PinPointe FootLaser Receives FDA Clearance

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) 763‑6245 or visit PinPointeFootLaser.com/find. For podi­a­trists inter­ested in becom­ing a Pin­Pointe provider, call (530) 809‑3809 or visit PinPointeUSA.com.

http://pinpointeusa.com/in-the-news/press-releases/pinpointe-footlaser-receives-fda-clearance