<PAGE>
SECURITIES AND EXCHANGE COMMISSION
FORM S-3
REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933
AUTONOMOUS TECHNOLOGIES CORPORATION
(Exact name of registrant as specified in its charter)
Florida
(State or other jurisdiction of incorporation or organization)
59-2554729
(I.R.S. Employer Identification No.)
2800 Discovery Drive, Orlando, Florida 32826, (407) 384-1600
(Address, including zip code, and telephone number, including area code, of
registrant's principal executive offices)
Randy W. Frey, 2800 Discovery Drive, Orlando, Florida 32826, (407) 384-1600
(Name and address, including zip code, and telephone number, including area
code, of agent for service)
================================
Copy to:
William A. Grimm, Esq., Gray, Harris & Robinson, P.A.,
201 East Pine Street, Suite 1200, Orlando, Florida 32801, (407) 843-8880
================================
Approximate date of commencement of proposed sale to the public: __________,
1998.
If the only securities being registered on this Form are being offered pursuant
to dividend or interest reinvestment plans, please check the following box. [_]
If any of the securities being registered on this Form are to be offered on a
delayed or continuous basis pursuant to Rule 415 under the Securities Act of
1933, other than securities offered only in connection with dividend or interest
reinvestment plans, check the following box. [X]
If this Form is filed to register additional securities for an offering pursuant
to Rule 462(b) under the Securities Act, please check the following box and list
the Securities Act registration statement number of the earlier effective
registration statement for the same offering. [_]
If this Form is a post-effective amendment filed pursuant to Rule 462(c) under
the Securities Act, check the following box and list the Securities Act
registration statement number of the earlier effective registration statement
for the same offering. [_]
If delivery of the prospectus is expected to be made pursuant to Rule 434,
please check the following box. [_]
CALCULATION OF REGISTRATION FEE
<TABLE>
<CAPTION>
Title of each class of securities Amount to be Proposed maximum Proposed maximum Amount of
to be registered registered offering price per unit (1) aggregate offering price (1) registration fee
- -----------------------------------------------------------------------------------------------------------------------------------
<S> <C> <C> <C> <C>
Common Stock, $0.01 par value 600,573 shares $4.3125 $2,589,977 $765
- -----------------------------------------------------------------------------------------------------------------------------------
</TABLE>
(1) Estimated solely for the purpose of computing the registration fee pursuant
to Rule 457(c) based on the average of the high and low prices of the
Registrant's Common Stock as reported on the Nasdaq National Market on August
18, 1998.
The Registrant hereby amends this Registration Statement on such date or dates
as may be necessary to delay its effective date until the Registrant shall file
a further amendment which specifically states that this Registration Statement
shall thereafter become effective in accordance with Section 8(a) of the
Securities Act of 1933 or until the Registration Statement shall become
effective on such date as the Commission acting pursuant to said Section 8(a)
may determine.
<PAGE>
Information contained herein is subject to completion or amendment. A
registration statement relating to these securities has been filed with the
Securities and Exchange Commission. These securities may not be sold nor may
offers to buy be accepted prior to the time the registration statement becomes
effective. This prospectus shall not constitute an offer to sell or the
solicitation of an offer to buy nor shall there be any sale of these securities
in any State in which such offer, solicitation or sale would be unlawful prior
to registration or qualification under the securities laws of any such State.
Subject to Completion, dated August 19, 1998
PROSPECTUS
600,573 Shares
AUTONOMOUS TECHNOLOGIES CORPORATION
This Prospectus relates to the public offering, which is not being underwritten,
of 600,573 shares (the "Shares") of Common Stock, par value $0.01 per share (the
"Common Stock") of Autonomous Technologies Corporation (the "Company"). All of
the Shares may be offered by certain stockholders of the Company or by pledgees,
donees, transferees or other successors in interest that receive such Shares as
a gift, partnership distribution or other non-sale related transfer (the
"Selling Stockholders"). The Company completed the sale of 600,573 shares of
Common Stock at $5.166 per share to the Selling Stockholders on May 26, 1998 in
a private placement. The Common Stock has been issued pursuant to an exemption
from the registration requirements of the Securities Act of 1933, as amended
(the "Securities Act"), provided by Section 4(2) thereof. The Shares are being
registered by the Company as requested by the Purchase Agreements between the
Company and each of the Selling Stockholders.
The Shares may be offered by the Selling Stockholders from time to time in
transactions on the Nasdaq National Market, in privately negotiated
transactions, or by a combination of such methods of sale, at such fixed prices
as may be negotiated from time to time, at market prices prevailing at the time
of sale, at prices related to such prevailing market prices or at negotiated
prices. The Selling Stockholders may effect such transactions by selling the
Shares to or through broker-dealers and such broker-dealers may receive
compensation in the form of discounts, concessions or commissions from the
Selling Stockholders or the purchasers of the Shares for whom such broker-
dealers may act as agent or to whom they sell as principal or both (which
compensation to a particular broker-dealer might be in excess of customary
commissions). See "Plan of Distribution."
The Company will not receive any of the proceeds from the sale of the Shares by
the Selling Stockholders. The Company has agreed to bear certain expenses in
connection with the registration and sale of the Shares being offered by the
Selling Stockholders. The Company has agreed to indemnify the Selling
Stockholders against certain liabilities, including liabilities under the
Securities Act.
The Common Stock of the Company is traded on the Nasdaq National Market tier of
the Nasdaq Stock Market under the symbol "ATCI." On May 26, 1998, the last sale
price for the Common Stock as report by Nasdaq was $5.50 per share. On August
18, 1998, the last sale price for the Common Stock as reported by Nasdaq was
$4.5625 per share.
The Selling Stockholders and any broker-dealers or agents that participate with
the Selling Stockholders in the distribution of the Shares may be deemed to be
"underwriters" within the meaning of Section 2(11) of the Securities Act, and
any commissions received by them and any profit on the resale of the Shares
purchased by them may be deemed to be underwriting commissions or discounts
under the Securities Act. See "Plan of Distribution" herein for a description of
agreements by the Company to indemnify the Selling Stockholders against certain
liabilities.
THE COMMON STOCK OFFERED HEREBY INVOLVES A HIGH DEGREE OF RISK.
SEE "RISK FACTORS" ON PAGE 5.
THESE SECURITIES HAVE NOT BEEN APPROVED OR DISAPPROVED BY THE
SECURITIES AND EXCHANGE COMMISSION NOR HAS THE COMMISSION PASSED UPON
THE ACCURACY OR ADEQUACY OF THIS PROSPECTUS.
ANY REPRESENTATION TO THE CONTRARY IS A CRIMINAL OFFENSE
THE DATE OF THIS PROSPECTUS IS AUGUST 19, 1998.
<PAGE>
AVAILABLE INFORMATION
This Prospectus, which constitutes a part of a Registration Statement on Form S-
3 (the "Registration Statement") filed by the Company with the Securities and
Exchange Commission (the "Commission") under the Securities Act, omits certain
of the information set forth in the Registration Statement. Reference is hereby
made to the Registration Statement and to the exhibits thereto for further
information with respect to the Company and the securities offered hereby.
Copies of the Registration Statement and the exhibits thereto are on file at the
offices of the Commission and may be obtained upon payment of the prescribed fee
or may be examined without charge at the public reference facilities of the
Commission described below.
The Company is subject to the informational requirements of the Securities
Exchange Act of 1934, as amended (the "Exchange Act"), and, in accordance
therewith, files reports, proxy statements and other information with the
Commission. Such reports, proxy statements and other information can be
inspected and copied at the public reference facility maintained by the
Commission at Room 1024, 450 Fifth Street, N.W., Washington, D.C. 20549 and at
the Commission's regional office located at 1401 Brickell Avenue, Suite 200,
Miami, FL, 33131. The Commission maintains a website that contains reports,
proxy statements and information statements and other information regarding
registrants that file electronically with the Commission. The address of such
web site is http://www.sec.gov. Copies of such material can be obtained from
the Public Reference Section of the Commission, located at 450 Fifth Street,
N.W., Washington, D.C. 20549, at prescribed rates. The Company's Common Stock
is quoted on the Nasdaq National Market. Reports, proxy statements and other
information concerning the Company may be inspected at the National Association
of Securities Dealers, Inc. at 1735 K Street, N.W., Washington, D.C. 20006.
INCORPORATION OF CERTAIN DOCUMENTS BY REFERENCE
The following documents or portions of documents filed by the Company (File No.
0-28278) with the Commission are incorporated herein by reference: (a) Annual
Report on Form 10-K/A for the Fiscal Year ended December 31, 1997; (b)
Definitive Proxy Statement dated April 24, 1998, filed in connection with the
Company's 1998 Annual Meeting of Stockholders; (c) Form 8-K filed on April 27,
1998; (d) Form 10-Q for the quarter ended March 31, 1998; (e) Form 8-K filed on
June 12, 1998; (f) Form 8-K filed on July 22, 1998; (g) Form 10-Q for the
quarter ended June 30, 1998; (h) Form 8-K filed August 18, 1998; and (i) the
description of the Company's Common Stock which is contained in its Form S-1
filed under the Securities Act on March 8, 1996 (File No. 333-2068). The
discussion regarding the private placement of Series I Convertible Preferred
Stock on page 4 of this Prospectus should be read in conjunction with the
audited financial statements incorporated herein by reference.
All reports and other documents filed after August 19, 1998 by the Company
pursuant to Sections 13(a), 13(c), 14 or 15(d) of the Exchange Act, prior to the
filing of a post-effective amendment which indicates that all securities offered
hereby have been sold or which deregisters all securities remaining unsold,
shall be deemed to be incorporated by reference herein and to be a part hereof
from the date of the filing of such reports and documents. Any statement
contained in a document incorporated by reference herein shall be deemed to be
modified or superseded for purposes of this Prospectus to the extent that a
statement contained or incorporated by reference herein modifies or supersedes
such statement. Any statement so modified or superseded shall not be deemed,
except as so modified or superseded, to constitute a part of this Prospectus.
The Company will provide without charge to each person to whom this Prospectus
is delivered a copy of any or all of such documents which are incorporated
herein by reference (other than exhibits to such documents unless such exhibits
are specifically incorporated by reference into the documents that this
Prospectus incorporates). Written or oral requests for copies should be
directed to Secretary, Autonomous Technologies Corporation, 2800 Discovery
Drive, Orlando, Florida 32826, (407) 384-1600.
- --------------------------------------------------------------------------------
LADARVision and T-PRK are registered trademarks of the Company. T-LASIK and
CustomCornea are trademarks of the Company. Ciba Vision is a registered
trademark of Ciba Vision Corporation. Other trademarks used herein are the
property of their respective owners.
- --------------------------------------------------------------------------------
In evaluating the Company's business, prospective investors should carefully
consider the following risk factors before purchasing the securities offered
hereby. This Prospectus contains certain forward-looking statements.
Statements of plans, intentions and objectives by the Company and statements of
future economic performance contained in this Prospectus should be deemed to be
forward-looking statements. Cautionary statements are made in certain sections
of this Prospectus. These cautionary statements should be read as being
applicable to all related forward-looking statements wherever they appear in
this Prospectus, the materials referred to in this Prospectus or the materials
incorporated by reference into this Prospectus.
