Eye Surgery Equipment Maker Business Plan

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., a start-up company, has developed and plans to market ophthalmological surgical instruments and techniques. NovOculi’s principals have extensive experience in refractive correction techniques, both laser-based and non-laser-based. On the basis of this experience, NovOculi’s principals have created and begun testing a unique method for incisionless refractive adjustment 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. They have created a method using iontophoresis with an ionic color and a wavelength specific laser to achieve effective refraction without the need for epithelium destruction.

NovOculi plans on using NICS to profit from the market opportunities for market expansion and penetration within the laser refraction industry, which is experiencing a nearly doubled demand 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. The funds will be used for NICS testing and market. They also provide working capital in the initial two years.

Market Potential

The laser refractive industry has a huge market potential. Refractive errors affect approximately 54% of Americans (162 millions). Nearly 90% of them are eligible to be corrected using current techniques (Federal Air Surgeon&#8217’s Medical Bulletin). Only 900,000. Americans have had LASIK since 2002. This market represents 0.6% of total available market. 99.4% remains untapped. (#8220’ByeBye Glasses; EyCare Business Online). The demand for laser refractive surgeries is increasing at an average of twice a year (&#8220/Bye-Bye glasses,&#8221/EyeCare Business Online ).

Nine of the top ophthalmological hospitals in the U.S. were contacted by the company. 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’s principals conducted a preliminary market study at a Durham, NC supermarket. The survey included questions for fifty refractive-effected consumers who were randomly selected from a nearby grocery store. Market Survey Topic contains a copy and summary of the survey.

Technology

Two novel devices, the NICS and NICS, have been patented by the principals. They are used to perform incisionless refractive adjustment. 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). After the ionic dye is successfully driven into the cornea, away from sensitive structures and other delicate structures, a laser tuned according to the wavelength of dye can be used to target the dyed cornea to alter its shape. This is similar to current laser refraction protocols. After the procedure is over, the iontophoretic instrument is used again with the opposite polarity. Due to the attraction and mutual dependence of opposite charges, the dye is pulled from the cornea. The patented technique and device will allow the ophthalmologist to perform the procedure without the need for complicated corneal incisions. 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. Once publicity and research data have been generated, sales will take over to encourage initial investment in the laser equipment and the procedure. A ‘#8220â€™ demand pull will then be generated for the parts required for institutions to perform this procedure by marketing directly to patients.

The sales team will be comprised of six experienced sales staff and will increase to 44 members by year 5. To promote laser technology to surgeons and patients, the sales team will collaborate closely to laser manufacturers.

Ophthalmologist training for the NICS procedure will be available at six sites throughout the U.S.: San Francisco, Boston, Atlanta, Philadelphia, Kansas City, and 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 is expected to extract about half of the $1000 premium from licensing fees, sales of individual components and other costs associated with the patented procedure.

Regulative Issues

Like its predecessor, LASIK, the FDA will not approve the company’s product before widespread usage. 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 as the FDA doesn’t approve procedures. However, they do approve the equipment used in them. (&#8220: Eye centers aim to LASIK surgical growth. Houston Business Journal. July 16). Also, all components of their procedure have been approved for medical use by the FDA. NovOculi’s patented device and technique will be available for sale without FDA approval. FDA approved similar devices for medical uses in the following fields: 1) The FDA approved the dermatologic use of the 440nm Laser. 2) Iontophoretics devices have been approved to deliver drugs on the epidermis. 3) Polymeric contact lens have been approved. They are used to aid in refractive correction. 4) Tartrazine is the most widely-used food coloring agent on the market.

Major Milestones

Here are some milestones to help you get started.

Nine months from the date of starting, complete the strategic company plan.
For research grants, applicants must apply at least seven months prior to the date of start.
All patents, domestic and foreign, applied for by six months before starting date.
Start-up capital raised starting date
All other first-year milestones have been completed according to the business plans.

Competitive Advantage

NovOculi has unique, protected positions that allow it to profit from 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, to date, have spent ample time on development and research of the current products which will satisfy the market demand for a safer, less complicated laser refraction correction technique.

Financial Summary

Based on detailed financial projections, if the company receives its funding, it will operate profitably by Year 4 with a hefty net profit. Below is a summary of the projected financial information.