EU and Canada (which are the first regions targeted), it is impossible to
    predict potential revenues from product sales. However, on the assumption that the
    ophthalmic sector adopts PNT as a key component of glaucoma treatments, especially if
    it replaces a percentage of current pharmaceutical treatment, then revenues could
    increase substantially and the projections provided by the Company might even be low.

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    Ophthalmic International (OI) was founded in 1997 and, until January 2007, was a
    subsidiary of Coronado Industries, Inc., a publicly traded company. In January 2007, OI
    was acquired from Coronado Industries by Richard Smith, OI’s President and majority
    shareholder, and operated as a private company until 2008.
    On December 5, 2008, CYTTA Corp. (OTC:BB) consummated a Share Exchange
    Agreement and Plan of Reorganization and issued 56,000,000 shares of restricted
    commons stock to the shareholders of OI, in exchange for all the issued and outstanding
    common stock of OI. Under the terms of the Agreement, OI is now a subsidiary of
    CYTTA Corp., with all of its existing employees and Board of Directors remaining in
     CYTTA Corp. was incorporated in May 2006 under the laws of the State of Nevada. The
    company was previously located in Vancouver, BC, but following the share exchange, its
    operations are now based in Fountain Hills, Arizona where OI has its manufacturing
    facilities and corporate offices.
    The current management of CYTTA Corp. consists of Richard Smith, who is the sole
    officer and director. At present, he holds the positions of CEO, President, Chief Financial
    Officer, Treasurer, Secretary and Director. Beneficially, he owns approximately 65.8% of
    the common stock in the Company. Currently, there are no employment agreements
    with Mr. Smith, but the Board of Directors has approved an annual salary of $180,000.
    DILIGENCE COMMENTS: Snowdon has reviewed the above transaction and confirmed
    the corporate structure in conversations with Richard Smith. CYTTA provides the
    Company with a public listing, which will assist in raising the funding that is required to
    support the corporate activities as discussed in this report,. In addition, funds will be
    required for other corporate activities, including expansion of marketing, additional
    clinical studies, future enhancements to the PNT technology and potentially other
    The Company recognizes that this public listing will generate additional costs, which
    have been estimated at ~US$70,000 per year for legal and auditing services. OI also
    indicated that it intends to move CYTTA Corp. from the OTC to either the NASDAQ
    small cap or junior New York exchange in the future, once the business plan has been
    implemented and there are sufficient shareholders to meet the exchange requirements.
    Snowdon has assisted other companies on junior US exchanges that used a similar
    strategy, and agrees that this strategy might assist in securing the financing needed to
    attain the Company’s business objectives.

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    The current members of the OI management team are:
    o   Richard Smith, President & Chairman: He has 25 years of experience in
        developing, manufacturing and marketing ophthalmic products, including serving as
        CEO & President of OI since 1994. Prior to founding OI in 1994, he was Vice
        President (1984-1986) and later President (1984-1994) of SCMD (Southern
        California Medical Distributors), a company that developed and marketed ophthalmic
        equipment to treat MKM (Myopic Kerato Milusis). Previously, he was a Director of
        IFORE (International Foundation for Ophthalmic Research & Education).
    o   Jeff Smith, Vice President of Compliance & Regulatory Affairs: He has been
        with the Company for 16 years and has been involved in engineering, manufacturing
        and regulatory approval processes. In his current role, he is responsible for ISO and
        CE compliance, as well as FDA manufacturing compliance.
    o   Dr. Francesco Aspes, Head of European Operations: Dr. Aspes has been Head
        of EU Operations for OI since 2004, including organizing distributors and assisting
        with planning for clinical studies. Prior to joining OI, he was Vice President of
        European Operations for Novartis Ophthalmics (2000-2003), where he managed
        marketing and sales. Before joining Novartis, he was with CIBA Vision (1991-1999),
        IRFA (1989-1991) and Angelini (1983-1989), all companies in the ophthalmic sector.
        Dr. Aspes studied at Harvard Business School and at the University of Rome.
    o   Dr, Leo Bores, Medical Research Director: Dr. Bores is an ophthalmologist who
        has over 20 years experience in clinical, corporate and teaching positions. He has
        been a medical research director at the Company since 1997. Previously he was a
        medical consultant to a number of ophthalmology companies and a visiting professor
        at a number of international ophthalmology research centres.
    o   Dr. John Sharkey, Director: Dr. Sharkey has over 20 years experience in the
        pharmaceutical and medical device industry. Currently he is Vice President,
        Business Development at Sciele Pharma (Atlanta, GA). Previously, he was Director
        of Operations (2003-2004) and then President (2003-2007) of OI. Prior to joining OI,
        he was at Novartis Ophthalmics (1988-2003) and at CIBA-GEIGY (1985-1988).
    The Company indicated that it may add additional management and/or advisors to the
    corporate team following securing financing.
    DILIGENCE COMMENTS: Snowdon has met with Richard Smith and Jeff Smith, as well
    as received background information on the other members of the management team.
    Our opinion is that the management team has substantial experience in the medical
    device sector, specifically with respect to medical devices for treating glaucoma,
    including product development, manufacturing and marketing. We have also evaluated
    the marketing plans of the French and Italian distributor, as well as received information

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    from them on their marketing programs. In addition, we have reviewed the background
    of Dr. Francesco Aspes, Head of European Operations, and recognize that he brings
    significant business expertise in the ophthalmic market based on his prior experience
    working with Novartis Ophthalmics and CIBA Vision. His assistance in both organizing
    distributors and planning clinical trials in the EU provides confidence and credibility to the
    Company’s marketing plans. In summary, Ophthalmic International has built a strong
    management and advisory team that have the experience and expertise to accomplish
    its business objectives.