<PAGE>
PROSPECTUS SUMMARY
The following summary is qualified in its entirety by the more detailed
information and financial data appearing elsewhere and incorporated by reference
in this Prospectus. In evaluating the Company's business, prospective investors
should carefully consider the information set forth under the heading "Risk
Factors." This Prospectus contains certain forward-looking statements within
the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the
Securities Exchange Act of 1934. Statements of plans, intentions and objectives
by the Company and statements of future economic performance contained in this
Prospectus should be deemed to be forward-looking statements. Statements
containing terms such as "believes," "does not believe," "no reason to believe,"
"expects," "plans," "intends," "estimates," "anticipated," or "anticipates" are
considered to contain uncertainty and are forward-looking statements.
Cautionary statements are made in certain sections of this Prospectus. These
cautionary statements should be read as being applicable to all related forward-
looking statements wherever they appear in this Prospectus, the materials
referred to in this Prospectus or the materials incorporated by reference into
this Prospectus.
For definitions of certain unique medical and regulatory terms used throughout
this prospectus, please see the Glossary on page 16 of this prospectus.
THE COMPANY
Autonomous Technologies Corporation ("Autonomous" or the "Company"), a Florida
corporation formed in 1985, has been engaged since 1993 in the design and
development of the next generation of excimer laser instruments for laser vision
correction ("LVC") to reduce or eliminate a person's dependence on eyeglasses or
contact lenses. The Company's technology combines eye tracking with a narrow
beam excimer laser to treat common refractive vision disorders such as myopia
(nearsightedness), hyperopia (farsightedness) and astigmatism (blurred vision).
The Company's objective has been to improve refractive surgical outcomes for
these conditions over those achieved by earlier LVC systems.
The Company's clinical results were reviewed by the Food and Drug
Administration's ("FDA") Ophthalmic Devices Advisory Panel in February 1998,
which unanimously recommended that the Company's PMA application be granted
approval by the FDA.
Vision correction is one of the largest medical markets, with approximately 136
million people in the United States using eyeglasses or contact lenses./1/
Within this group, approximately 60 million people are myopic./2/ Industry
sources/3/ estimate that Americans spend approximately $13 billion, at retail
prices, on eyeglasses, contact lenses and other vision correction products and
services each year.
- ------------------
/1/ According to a private market study and publications of Market Scope
(www.mktsc.com).
/2/ Excerpted from a presentation by Dr. Richard Lindstrom, entitled "Excimer
Laser Photorefractive Keratectomy: Clinical Outline."
/3/ From an article published in the January 8, 1996 issue of Vision Monday,
a trade publication for the ophthalmic industry, entitled "Tracking the
Trends for '96 - Eyewear retailers look forward to a successful year as
they focus on what's hot."
1
<PAGE>
The Company's marketing strategy is designed to broaden the penetration of the
LADARVision System in the refractive surgery market by offering better clinical
outcomes to surgeons and patients than is currently available and by
significantly reducing the up-front cost to the ophthalmologist of current LVC
systems. This marketing strategy would allow physicians to utilize the
LADARVision System by paying an advance procedure fee for the equipment and
paying a per procedure service fee thereafter. In 1997, the Company and CIBA
Vision Group Management ("CIBA") conducted a market research project that
buttresses those performed in 1995 and 1996 demonstrating that there is
significant interest in both the technical features and benefits of the
LADARVision System and in the pricing strategy of lower up-front costs and
competitive procedure fees. The Company may, however, elect to change this
marketing strategy on a country-by-country and account-by-account basis
depending on applicable law and regulation, tax considerations, and competitive
conditions.
The Company's LADARVision System technology combines high speed, laser radar eye
tracking with narrow beam shaping to form its new and proprietary technology
platform. The LADARVision System is designed to address a need for
sophisticated eye tracking to compensate for saccadic eye movement during
surgery. Saccadic eye movements are very rapid, involuntary and random in
amplitude and direction and are not suppressed or reduced by medication used
during LVC. These eye movements degrade LVC predictability and visual quality.
The Company believes that the LADARVision System provides higher accuracy
ablation by virtually eliminating decentration and shaping error caused by eye
movement. Additionally, the narrow beam excimer provides a smooth ablation, and
the Company's algorithms and shaping apparatus offer high speed to minimize
surgical duration while retaining a high degree of pointing accuracy to achieve
predictable shaping.
The Company believes the LADARVision System will yield more stable, predictable
results with less post-operative regression, potentially improving visual
quality and clinical outcomes for low to moderate myopia compared to first
generation excimer laser PRK systems manufactured and sold by its competitors.
The Company submitted its PMA application on September 5, 1997 for its initial
indications of myopia and astigmatism. On February 13, 1998, the FDA's
Ophthalmic Devices Advisory Panel reviewed the application and unanimously
recommended that the FDA grant the PMA approval for myopia up to -8 diopters and
astigmatism up to -4 diopters. On July 28, 1998, the Company received a letter
from the Center for Devices and Radiological Health stating that it concurred
with the Panel's recommendation and informed the Company that its PMA is
approvable for up to -10 diopters of sphere and -4 diopters of cylinder. Final
PMA approval cannot occur until the FDA determines that the Company's
manufacturing facilities, methods and controls comply with the FDA Quality
System Regulations ("QSR"). Normally, the FDA takes several months after a
recommendation from a panel to complete its work on the file, conduct
inspections of the Company and its systems and records and grant a PMA.
In 1994, the Company entered into a strategic alliance with CIBA, a wholly-owned
subsidiary of Novartis AG. The strategic alliance with CIBA is for the
worldwide co-promotion of the LADARVision System. Through March 31, 1998, CIBA
has invested an aggregate of approximately $5 million in cash and $1.3 million
in services in the Company. As a result of this investment, CIBA owns
approximately 15% of the Company's Common Stock at August 18, 1998, not
including 171,713 shares that may be issuable to CIBA in 1999 the issuance of
which would raise its ownership to approximately 16% of the Company's Common
Stock, subject to certain anti-dilution provisions. CIBA may, at its sole
discretion, terminate the strategic alliance upon 180 days notice to the
Company. See "Risk Factors - Possible Termination of Strategic Alliance with
CIBA" herein, "Risk Factors - Commission Obligation to CIBA; Future Dilution"
herein and "Item 13. - Certain Relationships and Related Transactions" in the
Company's Annual Report on Form 10-K for the fiscal year ended December 31, 1997
("Form 10-K"). With experience in physician and retail marketing and the second
largest worldwide market share for contact lenses, CIBA provides the Company
with credibility and awareness in both the ophthalmic and consumer markets.
Under the strategic alliance, the Company plans co-promotion strategies, such as
product tie-ins, joint advertising and shared exhibit space, on a project-by-
project basis. The Company retains the worldwide marketing rights for its
LADARVision System.
POSSIBLE CREDIT FACILITY FOR COMMERCIAL SYSTEM PLACEMENTS. The Company and a
finance company (the "Lender") have entered into a letter of intent for secured
financing of LADARVision Systems placed in the U.S. This disclosure is being
made by the Company because the Company believes it is probable that the Company
and the Lender will enter into definitive agreements regarding this credit
facility before the commencement of commercial system placements in the U.S.
(end of summer or early fall 1998) and because the Company believes that
investors should know the general terms under which the Company believes it will
obtain this financing. The Lender has requested that its name not be disclosed
unless and until the Company and the Lender execute definitive agreements. It
is contemplated that the Lender will advance funds to the Company shortly after
each accepted commercial system placement. The Company would obtain agreements
from each of its customers to perform a certain minimum number of procedures on
each system over the course of three years with significant termination payments
to be made by the customer if the customer terminates the agreement before
performing the minimum number of procedures. The minimum number of procedures
currently contemplated is 600 procedures per year. Additionally, the Company is
required to obtain from each customer a user agreement that (i) provides for
minimum payments equal to or exceeding the monthly payments required under the
related financing, (ii) requires a termination payment equal to at least the
amount that remains to be paid under the financing arrangement if the user
agreement is terminated, and (iii) on a case-by-case basis as required by the
Lender, contains one or more personal guarantees of each user agreement if the
user is a corporate entity. Under the financing arrangement, the Company would
receive from the Lender the approximate amount directly invested by the Company
in the manufacture of each system (up to a maximum of $220,000
2
<PAGE>
per system). The total amount of this financing is contemplated to be
$15,000,000 over a one-year period subject to renewal thereafter. Under the
financing arrangement, the Company will make monthly payments of approximately
$7,500 per system placed for a three year period. The minimum payment per month,
the termination payment and the personal guarantees, if needed under the user
agreements, could affect the ability of the Company to place LADARVision Systems
into use in the United States. The Lender continues to conduct due diligence on
the Company and there can be no assurances that the Company and the Lender will
enter into a definitive agreement regarding this type of financing.
SINGLE MANUFACTURER FOR THE LASER COMPONENT. The laser component in the
LADARVision System has been custom designed for the Company for high performance
and small size. The Company owns the design of the laser component including
all drawings and trade secrets relating to the design and manufacture of the
laser component. The laser component is currently manufactured by a small
manufacturer in the Eastern U.S. that specializes in manufacturing excimer
lasers. The Company agreed to purchase 50 laser components from this small
company before purchasing laser components from other manufacturers or making
the laser component itself. As of the date of this prospectus, the Company has
purchased approximately 20 of the 50 laser components. Either the Company or
this manufacturer (as the non-breaching party) may terminate this relationship
in the event of an uncured breach of the manufacturing agreement. This
agreement continues until the Company has purchased 50 laser components. The
Company decided to use a single manufacturer for the laser component in order to
achieve economies of scale in the manufacture of the laser component and to
assure better control of the quality of the laser component. Achieving
economies of scale and controlling the quality of the laser component are and
will continue to be important factors regarding the laser component and will
significantly influence the Company's decision as to whether or not to engage
another manufacturer (or manufacture the laser component itself) after the
Company has met its obligation to purchase 50 laser components from this
manufacturer. In order to protect itself against this manufacturer being unable
to manufacture the laser component, the Company required this manufacturer to
lease a separate facility for the manufacture of the laser component and to
assign to the Company a security interest in all of the equipment, drawings and
inventory relating to the manufacturing of the laser component as well as the
facility lease. The Company also placed two of its engineers at this
manufacturer, beginning November 1997, for approximately six months in order for
these engineers to learn and document all of the details of manufacturing the
laser component. The Company does not currently have its engineers working at
this manufacturer on a full-time basis. However, the two engineers have
returned to this manufacturer for further documentation and the Company
anticipates its personnel returning to this manufacturer on occasion in the
future. In the event that this manufacturer is unable to supply the laser
components as required by the Company, the Company believes it has the ability
to promptly step in and manufacture the laser components on its own or have
another qualified manufacturer make the laser components at the current site
where the laser components are manufactured. With these protective measures in
place, the Company does not believe there is a significant risk that it will be
unable to obtain laser components from a qualified manufacturer or make such
components itself in the event that this manufacturer cannot manufacture the
laser components.
RECENT DEVELOPMENTS
LASIK HYPEROPIC ASTIGMATISM TRIALS APPROVED BY THE FDA. In June 1998, the FDA
granted permission for the Company to conduct LASIK Hyperopic Astigmatism trials
for up to +6 diopters of sphere and up to -6 diopters of cylinder. These trials
began on August 10, 1998, will include up to 150 subjects and are subject to
certain conditions required by the FDA. Laser In-Situ Keratomileusis or "LASIK"
is a technique which involves both a corneal cut and excimer laser ablation.
During the procedure, the ophthalmologist cuts a thin flap on the cornea before
using the laser. After the laser ablation is completed, the flap is replaced.
According to trade publications, LASIK typically offers patients less pain and
shorter recovery times after surgery.
