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SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
Date of Report (Date of earliest event reported) July 26, 1999
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Sunrise Technologies International, Inc.
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(Exact name of registrant as specified in its charter)
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Delaware 1-10428 77-0148208
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(State of or other (Commission (IRS Employer
jurisdiction of File Number) Identification
incorporation) Number)
3400 West Warren Avenue, Fremont, California 94538
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(Address of principal executive offices) (Zip Code)
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Registrant's telephone number, including area code (510) 623-9001
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(Former name or address, if changed since last report)
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ITEM 5. OTHER EVENTS
On July 26, 1999, Sunrise Technologies International, Inc. (the "Company")
issued a press release to announce that it had published a letter to its
Shareholders on the Company website, www.sunrise-tech.com, to respond to
frequently asked questions resulting from the FDA's Opthalmic Devices Panel
recommendation not to approve the Company's Premarket Approval Application for
the Company's laser technology for the treatment of hyperopia.
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ITEM 7. FINANCIAL STATEMENTS AND EXHIBITS.
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99.1 Press Release dated July 26, 1999.
99.2 Letter to Shareholders dated July 26, 1999.
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the
Registration has duly caused this report to be signed on its behalf by the
undersigned, thereunto duly authorized.
SUNRISE TECHNOLOGIES INTERNATIONAL, INC.
(Registrant)
DATE: July 26, 1999 By: /s/ C. RUSSELL TRENARY, III
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Name: C. Russell Trenary, III
Title: President and Chief Executive Officer
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EXHIBIT INDEX
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99.1 Press Release dated July 26, 1999.
99.2 Letter to Shareholders dated July 26, 1999.
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EXHIBIT 99.1
SUNRISE
TECHNOLOGIES
FOR IMMEDIATE RELEASE
CONTACT: Investor Relations
Susan Lorigan (510) 623-9001
Ed Coghlan (510) 771-2399
SUNRISE TECHNOLOGIES INTERNATIONAL INC. RESPONDS TO
FREQUENTLY ASKED QUESTIONS
Fremont, California, July 26, 1999 -- Sunrise Technologies International, Inc.
(NASDAQ/NMS: SNRS)- today responded to frequently asked questions from investors
regarding its regulatory and business-development strategies. Those responses
can be found on the Company's website at www.sunrise-tech.com.
"The questions and answers posted on our website are part of our stated desire
to continue to be accessible to those who want to know about and understand our
Company," said C. Russell Trenary III, President and CEO of Sunrise
Technologies. The Company indicated that it will update this document
periodically as additional information is available.
Founded in 1987, the Company produces and markets high technology products
revolutionizing treatment methods in eye care. The Company develops Holmium
laser-based systems, which utilize a patented process for shrinking collagen
developed by Dr. Bruce Sand (the "Sand Process") in correcting ophthalmic
conditions. These Systems* incorporate a non-contact simultaneous application
for correction of hyperopia (farsightedness), presbyopia (loss of focus due to
natural aging), and overcorrection resulting from PRK and LASIK treatments for
myopia. The system is currently in use in Europe and the Americas, and is in
clinical trials in the United States.
Except for historical information, this news release contains certain
forward-looking statements that involve risk and uncertainties which may cause
actual results to differ materially from the statements made, including market
potential, regulatory clearances, business growth and other risks listed from
time to time in the Company's Securities and Exchange Commission (SEC) filings.
These forward-looking statements represent the Company's judgment, as of the
date of this release, and the Company disclaims any intent or obligation to
update these forward-looking statements.
*Caution-Investigational Device: Federal law restricts this device to
investigational use in the U.S. Internet users can access Sunrise's World Wide
Web site at http://www.sunrise-tech.com.
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EXHIBIT 99.2
July 26, 1999
Dear Shareholder,
Last week, the FDA's Ophthalmic Devices Panel recommended not to approve our
Premarket Approval Application (PMA) for the treatment of hyperopia from +.75 to
+2.50 diopters.
We have stated that, while we disagree with the recommendation, we look forward
to working with the FDA to discuss the Panel's findings and continuing to move
down the regulatory track to get our Sunrise LTK System approved for sale and
use in the United States.
Since Thursday's vote, a flurry of information has been released about the
Company and its prospects. Much of that information has been inaccurate. We have
also received literally thousands of phone calls and e-mails with questions
essentially asking, "WHAT HAPPENS NOW?" We wanted to take some time to inform
our shareholders, the investment community, and the general public about what
the Company plans to do in the coming months. We invite you to check this letter
in the coming days on our website because we plan to update it continually.
QUESTION #1: What does the Panel recommendation really mean to the Company?
ANSWER #1: The Panel vote was disappointing. The Company has stated and
continues to believe that the Sunrise LTK system met or exceeded targeted
endpoints set by the FDA in its existing guidance pronouncements.
Our next step is that we will sit down with the FDA staff in Washington and
begin to discuss and plan what the Company will need to do to get the
process moving forward again. We plan to begin the process of setting up
those discussions this week.
QUESTION #2: Can the Sunrise LTK System still be approved even though the Panel
has recommended not to approve it?
