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IOPtima 11. The Company 12. Glaucoma 13. The Technology 14. Background - Current Non-Penetrating Filtration Surgery (Trabeculectomy) 15.

IOPtima’s Approach - CO2 Laser Filtration Surgery 16. Intellectual Property (IP) 17. Regulatory Pathway 18. The Market 19. Business Strategy 20. Development Status 21. Glaucoma Treatments – Comparison 22. Team 23. References The Company IOPtima Ltd. (IOPtima) focuses on the discovery, development and commercialization of its innovative and proprietary technologies for the treatment of Glaucoma – A common eye disease that might lead to loss of sight. IOPtima’s initial focus is on the treatment of glaucoma. Glaucoma is the second leading cause of vision loss in the world – affecting millions. The company has developed an innovative, on penetrating, easy-to-use system, based on CO2 laser technology, for the treatment of glaucoma. IOPtima has completed its pre-clinical trials in animal and cadaver eyes. The trials showed great effectiveness and safety. The company successfully performed 23 human clinical trials. IOPtima believes that its innovative new system will offer significant advantages over traditional therapies for glaucoma, such as simplicity, higher efficacy, lower side effects, lower risks to the patient, and lower costs. Glaucoma Glaucoma is a progressive optic neuropathy (a disease of the optic nerve) characterized by damage to the optic nerve and visual field loss, often leading to blindness. Glaucoma represents a final common pathway resulting from a number of different conditions that can affect the eye; most of them associated with elevated intraocular pressure - IOP. It has been shown that the most effective means of preventing glaucomatous damage is to reduce IOP, even in cases of "normal" tension glaucoma. Therefore, the primary goal of the treatment is to reduce the elevated intraocular pressure by medication, laser therapy, implants, or surgery (Trabeculectomy). Approximately 1%-2% of the world’s population over the age of 40 suffers from glaucoma. Until now, the common treatment has been medication, yet associated with

many side effects and low compliance. Surgical intervention, though a good treatment for reducing intraocular pressure, is performed mainly as a last resort, due to the many complications inherent in the procedure, such as intraocular penetration, hypotony, bleeding, infection, inflammation, etc. Today, about 500,000 surgical procedures are performed annually in the USA. With the introduction of a new and safer surgical technique, that number is expected to increase. In recent years, a new and safer surgical procedure – the non-penetrating trabeculectomy (deep sclerectomy) – has been developed. In this procedure a thin layer of tissue is left behind. The main advantage of this technique, if properly performed, is that almost all complications such as those found with the conventional trabeculectomy are avoided. The main drawback, however, is that it demands careful and delicate surgery, relatively long learning curve, performed only by highly skilled surgeons, this, to avoid penetrating the anterior chamber – the most common complication in this type of surgery. And should this occur, then this non-penetrating procedure, as it were, becomes a conventional penetrating trabeculectomy with all its disadvantages. IOPtima has developed an innovative approach to the non-penetrating trabeculectomy – CO2 Laser Non-Penetrating Deep Sclerectomy ™ (LNPDS™). Based on IOPtima’s unique CO2 Laser Filtration System – OT133™, the nonpenetrating trabeculectomy can be performed easily, safely and successfully – by any eye surgeon. IOPtima expects that with the introduction of the new OT133™ system, the number of surgical procedures is expected to increase dramatically, since it may be used to reduce IOP in earlier stages than when the current surgery is performed. It may also replace some of the drug therapies that have negative side effects, including causing damage to the eye after years of treatment and to become the solution for non-compliant patients. This approach can change the way glaucoma is being treated today. It does not require re-education of the marketplace, but rather comes as a natural response to a longstanding request found on ophthalmologists’ wish-lists, and is expected to be readily embraced by them.