ISO 9001 CERTIFICATION. On June 10, 1998, the Company received ISO 9001/EN
46001 Certification. This Certification was awarded following inspections and
audits of the design, manufacturing, installation and servicing of the Company's
laser vision correction systems. ISO 9001 Certification is needed when applying
for the CE Mark, necessary for marketing in European Community countries.
PRIVATE PLACEMENT OF COMMON STOCK. On May 26, 1998, the Company completed a
private placement of 600,573 shares of unregistered Common Stock for $5.166 per
share to four European investors (the "Selling Stockholders"). The Common Stock
was sold pursuant to an exemption from the registration requirements of the
Securities Act provided by Section 4(2) thereof. EVEREN Securities, Inc. acted
as placement agent for this sale and was paid a commission of 6% of the gross
3
<PAGE>
proceeds. The Company estimates the net proceeds of this sale to be $2,884,000.
The Company will use the proceeds from the sale of the Common Stock to fund
operating expenses and working capital. The Company agreed to file a
Registration Statement on Form S-3 on behalf of the Selling Shareholders
covering the resale of the shares of Common Stock. This Prospectus forms a part
of the Form S-3, pursuant to which the Shares may be offered from time to time
by the Selling Stockholders.
PRIVATE PLACEMENT OF SERIES I CONVERTIBLE PREFERRED STOCK. On April 16, 1998
the Company completed a private placement with the OZ Master Fund, Ltd. (the
"Investor") of 500 shares of the Company's Series I Convertible Preferred Stock
(the "Initial Shares"), with an option to purchase 400 shares of Series I
Convertible Preferred Stock (the "Option Shares") and a stock purchase warrant
for 300,000 shares of Common Stock (the "Warrant") (collectively, the "Option").
On August 7, 1998, the Company closed the sale of the Initial Shares, which are
convertible into a maximum of 1,750,000 shares of the Company's Common Stock.
In the event the Option is exercised, the Initial Shares and the Option Shares,
together, may be converted into an aggregate maximum of 2,263,197 shares of the
Company's Common Stock. The Company anticipates using the proceeds from the
sale of the Series I Convertible Preferred Stock to fund operating expenses and
working capital. The Series I Convertible Preferred Stock and Option were sold
to the Investor pursuant to an exemption from the registration requirements of
the Securities Act provided by Section 4(2) thereof. The Company has an
effective Registration Statement on Form S-3 on file with the Commission, which
it filed on behalf of the Investor covering the resale of the shares of Common
Stock into which the Initial Shares are convertible. If the Option is
exercised, the Company will file a separate Form S-3 for the shares of Common
Stock underlying the Option Shares and the Warrant.
FOOD AND DRUG ADMINISTRATION PANEL APPROVAL. On February 13, 1998, the FDA's
Ophthalmic Devices Panel reviewed the Company's PMA application for its initial
indications of myopia and astigmatism and unanimously recommended that the FDA
grant the PMA approval for myopia up to -8 diopters and astigmatism up to -4
diopters for the Company's LADARVision System. On July 28, 1998, the Company
received a letter from the Center for Devices and Radiological Health stating
that it concurred with the Panel's recommendation and informed the Company that
its PMA is approvable for up to -10 diopters and sphere and -4 diopters of
cylinder. Delays could occur in receiving final PMA approval of the LADARVision
System resulting from possible delays in passing FDA inspection of the Company's
quality management system in order to manufacture the Systems.
In March 1998, Mr. Bruce Hays joined the Company as Director of Quality and
Compliance. Mr. Hays had been employed by Beckman Coulter for 11 years where
most recently he was responsible for Quality Systems in the Research and
Development Division, with 30 years experience in building complex systems to
high-quality standards. Additionally, in May 1998, Dr. Steven Bott, Ph.D.,
joined the Company as Vice President of Engineering and Product Development.
Dr. Bott also joins the Company after being employed by Beckman Coulter for 15
years where most recently he was Director of Research and Development, with
experience in quality management positions and has significant experience in
developing a manufacturing process that complies with QSR.
PROSPECTIVE INVESTORS SHOULD CAREFULLY CONSIDER THE INFORMATION SET FORTH HEREIN
IN THE SECTION CAPTIONED "RISK FACTORS" WHICH IMMEDIATELY FOLLOWS THIS SECTION
ON PAGE 5.
-------------------------------------
The Company's executive offices are located at 2800 Discovery Drive, Orlando,
Florida 32826,
where it also maintains its primary research and manufacturing facilities.
Its telephone number at that location is (407) 384-1600.
-------------------------------------
4
<PAGE>
RISK FACTORS
In evaluating the Company's business, prospective investors should carefully
consider the following risk factors. This Prospectus contains certain forward-
looking statements within the meaning of Section 27A of the Securities Act of
1933 and Section 21E of the Securities Exchange Act of 1934. Statements of
plans, intentions and objectives by the Company and statements of future
economic performance contained in this Prospectus should be deemed to be
forward-looking statements. Statements containing terms such as "believes,"
"does not believe," "no reason to believe," "expects," "plans," "intends,"
"estimates," "anticipated," or "anticipates" are considered to contain
uncertainty and are forward-looking statements. Cautionary statements are made
in certain sections of this Prospectus. These cautionary statements should be
read as being applicable to all related forward-looking statements wherever they
appear in this Prospectus, the materials referred to in this Prospectus or the
materials incorporated by reference into this Prospectus.
For definitions of certain unique medical and regulatory terms used throughout
this prospectus, please see the Glossary on page 16 of this prospectus.
ABSENCE OF OPERATING HISTORY AND PROFITABILITY; EXPECTED FUTURE LOSSES. The
Company was founded in 1985 to develop laser tracking technology for the
Department of Defense under the Strategic Defense Initiative and did not pursue
development of the LADARVision System product until 1993. The Company has
generated limited revenues to date, of which very little so far relate to its
LADARVision System, and has incurred net losses since 1991 for an aggregate
accumulated total of approximately $36.9 million. The Company's net losses for
the fiscal years ended December 31, 1995, 1996 and 1997 were approximately $4.1
million, $9.0 million, and $11.6 million, respectively. The Company's
LADARVision System may require additional product development, will require
additional clinical studies for indications beyond low and moderate myopia and
astigmatism and will require marketing investment as well as its PMA from the
FDA as a Class III device prior to United States commercialization. There can
be no assurance that any of the Company's product, clinical or market
development efforts will be successfully completed, that regulatory approvals
will be obtained, or that the Company's products will be capable of being
produced in commercial quantities at reasonable cost and quality. Further, it
is expected that the Company will continue to incur substantial losses for some
time after it enters the United States market for laser vision correction, and
there can be no assurance that the Company will attain profitability at any time
in the future.
Management intends to seek funding from time-to-time to ensure adequate
liquidity to fund operations until profitability and positive cash flow is
achieved. As of the date of this prospectus, the Company has completed a sale
of Common Stock to the Selling Stockholders for net proceeds of $2.9 million and
completed a private placement of Series I Convertible Preferred Stock and an
option to purchase additional Series I Convertible Preferred Stock to an
Investor for initial net proceeds of approximately $4.7 million (the Company
will receive additional proceeds of approximately $3.9 million if the Option is
exercised). Additionally, the Company and a financial institution have entered
into a letter of intent whereby the lender may provide up to $15 million of
financing to the Company secured by LADARVision Systems placed in the U.S.
commercial marketplace. See "The Company," page 1.
DEVELOPMENT STAGE COMPANY; GOING CONCERN ACCOUNTANTS' OPINION. The Company is
classified as a development stage company and its financial statements are
therefore presented in accordance with Statement of Financial Accounting
Standards (SFAS) No. 7. The Company must begin generating significant revenues
before SFAS No. 7 permits dropping the development stage company designation.
Additionally, the Company's independent certified public accounting firm has
modified its report on the Company's financial statements as of December 31,
1997, stating that factors discussed in Note 1 to the financial statements raise
a substantial doubt about the ability of the Company to continue as a going
concern. See "Absence of Operating History and Profitability; Expected Future
Losses" for a discussion of the Company's strategy to secure adequate liquidity.
GOVERNMENT REGULATION; FOOD AND DRUG ADMINISTRATION; POSSIBLE FAILURE TO OBTAIN
REGULATORY APPROVAL FOR PRODUCTS. Medical devices are subject, prior to
clearance for marketing, to rigorous pre-clinical and clinical testing mandated
by the FDA and comparable agencies in other countries and, to a lesser extent,
by state regulatory authorities. The Company filed a PMA application with the
FDA for approval of its LADARVision System as a Class III device for treating
low myopia on September 5, 1997 and in November 1997, amended the application to
include myopia with astigmatism. The Company must file an amendment or
amendments to its original PMA application for other vision disorders.
5
<PAGE>
The process of obtaining approval of a PMA application is lengthy, typically
taking approximately one year, is expensive and there is no assurance that a PMA
will be granted at the end of this process. The PMA process requires the
submission of extensive clinical data and supporting information to the FDA.
The PMA process also typically requires a public hearing before an advisory
panel comprised of experts in the field (this hearing took place in February
1998). However, the FDA is not bound by the advisory panel's recommendations.
In late 1996, the FDA issued a definitive statement entitled "FDA Guidance for
Photorefractive Keratectomy Laser Systems: IDE Studies and PMA Applications"
(the "Guidance Document"). The Guidance Document offers companies pursuing FDA
approval of LVC systems substantially more defined filing paths, study design
and execution requirements, and safety and efficacy data levels that will have
to be achieved in order to be a candidate for issuance of a PMA. The Company
believes that the Guidance Document will make the process of obtaining PMA
approvals for LVC systems less uncertain and more predictable but will not
eliminate the risk that the Company will not be granted a PMA. The Company
believes that its engineering, clinical trials and data gathering and analysis,
including that which was accomplished before the existence of the Guidance
Document, are in substantial compliance with the Guidance Document.
Products manufactured and distributed by the Company pursuant to a PMA will be
subject to extensive, ongoing regulation by the FDA. The FDA enabling
legislation, the Food, Drug and Cosmetic Act (the "FDC Act") also requires the
Company to manufacture its products in accordance with its current Quality
System Regulations ("QSR"). The Company's facilities will be subject to
periodic, surprise QSR inspections by the FDA. These regulations impose certain
procedural and documentation requirements upon the Company with respect to
manufacturing and quality assurance activities. QSR regulations are consistent,
to the extent possible, with the requirements for quality systems contained in
applicable international standards, primarily, the International Standards
Organization (ISO) 9001. The Company has recently received its ISO 9001
certification.
The Company's manufacturing facilities must comply with FDA QSR guidelines
before the Company's PMA can be granted. The Company must still pass an FDA
inspection regarding compliance with QSR. Delays could occur in receiving FDA
approval of the LADARVision System resulting from possible delays in obtaining
FDA approval of the Company's quality management system in order to manufacture
the Systems. If any major noncompliances with the QSR guidelines are noted
during facility inspections, continued marketing of the Company's products may
be adversely affected.
Additionally, product and procedure labeling and all forms of promotional
activities are subject to examination by the FDA, and current FDA enforcement
policy prohibits the marketing of approved medical devices for unapproved uses.
Noncompliance with these requirements may result in warning letters, fines,
injunctions, recall or seizure of products, suspension of manufacturing, denial
or withdrawal of PMAs, and criminal prosecution.
In September 1997, the Company filed a PMA application with the FDA for approval
of its LADARVision System as a Class III device. In October 1997, the Company's
PMA application was accepted for review by the FDA. In February 1998, the U.S.
