Hi, Skane,
This is very interesting. I'm reading the article now. I'll copy it below.
Probably the stock didn't interest the group because it's a BB stock, which carries higher risk.
Linda
Phase III Approval from FDA for Sunrise Technologies' Hyperopia Study
BusinessWire, Wednesday, November 19, 1997 at 17:39
FREMONT, Calif.--(BW HealthWire)--Nov. 19, 1997--Sunrise
Technologies International, Inc. (OTC BB:SNRS) announced it has
received approval from the FDA to move into the final phase for their
study on treating hyperopia.
"Approval to begin our third and final phase for treating
hyperopia is a huge milestone because it brings us that much closer
to being able to file for pre-market approval," according to C.
Russell Trenary III, President and Chief Executive Officer.
Jeannie Gifford Cecka, Vice President, Clinical and Regulatory
Affairs, explained that the amount of expertise targeted at the
current study is impressive. "For us to be in the final phase now is
a tribute to our team. Dr. Douglas D. Koch from the Cullen Eye
Institute, Baylor University, Houston, TX, Dr. Donald Sanders from
the Center for Clinical Research in Elmhurst, IL, and BioReg and
Associates in Laurel, MD, have made significant contributions to the
clinical study resulting in a well-controlled, high quality
investigation. This team, in conjunction with our U.S. clinicians
continues to deliver tremendous expertise and results. We will
enroll at most 200 additional patients to complete our hyperopia
study."
Dr. Koch (Medical Monitor for Sunrise's clinical studies)
explained that patient satisfaction from the Sunrise Laser Thermal
Keratoplasty (LTK) treatments is excellent. "This treatment yields
impressive results both short term and long term. We reported at the
1997 American Society of Cataract and Refractive Surgery (ASCRS)
meeting that between 6 months and 3 years, post operative regression
is negligible. To our knowledge, no other treatment for hyperopia
has demonstrated that. Also, the near-term post-operative course for
hyperopia is interesting. As the patient regresses from a little
nearsightedness to normal vision, they are usually quite satisfied.
These formerly farsighted patients initially gain the ability to see
near, which is quite satisfying, and then their distance vision
improves during the post-operative course. Oftentimes, they end up
with vision that has improved near and far."
Dr. Alan Aker from the Aker-Kasten Cataract and Laser Institute
in Boca Raton, FL, believes patients treated with the Sunrise
CorneaSparing LTK(TM) System are among the most satisfied. "Compared
to nearsighted patients, farsighted patients tend to be happier and
more grateful for the improvement they receive. The Sunrise patients
are among our best ambassadors at our practice."
As a final comment, Trenary revealed, "This year has been a
very positive one for Sunrise. We have attracted 100 years of
ophthalmic or laser experience to the senior management team, we have
revealed that we have compelling clinical data for treating
hyperopia, and now we are in the final phase of our FDA clinicals.
The New Sunrise Team is performing according to plan, and the proof
is in what we have accomplished recently and by the company we keep.
Some of the most skilled and respected ophthalmologists in the world
have agreed to participate in our clinical trials."
Phase III investigators will include:
*T
Dr. Paul H. Ernest Eye Care Physicians of Jackson, MI
Michigan
Dr. I. Howard Fine The Focal Point Eugene, OR
Dr. Richard L. Lindstrom Lindstrom Samuelson & Minneapolis, MN
Hardten Phillips Eye
Institute
To be joined with the Phase II investigators:
Dr. Alan Aker Aker-Kasten Cataract & Boca Raton, FL
Laser Institute
Dr. Sandra C. Belmont Belmont Eye Clinic New York, NY
Dr. David C. Brown Eye Centers of Florida Fort Myers, FL
Dr. Daniel Durrie Hunkeler Eye Clinic Kansas City, MO
Dr. Douglas Koch (Medical Monitor) Baylor Houston, TX
College of Medicine-Cullen
Eye Institute
Dr. Manus C. Kraff Kraff Eye Institute Chicago, IL
Dr. Robert Gale Martin Carolina Eye Associates Southern Pines,
NC
Dr. Peter J. McDonnell Doheny Eye Institute Los Angeles, CA
Univ. of So. Calif.
*T
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. Its CorneaSparing LTK
System(a) is 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 FDA 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.
Internet users can access Sunrise's World Wide Web site at
sunrise-tech.com .
(a) Caution -- Investigational Device: Federal law restricts this
device to investigational use in the U.S.
CONTACT: Sunrise Technologies International, Inc.
Susan Lorigan, 510/623-9001
KEYWORD: CALIFORNIA MARYLAND TEXAS FLORIDA ILLINOIS NORTH
CAROLINA MISSOURI MICHIGAN OREGON MINNESOTA NEW YORK
INDUSTRY KEYWORD: MEDICINE
Today's News On The Net - Business Wire's full file on the Internet
with Hyperlinks to your home page.
URL: businesswire.com
Copyright 1997, Business Wire |