ANSWER #2: It is possible. There are precedents for such approval. It
certainly is going to take more work, but remember in the process, the
Panel's role is advisory. This is a new technology. Most ophthalmologists,
including the Panel members, haven't ever experienced it. It is important
to note that the FDA staff has been studying our file since late January
and thought enough of it to bring it to the Panel for review.
In addition, in recent weeks, the Company has been given approval by the
FDA to expand the clinical studies to include the treatment of hyperopia
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from +2.75 to +4.0 diopters. And then just two weeks ago, the FDA also gave
the Company conditional approval to treat the fellow eye (second eye) on
the same day during those clinical trials.
QUESTION #3: How many cases were presented at the FDA Panel meeting?
ANSWER #3: Sunrise presented clinical date on 656 eyes that were followed
at various intervals from one day to two years. All patients received
treatment pertaining to the algorithm that relates to laser surgery, the
number of 8-spot rings, ring diameters, and pulse frequency. However, the
first 46 eyes underwent treatment using a cornea drying technique that did
not allow for a complete enough drying, resulting in under correction of
these patients. Because of that, the Company requested the first 50 cases
(rounded up from 46) be disregarded as the data were presented.
QUESTION # 4: I heard it reported that all of the effect of the Sunrise LTK
System goes away at 18 months to two years?
ANSWER #4: This is a strange comment when you look at the data from the
clinical studies:
88% of the patients saw 20/40 or better at six (6) months.
85% of the patients saw 20/40 or better at twelve (12) months.
86% of the patients saw 20/40 or better at eighteen (18) months.
The average visual acuity is 20/27 at 6 months, 20/27 at 12 months and
20/28 at 18 months. In addition, our data show that lessening of effect
(regression) stopped at 20 months.
At the Panel meeting, we were not equipped with very much 24-month data.
The Panel wants to see up to 300 patients with up to 90% accountability for
a 24 month period.
QUESTION #5: I heard that regression for excimer laser treatment of hyperopia is
similar to the Sunrise LTK?
ANSWER #5: Published peer reviewed studies absolutely support this
contention.
QUESTION #6: I heard the Panel acknowledged that Sunrise had a very well run
study with great accountability?
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ANSWER #6: Yes, they indicated that on several occasions last Thursday.
QUESTION #7: Was the Panel pleased with anything else?
ANSWER #7: They generally acknowledged that our study showed good safety
with the Sunrise LTK System.
QUESTION #8: What is the status of the Hyperion LTK System?
ANSWER #8: Approximately 90% of the development of the hardware and
software is now complete. We anticipate that validation of this new and
exciting instrument will be completed in the 3rd Quarter of 1999.
QUESTION #9: What will the Company do in the meantime?
ANSWER #9: Obviously, priority #1 is to discuss more fully with the FDA the
Panel vote and what the Company will need to do to address the regulatory
situation.
We will also continue to fine-tune the final changes and additions to the
Hyperion(TM) LTK System to ready our medical instrument for market.
We will also expand our educational efforts regarding both our technology
and the hyperopia market in international markets.
There is still much to do, and we are energized by the prospect of creating
a Company that could become a major player in the dynamic and growing
refractive surgery industry.
QUESTION #10: How much money does the Company have?
ANSWER #10: We are in a good cash position. We will report our 2nd Quarter
results from operations this coming week, and they will reflect a cash
position in the neighborhood of $20 million. As you know, we have been
historically frugal with our "cash burn". We have the money to continue our
work with the FDA, to conclude the development of our manufacturing
processes and to expand the educational programs in the international
ophthalmic community about the Sunrise LTK System.
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QUESTION #11: What about the comments and articles that some of our clinical
investigators are also shareholders of the Company?
ANSWER #11: It is true that some of them are shareholders. It is not
unusual for early stage development companies like ours to have clinical
investigators who are also shareholders. Other refractive surgery companies
that have already received approvals by the FDA had clinical investigators
who were large shareholders.
The FDA has a compliance division that audits the clinical results to make
sure they reflect the reality of the safety and efficacy of any new
surgical device.
We have been congratulated repeatedly for the quality of our clinical
investigators, some of the most important names in American ophthalmology.
We stand by them and thank them for their work with us.
It is also worth noting that over 99% of the shares owned by the clinical
investigators were purchased by them, not given to them by the Company. The
investigators were so impressed by their clinical results that they wanted
to own Sunrise stock.
QUESTION #12: Who cares that the investigators own stock?
ANSWER #12: There have been veiled references that stock ownership could
bias our clinical results. That innuendo is plain wrong.
Usually, it is the Company that gathers the data, but our clinical data are
gathered by Bio Reg and Associates, a third party. All the investigators
did was perform the surgery. The rest of the work was done by the doctors'
staff and Bio Reg.
SOME ADDITIONAL THOUGHTS:
We are disappointed by this setback caused by the Panel vote. However, we
continue to believe that the safety and efficacy of the Sunrise LTK System meets
or exceeds FDA guidances. We will be working with the FDA to resolve those
concerns.
In the meantime, we will continue to be accessible to those who want to know
about our Company. We urge you to continue to check this website for any
additional questions and answers that may come up in the coming days and weeks.
I hope these questions and answers have shed some light on where we think the
Company is today and what we plan to do in the near future.
Sincerely,
C. Russell Trenary III
President/Chief Executive Officer