Food and Drug Administration's (FDA) Ophthalmic Devices Advisory Panel
unanimously recommended approval of the PMA for the LADARVision System, within
certain parameters. On July 28, 1998, the Company received a letter from the
Center for Devices and Radiological Health Stating that it concurred with the
Panel's recommendation and informed the Company that its PMA is approvable for
up to -10 diopters of sphere and -4 diopters of cylinder. Final PMA approval
cannot occur until the FDA determines that the Company's manufacturing
facilities, methods and controls comply with the FDA Quality System Regulations.
The FDA typically follows a panel's recommendation and grants the PMA after
product labeling is established and after an inspection finding that the
manufacturer is in compliance with FDA Quality System Regulations. See "Risk
Factor - "Limited Manufacturing Experience; QSR and ISO 9001 Requirements" on
page 7.
The FDA Quality System Regulation and ISO 9001 require the Company to maintain a
supplier-quality program with major sub-contractors in order for the Company's
product to carry the claim of having been manufactured in a quality environment.
The Company must demonstrate that it is properly managing the quality of all of
its vendors. There is always the risk that existing sub-contractors who meet
the requirements currently will not meet them at some time in the future. As a
result, it is possible that the Company's commercial capability could be
hindered at some time in the future because it is unable to pass QSR inspections
by the FDA, its subcontractor's documented quality systems fail to be
sufficient, or the Company is unable to obtain the "CE" mark to enable the
Company to distribute products in Europe in 1998 and beyond. (See "Risks
Associated with International Commercial Activities" on page 11 for a discussion
of the "CE" mark.)
6
<PAGE>
Requirements for regulatory approval relating to the LADARVision System may vary
widely from country to country, ranging from simple product registrations to
detailed submissions such as those required by the FDA. The Therapeutic
Products Directorate of Canada, by letter dated July 28, 1998, informed the
Company that the LADARVision System was reviewed pursuant to the Medical Devices
Regulations and that the System satisfies the requirements for safety and
efficacy for -1 to -10 diopters of sphere and up to -6 diopters of astigmatism.
On August 12, 1998, the Company submitted its application for final approval of
its LADARVision System in Canada. The Therapeutic Products Directorate has 75
days from its receipt of the Company's application to act on the application. No
regulatory clearances have been obtained in any countries, and there is no
assurance that any will be issued.
Changes in existing regulatory requirements or adoption of new requirements
could have a material adverse effect on the Company's business, financial
condition and results of operations. There can be no assurance that the Company
will not be required to incur significant costs to comply with laws and
regulations in the future or that laws and regulations will not have a material
adverse effect on the Company's business, financial condition or results of
operations.
NEED FOR ADDITIONAL CAPITAL TO FUND PLACEMENT OF THE LADARVISION SYSTEMS AND FOR
OPERATIONS. The Company's business strategy calls for the placement of the
LADARVision Systems with ophthalmologists primarily under procedure fee
agreements. As a result, the Company will be required to fund the direct
manufacturing costs of each system, estimated to be $200,000 for each system.
Although the Company intends to receive prepaid fees for the placement of each
machine and to seek financing for additional balances of capital investment,
such prepaid fees and funding will not cover the initial manufacturing and
installation costs of each system. The Company will be required to obtain
financing prior to achieving high volume commercial use of its LADARVision
Systems. The Company has entered into a letter of intent with a financial
institution for financing of LADARVision Systems. See "The Company" on page 1.
There can be no assurance that the Company will be able to obtain funds under
such financing arrangement or similar debt agreement or raise equity capital as
needed for the commercial placement of its LADARVision Systems or, if such
funding is obtained, that the terms of such funding will be favorable to the
Company. Until such time as the cash provided from the procedure fees derived
from LADARVision System placements is sufficient to cover the Company's
clinical, research, development and administrative expenses, the Company will
need additional capital for funding of its operations. These expenses are
currently running at approximately $1.3 million per month. To the extent that
such additional capital is obtained via equity sales, the holdings of existing
shareholders may be materially diluted. Further, additional dilution will occur
to existing shareholders upon the exercise of outstanding warrants and stock
options, the potential issuance of shares to CIBA in 1999, the conversion of
Series I Convertible Preferred Stock and the exercise of the Warrant.
LIMITED MANUFACTURING EXPERIENCE; QSR AND ISO 9001 REQUIREMENTS. The Company's
manufacturing operations consist primarily of the final assembly of out-sourced
parts and components, followed by testing to assure field performance and
quality control. The Company must expand its manufacturing capabilities for
commercial production of the LADARVision System to have the capacity to address
the market. The Company has recently experienced delays in the production of
LADARVision Systems in order for it to finalize its QSR systems and complete
implementation of several engineering changes. The Company believes it will
have the engineering changes and QSR system completed by the end of summer 1998.
After an initial inspection by the FDA in January 1998, the Company addressed
deficiencies in QSR compliance to the FDA and believes it will have its QSR
system ready for FDA inspection by the end of summer 1998, including
manufacturing process validation, which was a deficiency noted in May 1998 by
the FDA. The Company believes it has cured all significant deficiencies. There
can be no assurance that the Company will not continue to experience such
production and FDA inspection difficulties as it converts from a research and
development operation into a commercial manufacturing operation. Any delay in
commercial production beyond the Fall of 1998 could have a material adverse
effect on the Company's operations. In addition, the Company must continue to
meet the FDA's QSR guidelines in order to ship systems for use in the United
States. In addition, if any of the Company's suppliers of significant
components or sub-assemblies cannot meet the quality requirements of the
Company, the Company could be delayed in producing commercial systems for the
United States market. The Company has received its ISO 9001 certification which
is needed when applying for the CE Mark, necessary for marketing in European
Community countries.
RELIANCE ON THIRD PARTY AND SINGLE MANUFACTURER. The Company relies on third
party suppliers to provide the components necessary for the manufacture of the
LADARVision System. The Company-patented laser component of the LADARVision
System is currently manufactured by a small company according to Company-owned
design documentation and specifications. The Company has the right to make or
have made the laser component in the event this manufacturer is
7
<PAGE>
unable to deliver the Company's requirements for the laser component. For a more
detailed discussion of the manufacturer of the laser component, see "The
Company - Single Manufacturer for the Laser Component" on page 3. In addition
to the laser component, the most significant system component is the tracking
hardware. Other components of the LADARVision System such as the stereo
microscope, computer hardware and system casing are available from several
sources. The Company may be unable to obtain sufficient quantities of these
components or it may be unable to effect a change from the laser component
manufacturer to another manufacturer. In these instances, reductions in
manufacturing capability could occur that could cause delays in clinical trials,
regulatory approvals and commercialization which would have a material adverse
effect on the business, financial condition, and results of operations of the
Company.
DEPENDENCE ON PATENTS AND PROPRIETARY TECHNOLOGY. The Company's success will
depend in part on its ability to obtain patents for its products and processes,
to preserve its trade secrets and to operate without infringing upon the
proprietary rights of third parties. In particular, whether the Company can
protect its proprietary tracking and narrow-beam shaping technology is critical
to its ability to differentiate it from existing LVC systems. The Company has
filed fourteen U.S. and foreign patent applications related to several features
of its eye tracking technology as well as to its narrow beam delivery, corneal
sculpting methods and advanced topographical analysis. Five of these
applications have resulted in the issuance of United States patents, which have
expiration dates ranging from 2012 to 2018, and multiple claims for two
additional U.S. patents have been allowed. It is uncertain as to whether any
other patents will be issued, whether the scope of any patent protection will
exclude competitors or provide meaningful competitive advantages to the Company,
whether any of the Company's patents will be held valid if subsequently
challenged, or whether others will not claim rights in or ownership of the
patents and other proprietary rights held by the Company.
In both the United States and overseas, there are a number of patents covering
methods, procedures and apparatus for performing corneal surgery with
ultraviolet laser ablation. Furthermore, there are existing patents in eye
tracking and narrow beam excimer shaping. The patent positions of medical
technology are generally uncertain and involve complex legal and factual
questions. Consequently, the Company does not know whether any of its pending
applications will result in the issuance of any patents or whether issued
patents will provide significant proprietary protection or will be circumvented
or invalidated. Since patent applications in the United States are maintained
in secret until patents are granted and since publication of inventions in
scientific or patent literature tend to lag behind patent grants by several
months, the Company cannot be certain that it was the first creator of
inventions covered by its pending patent applications or that it was the first
to file patent applications for such inventions.
PATENT LITIGATION. There has been significant patent litigation in the medical
device industry generally, and in LVC in particular. The defense and
prosecution of patent proceedings is costly and involves substantial commitments
of management time. Adverse determinations in litigation or other patent
proceedings to which the Company may become a party could subject the Company to
significant legal judgments or other liabilities to third parties and could
require the Company to seek licenses from third parties that may or may not be
obtainable and may or may not be economically viable. Patent and other
intellectual property disputes in the medical device industry often are settled
through licensing arrangements. The costs associated with such arrangements may
be substantial, and could include ongoing royalties. Furthermore, there can be
no assurances that a settlement through licensing can be reached, accordingly,
an adverse determination in a judicial or administrative proceeding, or the
Company's failure to obtain necessary licenses, could prevent the Company from
manufacturing and selling its products in one or more markets, which could have
a material adverse effect on the Company's business, financial condition and
results of operations.
Two of the Company's competitors, Summit Technology, Inc. ("Summit") and VISX,
Inc. ("VISX") formed a United States partnership, Pillar Point Partners ("Pillar
Point"), in 1992 to pool certain of their respective patents related to corneal
sculpting technologies. In October 1996, the Company filed suit in the U.S.
against Pillar Point, Summit and VISX alleging non-infringement,
unenforceability and invalidity of certain of the patents then controlled by
Pillar Point. On June 9, 1998, Summit and VISX announced that they had reached
agreement on the dissolution of Pillar Point to be effected as soon as possible.
As a part of the dissolution of Pillar Point, Summit and VISX granted each other
a worldwide, royalty free cross-license whereby each party will have full rights
to license all existing patents owned by either company relating to LVC for use
with their systems. The dissolution of Pillar Point will not affect the
Company's lawsuit against Summit and VISX, however, there can be no assurance
that the Company will prevail in this lawsuit or that other such suits will not
arise. As of the date of this prospectus, this suit has proceeded into the
discovery phase. See "Item 3. - Legal Proceedings" in the Company's Annual
Report on Form 10-K for the fiscal year ended December 31, 1997.
8
<PAGE>
TECHNOLOGY LICENSES FROM VISX AND OTHERS. Depending upon whether the Company's
LADARVision System incorporates patented technology owned by VISX and as may be
required by any license agreement that the Company may enter into with VISX, the
Company or its LADARVision System users may be required to pay royalties and per
procedure fees to VISX for all revenues generated in the United States. The
Company has not obtained a license from VISX as of this date, and the actual per
procedure fee and other terms of any license, if such license is granted, have
yet to be determined. The Company has been informally advised by Summit, and the
Company believes, that the LADARVision System or its use does not infringe on
patents owned by Summit. However, there can be no assurances that the Company
will not be required to obtain a license from Summit with regard to patents
owned by Summit.
In addition, there may be other United States and foreign patents for which the
Company will need to negotiate licenses in order to sell, lease or use the
LADARVision System in certain markets.
There can be no assurance that the Company or its customers will be successful
in securing licenses, including any necessary licenses from VISX or others, or
that if the Company does obtain licenses, such licenses will be on terms
acceptable to the Company. The failure to either obtain required licenses or to
obtain licenses on terms favorable to the Company could have a material adverse
effect on the business of the Company.