    Ophthalmic International and its related companies have invested over US$8.8 million in
    research, product development, patents, clinical trials, regulatory approvals and market
    development since the PNT technology was developed in the early 1990’s. In addition,
    the Company indicated that its distributors in the EU have invested an additional US$6.3
    million in market development activities.
    From October 1, 2007 to December 31, 2008, Richard Smith and his family have loaned
    a net total of US$290,110 to the Company, with annual interest at 12% (except for
    $33,000 of credit card loans at an annual interest rate of 31%). Non-affiliated persons
    have loaned the Company $180,000 bearing annual interest at 12%. These loans are
    due on demand or before December 31, 2009.
    The Company is now seeking funding for CYTTA Corp. to support its business activities,
    including manufacturing of the PNT equipment, expanding its distributor network, as well
    as conducting additional clinical studies. This funding will be dependent on market
    conditions, but the Company is confident that its expanding marketing activities will
    demonstrate the safety and effectiveness of PNT for treating glaucoma.
    One of the keys in achieving these financial objectives is the support that OI is receiving
    from leading ophthalmologists, a number of whom are considered “Key Opinion
    Leaders” in their field. The Company future business activities will be focused on
    marketing the PNT devices through established distributors in a number of countries, as
    well as developing and implementing future enhancements to the PNT technology to
    position it as one of the leading therapies for treatment of glaucoma.
    To support these activities, the Company intends to raise up to US$4 million during the
    remainder of 2009. These funds would be used to support the costs of:
     o   Securing EU reimbursement for PNT treatment (US$1 million),
     o   Conducting a Canadian clinical study to secure reimbursement (estimated at US$2
         million), and
     o   Support corporate activities (~US$1 million).

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    Once reimbursement has been established in Italy, France, Germany, China and
    Canada, the Company anticipates that it will be close to profitability. At that time, it
    should be in a position to raise the estimated US$4.5 million required to conduct a US
    clinical trial or to secure a distribution contract for the US which would require the new
    distributor to fund the US clinical trial and secure the regulatory approval.
    In March 2009, the Company announced that its distributors in France and Italy are
    proceeding with the clinical studies required to secure reimbursement for PNT in these
    countries. Reimbursement approval in each region would substantially expand sales of
    PNT devices, since patients would be able to recover some or all the cost of treatment.
    DILIGENCE COMMENTS: The proposed financing plan appears appropriate for the
    proposed activities and appears to be a realistic path to advance the PNT technology to
    the next stage (i.e. secure reimbursement approvals so that distributors can initiate
    intensive marketing programs). Although Snowdon has not received the detailed
    analysis from which the costs of the EU and Canadian reimbursement studies were
    derived, the estimated costs noted above appear realistic. The proposed plan to delay
    the US clinical trial until a later date or until a US distributor is appointed (i.e. a group
    that could support the costs of US regulatory approval), is a realistic strategy, especially
    in the current difficult financial markets.

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    Based on the information provided by the Company and on the independent diligence
    conducted by Snowdon & Associates, Ophthalmic International appears to be an
    attractive investment opportunity based on the following:
    o Large Worldwide Market Opportunity
        Ol has identified a large and growing market in the treatment of glaucoma. This
        critical eye disorder is projected to increase substantially in the next decade, with
        estimates of over 80 million persons being affected by 2020.
    o Novel Technology for Non-invasive Treatment of Glaucoma
        OI has developed PNT (Pneumatic Trabeculoplasty) a patented, non-invasive
        medical device for treating both POAG (Primary Open-Angle Glaucoma) and Ocular
        Hypertension (OH), which account for nearly 90% of the total glaucoma cases.
    o   Simple & Safe Procedure
        PNT uses a disposable, sterile plastic ring placed onto the surface of the eye and
        connected to a vacuum controller. A short duration of vacuum reduces pressure
        within the eye, which is the cause of vision loss. The process is repeated every 3-4
    o Reduce Other Glaucoma Medications
        PNT is an “adjunct therapy” to existing pharmaceutical agents for treating glaucoma.
        Clinical studies have indicated that patients may be able to reduce the amount of
        their medications, primarily eye drops that are being used to control their glaucoma.
    o Low Cost per Procedure
        PNT is an inexpensive procedure compared to existing laser or surgical treatment,
        costing approximately $200 per treatment session and requiring less than 15
        minutes to complete. PNT is normally repeated every 3-4 months to maintain its
    o Product Development Completed
        OI has completed the commercial development of PNT, received certification as an
        ISO 13485 medical manufacturer, and is currently manufacturing the product in its
        facility in Fountain Hills, Arizona.
    o Simplified Manufacturing Process
        The PNT Vacuum Controllers are manufactured, assembled and tested in OI’s
        facility. The Suction Rings are manufactured, sterilized and packaged by a certified
        medical device manufacturer.

