FDA Accepts Final Module for Refractec's Pre-Market Approval Application of the ViewPoint(TM) CK System

- Device Uses Radio Frequency Energy to Correct Farsightedness -



Apr 25, 2001, 01:00 ET from Refractec Inc.

    IRVINE, Calif., April 25 /PRNewswire/ -- Refractec, Inc., a California
 medical technology and research firm, announced today that the FDA accepted,
 for filing, the companies Pre-Market Approval (PMA).  The PMA requests
 approval of Conductive Keratoplasty (CK) using the ViewPoint(TM) CK System for
 the treatment of spherical hyperopia (farsightedness) between 0.75 and 3.00
 diopters.
     "This is a pivotal FDA submission for Refractec because it marks the end
 of the clinical trial phase for the ViewPoint(TM) CK System and the beginning
 of an exciting period for Refractec," said Mitchell B. Campbell, Refractec's
 President and CEO.  "We look forward to introducing this product to the U.S.
 market, where more than 40 million people who suffer from hyperopia would
 benefit from an FDA approval of the ViewPoint(TM) CK System."
     Refractec is the only company to use radio frequency energy to reshape the
 cornea and permanently correct farsightedness (hyperopia).  The ViewPoint(TM)
 CK System is already approved in most major international markets.
     According to world-renowned ophthalmologist Marguerite B. McDonald, MD,
 medical monitor of the clinical trials and director of the Southern Vision
 Institute in New Orleans, LA, "The FDA clinical study of CK indicated that
 most patients continue to not need glasses one year after the procedure. "
     More than 400 eyes in the United States have been treated in the FDA
 Clinical Trials.  Dr. Edward Manche, an FDA clinical trial investigator from
 Stanford University School of Medicine, performed the first CK procedure in
 America.  "I treated the first half a dozen patients in the United States,"
 Manche said.  "So I've been following them now for two and half years and I
 noticed the benefits of CK immediately.  My patients have experienced
 consistent visual outcomes throughout the clinical trials."
     In addition, principle investigator and leading ophthalmologist, Dr.
 Robert K. Maloney, from the Maloney Vision Institute in Santa Monica, CA said,
 "The CK procedure is a less invasive and less expensive alternative to LASIK
 for the treatment of hyperopia.  CK patients are gaining improved eyesight and
 they no longer need their glasses, just as with LASIK.  But it's faster to
 perform because no tissue is cut or removed from the eye."
 
     About Refractec Inc.
     Refractec, Inc., is "Reshaping Vision Correction" as a privately held
 medical technology and research firm that specializes in innovative,
 ophthalmic, refractive surgery technologies.  Refractec, Inc., founded in
 1993, is headquartered at 3 Jenner, Suite 140, Irvine, California.  For more
 information visit its web site at www.refractec.com.
 
                     MAKE YOUR OPINION COUNT -  Click Here
                http://tbutton.prnewswire.com/prn/11690X37468961
 
 

SOURCE Refractec Inc.
    IRVINE, Calif., April 25 /PRNewswire/ -- Refractec, Inc., a California
 medical technology and research firm, announced today that the FDA accepted,
 for filing, the companies Pre-Market Approval (PMA).  The PMA requests
 approval of Conductive Keratoplasty (CK) using the ViewPoint(TM) CK System for
 the treatment of spherical hyperopia (farsightedness) between 0.75 and 3.00
 diopters.
     "This is a pivotal FDA submission for Refractec because it marks the end
 of the clinical trial phase for the ViewPoint(TM) CK System and the beginning
 of an exciting period for Refractec," said Mitchell B. Campbell, Refractec's
 President and CEO.  "We look forward to introducing this product to the U.S.
 market, where more than 40 million people who suffer from hyperopia would
 benefit from an FDA approval of the ViewPoint(TM) CK System."
     Refractec is the only company to use radio frequency energy to reshape the
 cornea and permanently correct farsightedness (hyperopia).  The ViewPoint(TM)
 CK System is already approved in most major international markets.
     According to world-renowned ophthalmologist Marguerite B. McDonald, MD,
 medical monitor of the clinical trials and director of the Southern Vision
 Institute in New Orleans, LA, "The FDA clinical study of CK indicated that
 most patients continue to not need glasses one year after the procedure. "
     More than 400 eyes in the United States have been treated in the FDA
 Clinical Trials.  Dr. Edward Manche, an FDA clinical trial investigator from
 Stanford University School of Medicine, performed the first CK procedure in
 America.  "I treated the first half a dozen patients in the United States,"
 Manche said.  "So I've been following them now for two and half years and I
 noticed the benefits of CK immediately.  My patients have experienced
 consistent visual outcomes throughout the clinical trials."
     In addition, principle investigator and leading ophthalmologist, Dr.
 Robert K. Maloney, from the Maloney Vision Institute in Santa Monica, CA said,
 "The CK procedure is a less invasive and less expensive alternative to LASIK
 for the treatment of hyperopia.  CK patients are gaining improved eyesight and
 they no longer need their glasses, just as with LASIK.  But it's faster to
 perform because no tissue is cut or removed from the eye."
 
     About Refractec Inc.
     Refractec, Inc., is "Reshaping Vision Correction" as a privately held
 medical technology and research firm that specializes in innovative,
 ophthalmic, refractive surgery technologies.  Refractec, Inc., founded in
 1993, is headquartered at 3 Jenner, Suite 140, Irvine, California.  For more
 information visit its web site at www.refractec.com.
 
                     MAKE YOUR OPINION COUNT -  Click Here
                http://tbutton.prnewswire.com/prn/11690X37468961
 
 SOURCE  Refractec Inc.