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

CHICO, CA – October 20, 2010 – Pin­Pointe USA, Inc., a leader in podi­atric light-based ther­apy, announced today 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  podi­a­trists, 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.  This 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.

“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 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  med­icated nail pol­ish or oral med­ica­tions, which can be asso­ci­ated with side effects and seri­ous drug inter­ac­tions. 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 of 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.

About Pin­Pointe USA, Inc.

Pin­Pointe USA, Inc., located in Chico, Cal­i­for­nia, devel­ops and mar­kets inno­v­a­tive laser-based solu­tions for podi­a­trists and patients world­wide.  The Pin­Pointe Foot­Laser for treat­ing nail fun­gus and other con­di­tions is avail­able in nearly every major met­ro­pol­i­tan area in the United States.  All Pin­Pointe prod­ucts pro­vide supe­rior clin­i­cal per­for­mance which is the result of years of research, sound sci­ence and clin­i­cal studies.

For patients want­ing addi­tional infor­ma­tion or to find a doc­tor in their area offer­ing the Pin­Pointe Foot­Laser pro­ce­dure, call (877) Toe-Nail or (877) 863‑6245 or visit PinPointeFootLaser.com/find. For podi­a­trists inter­ested in becom­ing a Pin­Pointe provider, call (530) 809‑3809 or visit PinPointeUSA.com.