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    o Regulatory Approvals Obtained in EU & Canada
        OI has obtained the required regulatory approvals to market PNT in the EU and in
        Canada, based upon results from a series of clinical studies conducted at approved
        ophthalmology research centers. Regulatory approvals in other countries will be
        applied for in the future after completing additional clinical trials.
    o Distributors Appointed in EU
        OI has appointed distributors for the PNT device in 12 countries in the EU, as well as
        in China. The Company intends to market directly in Canada, but plans to appoint
        distributors in other countries and regions in the future.
    o Initial Sales Secured
        OI has received initial revenues from distributors in the EU and China, with
        increasing revenues anticipated in the next few years as the technology becomes
        more widely known and other distributors are appointed.
    o Experienced Management Team
        OI has built a small, but experienced, management team and advisors. The team will
        be expanded in the future as required to support growing sales. In addition, OI
        intends to establish an international group of KOL (“Key Opinion Leaders”)
        ophthalmologists to support worldwide marketing.

    o Company Needs Sufficient Financing for Key Tasks
        OI has prepared a realistic program for initiating a number of key tasks that are
        essential to accelerate PNT sales and expand the marketing opportunities, but the
        Company urgently needs additional funding to proceed with the these activities.
        Without sufficient funding, these programs could be delayed and other treatments
        may enter the market that could reduce the sales of PNT therapy.
    o Regulatory Approvals are Required in Other Countries & Regions
        At present, OI has obtained regulatory approval to market PNT in the EU and, based
        on the EU approval, in Canada. The Company urgently needs to secure regulatory
        approval for PNT in other regions where it has appointed distributors before they can
        market this treatment for glaucoma. Since regulatory guidelines for securing approval
        of a medical treatment differ from country to country, OI should retain a regulatory
        group with worldwide experience in clinical studies and regulatory filings for medical
        devices to assist with this critical task.
    o Distributors Need Reimbursement Approval for PNT Treatment
        In addition to regulatory approval, PNT distributors need to obtain reimbursement
        approval for patient treatments. Without this, PNT is competing with glaucoma drugs
        and other therapies that have this approval and, therefore, are less expensive to the

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        patient. Reimbursement is essential to securing any significant portion of the
        glaucoma treatment market and need to be obtained in each marketing region.
    o Ophthalmic Market Needs to Accept PNT Treatment for Glaucoma
        Even with regulatory and reimbursement approval for PNT, the Company still needs
        to develop an effective marketing plan to encourage ophthalmologists and other
        potential users to use PNT. To achieve this, OI will need to implement an effective
        communications program on the advantages of PNT and retain distributors with
        experience in marketing medical device products to this sector. The marketing
        program must clearly differentiate PNT from other devices used to treat glaucoma
        and demonstrate the benefits of a non-drug therapy.
        OI Needs to Demonstrate that PNT Treatment is Safe & Effective
        OI has conducted a number of clinical studies with PNT which identified some side-
        effects in patients. The Company needs to be able to clearly demonstrate both that
        PNT is effective in controlling glaucoma and that any possible side-effects are both
        minor and very short-term. These other studies also need to confirm that PNT can be
        used repeatedly for a number of years so that ophthalmologists are confident that
        their patients can reply on this therapy. In addition, the Company should consider
        other studies to confirm that PNT combined with selected glaucoma drugs provides
        an improved outcome for patients.
    o New Patent Filings
        The Company has issued patents in the US, EU, China, Hong Kong, Japan and
        Mexico which expire in the next 4-5 years. However, it is establishing distribution
        agreements in countries where no patents have been filed, which leaves the PNT
        technology without adequate protection. Without a strong patent strategy and
        immediate attention on those areas without patent filings, the Company is at risk that
        competitive technologies could be developed and sold in these areas.
    o New Technologies Enter Glaucoma Market with Superior Results
        The glaucoma market is growing, based both on earlier and better diagnosis of this
        disease and also recognition of the large number of glaucoma cases in Africa, Asia
        and less developed countries. At the same time, a number of large pharmaceutical
        and medical device companies are developing new treatments for glaucoma based
        on recent scientific discoveries about the underlying cause of this disease. OI needs
        to implement an ongoing program for improvement to PNT, as well as evaluating
        other technologies and/or disease targets for future products.

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APPENDIX 1: Companies with Medical Devices to Treat Glaucoma