The Technology Background - Current Non-Penetrating Filtration Surgery (Trabeculectomy) Trabeculectomy is the standard filtration surgery for glaucoma. In this operation, a filtering system is created by making a hole in the sclera of the eye, which then drains the

intraocular fluid through superficial ocular tissue. Numerous postoperative complications may occur however, so the non-penetrating filtration procedure is therefore gaining widespread popularity. In this procedure a thin layer of membrane is left behind – allowing for the free fluid percolation, or oozing, through this remaining tissue – producing the desired effect. When done properly, by a highly skilled surgeon, the anterior chamber of the eye is not penetrated, decreasing significantly the incidences of early postoperative complications. The procedure involves dissecting the scleral tissue to approximately 95% (of its depth), leaving a residual intact layer of only several dozen microns. Inadvertent perforation of the thin trabecular membrane is a frequent complication, occurring in as many as 30%-50% of the cases at the beginning of the learning curve. If, on the other hand, the tissue is not cut deep enough, filtration may not be effective enough to reduce intraocular pressure to the desired level. This conventional procedure is very demanding and requires great skill and vast experience. IOPtima’s Approach - CO2 Laser Filtration Surgery IOPtima has developed a dedicated system, the OT133™ comprised of a CO2 laser, scanner and micromanipulator. The system offers the eye surgeon a simple, easy-touse, safe, automatic and self-controlled way of performing non-penetrating filtration surgery. Applying the CO2 laser’s energy to the dry scleral tissue results in localized ablation of the tissue – until a thin wall is achieved, and once enough fluid percolate through the thin wall, the CO2 laser’s energy becomes ineffective and will not cause any further tissue ablation (i.e., perforation is avoided). Thus tissue ablation automatically ceases once the desired physiological result (perculation) is achieved. Those are the unique qualities of the CO2 laser, it is very effective in ablating dry tissue, but its laser energy is absorbed and dissipated when it comes in contact with water. The use of a scanning device and micromanipulator further assists the surgeon to accurately control the shape of the ablation and distribution of energy. Intellectual Property (IP) IOPtima has filed for two broad patent applications covering different aspects of the technology and method. Regulatory Pathway After the company meeting with the FDA, IOPtima expects a 510(K) regulatory

pathway in the US. As reflected in the summary of the meeting and from the FDA response, IOPtima should expect to conduct a relatively small study, which will be compared with historical data and with one-year follow-up. The Market It is estimated that nearly 67 million people worldwide suffer from glaucoma8. Glaucoma is a chronic disease and requires life-long therapy. Medication therapy often fails because of low patient compliance. Early surgical intervention is sometimes more effective than surgery performed after many years of drug therapy. The availability of a safe surgical procedure is expected to increase the number of surgical interventions. Untreated, glaucoma is the second leading cause of vision loss in the world 9. Approximately 1%-2% of the population aged 40-50 and 8% over 70 have elevated intraocular pressure8. As the world’s population becomes older, the number of Americans aged 65 and older grows by 3.3% annually, while those aged 85 and older grows by 6.5% annually. Most glaucoma patients suffer from glaucoma in both eyes, so for practical estimates one should consider the number of eyes to be treated as double those of the number of glaucoma patients. In the United States, glaucoma is the leading cause of blindness8: 100,000 people are totally blind from glaucoma8, approximately 300,000 people are blind in one eye8 and about 2,000,000 more have some degree of visual loss from glaucoma8. It is estimated that up to 3 million Americans, aged 40 and over, have glaucoma9 and 15 million more are at risk for vision loss from glaucoma12. In cases of IOP above 25 mmHg, even without any indication of vision damage, most ophthalmologists will recommend starting treatment to lower IOP. Furthermore, research shows that patients with low-tension glaucoma, who were treated to lower their IOP by 30%, suffered 4 times less than untreated patients from glaucomatous optic disc progression or visual loss11. Today, about 500,000 surgical procedures are performed annually in the USA alone: 125,000 trabeculectomies, 250,000-300,000 trabeculoplasties, and 75,000-125,000 other surgical procedures, representing a total expenditure of approximately $750 million7. Glaucoma accounts for over 7 million doctor-visits each year8 in the USA, and $2-3 billion are spent globally each year on glaucoma medication4. It is accepted that the rest of the world market is 2-3 times that of the US market7. Business Strategy IOPtima’s target markets include hospitals, private ophthalmic surgical centers and outpatient facilities. . The OT133™ device is designated to be used in ophthalmic surgery rooms in both ambulatory centers and hospitals. IOPtima believes that the device will be adopted first by glaucoma surgeons. The high rate of success using the device