LIMITED HUMAN CLINICAL TRIAL DATA IN HYPEROPIA AND LASIK; LACK OF LONG-TERM
FOLLOW-UP. Substantial additional human clinical trials must be completed under
rigorous protocols at multiple sites in order to submit the required outcome
data for hyperopia/astigmatism and LASIK with the Company's PMA application(s).
The Company currently anticipates completing patient enrollment for these two
additional patient protocols by December 1998; however, there can be no
assurances that the Company will be able to complete the patient enrollment by
that date. The results of the Company's early clinical trials in
myopia/astigmatism appear satisfactory, but may not be indicative of results to
be expected in future clinical trials for expanded indications. If the
Company's clinical trials do not show consistently good outcomes, the Company
may not be able to secure a PMA for its products. Moreover, the results of
clinical trials are not within the Company's control, and the Company could
experience delays in completing its clinical trials for a variety of reasons.
Any failure to obtain a PMA or delay in clinical trials would have a material
adverse effect on the Company's business, financial condition and results of
operations.
There have been concerns with respect to the safety and efficacy of LVC,
including the predictability and stability of results. Potential complications
and side effects in early LVC systems have included post-operative discomfort
due to re-epithelialization (eye membrane re-growth); corneal haze during
healing (an increase in the light scattering properties of the cornea);
glare/halos (undesirable visual sensations produced by bright lights); decreases
in contrast sensitivity; temporary increases in intraocular pressure in reaction
to topical medication administered during and after the procedure; fluctuations
in refractive capabilities during healing; occasional decreases or permanent
loss in best corrected vision post-operatively (i.e., with corrective eyewear);
unintended over-corrections or under-corrections; regression of operative
effect; disorders of corneal healing; corneal scars; corneal ulcers and
unintentionally induced astigmatism. It is entirely unpredictable as to whether
long-term follow-up data on either clinical or later commercial patients from
any LVC system will reveal additional complications that may have a material
adverse effect on acceptance of LVC and market size which in turn would have a
material adverse effect on the Company's business, financial condition and
results of operations. Concern over the safety of LVC in general could, in
turn, result in adverse regulatory action which could have a material adverse
effect on the Company's business, financial condition and results of operations.
UNCERTAIN MARKET ACCEPTANCE OF LVC. The Company believes that its long-term
growth and ultimate profitability will depend upon acceptance of LVC in the
United States and certain international markets and the Company's ability to
penetrate the LVC market successfully. LVC has only been marketed in the United
States for approximately three years and initial market growth has been slower
than originally anticipated in 1994 (market estimates published by Market Scope
(www.mktsc.com) have shown approximately 100,000 and 250,000 U.S. procedures for
the calendar years 1996 and 1997, respectively). The degree of eventual
acceptance of LVC by ophthalmologists and persons needing refractive correction
as an alternative to existing methods of treating or correcting vision disorders
is still undeterminable. The acceptance of LVC by the general population may be
affected adversely by its retail price (which is not expected to be reimbursed
to the patient by medical insurance), concerns relating to its safety and
efficacy, and the accepted effectiveness of alternative methods of correcting
refractive vision disorders. Additionally, the current lack of long-term
follow-up data, the possibility of unknown side effects, and the expected lack
of third-party reimbursement for the procedure might also adversely affect
demand. Any
9
<PAGE>
future reported adverse events or other unfavorable publicity involving patient
outcomes from the use of legal or illegal LVC systems manufactured by any
participant in the LVC market could also adversely affect consumer acceptance.
Ophthalmologist and optometrist acceptance (the latter for referrals) could also
be affected by the high costs and expenses of excimer laser systems, which might
preclude access to such systems by some professionals. In addition, the
Company's marketing strategy relies, in part, on ophthalmologists who are
currently using an existing excimer laser system to replace their equipment with
the Company's LADARVision System. Emerging new refractive surgery technologies
and procedures may also have the potential to compete with or materially limit
the acceptance of LVC. Current ophthalmic product suppliers whose products,
including eyeglasses and contact lenses, are alternatives to LVC also may
adversely affect the market acceptance of LVC by their retail marketing
strategies, including aggressive pricing. The failure of LVC to achieve broad
market acceptance would have a material adverse effect on the Company's
business, financial condition and results of operations. There can be no
assurance that there will be demand for the Company's LADARVision System.
RAPIDLY CHANGING TECHNOLOGY; HIGHLY COMPETITIVE MARKETS. The refractive surgery
market is characterized by rapidly evolving technology and intense competition.
The Company is aware of two companies, Summit and VISX, that have been granted
their PMA's and are actively marketing LVC systems in the United States for
myopia and astigmatism. Several companies, including Bausch & Lomb's Surgical
Division (formerly Chiron/Technolas), Coherent/Schwind, Nidek, Meditek,
Lasersight and Novatec, have introduced LVC systems outside the United States,
where LVC has been commercialized for treating refractive disorders. Three of
these companies have made announcements of PMA filings with the FDA subsequent
to the Company's filing, indicating substantial completion of their U.S. Phase
III protocols. Other companies either have begun or may soon begin clinical
trials in the United States, including Phase III trials, the last stage before
approval. LVC providers who purchase equipment from Summit or VISX may be
reluctant to change to the new LADARVision System because of the significant
capital investment they have made or the familiarity with the equipment and the
inconvenience of changing to a new system. If other providers of LVC systems
are able to saturate the United States market with their equipment before the
Company obtains FDA approval to market the LADARVision System in the United
States, the Company could experience a significantly lower share of the market
than anticipated which would have a material adverse effect on the Company's
business, financial condition and results of operations.
Several of the Company's competitors have allied with or developed their own
vision care centers in Europe and the United States and have entered into
strategic alliances with prominent corporations in the worldwide ophthalmic
industry to promote their LVC excimer lasers. Many of these companies have
substantially greater capabilities than the Company in the areas of capital
resources, research and development resources and regulatory, manufacturing and
marketing experience. There can be no assurance that the Company's competitors
will not succeed in developing or marketing technologies and products that are
more effective and less expensive than those developed or marketed by the
Company or that would render the Company's technology and products obsolete or
noncompetitive.
Non-laser corrective refractive procedures and technologies are under
development, and it is possible that these technologies and procedures will be
successfully developed as competition to the Company's technology.
RELIANCE ON A SINGLE POTENTIAL PRODUCT. Currently the Company's only
significant planned product is the LADARVision System for refractive correction.
The Company's existing plans assume that it will derive substantially all of its
revenues from the LADARVision System. If the Company is unable to make
significant commercial placements of the LADARVision System for vision
correction, the viability of the Company would be jeopardized. Furthermore, if
the Company is unable to successfully design, clinically test and gain FDA
approval on various indications, such as low and moderate myopia, astigmatism,
and hyperopia, the Company's future growth could be significantly limited.
DEPENDENCE ON AND NEED FOR KEY PERSONNEL; POTENTIAL FAILURE TO MANAGE GROWTH.
Prior to 1995, the Company relied on consultants and contractors to assist
senior management in certain financial, regulatory, marketing and manufacturing
functions. Since 1995, the Company has attracted senior personnel in marketing,
clinical trials management, finance, research, engineering and operations. As
the Company continues the clinical development of the LADARVision System and
prepares for regulatory approvals and other commercialization activities, it
will need to continue to implement and expand its operational, financial and
management resources and controls. Particularly important will be the need of
the Company to build a manufacturing and field service organization. The
failure of the Company to attract and retain experienced individuals for these
positions, as well as any inability of the Company to effectively manage growth
in its domestic and
10
<PAGE>
international operations as it transitions from a development stage enterprise
to a commercial entity, could have a material adverse effect on the Company's
business, financial condition and results of operations .
The Company follows a policy of "at-will" employment and has no employment
contracts with any of its employees. The Company is in the process of obtaining
key-man life insurance for all of its officers. Not all of its officers are yet
covered under the key-man life insurance. There can be no assurance that the
Company will be able to obtain key-man life insurance on each of its officers.
NO SIGNIFICANT SALES AND MARKETING EXPERIENCE; RELIANCE TO DATE ON STRATEGIC
ALLIANCE PARTNER. The Company's efforts to date have focused on the development
and evaluation of the LADARVision System for treating refractive disorders. As
the Company continues clinical studies with the LADARVision System and prepares
for commercialization of the product internationally and in the United States,
it must build a sales and marketing infrastructure. The Company has limited
experience in the sales and marketing of capital equipment for laser vision
correction. In 1994 and 1995, the Company entered into agreements that form a
strategic alliance with CIBA for the worldwide co-promotion of the Company's
LADARVision System excimer laser. Although it has developed a strong reputation
in certain ophthalmic markets such as contact lenses, lens care and ophthalmic
pharmaceuticals, CIBA does not have considerable experience in the sale of
ophthalmic equipment or in the refractive surgery market. It is possible that
the Company will not be able to attract the personnel to develop the
infrastructure to effectively market the LADARVision System or that CIBA will
not be able to provide sufficient or effective co-marketing and business
support.
RISKS ASSOCIATED WITH INTERNATIONAL COMMERCIAL ACTIVITIES. International
commercial activities may be limited by or disrupted by the imposition of
government controls, unique license requirements, political instability, trade
restrictions, changes in tariffs or taxes, regional economic conditions, such as
currently in Asia, currency fluctuations and changes, and difficulties in
staffing and managing such complexities.
The Company has received its ISO 9001 certification, which is needed when
applying for a "CE" mark certification, an international symbol of quality and
compliance with applicable European medical device directives. Until the
Company receives its CE Mark certification it is prohibited from placing the
LADARVision System in Europe which could have a material adverse effect on the
business, financial condition, and results of operations of the Company. The
Company expects to apply for the CE Mark in the fall of 1998.
COMMISSION OBLIGATION TO CIBA; FUTURE DILUTION. As part of the strategic
alliance with CIBA, the Company will pay a 6% commission on net revenue
worldwide from all equipment sales and patient procedure fees relating to
ophthalmic refractive surgery. The initial commission is limited to $10,000,000
in the aggregate. In the event the Company has not paid commissions to CIBA
totaling $10,000,000 or more by May 15, 1999, the Company must deliver to CIBA
171,713 shares Common Stock (the "Additional Shares"), and continue to pay
commissions until the $10,000,000 aggregate amount is reached. If the
Additional Shares are issued, the number of such shares must be adjusted so that
the Additional Shares have a market value of at least $675,000 on May 15, 1999.
The Company's current business plan contemplates that commissions to CIBA by May
15, 1999 will not total $10,000,000. Therefore, it should be assumed that the
Company will issue the Additional Shares on May 15, 1999. The 6% commission
will reduce the Company's income and margins from its business for the period it
is payable, and the Additional Shares are prospectively dilutive to stockholders
in 1999.