    Glaucoma Medical Device
                                                     Glaucoma Devices & Technology
Advanced Medical Optics, Inc.               Baerveldt Glaucoma Implant: Drainage device with
Santa Ana, CA                               large surface area to provide intermediate IOP control in
www.amo-inc.com                             patients with refractory glaucoma. Manufactured by
INVASIVE                                    Pharmacia Corp.
Aqueous Biomedical Inc. (ABI)               Oculieve: Shunt to control pressure inside by forming
Colorado Springs, CO                        dual filtration channels in the sclera to vent fluid from the
www.acqueousbio.com                         eye. Eliminates some complications experienced by
INVASIVE                                    other drainage devices on the market.
AqueSys, Inc.                               Drainage Shunt: Shunt uses a soluble duct to treat
Duluth, GA                                  glaucoma. Reduces intraocular pressure by creating a
http://www.tif.net/portfolio aquesys.htm    drainage pathway for excess fluid to flow from the
INVASIVE                                    anterior chamber into the sub conjunctiva.
E. Benson Hood Laboratories, Inc.           Krupin Eye Disk: Silastic tube attached to a silicone
Pembroke, MA                                plate. Rather than simply allowing fluid in eye to drain
www.hoodlabs.com                            into the explant plate, as IOP increases, the tube
INVASIVE                                    elastically deforms and permits fluid to enter the explant.
EagleVision, Inc.                           EG209V (valved) and EG365 (non-valved): Glaucoma
Memphis, TN                                 drainage devices with a unique tube shield, smooth
www.eaglevis.com                            edges, cannula and large area for more effective IOP
INVASIVE                                    control.
Ellex Medical Lasers                        Solo: A solid-state laser system for SLT (Selective
Adelaide, Australia (offices in US,         Laser Trabeculoplasty), a non-invasive surgical
Japan and EU)                               approach to managing glaucoma. Ellex develops and
www.ellex.com                               markets leading technologies to ophthalmologists, with
NON-INVASIVE LASER                          focus on lasers and ultrasound products.
Glaukos Corp.                               iStent: Trabecular micro-bypass stent used to reduce
Laguna Hills, CA, USA                       intra-ocular pressure in open-angle glaucoma.
www.glaukos.com                             Associated with the University of California, Irvine.

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GMP Vision Solutions, Inc.             Eyepass Glaucoma Implant: Two flexible silastic tubes
Fort Lauderdale, FL                    joined in a Y configuration; arms of the Y are inserted
www.gmpcompanies.com                   into Schlemm’s canal, and the stem of the Y is inserted
INVASIVE                               into the anterior chamber. Approved, but not being
                                       marketed as it was not as effective as expected.
InnFocus LLC,                          Miami-InnFocus Drainage Implant (MIDI): Drainage
Miami, FL                              shunt made with novel polymer. Less than 1/100th the
www.innovia-llc.com                    size of conventional devices. Easily implanted with less
INVASIVE                               risk.
IOPtima Ltd.                           OT134: Carbon dioxide laser. IOPtima claims that this
Israel                                 device enables an eye surgeon with little expertise to
http://www.bio-                        easily operate on the eyes of a glaucoma patient,
light.co.il/portfolio/?page=4          making the formerly complex operation as simple as
NON-INVASIVE LASER                     going for a cataract operation.
iScience Interventional                iCath Canaloplasty: Minimally-invasive micro-catheter
Menlo Park, CA, USA                    to reduce IOP and lower dependence on medications in
www.iscienceinterventional.com         primary open-angle glaucoma. Revitalizes aqueous
INVASIVE                               outflow.
Lumenis Ltd.                           Selective Laser Trabeculoplasty: Laser therapy shown
Israel                                 to be safe for treating glaucoma by reducing intraocular
www.lumenis.com                        pressure in a single, office procedure. Also proven
NON-INVASIVE LASER                     equivalent to Latanoprost at lowering IOP.
Medical Sensors Technologies, Inc.     Micro Eye Implant: Micro eye implant is coupled with a
(Mesotec)                              handheld device for telemetry and data storage. Enables
Greentree, PA – formerly in Germany    doctors and patients to quickly and accurately measure
www.mesotec.com                        and chart IOP. The Company is anticipating regulatory
INVASIVE                               approval and product launch by 2010.

Medtronic, Inc.                        CellPlant Aqueous Stent: Stent designed to operate
Minneapolis, MN                        like a microscopic piping system to drain excess fluid
www.medtronic.com                      from the eye. Uses a proprietary polymer and creates a
INVASIVE                               permanent opening to improve fluid outflow.
Molteno Ophthalmic Limited             Molteno3: Glaucoma drainage device with larger,
New Zealand                            thinner and more flexible plates fit the curvature of the
www.molteno.com                        eyeball. Implant forms a self-cleaning ‘biological valve’
INVASIVE                               that cannot become blocked by exudate or blood clot.
                                       The first aqueous shunt to gain widespread acceptance.
NeoMedix Inc.                          Trabectome: Device for minimally invasive surgical
Tustin, CA, USA                        treatment of glaucoma that ablates and removes a strip
www.neomedix.net                       of the trabecular network and re-establishes access to
INVASIVE                               the eye’s natural drainage pathway.

