This business plan was developed to help NovOculi, Inc. present itself to potential investors. It also helps in raising capital required to produce its products and continue researching and developing them.

The Company

NovOculi, Inc., an innovative start-up, plans to develop and sell ophthalmological surgical tools. NovOculi&#8217 has had extensive experience with both laser and nonlaser refractive correction methods over the past two-years. Building on this experience, the principals have developed and begun testing a unique method of incisionless refractive correction dubbed NICS (Non-Invasive Corneal Sculpting).

Current refractive techniques such as LASIK (PRK) and Intacs require that at least a portion or more of the protective epithelial membrane overlying corneal tissue is destroyed. There are complications that can result from this loss. The principals have developed an effective method that involves iontophoresis using an ionic drug and a wavelength -specific laser. It allows for efficient refraction with minimal epithelium damage.

NovOculi will use NICS to capitalize on the market opportunities and penetration in laser refraction, where demand is almost doubling every 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 for NICS production, testing, and marketing, as well providing initial working capital during the first two year.

Market Potential

A massive potential market base exists for the laser refractive surgery industry. It is estimated that approximately 54% of the U.S. population (~162 million) has refractive errors, approximately 90% of which are eligible for correction using current techniques or those on the near horizon (Federal Air Surgeon’s Medical Bulletin). In contrast, only 900,000 Americans have had LASIK (the most popular laser correction technique) as of two years ago. This represents only 0.6% of the total current market, leaving the other 99.4% untapped. (&#8220/Bye-Bye glasses, EyeCare Online). Additionally, laser refractive surgery demand is about doubling annually (&#8220/ByeBye Glasses; EyeCare Business Online).

The company has reached out to nine top American ophthalmological and medical institutions. Seven of the nine institutions have expressed interest in collaboration research. The company has also reached out to Oregon Health Sciences, Duke University, and Harvard. Institutions expressing interest include: John Hopkins, Harvard, Stanford, Oregon Health Sciences, Duke University, and the University of California at San Francisco.

NovOculi&#8217’s principals also conducted an initial market survey at Durham’s grocery store. The survey included questions for fifty refractive-effected consumers who were randomly selected from a nearby grocery store. Market Survey topic provides a summary and a copy the survey.

Technology

The principals have patented NICS, a novel technique, and two devices that are used for incisionless refractive correction. The patented technique involves driving an Ionic dye from the polymeric vehicle into patient’s cornea using the patented, iontophoretic devices (a device that generates a charge that then repels/attracts other charges). Once the ionic drug has been successfully delivered to the cornea without damaging sensitive structures, the laser tuned to the wavelength is used to alter the shape of the dyed cornea. It is very similar to laser refraction protocols. The iontophoretic device can be reapplied with an opposite polarity. This is to draw the dye from the cornea because of the attraction between opposite charges. The patented method and device allows the surgeon to avoid the most difficult and complicated aspect of current laser surgery, the corneal incision. NovOculi’s technology could prevent nearly 90% of the complications associated with current laser refractive surgery.

Strategy NovOculi’s strategy is to promote its technology to both the people performing the procedure and to the ones who will be using it. 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 will be comprised of six experienced sales staff and will increase to 44 members by year 5. The sales team will work closely with laser manufacturers in order to promote the technology to patients and surgeons.

Six U.S. cities will host Ophthalmologist Training for NICS Procedure: San Francisco, Boston. Atlanta, Philadelphia. Kansas City. Durham, NC. Each site will have in-depth training sessions conducted by a prominent eye surgeon.

In order to offer patients access to the best technology, doctors will be allowed to charge a premium. NovOculi will collect approximately half of its nearly $1,000 premium through licensing fees related to its patented procedure as well as sales of the individual parts.

Regulations

Like its predecessor, LASIK, the FDA approval of the company’s product for widespread use will not be required. As of 2 years ago, LASIK had already been performed on nearly 900,000. Patients were not required to wait for FDA approval (Current Trends In Refractive Eye Surgery, 128th Anniversary Meeting of APHA).

This was possible because the FDA does not approve procedures but only equipment. (‘#8220’Eye centers have set their sights on LASIK procedure growth, Houston Business Journal July 16). The FDA has already approved the components of the procedure for medical use. NovOculi won’t need approval to market its patented technology and devices. The FDA has already approved similar devices in the following areas: 1) The FDA approved the 440 nm laser for dermatologic purposes. 2) Iontophoretic devices has been approved for drug delivery on the epidermis. 3) Polymeric contacts lenses have been approved. These are often used externally for refractive adjustment.

Milestones

Here are some milestones to help you get started.

• Nine months prior to the start date, completion of the strategic business plan.
• Research grants applied for by seven months before 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 are currently on schedule in accordance to the business plan.

Competitive Advantage

NovOculi’s protected, proprietary position makes it uniquely positioned to capitalize on this market opportunity. The U.S. has filed three patents: one to protect the reversible Iontophoretic Device, the second to protect the NICS technique, and the third to protect the unique vehicle for the ionic Dye.

To date, the principals spent much time researching and developing current products that meet the market demand.

Financial Summary

Based on detailed financial projections the company should be able to operate profitably in Year 4. The following table summarizes the projected financial information.

1.1 Mission

To offer innovative solutions to ophthalmology that will make it easier to treat ophthalmologic conditions and diseases.