OVERVIEW
SurgiLight (OTCBB: SRGL), a world leader of IR-laser for
vision correction, owns 4 US pending patents for new laser
technologies in "Presbyopia Reversal" which has a potential
US market over $150 billion. In addition, it operates 21 Laser Eye
Centers worldwide for recurring incomes based on royalty fees. The
Company also developed a new laser for psoriasis treatment which is
expected to obtain the FDA approval within few weeks. The Company has
recently signed a joint venture agreement with MicraUS for European
CE-mark approval and marketing. The Company's products model IR-3000,
and IR-5000 are the world's first systems for vision correction using
its new IR laser technologies and are currently under the
clinical trials. In addition to the Laser Eye Center incomes, the
Company also gains incomes from its two spun-off divisions in night
vision systems and cosmetic centers. As the results of over 10 years
R&D, the Company has been the pioneer and inventor of scanning
laser and advanced IR lasers. The Company is currently applying
for a listing on the Nasdaq NM.
Dr. J.T. Lin, the founder of SurgiLight
and the inventor of the scanning laser for vision correction (1994),
and the solid-state UV-laser for PRK (1992), was also the founder of
LaserSight (1991) and is a former Associate Professor (1987-91) at the
Univ. of Central Florida Laser Center. Dr. Lin has more than 80
publications and books.
Lasers for vision correction have been the most
important and largest market for all medical applications that use
lasers. Within this vision correction market SurgiLight
owns the patent-pending technology for presbyopia correction.
Presbyopia correction has a U.S. market of over $150 billion and a
worldwide market of over $1.5 trillion. SurgiLight
expects to have a minimum market penetration of 15% - 20% via its
sales of new devices and the income from royalty fees charged to the
surgeons.
The Company's strategy is to focus on the recurring revenue and
income from The royalty fee of new technology and from laser centers
operation. The Company, however, will continue to develop new products
for new markets mainly outside the U.S. These new products shall
include diode lasers for microsurgery, UV laser for skin treatments,
infrared lasers for vision correction and the Company's patent pending
new technology for presbyopia correction. The Company believes that it
is the only company has the in- house technologies to support and/or
up-grade the systems used in its Centers. The Company's start-up
system cost for its international Laser Centers, in which systems were
made by the Company, is only 30% of that of its competitors which
purchase systems from others. However, there can be no assurance that
the Company will be successful in operating these Laser Centers
without suffering future competitions from those that may also operate
Centers in and also own the in-house technologies.
The presbyopia worldwide potential procedure income is estimated to
be over $1,500 billion, since almost 100% of the worldwide population
for ages older than 45 will become presbyopia. This estimation is
based upon the worldwide population of 900 million (15%) who are
presbyopia and an average procedure fee of $2,000 per patient. The US
presbyopia population is approximately 40 million which also
representing a potential procedure income of about $160 million based
upon a fee of $2,000 per eye. The current treatments for presbyopia
including implants and diamond-knife incision which have drawbacks of
being a complex surgical procedure and require a lot of the surgeon's
experience. Another method is to use a Ho:YAG laser for monovision
correction, a clinical trial system made by Sunrise Technology. This
method however can only treat one eye for near view and requires the
second eye un-treated to see far. Strictly speaking the Ho:YAG method
is not a presbyopia correction but only correct hyperopia in one eye.
The Company's new method of using lasers for presbyopia reversal has advantages of a being precise, fast
and simple procedure which does not require surgeon's experience. The
new procedure will be less complications and more stable, less
regression than the mechanical, non-laser methods. The Company is
currently conducting clinical trials in Venezuela and the results was
presented at the 1999 Fall World Refractive Surgery Symposium
(Orlando, Oct. 24-26, 1999). The Company believes that it is the first
and the only company offering this new procedure which is now limited to the
international market prior to the US approval. The Company currently
has three pending patents relating to the new procedure and new IR- laser
technologies. However, there can be no assurance that the Company will
be successful in protecting its proprietary technologies or in
completing its market approval in the U.S. on schedule. (See ITEM 5 of
Part II in this filing for greater details).
