Sunrise HYPERION(TM) LTK System Approved for Sale in Canada

Apr 02, 2001, 01:00 ET from Sunrise Technologies International, Inc.

    FREMONT, Calif., April 2 /PRNewswire/ --
 Sunrise Technologies International, Inc. (Nasdaq: SNRS) announced today that
 the HYPERION(TM) LTK System has been approved for sale in Canada. The Company
 was granted a Medical Device Licence by the Therapeutic Products Directorate
 Medical Devices Bureau in Ottawa, Ontario.
     The Company emphasized that it will price the HYPERION in Canada as it
 does in the United States. It has decided not to follow the lead of some other
 refractive companies, which priced their refractive lasers in Canada cheaper
 than in the U.S., which adversely affected U.S. doctor's ability to compete
 along the northern tier of the U.S.
     "We are very pleased to receive this regulatory approval from the Canadian
 government. No Canadian doctor has yet used the HYPERION LTK System in Canada.
 We are grateful that Canadian refractive surgeons and their patients will now
 have the opportunity to experience this fast, safe procedure that does not cut
 or remove any corneal tissue. We believe it is an excellent choice for
 treating farsighted patients and will be a welcome addition for refractive
 surgery in Canada," said C. Russell Trenary III, Sunrise Chairman and Chief
 Executive Officer.
     The Canadian refractive surgeons will be able to use the international
 nomogram, which creates the opportunity for longevity of effect that is longer
 than the life of the patient.
     The U.S. Food and Drug Administration approved the Company's
 HYPERION(TM) LTK System on June 30, 2000 for the temporary reduction of
 hyperopia in patients with +0.75 TO +2.50 diopters of MRSE with less than or
 equal to +/- 0.75 diopters of astigmatism, who are 40 years of age or older
 with documented stability of refraction for the prior 6 months, as
 demonstrated by a change of less than or equal to 0.50D in spherical and
 cylindrical components of the manifest refraction. The magnitude of correction
 with this treatment diminishes over time, with some patients retaining some or
 all of their refractive correction.  The new labeling says that, based upon
 existing information for the clinical parameters used in the clinical trial,
 the Company's model for the average longevity for the procedure indicates that
 some of the effect lasts 10 years and beyond.  Age related drift towards
 hyperopia contributes to the loss of effect after the initial two years.
 Nomograms that are already in use outside of the U.S. treat up to
 5.625 diopters of hyperopia and the effect can last longer than a patient's
 lifetime.
     Sunrise Technologies International, Inc. is a refractive surgery company
 based in Fremont, California, that is developing holmium:YAG laser-based
 systems that utilize a patented process for shrinking collagen developed by
 Dr. Bruce Sand (the "Sand Process") in correcting ophthalmic refractive
 conditions.
     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
 http://www.sunrise-tech.com.
 
 

SOURCE Sunrise Technologies International, Inc.
    FREMONT, Calif., April 2 /PRNewswire/ --
 Sunrise Technologies International, Inc. (Nasdaq: SNRS) announced today that
 the HYPERION(TM) LTK System has been approved for sale in Canada. The Company
 was granted a Medical Device Licence by the Therapeutic Products Directorate
 Medical Devices Bureau in Ottawa, Ontario.
     The Company emphasized that it will price the HYPERION in Canada as it
 does in the United States. It has decided not to follow the lead of some other
 refractive companies, which priced their refractive lasers in Canada cheaper
 than in the U.S., which adversely affected U.S. doctor's ability to compete
 along the northern tier of the U.S.
     "We are very pleased to receive this regulatory approval from the Canadian
 government. No Canadian doctor has yet used the HYPERION LTK System in Canada.
 We are grateful that Canadian refractive surgeons and their patients will now
 have the opportunity to experience this fast, safe procedure that does not cut
 or remove any corneal tissue. We believe it is an excellent choice for
 treating farsighted patients and will be a welcome addition for refractive
 surgery in Canada," said C. Russell Trenary III, Sunrise Chairman and Chief
 Executive Officer.
     The Canadian refractive surgeons will be able to use the international
 nomogram, which creates the opportunity for longevity of effect that is longer
 than the life of the patient.
     The U.S. Food and Drug Administration approved the Company's
 HYPERION(TM) LTK System on June 30, 2000 for the temporary reduction of
 hyperopia in patients with +0.75 TO +2.50 diopters of MRSE with less than or
 equal to +/- 0.75 diopters of astigmatism, who are 40 years of age or older
 with documented stability of refraction for the prior 6 months, as
 demonstrated by a change of less than or equal to 0.50D in spherical and
 cylindrical components of the manifest refraction. The magnitude of correction
 with this treatment diminishes over time, with some patients retaining some or
 all of their refractive correction.  The new labeling says that, based upon
 existing information for the clinical parameters used in the clinical trial,
 the Company's model for the average longevity for the procedure indicates that
 some of the effect lasts 10 years and beyond.  Age related drift towards
 hyperopia contributes to the loss of effect after the initial two years.
 Nomograms that are already in use outside of the U.S. treat up to
 5.625 diopters of hyperopia and the effect can last longer than a patient's
 lifetime.
     Sunrise Technologies International, Inc. is a refractive surgery company
 based in Fremont, California, that is developing holmium:YAG laser-based
 systems that utilize a patented process for shrinking collagen developed by
 Dr. Bruce Sand (the "Sand Process") in correcting ophthalmic refractive
 conditions.
     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
 http://www.sunrise-tech.com.
 
 SOURCE  Sunrise Technologies International, Inc.