Wednesday October 22 7:00 AM EDT
Company Press Release
Approval from FDA to Retreat Patients in the Hyperopia
Study
FREMONT, Calif.--(BW HealthWire)--Oct. 22, 1997--Sunrise Technologies International Inc.
(OTC BB:SNRS) announced it has received conditional approval from the FDA to retreat patients
in the LTK clinical study for hyperopia on an as needed basis.
The protocol approved consists of an initial study of 10 patients. Once the results from the 10
patients are obtained, Sunrise may request approval to expand the number of cases allowed.
''This is another exciting communication from the FDA because it allows us the chance to study our
procedure in a way that might enhance the already good results we have achieved in treating
hyperopia,'' stated C. Russell Trenary III, president and CEO. ''All patients who have been enrolled
in the study thus far have seen improvement in their vision. We believe the ability to retreat the few
patients who obtained a partial correction would make these patients even more satisfied,'' explained
Trenary.
According to Jeannie Cecka, vice president, Clinical & Regulatory Affairs, ''In the rare cases where
there was not enough refractive correction obtained or the patient's visual acuity is not as sharp as
desired, the Sunrise laser may be used again to 'touch up' the patient.''
Dr. Donald Sanders, Center for Clinical Research, Elmhurst, Ill. agrees that retreatment with the
non-contact simultaneous approach that Sunrise utilizes could be quite advantageous: ''One of the
advantages of Sunrise's approach is that all treated patients have improvement in their near or
distance visual acuity. Of those patients that could have even better visual acuity, virtually all of them
are under corrected. Since the study began in August 1996, utilizing the new treatment parameters
and nomograms, there have been only 3 (three) patients that we believe would currently benefit from
further treatment. If successful, this study will give surgeons increased data and information they can
utilize for treating patients in the real world after the study is complete and the technology is launched
in the U.S.''
Founded in 1987, Sunrise Technologies International Inc. 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(TM) 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 Sunrise Technologies' U.S. Securities and Exchange Commission (SEC) filings.
These forward-looking statements represent Sunrise Technologies' 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
Susan Lorigan, 510/623-9001 (IR)
More news for referenced ticker symbols: SNRS, and related industries: biotechnology,
government, medical.
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