To Your Health: Laser approved by FDA for toenail fungus treatment
August 16th, 2011A great read on the FDA’s recent approval for Laser treatments.
PinPointe FootLaser Receives FDA Clearance for the Treatment of Nail Fungus
November 4th, 2010CHICO, 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.
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New Laser to Treat Toenail Fungus (ONYCHOMYCOSIS)
June 2nd, 2010It is estimated that over 11% of the North American population has fungus of the toenails. That’s 35 million Americans. An astonishing 700 million people are afflicted worldwide. It is one of the most common afflictions foot specialists see. Until now, people suffering from toenail fungus, or onychomycosis, have had few options. Ointments, powders and sprays have little effect on the fungus because it lives deep under the nail, and the most popular prescription medication, Lamilsil, has recently been found to have profound effects on the liver.
In July 2008, PathoLase, Inc. introduced the PinPointe FootLaser, a breakthrough in toenail fungus treatment. The PinPointe FootLaser is a patented laser device that is specifically designed to kill toenail fungus. The laser beam passes through the toenail without causing damage to the nail or the surrounding skin. The PinPointe FootLaser is now available in Bucks and Montgomery Counties.
Unlike pharmaceutical treatments, which can take several months for any noticeable improvements to appear, the PinPointe FootLaser kills the fungal organisms immediately, promoting the growth of clear, healthy nails. The treatment takes between 30 – 60 minutes and the patient feels no pain. Additionally, there are none of the unpleasant side effects associated with oral medications. The fungus is usually completely killed in one treatment and the doctor can recommend techniques to reduce recurrence of the infection. Clinical studies through the National Institutes of Health showed improvements in 88% of patients after only one treatment.
The PinPointe Footlaser is cleared for use by the FDA and can be performed in a doctor’s office.
For more information on the PinPointe FootLaser,
call Bucks County FootLaser at 215-942-2347 or
email Lisa@LaserMyFungus.com.
Visit our web-site at LaserMyFungus.com.
Press Release – September 11
June 1st, 2010PathoLase, Inc. Launches PinPointe(TM) FootLaser(TM)
PathoLase, Inc., an emerging leader in the medical technology industry, reported today that a select group of leading podiatrists in several markets in the US are now treating patients who suffer from toenail fungus (Onychomycosis) with its ground breaking laser technology. Using PathoLase’s patented PinPointe FootLaser system, podiatrists in Sacramento, San Jose, Salt Lake City and Belleville, New Jersey are open for business treating their patients’ toenail fungus.
“The PinPointe FootLaser system is a technological marvel,” said Michael Uro, DPM from Sacramento. “My patients love that fact that I can treat them safely and quickly with no drugs, no anesthesia, no pain and no side effects.”
Led by medical laser pioneer, David Harris, PhD, Director of Science & Regulatory Affairs for PathoLase, the company recently brought its patented laser technology to market after several years of research and development. With over 20 years of medical laser development to his credit, Dr. Harris has overseen the development of this groundbreaking technology.
“With an estimated 35 million people in the US suffering from toenail fungus infections, PathoLase is committed to making our PinPointe FootLaser system available to as many sufferers as quickly as we can throughout the US,” noted John Strisower, CEO of PathoLase.
Commented Brian McDowell, DPM also from Sacramento, “Response to our initial advertising announcing the availability of this wonderful technology has been overwhelming. Patients are thrilled that the medical technology industry has finally developed a sophisticated laser system that kills the pathogens that cause toenail fungus quickly and efficiently. I have had patients call their friends and family from my examining room encouraging them to make their own appointments immediately. We’ve never seen a public response like this to new drugs or ointments that treat toenail fungus. Nor have we ever had a solution with PinPointe’s high rate of success to offer our patients.”
PathoLase is the only medical laser technology currently available in the marketplace that kills the pathogens that cause toenail fungus. The company expects to introduce its leading edge laser technology into another 20 major markets in the next several months.
About PathoLase
Founded in 2004, PathoLase, Inc. is a privately held emerging medical technology company with headquarters in Northern California. PathoLase has assembled a world‐class group of top scientists, academic thought leaders and leading practitioners from around the US and Canada to develop and bring to market a new generation of laser technology solutions that address a series of medical issues, from toenail fungus and periodontal disease to more serious life threatening problems, such as blood borne and respiratory infections.
PathoLase’s first laser solution now available in the marketplace addresses the pathogens that cause toenail fungus (Onychomycosis), an infection that afflicts an estimated 40 million people in the US alone. With Series A private equity capital recently secured from Nexus Medical Partners, PathoLase is rapidly placing its patented technology in the hands of leading podiatrists around the country.