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New World Medical, Inc.                Ahmed Glaucoma Valve (AGV): A plate with a
Rancho Cucamonga, CA                   unidirectional valve system to control IOP by draining
www.ahmedvalve.com                     excess fluid out of the eye through a tube. Implanted
INVASIVE                               outside of the eye but covered with skin.
Ophthalmic International               PNT (Pneumatic Trabeculoplasty): Non-surgical
Fountain Hill, AZ                      device used to reduce elevated IOP. Disposable vacuum
www.ophthalmicinternational.com        fixation ring uses vacuum from a computerized vacuum
www.oi-pnt.com                         controller. Restores flow through the tracebular network.
NON-INVASIVE, NON-LASER                The procedure is normally repeated every 3-4 months.
OPKO Health, Inc.                      Aquashunt: Implantable stent designed to address the
Miami, FL                              shortcomings of current glaucoma treatments.
www.opko.com                           In 2008, Opko Health acquired Vidus Ocular, a privately
INVASIVE                               held company developing Aquashunt.
OPTONOL Inc.                           Ex-PRESS™ Mini Glaucoma Shunt: Shunt implanted
Kansas City, KS                        under a scleral flap using simplified surgical procedure.
www.optonol.com                        The shunt reduces IOP by diverting aqueous humor
INVASIVE                               from the anterior chamber to the subconjunctival space
                                       using a unique flow-modulating design.
Refocus Group, Inc.                    PresView Scleral Spacing Procedure (SSP): Includes
Dallas, TX                             a scleral Implant, fixation system and scleratome.
www.refocus-group.com                  Scleral Implant includes 4 tiny plastic segments with
INVASIVE                               locking inserts.
Solx Inc.                              SOLX Gold Shunt: Biocompatible, gold implant that
Waltham, MA, USA                       uses the eyes’ natural pressure differential to reduce
www.solx.com                           IOP by creating a new fluid pathway. Sensor
INVASIVE                               continuously monitors IPO.
STAAR Surgical Company                 AquaFlow Collagen Glaucoma Drainage Device:
Monrovia, CA                           Collagen implant that creates and maintains a channel
www.staar.com                          for excess intraocular fluid to reduce intraocular
INVASIVE                               pressure in the eye.
Tamcenan Corporation                   White Glaucoma Pump-Shunt: Shut includes an inlet
Sioux Falls, SD                        tube with anchoring wings, and a reservoir with valves
(no website)                           that lead to an outlet tube. This differs from other shunts
INVASIVE                               that use a large plate as the reservoir.
Transcend Medical Inc.                 CyPass: Stent-based system to reduce IOP. Miniature
Menlo Park, CA, US                     medical device that can be inserted with a needle in a
www.transcendmedical.com               procedure that only takes 5 to 10 minutes. Spin-off of
INVASIVE                               ForSight Labs, an ophthalmology-focused incubator.

Note: This table should not be considered as comprehensive. Also, some of these companies
may have merged with another company or are no longer in business.

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APPENDIX 2: Clinical Studies Conducted on PNT
Snowdon reviewed a number of clinical studies have been conducted on PNT that
demonstrate its ability to reduce elevated IOP in glaucoma. The following is a summary of
these studies and associated publications.
1. PNT Device for Treating Primary Open-Angle Glaucoma and Ocular Hypertension
   (1997 – Arizona Glaucoma Institute)
   This clinical study was designed to provide information for submission to the FDA (Food &
   Drug Administration) for approval of PNT to treat glaucoma. The protocol had been
   approved by the IRB (Institutional Review Board) of the New York Eye Surgery Center for a
   study of another glaucoma treatment. This study was initiated in 1997 at the Arizona
   Glaucoma Institute, a subsidiary of Coronado Industries. It was discontinued in 1998 at the
   request of the FDA on the basis that the protocol was not approved for a study on PNT.
2. PNT – Efficacy Trial (2003 - Ophthalmology Clinic, Guadalajara, Mexico)
   This study was a retrospective analysis of patients using PNT in combination with current
   glaucoma drugs. This study included a “feasibility study” with 177 patients (conducted at an
   ophthalmology clinic in Guadalajara, Mexico) and an “efficacy study” on 317 patients
   (conducted at the Arizona Glaucoma Institute). The “feasibility” study reported a drop of
   IOP (Intra-Ocular Pressure) of 6.3 mmHg, but the “efficacy study” reported a much lower
   reduction of only 1-2 mmHg. However, it was noted that the patients in the second group
   were already taking glaucoma medications that had partially reduced their IOP. The
   conclusion of this study was that PNT was “a safe procedure that can reduce both IOP and
   concomitant medication requirements.”
   PUBLICATION: PNT: A new Method to Treat Primary Open-angle Glaucoma and Reduce
   the Number of Concomitant Medications (2004). G. Urzúa, L. Bores & J. Livechhi. Annals
   This publication contained the results of the above study. It also noted that Dr. Bores and
   Livechhi have “significant financial interest or other relationships” with Ophthalmic
   International and/or Coronado Industries.

3. Pilot Study to Evaluate Efficacy and Safety of PNT in Glaucoma and Ocular
   Hypertensives (2004 - Ophthalmology Clinics, Rome Italy)
   This was a pilot study on 37 patients with POAG or OH conducted in Rome, Italy at two
   ophthalmic clinics. This study evaluated PNT combined with glaucoma medications to
   determine efficacy and safety in lowering IOP. This study was “intra-patient controlled” (i.e.
   one eye received PNT and the opposite eye was a control) for the first 30 days, then the
   second eye was treated with PNT. The patients were then followed for 120 days. This study
   showed that PNT lowered IOP, but 34 of the patients had mild adverse effects that
   resolved within a few days. However, 9 of the patients were “non-responders”, indicating

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   that a better definition of which patients will respond to PNT is needed, as well as a review
   of potential risk factors.
   PUBLICATION: Pilot Study to Evaluation the Efficacy and Safety of PNT in Glaucoma and
   Ocular Hypertension (2005). .G. Bucci, M. Centofanti, F. Oddone, M. Parravano, C
   Gabrielei, J. Pecori-Giraldi, L. Librando, E. Paone, L. Bores. European Journal of
   This publication contained the results of the above study and also noted that Dr. Bores has
   “significant financial interest or other relationship with Ophthalmic International.”