The Company believes that it is the only company currently owning
both the ultraviolet (UV) and infrared (IR) laser technologies for
vision corrections. For vision corrections using UV lasers, there are
several existing patents which may prohibit our sales of the UV lasers
without obtaining a license. The Company has three pending patents for
the use of IR lasers which has the potential of replacing the existing
UV lasers currently used by most of its competitors including Visx,
Summit, Bausch & Lomb, LaserSight, Nidek, Schwind and Meditec. The
IR lasers, the Company believes, will be have less mutagenic effects
and safer than the UV lasers which may have potential risk of
long-term biological complications. However, prior to the market
approval in US the Company's new products will be limited to
international sales. The Company believes that its Infrared (IR)
lasers for vision corrections will be protected by its proprietary
technology and its pending patents. In addition, the users of the
Company's IR lasers will not have to pay the license fee or royalty
fee which are required for the use of UV lasers. Currently, the UV
laser royalty fee in the U.S. is about $250 per case paid to the
patent owners Visx and Summit. The UV laser manufacturers also need to
pay the IBM-patent fee of about 3%-7% of their sale price. Without
paying these fees, the Company believes that its IR lasers will have
advantages in both profit margin and the market competitions. However,
there can be no assurance that the Company will be successful in
protecting its proprietary and pending patents to avoid these license
and or royalty fees.
The medical laser industry is new and needs the approval from FDA
prior to marketing in the U.S. Our competitors are significantly
larger in their financial condition and several of them have now
received FDA approval in vision correction using excimer lasers. We
will also face increased competition from manufacturers of vision
correction lasers and from companies operating laser centers in the
U.S. and internationally. The Company's medical lasers will need
either 510(K) approval, which takes only 6-12 months, or PMA and IDE
approvals which may take a few years to complete prior to the market
approval in the U.S. Prior to these market approvals, the Company's
medical products will be limited to international sales and these
products need to be manufactured outside US. The Company believes that
its UV-laser for dermatology uses and the waterjet system (made by
VisiJet and marketed by the Company in certain countries) will only
need 510(K) approval. The other new products of the Company will
require PMA approval. However there can be no assurance that the
Company will be successful in obtaining these market approvals as
scheduled. The Company has recently submitted a 510(K) application for
its UV-308 laser for the treatment of skin diseases including
psoriasis and vitiligo.
The Company's Plantation Eye Center currently has over 20 surgeons
using the excimer laser facility. These existing surgeons however may
leave the Company if they decide to operate their own Center or join
other Centers offering a better term than the Company. All of these
factors may influence our systems sales and income from laser centers.
Accordingly, our past results may not be useful in predicting our
future results.
LASIK
LASER EYE CENTERS
SurgiLight currently operates 18 Laser Eye Centers (LEC) worldwide
using the most advanced systems:
- Scanning Lasers for international hospitals out-patient centers
- VISX Lasers for US Centers. For dates of Visx
physician
certification courses to be held at our Plantation
Florida Center
go to VISX.
- A VISX PHYSICIAN CERTIFICATION COURSE will
be held
TUESDAY, JULY 18, 2000
(to coincide with ISRS Miami meeting) will be held at:
SURGILIGHT LASER CENTER, PLANTATION, FL 33324
(30 minutes north of Miami meeting site)
(954) 370-3352 Telephone
(954) 370-2262 Fax
Contact person: Georgie Reffner, RN
Call for information and registration process (limited class
size). For more
information visit: www.isrs.com.
Our International LECs now offer clinical trials for the new Laser
Presbyopia Reversal (LPR) procedure using the Company's patent pending
technologies. Clinical studies in the US will begin in the near
future.
Our LEC at Ft. Lauderdale-Plantation is a state-of-the-art facility
with over 25 certified MDs providing highest quality LASIK procedures.
For Surgeons interested in joining our Centers, please call
(407)482-4555 or fax:(407)482-0505
For patient complimentary consultation, please contact any
of the following doctors in your local area or call Georgeann at
(954)370-3352.