POSSIBLE TERMINATION OF STRATEGIC ALLIANCE WITH CIBA. The strategic alliance
provides CIBA and the Company with certain termination rights. CIBA may, at its
sole discretion, terminate the strategic alliance upon 180 days notice to the
Company. In such event, the Company would be obligated to continue to pay to
CIBA for up to three years beyond termination the 6% commission on procedure fee
revenue derived from LADARVision Systems that were commercially placed at the
time of the termination. Additionally, CIBA has the right to terminate the
strategic alliance upon 30 days notice should there be a change of control of
the Company (defined as the transfer of greater than 50% of the voting stock or
substantially all of the assets of the Company in a single transaction or series
of related transactions, excluding a bona fide public offering). CIBA also has
the right to terminate the strategic alliance upon 30 days notice if it
determines, in its sole discretion, that the Company's core technology or the
commercial essence of the technology is not patentable, or that additional
licenses (other than that with VISX or Summit) are necessary, are not obtained
or would have a material adverse impact upon the commercial value of the
Company's technology. CIBA also has the right to terminate such agreement (i)
if the Company materially breaches such agreement and does not cure such breach
within the cure period, (ii) if the Company
11
<PAGE>
becomes insolvent, or (iii) if the control of the Company falls into the hands
of a competitor to CIBA. In the event that CIBA terminates the strategic
alliance, such termination would have a material adverse effect on the
operations, financial condition and the results of operations of the Company, in
that the Company would be unable to utilize the CIBA name in connection with
marketing the LADARVision System, or to utilize other planned services as agreed
to in the strategic alliance.
POTENTIAL PRODUCT LIABILITY CLAIMS AND UNINSURED RISKS. The Company's business
involves the risk of product liability claims. Any inability of the Company to
maintain adequate insurance coverage at any time could, in the event of product
liability or other claims in excess of the Company's insurance coverage, have a
material adverse effect on the Company's business, financial condition and
results of operations. The Company currently has product liability insurance
coverage which it believes is adequate and which covers the Company's exposure
under both clinical and commercial surgeries. This is a "claims made" product
liability insurance policy with coverage limits of $5 million per occurrence and
$5 million in the aggregate annually. The Company has in the past agreed, and
is likely to in the future agree, to indemnify certain medical institutions and
personnel thereof conducting and participating in the Company's clinical
studies. The Company will indemnify its commercial customers for product
liability claims arising out of defects, if any, in the system.
VOLATILITY OF STOCK PRICE. The Company's Common Stock has experienced
substantial price volatility, and such volatility may occur in the future.
Additionally, the stock market has from time to time experienced significant
price and volume fluctuations that are unrelated to the operating performance of
particular companies. These broad market fluctuations may adversely affect the
market price of the Company's Common Stock. In addition, the market price of
the shares of Common Stock is likely to be highly volatile. Factors such as
fluctuations in the Company's operating results, announcements of technological
innovations or new products by the Company or its competitors, FDA and
international regulatory actions, developments with respect to patents or
proprietary rights, including lawsuits, the perceived ability of the Company to
obtain any new financing necessary, public concern as to the safety of products
developed by the Company or its competitors, changes in health care policy in
the United States and internationally, changes in analysts' recommendations
regarding the Company, other LVC or medical device companies or the medical
device industry generally and general market conditions may have a significant
effect on the market price of the Common Stock.
CONTROL BY CERTAIN EXISTING STOCKHOLDERS. The directors, executive officers and
certain entities affiliated with directors of the Company beneficially own
approximately 23.2% of the Company's outstanding Common Stock. Accordingly,
these stockholders, individually and as a group, may be able to influence the
outcome of stockholder votes, including votes concerning the election of
directors, the adoption or amendment of provisions in the Company's Third
Amended and Restated Articles of Incorporation (the "Articles") and Bylaws and
the approval of certain mergers or other similar transactions. Such control by
existing stockholders could also have the effect of delaying, deferring or
preventing a change in control of the Company.
NO FORESEEABLE DIVIDENDS. The Company has never paid cash dividends on its
capital stock and does not anticipate paying cash dividends in the foreseeable
future. The Company intends to retain future earnings for reinvestment in its
business. Any future determination to pay cash dividends will be at the
discretion of the Board of Directors and will be dependent upon the Company's
financial condition, results of operations, capital requirements and such other
factors as the Board of Directors deems relevant.
ANTI-TAKEOVER MEASURES; POTENTIAL ADVERSE EFFECT ON COMMON STOCK PRICE. The
Company's Articles authorize the Company's Board of Directors to issue shares of
the Company's Preferred Stock and to determine the rights, preferences,
privileges and restrictions of such shares without any vote or action by the
stockholders. The issuance of Preferred Stock under such circumstances could
have the effect of delaying or preventing a change in control of the Company.
The rights of the holders of the Common Stock will be subject to, and may be
adversely affected by, the rights of the holders of any Preferred Stock that may
be created and issued in the future. In addition, the Company's Articles
provide that any action to be taken by written consent in lieu of an annual or
special meeting of the stockholders is prohibited unless the use of written
consents is approved in advance thereof by the Board of Directors and that an
affirmative vote of the holders of not less than two-thirds of the outstanding
voting shares is required to amend such prohibition of use of written consents
by the stockholders set forth above.
12
<PAGE>
In addition, certain provisions of the Florida Business Corporation Act have
anti-takeover effects and may inhibit a non-negotiated merger or other business
combination. These statutory provisions are intended to encourage any person
interested in acquiring the Company to negotiate with and obtain the approval of
the Board of Directors in connection with such a transaction. One of the
effects of the provisions described above may be to discourage a future attempt
to acquire control of the Company that is not presented to and approved by the
Board of Directors, but which a substantial number, and perhaps even a majority
of the Company's stockholders, might believe to be in their best interests or in
which stockholders might receive a substantial premium for their shares over the
current market prices. As a result, stockholders who might desire to
participate in such a transaction may not have an opportunity to do so.
SHARES ELIGIBLE FOR RESALE. At August 18, 1998, the Company had 11,326,491
shares of Common Stock outstanding. Of the shares of Common Stock currently
outstanding, the Company estimates that there are currently 1,710,000
unregistered shares of Common Stock outstanding of which 674,500 may be freely
traded or may be traded under certain volume and other restrictions set forth in
Rule 144 (as recently amended).
At August 18, 1998, the Company had reserved 1,932,480 shares of Common Stock
for issuance pursuant to the 1995 Stock Option Plan and the 1996 Employee Stock
Purchase Plan (collectively, the "Stock Plans"). Of this amount, 1,567,766
shares were subject to outstanding options at August 18, 1998, with a weighted
average exercise price of $4.26 per share. Since the Stock Plans have been
registered on Form S-8 with the SEC, Common Stock issued in conjunction with the
Stock Plans are generally eligible for resale in the open market.
At August 18, 1998, the Company has reserved 925,350 shares of Common Stock for
issuance upon the exercise of warrants outstanding. At the current time, should
such warrants be exercised, they would generally result in unrestricted Common
Stock being issued. Of these 925,350 warrants, all are exercisable at August
18, 1998, with a weighted average exercise price of $4.02 per share, and 820,350
are "in the money."
Certain holders of the Company's Common Stock and stock purchase warrants
totaling 468,821 shares (together, the "Registrable Securities") have certain
rights to cause the Company to register the sale of such shares under the
Securities Act. If the Company proposes to register any of its securities under
the Securities Act for its own account, holders of the Registrable Securities
are entitled to notice of such registration and are entitled to include
Registrable Securities therein, provided, among other conditions, that the
underwriters, if any, of such offering have the right to limit the number of
shares included in such registration. Of the total number of Registrable
Securities, 438,821 shares of the 1,695,371 shares owned by CIBA are included
in the total of Registrable Securities. CIBA may require the Company to file
additional registration statements covering those shares of Common Stock it
owns, which are not otherwise registered, on Form S-3, subject to certain
conditions and limitations. Registration of such shares under the Securities
Act would result in such shares becoming freely transferrable under the
Securities Act (except for shares held by affiliates of the Company) immediately
upon the effectiveness of such registration. CIBA has waived its right to have
shares registered on this Form S-3.
No prediction can be made as to the effect, if any, that sales of shares of
Common Stock under Rule 144 or pursuant to the registration rights described
above, or the future availability of such shares for sale, will have on the
market price of the Common Stock. Sales of substantial amounts of Common Stock
in the public market, or the perception that such sales could occur, could
adversely affect prevailing market prices for the Common Stock.
POTENTIAL ADVERSE EFFECTS OF SERIES I CONVERTIBLE PREFERRED STOCK CONVERSIONS;
NEW SIGNIFICANT STOCKHOLDER; POTENTIAL DECLINE IN PRICE OF COMMON STOCK. The
Initial Shares sold (see "Recent Developments," page 3) are convertible into a
maximum of 1,750,000 shares of Common Stock (the "Initial Maximum Shares"). In
the event the Option is exercised, the Initial Shares and the Option Shares,
together, are convertible into an aggregate maximum of 2,263,197 shares of
Common Stock (the "Total Maximum Shares"). Upon the exercise of the Option, the
Investor will receive the Warrant for 300,000 shares of Common Stock. In the
event all such conversions occur for the Total Maximum Shares, the Warrant is
exercised and the Investor retains ownership of all such shares, the Investor
would own 2,563,197 shares of Common Stock (see "Recent Developments," page 3)
which would be an 18.5% interest in the Company's Common Stock. If this
beneficial interest in the Company's Common Stock is established by the
Investor, the Investor would be the largest beneficial owner of the Company's
Common Stock.
13
<PAGE>
The Investor may convert the Series I Convertible Preferred Stock at a maximum
rate of 115 shares of Series I Convertible Preferred Stock per month. Thus, the
conversion of the Initial Shares may occur over a period of approximately 5
months. As an example, based on an average trading price of $4.50 per share, 115
shares of Series I Convertible Preferred Stock would be convertible into 283,951
shares of Common Stock per month where the conversion formula is based on 90% of
the $4.50 per share trading price. The Investor will be able to convert into
the Initial Maximum Shares if the conversion price drops below $2.86 per share,
which represents 90% of a trading price of $3.18 per share. The limitation
imposed on conversion of the Series I Convertible Preferred Stock (115 shares
each 30 days as described in the Company's Articles of Incorporation) may not be
waived or changed by the Company without amending the Company's Articles of
Incorporation with respect to this provision. Such amendment could only occur
upon adoption of such amendment by the vote or consent by the holders of a
majority of the shares of both Common Stock and Series I Convertible Preferred
Stock.
The conversion feature of the Series I Convertible Preferred Stock operates such
that the Investor receives more shares of Common Stock upon conversion when the
market price of the Company's Common Stock is lower. In the event the trading
price of the Company's Common Stock decreases such that the Investor is able to
convert less than the total number of Initial Shares into the Initial Maximum
Shares (1,750,000 shares); or in the event the Option is exercised and the
Investor is able to convert less than the total of the Initial Shares and the
Option Shares, together, into the Total Maximum Shares (2,263,197 shares), and
as a result, the Investor has shares of Series I Convertible Preferred Stock
remaining in its possession following all such conversions, the Company is
obligated to redeem those remaining shares of Series I Convertible Preferred
Stock for an amount equal to 110% of the face value of the remaining shares of
Series I Convertible Preferred Stock. Thus, the Investor will receive $11,000
(110% of the Series I Convertible Preferred Stock face value of $10,000 per
share) for every share of Series I Convertible Preferred Stock redeemed by the
Company. In this event, the Investor will realize a gain on its redeemed
investment without being exposed to uncertain market and trading conditions.
Further, in the event the price of the Common Stock declines during that time
within which the investor holds shares of Series I Convertible Preferred Stock,
the number of shares of Common Stock issuable upon conversion will increase
proportionately to no more than the aforementioned limits. There have been
instances of a stock price decline in other companies' shares of common stock
upon the sale of similar convertible securities, where such decline occurs in
anticipation of the conversion and sale of those companies' common stock into
the public market. The Company is unable to predict the effect that the
conversion of the Series I Convertible Preferred Stock into Common Stock and the
sale of the Common Stock into the public market will have on the price of the
Company's Common Stock. In the event the Investor sells a large number of
shares of Common Stock into the public market over a short time period, the
market price of the Company's Common Stock could decline. Such a decline in the
price of the Company's Common Stock may make future financing more difficult for
the Company to obtain on a favorable basis, if at all.
