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PinPointe FootLaser Receives FDA Clearance for
the Treatment of Nail Fungus (Onychomycosis)
Offers New Treatment Option for More Than 35
Million Americans With the Condition
the Treatment of Nail Fungus (Onychomycosis)
Offers New Treatment Option for More Than 35
Million Americans With the Condition
CHICO, CA -- (Marketwire) -- 10/20/10 -- PinPointe USA, Inc., a leader in podiatric
light-based therapy, announced today that the PinPointe™ FootLaser™ received
clearance from the U.S. Food and Drug Administration (FDA) for the treatment of nail
fungus (onychomycosis). During the procedure, which is administered by a podiatrist, a
specially designed laser beam is directed across the nail. The laser penetrates the nail
bed, targeting the fungi responsible for the infection, while leaving the nail and
surrounding healthy tissue intact.
Fungal nail infection is estimated to affect more than 10 percent of the U.S. population --
or 35 million Americans. The condition is caused by fungus under the nail. As they grow,
fungi feed on keratin, the tough protein that makes up the hard surface of the nails. The
nail becomes darker in color and debris may accumulate under the nail. And the infection
may spread to other toenails, the skin or the fingernails. Nail infection can cause nails to
be discolored, thickened, brittle, and 'crumbly' and in some people it can interfere with
wearing shoes and/or cause pain when walking.
light-based therapy, announced today that the PinPointe™ FootLaser™ received
clearance from the U.S. Food and Drug Administration (FDA) for the treatment of nail
fungus (onychomycosis). During the procedure, which is administered by a podiatrist, a
specially designed laser beam is directed across the nail. The laser penetrates the nail
bed, targeting the fungi responsible for the infection, while leaving the nail and
surrounding healthy tissue intact.
Fungal nail infection is estimated to affect more than 10 percent of the U.S. population --
or 35 million Americans. The condition is caused by fungus under the nail. As they grow,
fungi feed on keratin, the tough protein that makes up the hard surface of the nails. The
nail becomes darker in color and debris may accumulate under the nail. And the infection
may spread to other toenails, the skin or the fingernails. Nail infection can cause nails to
be discolored, thickened, brittle, and 'crumbly' and in some people it can interfere with
wearing shoes and/or cause pain when walking.
L: Before PinPointe(TM) FootLaser(TM); R: After PinPointe(TM)FootLaser(TM)
The PinPointe(TM) FootLaser(TM), which has been cleared by the U.S. Food and
Drug Administration for the treatment of nail fungus (onychomycosis), sends
invisible laser energy into and through the nail and/or surrounding skin, painlessly
targeting the fungi responsible for the infection while leaving the nail and
surrounding healthy tissue intact.
Drug Administration for the treatment of nail fungus (onychomycosis), sends
invisible laser energy into and through the nail and/or surrounding skin, painlessly
targeting the fungi responsible for the infection while leaving the nail and
surrounding healthy tissue intact.
L: Before PinPointe(TM) FootLaser(TM); R: After PinPointe(TM)FootLaser(TM)
The PinPointe(TM) FootLaser(TM) has received clearance from the U.S. Food and Drug
Administration for the treatment of nail fungus (onychomycosis), which affects approximately 35 million
Americans. Clinical studies show after a single PinPointe FootLaser treatment between 68% and 81%
of patients experienced increased clear nail at six and 12 months, and 81 percent of all patients had
sustained improvement at 12 months. For more information, visit www. LaserToenailCenter.com.
Administration for the treatment of nail fungus (onychomycosis), which affects approximately 35 million
Americans. Clinical studies show after a single PinPointe FootLaser treatment between 68% and 81%
of patients experienced increased clear nail at six and 12 months, and 81 percent of all patients had
sustained improvement at 12 months. For more information, visit www. LaserToenailCenter.com.
Fungal nail infection, which can cause nails to be discolored, thickened and brittle, can now be treated
with a laser that penetrates the nail bed, targeting the fungi responsible for the infection, while leaving
the nail and surrounding healthy tissue intact. The PinPointe(TM) FootLaser(TM) has been cleared
by the U.S. Food and Drug Administration for the treatment of nail fungus. For more information,
visit www.PinPointeFootLaser.com.
"Toenail fungus is an incredibly embarrassing, chronic condition affecting millions of people
worldwide that genuinely impacts a person's quality of life. For some with diabetes or immune
disorders, nail fungus can lead to serious health problems," said Dr. Adam Landsman, Assistant
Professor of Surgery at Harvard Medical School and Chief of the Division of Podiatric Surgery at
Cambridge Hospital in Massachusetts. "With the clearance of the PinPointe FootLaser, patients finally
have a pain-free treatment option that is more successful than topically applied antifungal drugs, safer
than oral medication, and less painful than surgical removal of the nail."
The treatment of fungal nail infection is difficult because the infection is under and inside of the nail.
This makes it hard for any treatment to reach and destroy the infection. Some people are treated with
oral medications, which can be associated with side effects and serious drug interactions, or medicated
nail polish. Another option is to surgically remove the nail. Many people also try bleach, vinegar,
mouthwash or household cleaners -- home remedies that ultimately do not resolve the problem.
"PinPointe submitted clinical evidence to FDA demonstrating that after a single treatment, between 68
percent and 81 percent of patients experienced increased clear nail at six and 12 months and 81
percent of all patients had sustained improvement at 12 months. Now, a single 30-minute treatment
can be done comfortably in the privacy of a doctor's office without the need for anesthesia," says
John Strisower, founder and Chief Executive Officer of PinPointe. "Our goal is continued market
leadership of podiatric light-based therapeutic technology."
The PinPointe FootLaser is also sold in the European Union under a CE Mark for the treatment of
nail fungus, and is TGA-approved and available in Australia and New Zealand.
with a laser that penetrates the nail bed, targeting the fungi responsible for the infection, while leaving
the nail and surrounding healthy tissue intact. The PinPointe(TM) FootLaser(TM) has been cleared
by the U.S. Food and Drug Administration for the treatment of nail fungus. For more information,
visit www.PinPointeFootLaser.com.
"Toenail fungus is an incredibly embarrassing, chronic condition affecting millions of people
worldwide that genuinely impacts a person's quality of life. For some with diabetes or immune
disorders, nail fungus can lead to serious health problems," said Dr. Adam Landsman, Assistant
Professor of Surgery at Harvard Medical School and Chief of the Division of Podiatric Surgery at
Cambridge Hospital in Massachusetts. "With the clearance of the PinPointe FootLaser, patients finally
have a pain-free treatment option that is more successful than topically applied antifungal drugs, safer
than oral medication, and less painful than surgical removal of the nail."
The treatment of fungal nail infection is difficult because the infection is under and inside of the nail.
This makes it hard for any treatment to reach and destroy the infection. Some people are treated with
oral medications, which can be associated with side effects and serious drug interactions, or medicated
nail polish. Another option is to surgically remove the nail. Many people also try bleach, vinegar,
mouthwash or household cleaners -- home remedies that ultimately do not resolve the problem.
"PinPointe submitted clinical evidence to FDA demonstrating that after a single treatment, between 68
percent and 81 percent of patients experienced increased clear nail at six and 12 months and 81
percent of all patients had sustained improvement at 12 months. Now, a single 30-minute treatment
can be done comfortably in the privacy of a doctor's office without the need for anesthesia," says
John Strisower, founder and Chief Executive Officer of PinPointe. "Our goal is continued market
leadership of podiatric light-based therapeutic technology."
The PinPointe FootLaser is also sold in the European Union under a CE Mark for the treatment of
nail fungus, and is TGA-approved and available in Australia and New Zealand.
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