Press Release – July 21
June 1st, 2010Breakthrough PinPointe FootLaser Treatment Receives Approval from the Therapeutic Goods Administration for Treatment of Toenail Fungus
Innovative New Laser Technology Treats Toenail Fungus Safely and Quickly, with No Drugs, No Anesthesia and No Pain
CHICO, Calif.–(Business Wire)–PinPointe FootLaser today announced it has received approval from the Therapeutic Goods Administration (TGA) for its new laser treatment for toenail fungus Onychomycosis), certifying it has met the TGA`s consumer and health safety standards and can be offered by certified health care providers throughout Australia and New Zealand. The treatment, introduced in 2008, has been awarded the CE Mark certifying it has met European Union consumer health and safety standards, has been cleared for use in the treatment of toenail fungus in the EU, and can be offered by healthcare providers throughout Europe. Additionally, it is FDA cleared for applications in dermatology, plastic surgery, and podiatry in the United States.
John Strisower, CEO of PathoLase, noted: “Approximately 700 million people around the world suffer from toenail fungus, including millions in Australia and New Zealand. We`re very much looking forward to making PinPointe FootLaser available to practitioners in both countries, offering them an excellent opportunity for providing a unique and valuable service to their patients.”
Safe Quick Treatment – No Drugs, Pain or Anesthesia
PinPointe FootLaser uses a patented laser technology to target the pathogens that cause toenail fungus. Patients are treated safely and quickly with no drugs, no anesthesia and no pain. PinPointe`s laser light passes through the toenail without causing damage to the nail or surrounding skin. Following the procedure, the new nail will grow in healthy and clear. Unlike medication-driven treatments for toenail fungus, PinPointe FootLaser presents minimal risk of side effects. Competing medication procedures can result in a wide variety of side effects, including liver toxicity.
Initial clinical studies for PinPointe FootLaser, as well as use with patients in the field, have proved extremely encouraging. Following an early clinical study conducted among a small group of patients (Harris, McDowell and Strisower, Laser Treatment for Toenail Fungus, Proc. SPIE 7161A, 2009), which indicated a potential efficacy rate as high as 87%, the treatment is currently undergoing a major multi-site clinical trial entitled “Multi-Center Trial: Evaluation of PinPointe FootLaser Treatment for Infected Toenails (Onychomycosis)” at four separate research centers across North America.
About PathoLase
Founded in 2004, PathoLase, Inc. is a privately held emerging medical technology company with headquarters in Northern California. PathoLase has assembled a world-class group of top scientists, academic thought leaders and leading practitioners from around the U.S. and Canada to develop and bring to market a new generation of laser technology solutions that address a series of medical issues, from toenail fungus and periodontal disease to more serious life threatening problems, such as blood borne and respiratory infections.
For more information please visit www.patholase.com.
About PinPointe FootLaser
PinPointe FootLaser is a groundbreaking laser treatment for toenail fungus that was launched in September 2008 by Chico, CA-based PathoLase, Inc. PinPointe FootLaser targets the pathogens that cause toenail fungus (Onychomycosis), an infection that afflicts an estimated 40 million people in the U.S. alone. PinPointe FootLaser recently received the first and only medical device clearance for toenail fungus treatment in Europe (CE Mark).
For more information, please visit www.pinpointefootlaser.com.
Press Release – June 24
June 1st, 2010PinPointe FootLaser Launches Major Multi-Center Clinical Trial to Evaluate Its Laser Treatment for Toenail Fungus
PinPointe™ FootLaser™ today announced it has begun a major multi-site clinical trial entitled “Multi-Center Trial: Evaluation of PinPointe FootLaser Treatment for Infected Toenails (Onychomycosis)” at four separate research centers across North America.
PinPointe FootLaser uses a patented laser technology to target the pathogens that cause toenail fungus (Onychomycosis), an infection that afflicts an estimated 40 million people in the U.S. alone. PinPointe FootLaser recently received CE Mark approval, certifying that it has met EU consumer and health safety standards and can be offered by PinPointe certified healthcare providers throughout Europe.
The current clinical trial initiative is a controlled multi-center study to evaluate the effectiveness of the PinPointe FootLaser treatment. It is a significantly expanded follow-up to an initial PinPointe FootLaser clinical study conducted among a small group of patients (Harris, McDowell and Strisower, Laser Treatment for Toenail Fungus, Proc. SPIE 7161A, 2009.) The early study indicated a potential efficacy rate as high as 87%, a finding which the current study aims to verify.
In the new study’s randomized blind trial, the right and left great toes of approximately 125 subjects infected with Onychomycosis will be evaluated. The toes will be randomized and subjected to analysis based on treatment or no-treatment with PinPointe FootLaser. Before and after samples from infected areas of each toe will be evaluated for the presence and species of fungus with the KOH, PCR and culture tests. In addition, a blind study of nail bed clearing and nail plate growth will be measured using high-resolution photographs by evaluators. Research subjects will be evaluated at baseline and at intervals out to 48 weeks for both safety and effectiveness of the PinPointe FootLaser treatment.