There are hazards for small companies issuing shares of convertible preferred
stock which are convertible at a floating ratio based on the stock price. Short
selling by the purchaser of convertible preferred stock could result in large
profits to the purchaser by driving the market price down, then converting the
convertible preferred stock at a low price. In the event of a downturn in the
price of the Company's Common Stock, the Investor could profit through a low
conversion price. Sales of shares of Common Stock by the Investor, whether
through short or long selling, could have the effect of driving the market price
down after which the Investor could convert additional shares of Series I
Convertible Preferred Stock at the lower price, then sell those shares after the
market price has risen to a higher level. There is a limitation on the number
of shares into which the Shares may be converted and a limitation on the number
of shares of Series I Convertible Preferred Stock which may be converted during
the next eight months.
"PENNY STOCK" TRADING RULES. In the event the Common Stock is delisted and no
longer quoted on Nasdaq, the Common Stock may become subject to the SEC's "penny
stock" trading rules. The penny stock trading rules impose additional duties
and responsibilities upon broker-dealers and salespersons effecting purchase and
sale transactions in common stock and other equity securities, including
determination of the purchaser's investment suitability, delivery of certain
information and disclosures to the purchaser, and receipt of a specific purchase
agreement from the purchaser prior to effecting the purchase transaction. In
addition, many broker-dealers will not effect transactions in penny stocks,
except on an unsolicited basis, in order to avoid compliance with the penny
stock trading rules. In the event the Common Stock becomes subject to the
"penny stock" trading rules, such rules may materially limit or restrict the
ability of a holder to resell such equity securities, and the liquidity
typically associated with listed publicly traded equity securities may not
exist.
14
<PAGE>
SELLING STOCKHOLDERS
The Common Stock was acquired from the Company pursuant to Purchase Agreements
at a price of $5.166 per share. The offer and sale by the Company of the Common
Stock to the Selling Stockholders pursuant to the Purchase Agreements was made
pursuant to an exemption from the registration requirements of the Securities
Act provided by Section 4(2) thereof. The Purchase Agreements contain
representations and warranties as to the Selling Stockholders' status as
"accredited investors" as such term is defined in Rule 501 under the Securities
Act.
Pursuant to the Purchase Agreements, the Selling Stockholders have represented
that they acquired the Common Stock for investment and with no present intention
of distributing the Common Stock. The Company agreed, in such Purchase
Agreements, to prepare and file a registration statement as soon as practicable
and to bear all expenses other than underwriting discounts and commissions and
brokerage commissions and fees. In addition, and in recognition of the fact
that the Selling Stockholders, even though purchasing the Common Stock without a
view to distribution, may wish to be legally permitted to sell the Shares when
each deems appropriate, the Company filed with the Commission a Registration
Statement on Form S-3, of which this Prospectus forms a part, with respect to,
among other things, the resale of the Shares as described below under "Plan of
Distribution."
The Selling Stockholders have not had a material relationship with the Company
within the past three years except as a result of the ownership of the Common
Stock.
The following table sets forth the name of the Selling Stockholders, the number
of Shares beneficially owned by the Selling Stockholders as of May 26, 1998 and
the number of Shares which may be offered pursuant to this Prospectus. This
information is based upon information provided by the Selling Stockholders. The
Shares are being registered to permit public secondary trading of the Shares,
and the Selling Stockholders may offer the Shares for resale from time to time.
<TABLE>
<CAPTION>
- ------------------------------------------------------------------------------------------------
Number of Shares Owned Ownership After
Prior to Offering (1) Offering
- ------------------------------------------------------------------------------------------------
Number of
Name of Number of Shares Being Number of
Selling Stockholder Shares Percent (2) Offered Shares Percent
- --------------------------------------------------------------------------------------------------
<S> <C> <C> <C> <C> <C>
The British Life Office Limited 250,000 2.2% 107,000 143,000 1.3%
- --------------------------------------------------------------------------------------------------
Veritas SG Investment Trust GMBH 621,500 5.5% 193,573 427,927 3.8%
- --------------------------------------------------------------------------------------------------
FIM Securities Ltd. 100,000 0.9% 100,000 0 0%
- --------------------------------------------------------------------------------------------------
Deutscher Investment Trust GMBH 200,000 1.8% 200,000 0 0%
- --------------------------------------------------------------------------------------------------
</TABLE>
(1) The number of Shares beneficially owned is determined under rules
promulgated by the Commission, and the information is not necessarily
indicative of beneficial ownership for any other purpose.
(2) Percent of total shares of Common Stock outstanding as of August 18, 1998.
PLAN OF DISTRIBUTION
The Company will receive no proceeds from this offering. The Shares offered
hereby may be sold by the Selling Stockholders from time to time in transactions
on the Nasdaq National Market, in the over-the-counter market, in negotiated
transactions, through the writing of options on the Shares or a combination of
such methods of sale, at fixed prices which may be changed, at market prices
prevailing at the time of the sale, at prices related to prevailing market
prices or at negotiated prices. The Selling Stockholders may effect such
transactions by selling the Shares to or through broker-dealers, and such
broker-dealers may receive compensation in the form of discounts, concessions or
commissions from the Selling Stockholders and/or the purchasers of the Shares
for whom such broker-dealers may act as agents or to whom they sell as
principals, or both (which compensation to a particular broker-dealer might be
in excess of customary commissions).
15
<PAGE>
In order to comply with the securities laws of certain states, if applicable,
the Shares will be sold in such jurisdictions only through registered or
licensed brokers or dealers. In addition, in certain states the Shares may not
be sold unless they have been registered or qualified for sale in the applicable
state or an exemption from the registration or qualification requirement is
available and is complied with.
The Selling Stockholders and any broker-dealers or agents that participate with
the Selling Stockholders in the distribution of the Shares may be deemed to be
"underwriters" within the meaning of the Securities Act, and any commissions
received by them and any profit on the resale of the Shares purchased by them
may be deemed to be underwriting commissions or discounts under the Securities
Act.
Under applicable rules and regulations under the Exchange Act, any person
engaged in the distribution of the Shares may not simultaneously engage in
market making activities with respect to the Common Stock of the Company for a
period of two business days prior to the commencement of such distribution, in
addition and without limiting the foregoing, the Selling Stockholders will be
subject to the applicable provisions of the Exchange Act and the rules and
regulations thereunder, which provisions may limit the timing of purchases and
sales of shares of the Company's Common Stock by the Selling Stockholders.
Any or all of the sales or other transactions involving the Shares described
above, whether effected by the Selling Stockholders, any broker-dealer or
others, may be made pursuant to this Prospectus. In addition, any Shares that
qualify for sale pursuant to Rule l44 under the Securities Act may be sold under
Rule 144 rather than pursuant to this Prospectus.
The Shares were issued to the Selling Stockholders pursuant to an exemption from
the registration requirements of the Securities Act provided by Section 4(2)
thereof. The Company agreed to register the Shares under the Securities Act and
to indemnify and hold the Selling Stockholders harmless against certain
liabilities under the Securities Act that could arise in connection with the
sale by the Selling Stockholders of the Shares. The Company has agreed to pay
all reasonable fees and expenses incident to the filing of this Registration
Statement.
EXPERTS
The financial statements incorporated by reference to the Annual Report on Form
10-K/A, in this Prospectus and elsewhere in the registration statement have been
audited by Arthur Andersen LLP, independent certified public accountants, as
indicated in their report with respect thereto, and are included herein in
reliance upon the authority of said firm as experts in auditing and accounting
in giving said report.
GLOSSARY
Ablation: Laser interaction with biological material whereby its
molecular bonds are agitated, released and the material is
removed in sub-micron amounts.
Astigmatism: Condition where surface of the cornea is not uniform, having
two different curvatures, that causes incoming light to be
focused at different points.
BSCVA: Best Spectacle Corrected Visual Acuity. The FDA's primary
measure of safety in LVC procedures. The FDA requires
gathering data and reporting on patients who lose more than
2 lines (on the standard ETDRS eye chart) of corrected (if
needed) visual acuity post-operatively, as compared to that
patient's best pre-operative corrected visual acuity.
CE Mark: Conformite Europeenne Mark. Required for all medical device
shipments into the European Union. It is a worldwide
standard for safety and quality assurance.
Class III Device: The FDA's device significance rating. The most difficult and
stringent trials and data requirements are placed on Class
III Devices, including implants such as pacemakers, heart
valves and artificial joints.
16
<PAGE>
Cornea: Transparent, sturdy tissue at the front of the eye that is
the eye's primary focusing element.
Decentration: To effect accurate oblations, the laser treatment must be
accurately centered on the pupil. Decentration is when this
does not occur and the patient's outcome is sub-optimal.
Diopter: A measurement unit of refractive error.
Hyperopia: Farsightedness that occurs when the curvature of the cornea
is too flat. As a result, light rays are focused behind,
instead of on, the retina and the person cannot see close
objects clearly. (Not to be confused with presbyopia.)
LASIK: Laser-In-situ Keratomileusis. A laser vision correction
procedure in which a flap is cut in the cornea and then
pulled back to allow a laser to remove a small amount of
tissue from the inner layers of the cornea.
LVC: Laser vision correction.
Myopia: Nearsightedness that occurs when the curvature of the cornea
is too steep. As a result, light rays are focused in front
of, instead of on, the retina and the person can not see
distant objects clearly.
Photorefractive
Keratectomy (PRK): Refractive surgery technique in which a laser is used to
remove or ablate submicron layers of the corneal tissue to
reshape the cornea.
Pillar Point
Partners: A United States patent pooling agreement formed by VISX and
Summit to solve patent disputes between them. The pooling
arrangement required the physician to pay PPP a certain
royalty on every laser vision correction procedure. The
partnership was recently dissolved by the forming parties.
PMA: Pre-market approval. The FDA's name for the approval to
begin commercial activities in the United States market.
Presbyopia: Vision condition that occurs in older individuals in which
the eye loses its ability to focus on near objects. The lens
is the ineffective refractive median in presbyopia.
QSR Guidelines: Quality System Regulation guidelines. The FDA's primary set
of rules that companies must follow in the design,
manufacture and modification of medical devices.
Refractive Surgery: Any surgery on the cornea or lens that changes the focal
point of light on the retina.
Saccadic Eye
Movements: Very rapid, involuntary movements of the eye that are random
in amplitude and direction.
17
<PAGE>
No dealer, salesperson or other person has been authorized to give any
information or to make any representations other than those contained in this
Prospectus and, if given or made, such information or representations must not
be relied upon as having been authorized by the Company, the Selling Stockholder
or by any other person. This Prospectus does not constitute an offer to sell or
a solicitation of an offer to buy any securities other than the shares of Common
Stock offered hereby, nor does it constitute an offer to sell or a solicitation
of an offer to buy any of the shares offered hereby to any person in any
jurisdiction in which such offer or solicitation would be unlawful. Neither the
delivery of this Prospectus nor any sale made hereunder shall under any
circumstances create any implication that the information contained herein is
correct as of any date subsequent to the date hereof.