4. Clinical Trial to Evaluate the Effects of PNT in Ocular Hypertension and Glaucoma
   Subjects (2007 - Italian University Eye Clinics: Chieti, Genova, Milan and Verona).
   This was a prospective, multicentre, open-label clinical trial conducted at 4 Italian University
   ophthalmology clinics with the protocol was approved by the Ethics Committee at each site.
   This study evaluated the effects of PNT in POAG patients and its efficacy. This study was
   initiated because prior studies (see above) indicated an IOP-lowering effect of PNT, but
   efficacy has not been fully demonstrated.
   The protocol was approved by the Ethics Committee at the University Eye Clinics. The
   study included 64 POAG patients, but excluded severe cases. With each patient, the eye
   with more advanced glaucoma received PNT and the other eye was left untreated. No
   changes in the patient’s current medications were allowed. Each patient received 2 PNT
   treatments a week apart, followed by assessments over the next 6 months to determine the
   safety of the procedure. The same investigator saw each patient throughout the study.
   The results indicated that PNT decreases IOP, but it progressively lost efficacy. After 5-6
   months, 50% of the subjects had IOP reduction of less than 10%. Side effects occurred in
   76% of the subjects, but most were minor and resolved within 2 weeks. However, there
   was one case of “blue eye” (i.e. corneal edema) and another of corneal abrasion (i.e.
   scratch or scrape on the cornea).
   Follow-up confirmed that PNT was most effective in the first 3 months and lost efficacy
   thereafter. The conclusion was that PNT reduced IOP more than a placebo, but it was
   inferior to glaucoma medications or laser treatments. A significant IOP decrease was also
   found in the control group, suggesting improved compliance with existing treatments during
   the study. Longer-term data is needed on PNT to define the duration of efficacy, how often
   treatments need to be repeated for stable IOP reduction, and determination of which of
   patient groups would most benefit from this procedure.

   PUBLICATION: The Effect of PNT on Intraocular Pressure: Results of a 6-Month, Open-
   Label, Multicenter Study (2008). P. Fogagnolo et al. EU Journal of Ophthalmology. 2008
   There were no potential conflicts of interest with these researchers.

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    In addition to the above, there are a number of studies on PNT that have been reported at
    conferences or published. The following is a brief summary of three studies:
o   Germany - Effect of PNT on Intraocular Pressure in Patients Suffering from POAG.
    This study was conducted at the Dept. Ophthalmology, Klinkum Karlsruhe, Karlsruhe,
    Germany. They tested 28 patients with POAG and concluded that PNT “seems to be a safe
    and effective treatment to decrease IPO in patients suffering from POAG.”
o   Italy - Efficacy of PNT in Primary Open-Angle Glaucoma and Ocular Hypertension.
    The study was conducted at the Institute of Ophthalmology, University of Catania, Catania,
    Italy. They tested 25 patients with POAG or OH and concluded that PNT “is a safe
    technique allowing a significant IOP reduction and probably an increase of outflow, but
    further studies are needs to identify good responder patients and the efficacy of
o   USA – Use of PNT’s Effectiveness and Mechanism of Action. This study was performed
    at Duke University Eye Clinic on 8 patients with POAG that was uncontrolled by glaucoma
    medication and who were eligible for ALT (Argon Laser Trabeculoplasty). This study was
    unable to detect a clinically significant reduction in IOP using PNT after 3 months, possibly
    due to the small sample size. No safety issues were reported.

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APPENDIX 3: Glossary of Medical Terms & Acronyms

Aqueous Humor: The fluid made in the front part of the eye. It is a clear, watery fluid that
flows between and nourishes the lens and the cornea; it is secreted by the ciliary processes.
CE Certification: CE marking is a mandatory conformity mark on many products on the
market in the EEA (European Economic Area). CE marking does not certify that a product has
met EU consumer safety, health or environmental requirements.
Clinical Study: Another term for Clinical Trial, but also used for research studies that are less
formally structured and may not involve multiple phases.
Clinical Trial: A clinical trial is a research study designed to answer specific questions about
new therapies or new ways of using known treatments. Clinical trials (also called medical
research and research studies) are used to determine whether new drugs or treatments are
both safe and effective.
Control Group: In many clinical trials, one group of patients will be given an experimental
drug or treatment, while the control group is given either a standard treatment for the disease
or a placebo (i.e. inactive treatment).
Cornea: The clear part of the eye located in front of the iris that is part of the eye’s protective
Double-blind Study: A clinical trial in which neither the participating individuals nor the study
staff knows which participants are receiving the experimental procedure and which are
receiving a placebo or another therapy.
Efficacy: The maximum ability of a drug or other treatment to produce a result, regardless of
dosage. A drug passes efficacy trials if it is effective at the dose tested against the illness for
which it will be prescribed.
Feasibility Study: Preliminary studies during drug development that are used to demonstrate
proof of principle.
FDA (Food & Drug Administration): US regulatory agency responsible for ensuring the
safety of all drugs, biologics, vaccines and medical devices. FDA reviews all new drug
applications, implements standards, and regulates the sale of drugs.
Glaucoma: A common eye condition in which the fluid pressure inside the eyes rises because
of slowed fluid drainage from the eye. If untreated, it may damage the optic nerve and other
parts of the eye, causing the loss of vision or even blindness.
GDD (Glaucoma Drainage Devices): Implanted device that creates an alternate pathway in
the eye to drain aqueous fluid from the eye. GDDs are used in the treatment of glaucoma that
is not responding to medications or trabeculectomy operations.