Plantation Florida Laser Eye Center Surgeons
| Richard Beckman, MD |
Ray P. Gailitis, MD (Medical
Director) |
| Wayne Bizer, DO |
Lee I. Klein, MD |
| Randy Burks, MD |
Andrew Logan, MD |
| David B. Cano, MD |
Paul W. Maurer, MD |
| Leon Cohn, MD |
Paul Rosenblum, MD |
| Jorge Camacho, MD |
Stanley M. Rous, MD |
| Noel L. Elgut, MD |
Douglas B. Shapiro, MD |
| Marc Feldman, MD |
David R. Simon, MD |
| Kenneth Kasten, MD |
Jacqueline E. Smith, MD |
| Richard S. Kalski, MD |
Russell Wolfe, MD |
| Hassan Tavakkoli, DO |
Taylor G. Poole, MD |
| Luis D. Villani, MD |
Manuel A. Airala, MD |
| Maged S. Habib, MD |
Richard P. Margolies, MD |
|
| Market Capitalization |
$190.7M |
| Shares Outstanding |
21.5M |
| Float |
6.20M |
| Price/Book (mrq) |
31.12 |
| Price/Earnings (ttm) |
2,916.67 |
| Price/Sales (ttm) |
45.02 |
| Sales (ttm) |
$3.06M |
| EBITDA (ttm) |
$321.0K |
| Income available to common (ttm) |
$28.0K |
COMPLETE
RATIO REPORT
BALANCE
SHEET
LIQUIDITY AND CAPITAL RESOURCES
The total current assets of the Company increased to $2,553,000 as of
March 31, 2000, compared with $1,542,000 of the end of March, 1999. This
increase in current assets is mainly attributed to the additional paid
in capital of $1,232,000 from an accredited investor. The Company
expects to obtain more proceeds from accredited or Institutional
investors in the second quarter of 2000. The Company will use this
addition funding to continue its on-going clinical trials and to expand
its international Laser Centers.
The net cash increased from $577,594 on December 31, 1999 to
$1,334,823 on March 31, 2000 mainly due to the addition paid in capital
of $1,232,000. The Company anticipates that its current cash, cash
equivalents, as well as anticipated cash flows from operations and
additional capital contribution from private placements, will be
sufficient to meet its working capital and capital equipment needs at
least through the next twelve months. The Company expects to raise
additional funds via private placements during the second quarter of
2000.
OTHER INFORMATION (Clinical Trials and New Products Up-date)
1. The Company is currently conducting clinical trials at Caracas,
Venezuela for the treatment of presbyopia patients using the Company's
patent pending technology.. The clinical results (for 15 cases)
performed by Drs. Perrasa and Martinez at the Company's Microsurgical
Laser Center at Caracas, Venezuela, were reported at the 1999 Fall World
Refractive Surgery Symposium (October 21-23, Orlando, FL). A second
paper for the results of 21 cases with follow-up longer than 8 months
was submitted for presentation in the Summer World Refractive Surgery
Symposium (July 21-23, Miami, FL). The Company plans to open several
more Laser Centers in Latin America countries for the LASA procedure
using its patent pending device.
2. The Company has another on-going clinical trial at Mt. Sinai
Hospital, New York, using a UV-laser for the treatment of Psoriasis and
vitiligo which affect a worldwide population of about 2% or 100 million,
according to the report by Dr. Spencer at Mt. Sinai Hospital, NY.
Clinical results were submitted for the application of a 510K marketing
approval.
3. The Company will continue its R&D for several new products
including the UV-laser for skin treatment (market approval is expected
in 2000, if a 510K approval can be completed) and the new infrared
lasers for microsurgery and vision correction, the models IR-3000 ,
IR-3001 and IR-2000 which will take several years for the U.S. market
approval. International marketing for these new products, however, will
start during the early part of year 2000, in addition to our existing UV
lasers market. The Company had signed an agreement with MicraUS
for a joint venture in UK to manufacture and market its products in
Europe. However there can be no assurance that the Company will be
successful in completing the clinical trials and obtaining necessary
approvals as scheduled.
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