TABLE OF CONTENTS
<TABLE>
<CAPTION>
<S> <C>
PROSPECTUS SUMMARY.......................................1
RECENT DEVELOPMENTS......................................3
RISK FACTORS.............................................5
SELLING STOCKHOLDERS....................................15
PLAN OF DISTRIBUTION....................................15
LEGAL MATTERS...........................................16
EXPERTS.................................................16
GLOSSARY................................................16
</TABLE>
18
<PAGE>
PART II
INFORMATION NOT REQUIRED IN PROSPECTUS
OTHER EXPENSES OF ISSUANCE AND DISTRIBUTION
The following table sets forth the costs and expenses payable by the Company in
connection with the sale of Common Stock being registered. All of the amounts
shown are estimates except the registration fee.
SEC Registration Fee $ 765
Accounting fees and expenses 10,000
Legal fees and expenses 20,000
Printing and engraving expenses 1,500
Miscellaneous 186,154
--------
Total $218,419
========
INDEMNIFICATION OF DIRECTORS AND OFFICERS
Section 607.0850 of the Florida Business Corporation Act, provides that a
corporation may indemnify any person who was or is a party (other than an action
by or in the right of the corporation) by reason of the fact that he is or was a
director, officer, employee or agent of the corporation, or is or was serving at
the request of the corporation as a director, officer, employee or agent of
another corporation, partnership, joint venture, trust or other enterprise,
against liability incurred in connection with such proceeding, including any
appeal thereof, if he acted in good faith and in a manner he reasonably believed
to be in, or not opposed to, the best interests of the corporation, and with
respect to any criminal action or proceeding, had no reasonable cause to believe
his conduct was unlawful. Section 0850 further provides that a corporation
similarly may indemnify any such person serving in any such capacity who was or
is a party in the right of the corporation to procure a judgment in its favor,
against the estimated expense of litigating the proceeding to conclusion
actually and reasonably incurred in connection with the defense or settlement of
such proceeding if he acted in good faith and in a manner he reasonably believed
to be in, or not opposed to, the best interests of the corporation and except
that no indemnification shall be made in respect of any claim, issue or matter
as to which such person shall have been adjudged to be liable unless, and only
to the extent that the court in which such proceeding was brought, or any other
court of competent jurisdiction, shall determine upon application that, despite
the adjudication of liability but in view of all the circumstances of the case,
such person is fairly and reasonably entitled to indemnity for such expenses
which such other court shall deem proper.
Section 607.0831 of the Florida Business Corporation Act provides that a
director is not personally liable for monetary damages to the corporation or any
other person for any statement, vote, decision, or failure to act, regarding
corporate management or policy, by a director, unless (i) the director breached
or failed to perform his duties as a director, (ii) the director's breach or
failure to perform constitutes a violation of criminal law unless the director
had no reasonable cause to believe his conduct was unlawful, the director
derived an improper personal benefit directly or indirectly, (iii) the directors
conduct triggers the liability provisions of Section 0834 (relating to unlawful
distributions), (iv) the director's conduct constitutes a conscious disregard
for the best interest of the corporation, or will misconduct in a proceeding by
or in the right of the corporation or a shareholder, or (v) the director's
conduct constitutes recklessness or an act or omission committed in bad faith or
with malicious purpose or in a manner exhibiting wanton and willful disregard of
human rights, safety, or property in a proceeding by or in the right of someone
other than the corporation or a shareholder.
The Registrant's Articles provide that the Registrant is authorized to indemnify
any director or officer, or former director or officer, in the manner provided
in the Company's bylaws and to the fullest extent permitted by the laws of the
State of Florida. There are no further provisions in the Company's bylaws for
indemnification of directors and officers.
19
<PAGE>
EXHIBITS
<TABLE>
<CAPTION>
Exhibit Number Exhibit Description
- -------------- --------------------------------------------------------------------------------------------------------------------
<S> <C>
3.1 * Third Amended and Restated Articles of Incorporation, as amended
4.1 ** The Rights of Securities Holders as set forth in Article IV of the Third Amended and Restated Articles of
Incorporation
10.1 *** Form of Purchase Agreement
23.1 Consent of Arthur Andersen LLP
24.1 Power of Attorney (see p. 23)
</TABLE>
<TABLE>
<CAPTION>
<S> <C>
* Incorporated by reference to Exhibit 3.1 in the Current Report on Form 8-K
filed August 18, 1998.
** 1996 previously filed by the Registrant (File no. 333-2068). Incorporated by reference to Exhibit 3 in the Quarterly Report on
Form 10-Q for the period ended September 30,
*** Incorporated by reference to Exhibit 10.1 in the Current Report on Form 8-K filed June 12, 1998.
</TABLE>
UNDERTAKINGS
The undersigned registrant hereby undertakes to file, during any period in which
offers or sales are being made, a post-effective amendment to this registration
statement, to include any material information with respect to the plan of
distribution not previously disclosed in the registration statement or any
material change to such information in the registration statement. For purposes
of determining any liability under the Securities
Act of 1933, each such post-effective amendment shall be deemed to be a new
registration statement relating to the securities offered therein, and the
offering of such securities at that time shall be deemed to be the initial bona
fide offering thereof. The undersigned registrant further undertakes to remove
from registration, by means of a post-effective amendment, any of the securities
being registered which remain unsold at the termination of the offering.
The undersigned registrant hereby undertakes that, for purposes of determining
any liability under the Securities Act of 1933, each filing of the registrant's
annual report pursuant to section 13(a) or section 15(d) of the Securities
Exchange Act of 1934 (and, where applicable, each filing of an employee benefit
plan's annual report pursuant to section 15(d) of the Securities Exchange Act of
1934) that is incorporated by reference in the registration statement shall be
deemed to be a new registration statement relating to the securities offered
therein, and the offering of such securities at that time shall be deemed to be
the initial bona fide offering thereof.
Insofar as indemnification for liabilities arising under the Securities Act of
1933 may be permitted to directors, officers and controlling persons of the
registrant pursuant to the foregoing provisions, or otherwise, the registrant
has been advised that in the opinion of the Securities and Exchange Commission
such indemnification is against public policy as expressed in the Act and is,
therefor, unenforceable. In the event that a claim for indemnification against
such liabilities (other than the payment by the registrant of expenses incurred
or paid by a director, officer or controlling person of the registrant in the
successful defense of any action, suit or proceeding) is asserted by such
director, officer or controlling person in connection with the securities being
registered, the registrant will, unless in the opinion of its counsel the matter
has been settled by controlling precedent, submit to a court of appropriate
jurisdiction the question whether such indemnification by it is against public
policy as expressed in the Act and will be governed by the final adjudication of
such issue.
The undersigned registrant hereby undertakes that:
(1) For purposes of determining any liability under the Securities Act of
1933, the information omitted from the form of prospectus filed as part of this
registration statement in reliance upon Rule 430A and contained in a form of
prospectus filed by the registrant pursuant to Rule 424(b)(1) or (4) or 497(h)
under the Securities Act shall be deemed to be part of this registration
statement as of the time it was declared effective.
20
<PAGE>
(2) For the purpose of determining any liability under the Securities Act
of 1933, each post-effective amendment that contains a form of prospectus shall
be deemed to be a new registration statement relating to the securities offered
therein, and the offering of such securities at that time shall be deemed to be
the initial bona fide offering thereof.
SIGNATURES
Pursuant to the requirements of the Securities Act of 1933, the registrant
certifies that it has reasonable grounds to believe that it meets all of the
requirements for filing on Form S-3 and has duly caused this Registration
Statement to be signed on its behalf by the undersigned, thereunto duly
authorized, in the City of Orlando, State of Florida on this 19th day of August,
1998.
Autonomous Technologies Corporation
By: /s/ Randy W. Frey Date: August 19, 1998
--------------------------
Randy W. Frey
Chairman of the Board and Chief Executive Officer
By: /s/ Monty K. Allen Date: August 19, 1998
--------------------------
Monty K. Allen
Vice President, Treasurer, Chief Financial Officer and Principal
Accounting Officer
21
<PAGE>
SIGNATURE PAGE TO FORM S-3
AUTONOMOUS TECHNOLOGIES CORPORATION
POWER OF ATTORNEY
KNOW ALL PERSONS BY THESE PRESENTS:
That the undersigned officers and directors of Autonomous Technologies
Corporation, a Florida corporation, do hereby constitute and appoint jointly and
severally, Randy W. Frey and Monty K. Allen, and each of them, the lawful
attorneys and agents, with power and authority to do any and all acts and things
and to execute any and all instruments which said attorneys and agents determine
may be necessary or advisable or required to enable said corporation to comply
with the Securities Act, and any rules or regulations or requirements of the
Securities and Exchange Commission in connection with this Registration
Statement. Without limiting the generality of the foregoing power and
authority, the powers granted include the power and authority to sign the names
of the undersigned officers and directors in the capacities indicated below to
this Registration Statement, to any and all amendments, both pre-effective and
post-effective, and supplements to this Registration Statement, and to any and
all instruments or documents filed as part of or in conjunction with this
Registration Statement or amendments or supplements thereof, and each of the
undersigned hereby ratifies and confirms all that said attorneys and agents or
any of them shall do or cause to be done by virtue hereof. This Power of
Attorney may be signed in several counterparts.
IN WITNESS WHEREOF, each of the undersigned has executed this Power of
Attorney as of the date indicated.
Pursuant to the requirements of the Securities Act of 1933, this
Registration Statement has been signed by the following persons in the
capacities and on the dates indicated.
<TABLE>
<CAPTION>
Signature Capacity Date
- --------- -------- ----
<S> <C> <C>
/s/ Randy W. Frey Chief Executive Officer and Chairman of the Board August 19, 1998
- ---------------------------
Randy W. Frey
/s/ Richard C. Capozza Director, President and Chief Operating Officer August 19, 1998
- ---------------------------
Richard C. Capozza, Ph.D.
/s/ G. Arthur Herbert
___________________________ Director August 19, 1998
G. Arthur Herbert
/s/ Stanley Ruffett
___________________________ Director August 19, 1998
Stanley Ruffett
/s/ Richard H. Keates, MD
___________________________ Director August 19, 1998
Richard H. Keates, MD
/s/ Whitney A. McFarlin
___________________________ Director August 19, 1998
Whitney A. McFarlin
</TABLE>
22
<PAGE>
INDEX TO EXHIBITS
<TABLE>
<CAPTION>
Exhibit Number Exhibit Description
- -------------- --------------------------------------------------------------------------------------------------------------------
<S> <C>
3.1 * Third Amended and Restated Articles of Incorporation, as amended
4.1 ** The Rights of Securities Holders as set forth in Article IV of the Third Amended and Restated Articles of
Incorporation
10.1 *** Form of Purchase Agreement
23.1 Consent of Arthur Andersen LLP
24.1 Power of Attorney (see p. 23)
</TABLE>
* Incorporated by reference to Exhibit 3.1 in the Current Report on Form 8-K
filed August 18, 1998.
** Incorporated by reference to Exhibit 3 in the Quarterly Report on Form 10-Q
for the period ended September 30, 1996 previously filed by the Registrant
(File no. 333-2068).
*** Incorporated by reference to Exhibit 10.1 in the Current Report on Form 8-K
filed June 12, 1998.
23
<PAGE>
EXHIBIT 23.1
CONSENT OF INDEPENDENT CERTIFIED PUBLIC ACCOUNTANTS
As independent certified public accountants, we hereby consent to the
incorporation by reference in this registration statement of our report on the
financial statements of Autonomous Technologies Corporation dated June 2, 1998,
included in Autonomous Technologies Corporation's Annual Report on Form 10-K/A
for the fiscal year ended December 31, 1997, and to all references to our firm
included in this registration statement.
/s/ Arthur Andersen LLP
August 19, 1998
Orlando, Florida