together with the relatively high reimbursement rates, the short learning curve of the procedure and the safety of the procedure will encourage the ophthalmic community to adopt the OT133™ system. IOPtima plans to start marketing in Europe, taking advantage of the willingness to adopt new devices. The company plans to sell systems as capital equipment. However, IOPtima believes that a fee-per-procedure payment model may create a very interesting opportunity. IOPtima will also develop a unique disposable eye protector patch, which will be used during the operation and will be specifically designed for it. Development Status Pre-clinical animal trials were successfully performed. Data was recorded as to the number, frequency, and power of the laser applications, the shape of the scanned area, as well as the distance of the laser probe tip from the tissue. In order to determine the IOPtima technical parameters, reproducibility and tissue effects prior to human clinical studies, experiments were conducted on human cadaver eyes at the Center for Research on Ocular Therapeutics and Biodevices, Storm Eye Institute, Charleston, SC, USA (Director David J. Apple, MD) and Sandhurt Eye Centre, Johannesburg, South Africa. IOPtima developed two prototypes, performed 23 human clinical trials and completed successfully its first stage of the clinical study. The surgical goal was achieved in all cases - early effective IOP reduction with no laser related complications. The objectives of the next stage are to evaluate and to achieve intermediate and long-term efficiency. Glaucoma Treatments – Comparison Glaucoma can be treated with medication or other treatments, such as laser or eye surgery, or a combination of methods. The following table summarizes the main advantages of the OT133™ system compared to other known treatments for glaucoma:
Attributes OT133™ System Surgery More than 95% (estimate) Non-Penetrating Trabeculectomy 60%-75%, the rest become trabeculectomies Conventional Trabeculectom y 70% - 90% for at least one year Argon Laser Trabeculopla sty (ALT/SLT) 75% temporary effect Glaucoma Implants

Success

NA

Penetration

NO

Yes/NO (in case of success) NO (if perforates) Yes (if perforates)

Yes

NO

Yes

Safety

Yes

NO

Yes

Yes

Complications

NO

Yes

NO

NO

Simplicity

Yes

NO

NO

Yes

Yes

Medication after surgery

Usually no

Usually no

Usually no

Yes

Usually no

Team Dr. Joshua Degani – CEO Professor Ehud Assia - CSO Dr. Nir Berzak – Project manager Dr. Adi Shargil – CTO Dr. Ami Eyal – Medical Director Richard Naimer – COO Dr. Gal Ehrlich – IP amd Regulation Ronit Gross – Strategy and business development

References 24. Benjamin F. Boyd, M.D. The Role of Non-Penetrating Filtering Operations for Open Angle Glaucoma. Highlights of Ophthalmology. Vol 28 N04, 2000 Series; 24-33. 25. Carlos Argento M.D., Ana C. Sanseau M.D., Daniel Badoza M.D., Javier Casiraghi M.D. Deep scleretomy with a collagen implant using the excimer laser. J Cataract Refract Surg. Vol 27, April 2001; 504-506. 26. David A. Therkelsen, William R. Quirk. Riding the Next Wave: 2001 Refractive Surgery Update and Outlook. Dain Rauscher Wessels, Ophthalmology. May 2001. 27. Theodore J. Huber, Anthony Sterling. Medical Devices-Eyecare Industry Overview, A Renaissance of New Technologies, Equity Research. Bank of America Securities. November 2000. 28. David A. Gruber M.D., Russell W. Johnson, Rosanne F. Ott. Medical Technology Industry, Ophthalmology In The Millennium, Equity Research. Usboncorp, Piper Jaffray. April 1999. 29. Eve J. Higginbotham M.D., Baltimore M.D. Reaffirming the Role of the Laser In Glaucoma Management. Arch. Ophthalmology. Vol 117, August 1999; 1075-1076. 30. http://www.optistock.com/overview.htm 31. http://www.glaucoma.com/fs-glaucoma-stats.html. 32. http://www.glaucoma.net/gany/faq/patindex.html. 33. http://www.revophth.com/2001/november/feature6.htm. 34. Collaborative Normal-Tension Glaucoma Study Group. Comparison of glaucomatous progression between untreated patients with normal-tension glaucoma and patients with therapeutically reduced intraocular pressures. American Journal of Ophthalmology. Vol 126, 1998; 487-497. http://www.nei.nih.gov/health/glaucoma/glaucoma_facts.htm.