The four sites at which PinPointe FootLaser clinical trials will be held include:
- Site #1 – London Ontario, Canada. The dermatology clinic and research facility of Aditya K. Gupta, M.D., Ph.D., M.A.(Cantab), DABD, FAAD, FRCPC, one of the world’s most respected researchers in Onychomycosis and Director of Mediprobe Research, a world class dermatology research and clinical trials center where the study will be conducted.
- Site #2 – Seattle, WA. The private practice/clinical research facility of Bernard Goffe, MD, Dermatology Associates, a dermatologist and world authority on nail diseases.
- Site #3 is – San Antonio TX. The chief investigator will be Richard Pollak DPM, a leading researcher in the field of Onychomycosis. The facility, Endeavor Clinical Trials, PA, located in the Medical Center of San Antonio, is a privately owned, multi-therapeutic, dedicated research center set up to conduct Phase II-V trials.
- Site #4 – Rochester, NY. The trial will be conducted under the guidance of Dr. Raymond Lanzafame MD MBA FACS and Rochester University. Dr. Lanzafame has been a pioneer in the development of lasers in surgery and medicine. He is past president of the American Society for Laser Medicine and Surgery (ASLMS) is currently Director of CME for ASLMS, and President of the North American Association for Laser Therapy (NAALT). He is also the editor of Photomedicine Magazine.
With PinPointe FootLaser, patients are treated safely and quickly with no drugs, no anesthesia and no pain. PinPointe’s laser light passes through the toenail without causing damage to the nail or surrounding skin. Following the procedure, the new nail will grow in healthy and clear. Unlike medication-driven treatments for toenail fungus, PinPointe FootLaser presents minimal risk of side effects. Competing medication procedures can result in a wide variety of side effects, including liver toxicity.
About PathoLase, Inc.
Founded in 2004, PathoLase, Inc. is a privately-held, emerging medical technology company with headquarters in Chico, California. PathoLase has assembled a world-class group of top scientists, academic thought leaders, and leading practitioners from around the world, to bring to market a new generation of laser technology solutions to address a series of medical issues from toenail fungus and periodontal disease to more serious life threatening problems, such as blood borne and respiratory infections.
For more information, please visit pinpointefootlaser.com.
Press Release – June 16
June 1st, 2010New York College of Podiatric Medicine Receives Donation of PathoLase, Inc.’s New PinPointe™ FootLaser™ and Will Teach Its Use in Conjunction with Clinical Research Study Evaluating It for Treatment of Toenail Fungus
NEW YORK — The New York College of Podiatric Medicine (NYCPM), the nation’s first and largest college of podiatric medicine, today announced that it has received a donation from PathoLase, Inc., of the company’s patented new PinPointe™ FootLaser™ for the treatment of nail fungus (Onychomycosis), and will be teaching the College’s students to use the new technology in conjunction with a clinical research study to be conducted at the College’s clinical affiliate, Foot Clinics of New York.
The PinPointe FootLaser, which was recently featured on Good Morning America, uses a patented technology to treat toenail fungus(onychomycosis), an infection that affects an estimated two to thirteen percent of the U.S. population. PinPointe’s laser light passes through the toenail without causing damage to the nail or surrounding skin. The procedure allows the new nail to grow in healthy and clear.
According to Dr. Michael Trepal, NYCPM Vice President for Academic Affairs and Dean, “We are very pleased to have the PinPointe FootLaser at the College to educate our students and faculty on an alternative method for treating the difficult and debilitating condition known as onychomycosis. We are also pleased that, as part of the clinical education we offer, and as part of the upcoming clinical trial, we will soon be able to offer patients at our clinical affiliate, Foot Clinics of New York, this alternative, non-invasive approach for patients suffering from toenail fungus.”
Foot Clinics of New York expects that it will be able to start offering treatment with the PinPointe FootLaser beginning in late June.
About NYCPM
The New York College of Podiatric Medicine, established in 1911, is the first and largest of the nine U.S. schools of podiatric medicine. Its clinical affiliate—Foot Clinics of New York—is the world’s largest foot health center, recording over 25,000 patient visits each year. NYCPM has graduated more than twenty-five percent of all practicing podiatrists in the nation, and is at the forefront of podiatric care in terms of education, public awareness, government legislation and professional advancement.
About PathoLase, Inc.
Founded in 2004, PathoLase, Inc. is a privately-held, emerging medical technology company with headquarters in Chico, California. PathoLase has assembled a world-class group of top scientists, academic thought leaders, and leading practitioners from around the world, to bring to market a new generation of laser technology solutions to address a series of medical issues from toenail fungus and periodontal disease to more serious life threatening problems, such as blood borne and respiratory infections.
For more information, please visit www.pinpointefootlaser.com
Is this covered by my insurance?
This procedure is considered aesthetic and therefore health insurance does not provide coverage. We do accept CareCredit; so while at the doctor’s office, select the payment plan that works best for your budget.
