Tag: maker

This business plan was created to introduce NovOculi, Inc. and help raise equity capital to start production as well as continue research and development on its patent products.

The Company

NovOculi, Inc., is a new company that plans to market and develop ophthalmological surgical techniques and tools. During the past two years, NovOculi’s principals have had extensive experience with refractive correction techniques (both laser and non-laser based). 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 technologies, including LASIK/PRK and Intacs all require the removal of at least a part of the protective epithelial overlying your cornea. They also come with complications due to this loss of protection. To achieve effective refraction, the principals developed a method that uses iontophoresis and an ionic dye along with a wavelength-specific laser. This allows for efficient refraction without the need to destroy epithelium.

NovOculi will use NICS to capitalize on the market opportunities and penetration in laser refraction, where demand is almost doubling every year.

Based on financial projections that were prepared by the company’s management it was estimated that equity investment would be required in order to start the company’s operations. The funds will be used for NICS testing and market. They also provide working capital in the initial two years.

Market Potential

Laser refractive surgery has huge potential. 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. 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’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. John Hopkins University (Harvard), Stanford University (Oregon Health Sciences), Duke University (Duke University) and University of California at San Francisco (UCSF) are just a few of the institutions who have expressed an interest.

NovOculi’s principals conducted a preliminary market study at a Durham, NC supermarket. 50 consumers with refractive problems were randomly selected and asked questions during the survey. A copy of the survey and a summary of its findings may be found in the Market Survey topic.

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 completed, the iontophoretic device is reapplied, this time with opposite polarity, and the dye is drawn from the cornea due to the attraction of opposite charges. The patented device and method will enable the ophthalmologist to avoid the most complicated and frustrating aspect of current laser refractive surgery. This is 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 It is important that NovOculi market its technology to both people who are performing the procedure, and those who will be performing 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 begin with six seasoned sales personnel and swell to forty-four members by Year 5. The laser manufacturers will work closely with the sales team in order for them to promote their technology to patients and surgeons.

Six U.S. sites will provide training opportunities for ophthalmologists in the NICS procedure: San Francisco and Boston, Atlanta, Philadelphia; Kansas City, Philadelphia, Kansas City, Durham, NC. Each site will be able to offer training sessions in depth led by a prominent surgeon in ophthalmology.

For providing access to the superior technology, those performing the procedure may charge a premium. NovOculi will take approximately half the almost $1,000 premium via licensing fees and sales of individual components.

Regulatory Issues

The FDA approval for the company’s product is not required, unlike 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 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 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) Iontophoretic devices have been approved for drug delivery to the epidermis. 3) Polymeric contact lenses were approved. They can be used as an external aid to refractive error.

Major Milestones

These are the key milestones that will define the startup period.

• Completion of strategic plan nine months before start date.
• 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 required by the start date
• According to the business plan, all other milestones for the first year are on schedule.

Competitive Advantage

NovOculi is uniquely positioned to take advantage of this market opportunity due to its protected, proprietary positions. In the U.S., there have been three patents filed. One protects the reversible, iontophoretic device; the second protects the NICS technique; and the third protects the unique vehicle to produce the ionic colour.

To date, the principals have invested a lot of time in research and development of the current products, which will satisfy market demand to create a safer, simpler laser refraction correction system.

Financial Summary

Based on detailed financial projections and if the company gets its funding, it will be profitable by Year 4 with a substantial net profit. Below is the summary of projected financial information.

1.1 Mission

To provide the field of ophthalmology with innovative designs which will facilitate the treatment of ophthalmologic diseases and conditions.