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GMP (Good Manufacturing Processes): Practices followed by the pharmaceutical and
biotech firms to ensure that the products produced meet specific requirements for identity,
strength, quality, and purity. FDA regulates these industries to ensure CGMPs are being
Health Canada: Canadian regulatory agency responsible for the safety of foods and
cosmetics, and the safety and efficacy of medicinal drugs and devices. Health Canada
reviews new drug applications, implements standards, and regulates the sale of drugs.
IOP (Intraocular Pressure): The inner pressure of the eye created by the continual renewal
of fluids within the eye. The intraocular pressure is increased in glaucoma.
IRB (Institutional Review Board): A group of scientists, doctors, clergy, and consumers that
reviews and approves the action plan for every clinical trial. There is an Institutional Review
Board at every health care facility that does clinical research. Institutional Review Boards are
designed to protect the people who take part in a clinical trial, as well as check to see that the
trial is well designed, legal, ethical, does not involve unnecessary risks, and includes
safeguards for patients.
ISO 13485 Certified: I S O ( International Organization for Standardization), located in
Geneva, Switzerland, sets out the requirements for a quality management system that
is oriented towards the design, development, production and installation of medical devices.
Laser Trabeculoplasty (or Laser Surgery): Procedure in which laser treatment attempts to
open the normal drainage channels of the eye so fluid can drain more effectively.
Primary Open Angle Glaucoma (POAG): The most common form of glaucoma that usually
develops slowly as the eye’s drainage canals gradually become clogged. There are no early
warning signs for open angle glaucoma, which is why it is called “the sneak thief of sight.”
Ocular Hypertension (OH): A condition of intraocular pressure that is higher than normal but
that has not resulted in a constricted visual field or increased cupping of the optic nerve head.
This is often associated with glaucoma.
Open Label Clinical Study: A clinical trial in which researchers and participants know which
drug or treatment is being administered.
Optic Nerve: The nerve in the back of the eye that carries visual images to the brain.
Placebo: An inactive substance given to one group of participants in a clinical trial, while the
treatment being tested is given to another group. The results obtained in the two groups are
compared to see if the investigational treatment is more effective than the placebo.
Retina: The part of the eye that carries light and images to the brain through the optic nerve.
Sclera: The tough, white, protective outer covering of the eye.
Side Effects: Any undesired actions or effects of a treatment.

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SUSD (Single Use Surgical Device): Medical device that is used once and then discarded.
Trabecular Meshwork: Small opening around the outer edge of the iris that provide a
pathway for fluid to leave the inside of the eye.
Trabeculectomy (Filtration Surgery): A surgical procedure that removes part of the
trabeculum in the eye to relieve pressure caused by glaucoma. A tiny piece of the eye-ball,
where the cornea connects to the sclera, is removed to create a flap that allows fluid to
escape the anterior chamber without deflating the eye. The area is called the trabeculum.
After the procedure, fluid can flow out onto the eye's surface
Trabeculoplasty (Laser Surgery): A type of laser surgery in which the laser is aimed toward
the normal drainage channels of the eye in an attempt to open those channels so fluid can
leave the eye more efficiently.
SLT (Selective Laser Trabeculoplasty): A type of laser surgery that uses a combination of
frequencies allowing the laser to work at very low levels. It treats specific cells “selectively”
and leaves untreated portions of the trabecular meshwork intact.
Tube Shunt (Ocular Implant): Tube-shunt surgery, or Seton tube shunt glaucoma surgery, is
a surgical method to treat glaucoma. Seton tube implants are also called glaucoma drainage
tubes or implants and is comprised of two parts: Tubing, a portion of which is implanted along
the inside of the front of the eye. The distal (furthest from the center) end of the tubing
protrudes through the anterior (front) or less commonly, the posterior (rear), chamber of the
eye. An attached reservoir, called a plate, is placed under the conjunctiva of the eye at its
equator, or midpoint.

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APPENDIX 4: Selected References
Glaucoma is the Primary Cause of Preventable Blindness. Medical News Today. 2008.
A summary of glaucoma, including its causes, susceptible populations, warning signs,
symptoms and current treatments.

Toward a Better Scientific Understanding of Glaucoma. Glaucoma Research Foundation.
2008. Summary of recent research findings in glaucoma, including molecular changes in the
eye, which could lead to improved treatments.

Glaucoma. Review of Optometry. June 2008. A review of pharmaceuticals used to treat
glaucoma, including a summary of combination therapies and anticipated future products.

