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. (“Bye-Bye Glasses,”
EyeCare Business Online). Furthermore, the demand for laser refractive surgery is
approximately doubling annually (“Bye-Bye Glasses,” EyeCare Business Online,).
The company has contacted nine of the leading ophthalmological medical institutions in the U.S.
Seven of the nine have expressed interest in participating in collaborative research and, given
encouraging research results, performing NICS commercially once it is available. Institutions
expressing interest include: John Hopkins, Harvard, Stanford, Oregon Health Sciences, Duke
University, and the University of California at San Francisco.
NovOculi’s principals have also conducted a preliminary market survey at a local grocery market
in the Durham, NC area. Fifty consumers with refractive errors were randomly selected outside
of a local grocery market and asked the questions in the survey. A copy of the survey and a
summary of its findings may be found in the Market Survey topic.
Technology The principals have developed and patented a revolutionary technique, NICS, and two novel
devices which are used to accomplish incisionless refractive correction. The patented technique
involves driving an ionic dye from its patented polymeric vehicle into the cornea of the patient
using the patented iontophoretic device (a device that creates a charge which then repels or
attracts other charges). Once the ionic dye has been effectively driven into the cornea and away
from sensitive structures, a laser tuned to the wavelength of the dye is then used to target the
dyed cornea and alter its shape, much as is done with 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. 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 The key element in NovOculi’s strategy is to market its technology to both those performing the
procedure as well as to those on which the procedure will be performed. Once research data and
publicity have been generated, the sales force will step in to encourage the initial investment in
the laser and equipment required for the procedure, creating a “demand push.” After this
investment has been made, a “demand pull” will be generated for the components required for
institutions to perform the procedure through marketing directly to patients.
The sales team will begin with six seasoned sales personnel and swell to forty-four members by
Year 5. The sales team will work closely with laser manufacturers in order to promote the
technology to patients and surgeons.
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 led by a prominent ophthalmic surgeon.
Those performing the procedure will be able to charge a premium for providing patients with
access to this superior 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
As with its predecessor, LASIK, the company’s product will not need to wait for FDA approval
prior to widespread use. LASIK had been performed on almost 900,000 patients without
approval by the FDA as of two years ago (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) Iontophoretic devices has been approved for drug delivery on the epidermis. 3)
Polymeric contact lenses have been approved and are commonly used as an external aid for
refractive correction, and 4) The targeting dye, tartrazine, is the most ubiquitous food coloring
additive on the market to date.
Major Milestones The following are key milestones for the startup period:
Completion of strategic business plan nine months before starting 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 raised by starting date.
All other first-year milestones are currently on schedule in accordance to the business
NovOculi is uniquely positioned to take advantage of this market opportunity due to its
protected, proprietary positions. Three patents have been filed in the U.S.: one for protecting the
reversible iontophoretic device, the second protecting the technique involved in NICS, and the
third protecting the unique vehicle for the ionic dye.
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
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. The following chart summarizes the projected