SNRS<----UNAPPROVABLE ,, I have been saying this over and over and now wee hear why from an FDA review member directly!!!!!!!!!!!!!!!! LATIMES TODAY!!!!!
Eye-Laser Maker to Get Second Chance With FDA
? Medical products: Sunrise Technologies' stock gains on news that rejection of device for farsightedness will be reconsidered.
From Bloomberg News
Sunrise Technologies International Inc. shares rose 14% on Wednesday after a federal panel agreed to reconsider a July decision on an eye laser that resulted in the company's losing three-quarters of its market value.
Sunrise shares rose $1.34 to close at $10.94 on Nasdaq. Sunrise said late Tuesday that the Food and Drug Administration's ophthalmic devices panel will consider the laser, on which the firm has placed its hopes for profitability, on Jan. 13.
In July, the same advisory panel voted unanimously to reject the laser after finding it didn't show lasting benefit in treating patients with mild farsightedness, or hyperopia. The Fremont-based company will have a difficult time changing panel members' minds, analysts said.
"Best-case scenario for the company: It receives approval for the temporary correction of hyperopia," said Richard Leza, an analyst at Craig-Hallum Capital Group. "And I can't see this happening because this means a patient would need to go back to be retreated every two years."
Lasers from Visx Inc. and Summit Technology Inc. are already approved to treat farsightedness, though those lasers don't work in the same way as Sunrise's product. While the Summit and Visx systems use a laser to cut the eye, Sunrise uses a Holmium laser to heat certain areas on the eye, shrinking tissue to change its shape.
Sunrise has no products for sale in the U.S. It sells lasers in other countries, including South Africa.
The company said it had compiled additional trial data and would use the meeting to address "earlier concerns regarding the change in refractive effect over time."
The panel in July asked to see two-year results from 300 surgeries, saying it wasn't satisfied with the 18-month results of 144 surgeries the company presented.
"The average patient will want more" than a temporary improvement in vision, said panel member Michael Grimmett of the University of Miami at the July meeting. "It is my firm opinion the [laser] is not approvable."
Sunrise's stock nearly doubled in the month before the July panel meeting, peaking at $20.38. Afterward, it plunged to as low as $2.75.
If the FDA approves the device, Sunrise plans to market the laser system to doctors, capitalizing on the growing number of people older than 40 who face the deterioration of their close vision.
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