Glaucoma Medications and Their Side Effects. Glaucoma Research Foundation. Sept
2008. Overview of eye drops used to treat glaucoma and their side-effects.

Risk Factors for Progression to Blindness in High-tension Primary Open Angle
Glaucoma (POAG): Comparison of Blind & Non-blind Subjects. Clinical Ophthalmology.
2008. This study determined which risk factors were most critical in patients with POAG. A
total of 487 patients with POAG were monitored for over 5 years, with detailed information
collected every 6 months. Results showed that the most critical factor associated with
development of blindness in glaucoma patients was elevated IOP, poor control of IOP, late
detection and non-compliance with therapy.

Global Toll of Glaucoma Set to Reach 80 Million by 2020. British Journal of
Ophthalmology. 2006. The global toll of glaucoma is set to reach 60 million by 2010 and 80
million by 2020, with women and people living in Asia, Africa and India the worst affected.
They noted that “the fact that glaucoma is irreversible, difficult to detect and difficult to treat
means that it is often viewed as a less urgent issued, particularly in developing countries.

More Americans Facing Blindness than Ever Before. National Eye Institute (NEI), part of
National Institutes of Health (NIH). March 2002. Report on leading causes of blindness in the

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US. Currently over 1 million Americans age 40 or older are blind and 2.5 million are visually
impaired. This is expected to double in the next 30 years. The leading causes of blindness in
the US are: Diabetic Retinopathy: 5.3 million, AMD (Age-Related Macular Degeneration: 1.6
million, Cataracts: 20.5 million, Glaucoma: 2.2 million + 2 million more who do not know they
have glaucoma.

The Effect of Pneumatic Trabeculoplasty on Intraocular Pressure: The Results of a Six-
month, Open-label, Multicenter Study. P. Fogagnolo et al. European Journal of
Ophthalmology. 2008
Summary of a clinical study conducted in Italy to evaluate the effects of PNT in glaucoma and
ocular hypertension. The results were that IOP (IntraOcular Pressure) was reduced by ~13%,
which was superior to placebo but less than the reduction from currently used medications or
laser treatment. However, ~80% of the subjects were using other treatments during this study,
so the effect of PNT may have been primarily additive.

Efficacy of Pneumatic Trabeculoplasty in Primary Open Angle Glaucoma. P. Ceruti et al.
Invest. Ophthalmol. Vis. Sci. 2006 (Abstract)
Summary of a study to determine the efficacy and safety of PNT in patients with Primary
Open Angle Glaucoma (POAG)), in combination with existing glaucoma medications. A
second aim of this study was to analyze the ocular anatomical changes due to the treatment,
using ultrasound biomicroscopy, in order to demonstrate the possible mechanisms of the PNT
lowering effect.

Pilot Study to Evaluate Efficacy and Safety of Pneumatic Trabeculoplasty in Glaucoma
and Ocular Hypertension. Greek Glaucoma Meeting. 2006.
Summary of a study to evaluate the effectiveness of PNT in 10 patients with Primary Open
Angle Glaucoma (POAG) or Ocular Hypertension (OH) for whom pharmacological therapy did
not achieve the target pressure. The result was that PNT provided a mean pressure decrease
of 4 mmHg in the treated eye. PNT proved to be a simple, effective and safe technique when
applied to correctly identified patients.

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APPENDIX 5: Dr. Linda Allison, Snowdon & Associates
Dr. Allison has over 25 years experience in biotechnology, pharmaceutical and medical
sectors. In addition to providing consulting services, she has provided senior management
services to a number of companies and worked in corporate finance for two Canadian
brokerage firms, assisting with private and public financings in North America and Europe.
 •   AHFMR (Alberta Heritage Foundation for Medical Research). Alberta (2006-2009)
 •   ALDA Pharmaceuticals: Board of Directors. BC (2002-2009)
 •   Aantara Medical Technologies: CEO. BC (2005-2008)
 •   MDX Medical: President & CEO. BC (2003-2005)
 •   Genesis Bioventures: President & CEO. New York &, BC (2001-2003)
 •   Ondine Biopharma: President, CEO. UK & BC (1998-2001)
 •   Haywood Securities: Corporate Finance. BC (1997-1998)
 •   Canaccord Capital: Corporate Finance. BC, UK & Switzerland (1992-1997)
Snowdon & Associates has provided professional consulting and corporate management
services to asset them to meet their corporate objectives, including:
 • Senior Management Services
 • Business Development & Strategic Planning
 • Preparation of Business Plans &
 • Technology Diligence Reviews & Valuation
 • Financing & Investor Relations
 • Product Development & Commercialization
 • Market Research & Launch Strategies
 • Corporate Communications Planning
Our clients include private and public companies, as well as medical research centers.
Dr. Allison received the following degrees in biotechnology, neurology and biophysics:
 •   PhD., Simon Fraser University (1978),
 •   DIC, Imperial College of Science & Technology, England (1972),
 •   MSc, University of London, England (1972),
 •   BSc, Simon Fraser University, Vancouver, BC (1969)

ADDRESS:      3074 Spencer Place                   PHONE:         (604) 926-9111
              West Vancouver, BC                   FAX:           (604) 926-9101
              Canada V7V 3C9                       E-MAIL:        snowdon@shaw.ca

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