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This business plan has been developed to present NovOculi, Inc. to prospective investors and to assist in raising equity capital needed to begin production and to continue research and development of its patented products.

The Company

NovOculi, Inc., a start-up company, has developed and plans to market ophthalmological surgical instruments and techniques. NovOculi&#8217’s principals are highly experienced in laser and nonlaser-based refractive treatment techniques. This experience has led to the development and testing of a novel method of incisionless, non-invasive refractive correction that is called NICS.

Current refractive techniques, including LASIK, PRK, and Intacs, all require destruction of at least a portion of the protective epithelial layer overlying the cornea of the eye and are accompanied by complications resulting from this loss of protection. The principals have developed a method involving iontophoresis, an ionic dye and a wavelength-specific laser to accomplish effective refraction without the troublesome destruction of epithelium.

Using NICS, NovOculi plans to take advantage of the opportunities for market development and penetration in the field of laser refraction in which demand is nearly doubling each year.

Based on the detailed financial projections prepared by the company’s management, it is estimated that equity investment is required to begin the company’s operations successfully. Funds will be used to produce, test and market NICS, as well as provide initial working capital for the first two years.

Market Potential

There is a large market for laser refractive surgeries. There are approximately 54% refractive mistakes in the U.S. (162,000,000), and approximately 90% of them can be corrected with current techniques or ones on the horizon according to Federal Air Surgeon’s Medical Bulletin. Two years ago, 900,000. Americans had LASIK. This is the most popular laser correction procedure. This is only 0.6% of the market. The remaining 99.4% are still untapped. (&#8220/Bye-Bye glasses, EyeCare Online). The demand for laser refractive surgeries is increasing at an average of twice a year (&#8220/Bye-Bye glasses,&#8221/EyeCare Business Online ).

The company has contacted nine of the leading ophthalmological medical institutions in the U.S. Seven of the nine have expressed their interest in joining collaborative research. Given encouraging research results, NICS will be commercially available once it is made available. John Hopkins University, Harvard University, Stanford University, Oregon Health Sciences University, Duke University and University of California at San Francisco are some of the institutions interested.

NovOculi’s principals also conducted a preliminary survey of the Durham, NC grocery store. A random selection of fifty consumers with refractive issues was made outside of a local grocery store and they were asked the following questions. A copy of the survey and a summary of its findings may be found in the Market Survey topic.

Technology

The principals invented and patent NICS, a revolutionary technique that allows for incisionless refractive correction. The patented method involves injecting an ionic drug from its patented polymeric container into the cornea of the patient with the patented iontophoretic (a device which creates a charge that repels or attracts others charges). Once the ionic solution has been successfully introduced into the cornea, it is removed from sensitive structures. A laser tuned to its wavelength is used to alter the cornea’s shape. It works similarly to current laser refractive protocols. After the procedure has been completed, the iontophoretic devices is reapplied. This time the dye is applied with oppositepolarity. Through the use of the patented device and technique, the ophthalmologist performing the procedure will be able to avoid the most troublesome and complication-ridden aspect of current laser refraction surgery: the corneal incision. Over 90% of all complications of current laser refraction surgery are related to difficulties associated with the incision and the subsequent healing process, virtually all of which could be avoided with NovOculi’s technology.

Strategy A key component of NovOculi&#8217’s strategy to market its technology is to both those performing the procedure and those to whom it will be performed. After the publicity and research data are collected, the sales force will assist in encouraging the initial investment in laser and equipment for the procedure. The demand pull for components will be generated by institutions through direct marketing to patients.

The sales team starts with six experienced salespeople and grows to forty-four by Year 5. To promote laser technology to surgeons and patients, the sales team will collaborate closely to laser manufacturers.

Six U.S. locations will offer NICS training to ophthalmologists: San Francisco (Boston), Atlanta, Philadelphia and Kansas City. Durham, NC is the sixth. Each site will be able to offer training sessions in depth led by a prominent surgeon in ophthalmology.

The procedure can be performed by anyone who is willing to pay a premium to provide patients with this advanced technology. NovOculi will extract approximately half of the nearly $1,000 premium through licensing fees associated with its patented procedure and sales of the individual components.

Regulative Issues

The FDA approval is not required for this product to be widely used, as it did with LASIK. As of two years ago, LASIK was performed on more than 900,000 patients, without FDA approval (Current trends in refractive eye surgery, 128th Annual meeting of APHA).

This was made possible due to the fact that the “FDA does not approve procedures, only the equipment used in them” (“Eye centers set their sights on LASIK surgery growth,” Houston Business Journal, July 16) and the components of the procedure have already been approved by the FDA for medical use. NovOculi will not need to obtain approval to market their patented technique and devices due to the fact that the FDA has approved similar devices for medical use in the following arenas: 1) The 440 nm laser has been approved for dermatologic uses. 2) Iontophoretics devices have been approved to deliver drugs on the epidermis. 3) Polymeric contact lenses were approved. They can be used as an external aid to refractive error.

Major Milestones

Here are some key milestones during the startup period.

• Completion of strategic plan nine months before start date.
• Requests for grants of research must be made at least seven weeks before the starting date.
• All patents, domestic and foreign, applied for by six months before starting date.
• Start-up capital raised by starting date.
• All other first-year milestones have been completed according to the business plans.

Competitive Advantage

NovOculi’s protected, proprietary position makes it uniquely positioned to capitalize on this market opportunity. The U.S. has granted three patents to NovOculi: the first protecting the reversible instrument for iontophoretics, the second protecting NICS techniques, and the last protecting the unique vehicle used for the ionic color.

The principals have spent considerable time developing and researching the current products to satisfy market demand for a simpler, more safe laser refraction correction procedure.

Financial Summary

Based on detailed financial projections the company should be able to operate profitably in Year 4. Below is a summary chart of the projected financial information.

1.1 Mission

Provide innovative designs for the treatment and prevention of ophthalmologic diseases.

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