Pilot clinical study results of laser treatment for toenail fungus presented

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PinPointe USA, Inc., a privately held emerging medical technology company which introduced the breakthrough PinPointe FootLaser treatment for toenail fungus in Europe, today announced that Dr. Brian McDowell presented the results of his pilot clinical study “Laser Treatment for Toenail Fungus” (Harris, McDowell and Strisower, Proc. SPIE 7161A, 2009) at the Society of Chiropodists and Podiatrists Annual Conference 2009 at Harrogate International Centre on November 19. Dr. McDowell, lead author of the study, presented the results at the poster session of the conference, which is the largest event in the UK focusing solely on podiatry.

The PinPointe FootLaser uses proprietary laser technology that is designed to target the pathogens that cause toenail fungus (onychomycosis), a fungal infection that afflicts an estimated 900 million people. PinPointe’s laser treatment passes through the toenail without causing damage to the nail itself or surrounding tissue, providing for the ability to treat toenail fungus patients without drugs or anesthesia.

The “Laser Treatment for Toenail Fungus” pilot clinical study recruited 16 subjects from podiatrist offices, all with both great toes afflicted with toenail fungus. Toes with visible signs of fungus were randomized to receive either a single PinPointe FootLaser treatment or no treatment. Notably, 14 out of 16 (88%) toenails that were treated showed significant improvement after a single session. All subjects tolerated the treatment without anesthesia and there were no occurrences of serious adverse effects.

Noted Dr. McDowell: “The results of this study represent truly significant findings for the millions of people who suffer from this nagging, painful and often embarrassing affliction. Most importantly, we found that a single treatment with PinPointe FootLaser resulted in nail clearing for the majority of subjects that was similar in clinical appearance to the results of the leading pharmacological treatment, which can be toxic and can induce pathogen resistance. In addition to superior safety over drug therapies, the PinPointe FootLaser treatment promises to be much more effective. The efficacy of drug therapy is in the range of 15-30% versus the over 85% efficacy we observed in this study.”

The results of this pilot clinical study demonstrated better than 85% of the patients had significant clear nail growth after just one in-office treatment. Dr. McDowell added that the study results are preliminary, and data from a much larger sample in a well-controlled, multi-center trial is essential to substantiate the findings. Currently, a major multi-site clinical trial entitled “Multi-Center Trial: Evaluation of PinPointe FootLaser Treatment for Infected Toenails (Onychomycosis)” is underway at four separate research centers across North America.

“Dr. McDowell’s study is the first of several clinical studies that the company is pursuing in order to expand our knowledge-base with regards to the potential for this PinPointe FootLaser treatment,” added Bob H. Katz, Chief Executive Officer of PinPointe USA, Inc. “We expect our on-going studies to add additional insight based on treating larger patient series in a prospective, randomized and controlled manner.”

The PinPointe FootLaser was introduced to Europe in the UK in May 2009 after receiving CE Mark approval. Since then, the PinPointe FootLaser has continued to expand its reach in Europe, certifying podiatrists in the United Kingdom and Germany to administer this revolutionary new laser treatment for toenail fungus.

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